Orange Book Cumulative Supplement 12 December 2019

CUMULATIVE SUPPLEMENT 12 DECEMBER 2019

APPROVED DRUG PRODUCTS

WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

39th EDITION

Department of Health and Human Services Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy

2019

Prepared By Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy

APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS

39th EDITION

Cumulative Supplement 12 December 2019

CONTENTS

PAGE

1.0 INTRODUCTION ...... v 1.1 How to use the Cumulative Supplement ...... v 1.2 Cumulative Supplement Content ...... vi 1.3 Applicant Name Changes ...... vii 1.4 Levothyroxine Sodium...... ix 1.5 Availability of the Edition ...... xi 1.6 Report of Counts for the Prescription Drug Product List ...... xii 1.7 Cumulative Supplement Legend ...... xiii

DRUG PRODUCT LISTS Prescription Drug Product List ...... 1-1 OTC Drug Product List ...... 2-1 Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research List ...... 3-1 Orphan Product Designations and Approvals List ...... 4-1 Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution ...... 5-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Lists ...... A-1 B. Patent and Exclusivity Terms ...... B-1

APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS

39th EDITION

CUMULATIVE SUPPLEMENT 12 DECEMBER 2019

1.0 INTRODUCTION

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT

This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations, 39th Edition (the List). The List is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations; approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; drug products with approval under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) administered by the Center for Biologics Evaluation and Research; and approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or that have had their approvals withdrawn for other than safety or efficacy reasons. The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data. The Addendum contains appropriate drug patent and exclusivity information required of the Agency by the "Drug Price Competition and Patent Term Restoration Act of 1984" for the Prescription, OTC, Discontinued Drug Product, and Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Lists. Because all parts of the publication are subject to changes, additions, or deletions, the List must be used in conjunction with the most current Cumulative Supplement. Users may wish to mark to the left of the ingredient(s) in the List to indicate that changes to that entry appear in the Cumulative Supplement. Drug product information is provided in each Cumulative Supplement for completeness to assist in locating the proper place in the List for the revision. The presence of any therapeutic equivalence code indicates that the drug product is multisource; the deletion of a therapeutic equivalence code indicates that the drug product has become single source. (An infrequent exception exists when a therapeutic equivalence code is revised. In that case, the deletion of the therapeutic equivalence code is followed immediately by the addition of the revised one.) Products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a

"@" symbol in the 12th Cumulative Supplement of this Edition List will then be added to the "Discontinued Drug Product List" appearing in the next Edition. The current Annual Edition Section 2.1, How To Use The Drug Product Lists, describes the layout and usage of the List. New additions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >A>. The Patent and Exclusivity List new additions are indicated by the symbol >A> to the left of Patent Number or Exclusivity Code. The >A> symbol is then dropped in subsequent Cumulative Supplements for that item. New deletions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >D> (DELETE) to the left of the line. The information line with the >D> symbol is dropped in subsequent Cumulative Supplements for that item. The Patent and Exclusivity List is arranged in alphabetical order by active ingredient name(s) and trade name. The trade name will follow the active ingredient name separated by a dash symbol. Also shown is the application number and product number (FDA's internal file number) for reference purposes. All patents with their expiration dates are displayed for each application number. Drug substance and drug product patents are indicated as such with DS or DP in the Patent codes column. Use patents are indicated with the symbol "U" followed by a number representing a specific use. Exclusivity information for a specific drug is indicated by an abbreviation followed by the date upon which the exclusivity expires. Refer to the Exclusivity Terms, Section B, in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations. Refer to Section 1.3 for internet access to the most current list of Patent and Exclusivity terms.

1.2 CUMULATIVE SUPPLEMENT CONTENT

Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. Previously, a first-time-generic product approved early in the month would not be published in the Cumulative Supplement (CS) for several weeks.

The CS monthly update publish goal is by the end of the following month’s second work week (e.g., November’s supplement will be updated by the end of the second full work week in December).

Currently, the monthly PDF CS includes:

• Generic product ANDA (Abbreviated New Drug Approval) approvals as of the date of publication.

• All product changes received and processed as of the date of publication. o Refer to CS Section 1.8 Cumulative Supplement Legend for types of changes o Discontinued products will be processed as of the date of publication. There will be circumstances where a product is discontinued in one month, however, it will be reported in a different month's CS. For example, the Orange Book Staff received a letter November 7 that the product has been

discontinued from manufacturing and marketing. The Orange Book subsequently publishes the October CS on November 14. The product will show in the October CS that it is discontinued even though the date of discontinuance is the day that the Orange Book Staff receives notification (November 7).

• New Drug Application (NDA) approvals appear in the CS month they were approved.

• Patent information, also updated daily in the EOB, is current to the date of publication.

• Exclusivity information is updated monthly and current to the date of publication.

Every effort is made to ensure the Cumulative Supplement is current and accurate. Applicant holders are requested to inform the FDA Orange Book Staff (OBS) of any changes or corrections. The OBS can be contacted by email at [email protected].

mail to: FDA/CDER Orange Book Staff Office of Generic Drugs 7620 Standish Place Rockville, MD 20855-2773

1.3 APPLICANT NAME CHANGES

It is not practical to identify in the Cumulative Supplement each and every product involved when an applicant transfers its entire line of approved drug products to another applicant, or when an applicant changes its name. Therefore, the cumulation of these transfers and name changes will be identified in this section only. Where only partial lines of approved products are transferred between applicants, each approved product involved will appear as an applicant name change entry in the Cumulative Supplement.

It is also not practical to identify each and every product involved when an applicant name is changed to meet internal publication standards (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this occurs, each product involved (either currently in the Cumulative Supplement or in the following year's edition) will reflect the new abbreviated name. Consequently, it will not appear as an applicant name change entry in the Cumulative Supplement nor will the cumulation of these name changes appear in this section. The Electronic Orange Book Query, updated monthly, will contain the most current applicant holder name.

FORMER APPLICANT NAME NEW APPLICANT NAME (FORMER ABBREVIATED NAME) (NEW ABBREVIATED NAME)

AMNEAL PHARMACEUTICALS CO GMBH AMNEAL EU LTD (AMNEAL PHARMS CO) (AMNEAL EU)

ANDA REPOSITORY LLC PHARMACEUTICS INTERNATIONAL INC (ANDA REPOSITORY) (PII)

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ANDA REPOSITORY LLC RISING PHARMA HOLDINGS INC (ANDA REPOSITORY) (RISING)

G AND W LABORATORIES INC ACP NIMBLE BUYER INC (G AND W LABS) (ACP NIMBLE)

G AND W LABORATORIES INC ACP NIMBLE BUYER INC (G AND W LABS INC) (ACP NIMBLE)

HOUSTON CYCLOTRON PARTNERS LP SOFIE CO DBA SOFIE (HOUSTON CYCLOTRON) (SOFIE)

INVATECH PHARMA SOLUTION INC ATHEM HOLDINGS LLC (INVATECH) (ATHEM)

IVAX PHARMACEUTICALS INC ANI PHARMACEUTICALS INC (IVAX PHARMS) (ANI PHARMS INC)

IVAX PHARMACEUTICALS INC SUB ANI PHARMACEUTICALS INC TEVA PHARMACEUTICALS USA (ANI PHARMS INC) (IVAX PHARMS)

LUITPOLD PHARMACEUTICALS INC AMERICAN REGENT INC (LUITPOLD) (AM REGENT)

MIKART LLC ANDA REPOSITORY LLC (MIKART) (ANDA REPOSITORY)

PD PARTNERS IV LLC PHARMACEUTICAL ASSOCIATES INC (PD PARTNERS) (PHARM ASSOC)

PFIZER CONSUMER HEALTHCARE GLAXOSMITHKLINE CONSUMER (PFIZER CONS HLTHCARE) HEALTHCARE HOLDINGS (US) LLC (GLAXOSMITHKLINE)

PFIZER INC GLAXOSMITHKLINE CONSUMER (PFIZER) HEALTHCARE HOLDINGS (US) LLC (GLAXOSMITHKLINE)

RISING HOLDINGS INC ANDA REPOSITORY LLC (RISING) (ANDA REPOSITORY)

RISING PHARMACEUTICALS INC RISING PHARMA HOLDINGS INC (RISING PHARMS) (RISING)

SUN PHARMA GLOBAL FZE SUN PHARMACEUTCIAL (SUN PHARMA GLOBAL) INDUSTRIES LTD (SUN PHARM)

SUN PHARMA GLOBAL INC SUN PHARMACEUTCIAL (SUN PHARMA GLOBAL) INDUSTRIES LTD (SUN PHARM)

TEVA PHARMACEUTICALS USA ANI PHARMACEUTICALS INC (TEVA PHARMS) (ANI PHARMS INC)

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TEVA PHARMACEUTICALS USA ANI PHARMACEUTICALS INC (TEVA PHARMS USA) (ANI PHARMS INC)

TEVA PHARMACEUTICALS USA INC ANI PHARMACEUTICALS INC (TEVA) (ANI PHARMS INC)

WATSON LABORATORIES INC ANI PHARMACEUTICALS INC (WATSON LABS) (ANI PHARMS INC)

WATSON LABORATORIES INC DR REDDYS LABORATORIES LTD (WATSON LABS) (DR REDDYS)

WATSON LABORATORIES INC HERITAGE PHARMA LABS INC (WATSON LABS) (HERITAGE PHARMA)

WATSON LABORATORIES INC WATSON LABORATORIES INC (WATSON LABS) (WATSON LABS INC)

WATSON LABORATORIES INC ANI PHARMACEUTICALS INC (WATSON LABS INC) (ANI PHARMS INC)

WATSON LABORATORIES INC DR REDDYS LABORATORIES INC (WATSON LABS INC) (DR REDDYS)

WATSON LABORATORIES INC HERITAGE PHARMA LABS INC (WATSON LABS INC) (WATSON LABS INC)

WATSON LABORATORIES INC AN ANI PHARMACEUTICALS INC INDIRECT WHOLLY OWNED SUB OF (ANI PHARMS INC) TEVA PHARMACEUTICALS USA INC (WATSON LABS TEVA)

WATSON LABORATORIES INC AN DR REDDYS LABORATORIES LTD INDIRECT WHOLLY OWNED SUB OF (DR REDDYS) TEVA PHARMACEUTICALS USA INC (WATSON LABS TEVA)

WATSON LABORATORIES INC AN HERITAGE PHARMA LABS INC INDIRECT WHOLLY OWNED SUB OF (HERITAGE PHARMA) TEVA PHARMACEUTICALS USA INC (WATSON LABS TEVA)

WEST-WARD PHARMACEUTICALS HIKMA PHARMACEUTICALS USA INC INTERNATIONAL LTD (HIKMA) (WEST-WARD PHARMS INT)

1.4 LEVOTHYROXINE SODIUM

Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs' sponsors have conducted studies to establish their drugs' therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium drug products.

Levothyroxine Sodium (Mylan ANDA 076187), Levoxyl (King Pharms NDA 021301), Synthroid (Abbvie NDA 021402), Levo-T (Cediprof Inc NDA 021342), and Levothyroxine Sodium (Lupin Atlantis ANDA 209713) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Stevens J NDA 021210) tablets.

Levo-T (Cediprof Inc NDA 021342), Euthyrox (Provell Pharma LLC NDA 021292), Levothyroxine Sodium (Mylan ANDA 076187), Unithroid (Stevens J NDA 021210), Thyro-tabs (Alvogen NDA 021116), and Levothyroxine Sodium (Lupin Atlantis ANDA 209713) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbvie NDA 021402) tablets.

Levo-T (Cediprof Inc NDA 021342), Unithroid (Stevens J NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Lupin Atlantis ANDA 209713) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301) tablets.

Levothyroxine Sodium (Mylan ANDA 076187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Thyro-tabs (Alvogen NDA 021116) tablets.

The chart outlines TE codes for all 0.025mg products in the active section of the Orange Book. Other product strengths may be similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products.

Trade Name Applicant Strength TE Code Appl No Product No UNITHROID STEVENS J 0.025MG AB1 021210 001 LEVOTHYROXINE MYLAN 0.025MG AB1 076187 001 SODIUM LEVOXYL KING PHARMS 0.025MG AB1 021301 001 SYNTHROID ABBVIE 0.025MG AB1 021402 001 LEVO-T CEDIPROF 0.025MG AB1 021342 001 INC LEVOTHYROXINE LUPIN 0.025MG AB1 209713 001 SODIUM ATLANTIS

SYNTHROID ABBVIE 0.025MG AB2 021402 001 LEVOTHYROXINE MYLAN 0.025MG AB2 076187 001 SODIUM EUTHYROX PROVELL 0.025MG AB2 021292 001 PHARMS LEVO-T CEDIPROF 0.025MG AB2 021342 001 INC UNITHROID STEVENS J 0.025MG AB2 021210 001 THYRO-TABS ALVOGEN 0.025MG AB2 021116 001 LEVOTHYROXINE LUPIN 0.025MG AB2 209713 001 SODIUM ATLANTIS

LEVOXYL KING PHARMS 0.025MG AB3 021301 001 LEVO-T CEDIPROF 0.025MG AB3 021342 001 INC UNITHROID STEVENS J 0.025MG AB3 021210 001 LEVOTHYROXINE MYLAN 0.025MG AB3 076187 001

SODIUM LEVOTHYROXINE LUPIN 0.025MG AB3 209713 001 SODIUM ATLANTIS

THYRO-TABS ALVOGEN 0.025MG AB4 021116 001 LEVOTHYROXINE MYLAN 0.025MG AB4 076187 001 SODIUM

1.5 AVAILABILITY OF THE EDITION

Since 1997, the Electronic Orange Book Query (EOBQ) http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been available on the internet and has become the updated-every-month Orange Book. The Query provides searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent number. Product search categories are: prescription, over-the counter, discontinued drugs. There are links to patent and exclusivity information that may be applicable to each product.

Commencing with the 25th edition, the Annual Edition and monthly Cumulative Supplements have been provided in downloadable Portable Document Format (PDF) at the EOB home page by clicking on Publications. The PDF annual and cumulative supplements duplicate previous paper versions. Over time, there will be an archive for the annuals and each year's December Cumulative Supplement.

The downloaded Annual Edition and Cumulative Supplements are also available in a paper version (Approved Drug Products with Therapeutic Equivalence Evaluations, ADP) from the U.S. Government Printing Office: http://bookstore.gpo.gov; toll free 866-512-1800.

There are historical lists of Orange Book cumulative supplement product monthly changes at http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are ASCII text files of the Orange Book drug product, patent, and exclusivity data at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The drug product text files are provided in eobzip.zip format. The files are updated concurrently with the monthly cumulative supplements. The annual Orange Book Edition Appendices A, B, and C in PDF format are updated quarterly.

Effective August 18, 2003, patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from the FDA Forms List, Effective August 18, 2003, patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from the FDA Forms List, https://www.fda.gov/about-fda/reports-manuals-forms/forms.

The current listing of the Orphan Product Designations and Approvals is available at https://www.fda.gov/industry/developing-products-rare diseases-conditions/designating-orphan-product-drugs-and-biological products.

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

DESCRIPTION OF REPORT

This report provides summary counts derived from the product information in the Prescription Drug Product List and the current Cumulative Supplement. Products included in the counts are domestically marketed drug products approved for both safety and effectiveness under section 505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved drug products marketed by distributors; those marketed solely abroad; and those now regarded as medical devices, biologics or foods.

The baseline column (December of the previous Annual Edition) refers to the products in the Prescription Drug Product List. For each three-month period, a column of quarterly data is added which incorporates counts of product activity from the previous quarter(s) with those in the baseline count.

DEFINITIONS

Drug Product

For this report, a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts, esters and derivatives) either as a single ingredient or as a combination product provided in a specific dosage form and strength for a given route of administration with approval for marketing by a firm under a particular generic or trade name.

New Molecular Entity

A new molecular entity is considered an active moiety that has not previously been approved (either as the parent compound or as a salt, ester or derivative of the parent compound) in the United States for use in a drug product either as a single ingredient or as part of a combination.

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST COUNTS CUMULATIVE BY QUARTER

CATEGORIES COUNTED DEC 2018 MAR 2019 JUN 2019 SEP 2019 DEC 2019

DRUG PRODUCTS 20295 20580 20693 20688 20567 LISTED SINGLE 2724 2713 2729 2713 2743 SOURCE (13.4%) (13.2%) (13.2%) (13.1%) (13.3%)

MULTISOURCE 17571 17867 17964 17975 17824 (86.6%) (86.8%) (86.8%) (86.9%) (86.7%)

THERAPEUTICALLY 17483 17777 17964 17892 17740 EQUIVALENT (86.1%) (86.4%) (86.8%) (86.5%) (86.3%)

NOT THERAPEUTICALLY 88 90 85 83 84 EQUIVALENT (0.4%) (0.4%) (0.4%) (0.4%) (0.4%)

EXCEPTIONS1 58 58 58 54 54 (0.3%) (0.3%) (0.3%) (0.3%) (0.3%)

NEW MOLECULAR 25 3 16 21 17 ENTITIES APPROVED

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NUMBER OF 1133 1129 1132 1140 1162 APPLICANTS

1Amino acid-containing products of varying composition (see Introduction, page xx of the List).

1.7 CUMULATIVE SUPPLEMENT LEGEND

The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form; Route of Administration and then by trade name (or established name of the active ingredient, if no trade name exists).

The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, Reference Standard symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date. The application number preceded by “N” is a New Drug Application (NDA or innovator). The application number preceded by an “A” is an Abbreviated New Drug

Application (ANDA or generic). The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred.

New ingredient(s), new dosage form, new route(s) of administration, new trade names, and new product additions are preceded by >A> during the action month. The change month is the current CS month; the change code for new approvals is NEWA. Following months will display the same information without the >A>.

Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record change addition being made will be preceded by >A>. Following months will display only the >A> record without the >A>. All changes that occur to the product through the Annual year will be listed. The change month and change code will document the change.

The change code and description:

NEWA New drug product approval usually in the supplement month. NFTG New first time generic approval. CAHN** Applicant holder firm name has changed. CAIN Change. There has been a change in the Ingredient(s) name. All products will be deleted under the old name and all products will be added under the changed ingredient(s) name. CDFR Change. Dosage Form; Route of Administration. CFTG Change. A first time generic for the innovator product. A TE Code is added. CMFD Change. The product is moved from the Discontinued Section due to a change in marketing status. CMS1 Change. Miscellaneous addition to list. CMS2 Change. Miscellaneous deletion from list. CPOT Change. Potency amount/unit. CRLD Change. Reference Listed Drug. CHRS Change. Reference Standard. CTEC Change. Therapeutic Equivalence Code. CTNA Change. Trade Name.

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DISC Discontinued. The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition.

**Note:

The Cumulative Supplement (CS) currently displays a condensed 20 character collapsed applicant holder firm name and the Electronic Orange Book (EOB) query may display up to a 240 character full applicant holder firm name. An applicant holder firm name change usually changes both the collapsed name and long name. On occasion, only the long name is changed resulting in the CS displaying only the collapsed name for the >D> and >A> action. The new firm long name will display in the EOB query.

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PRESCRIPTION DRUG PRODUCT LIST - 39TH EDITION RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -1

ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL ABACAVIR SULFATE AND LAMIVUDINE @ ZYDUS PHARMS EQ 600MG BASE;300MG A 208990 001 Nov 15, 2018 Mar DISC

ABIRATERONE ACETATE TABLET;ORAL ABIRATERONE ACETATE AB GLENMARK PHARMS 250MG A 209227 001 Oct 16, 2019 Sep NEWA AB MSN 250MG A 210686 001 Jul 10, 2019 Jun NEWA AB QILU 250MG A 212462 001 Sep 27, 2019 Sep NEWA AB WOCKHARDT BIO AG 250MG A 208380 001 Feb 27, 2019 Feb NEWA

ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE;ORAL ACAMPROSATE CALCIUM @ BARR LABS DIV TEVA 333MG A 200143 001 Nov 18, 2013 Nov DISC

ACARBOSE TABLET;ORAL ACARBOSE MY LAN@ MYLAN@ 25MG A 091053 001 Jan 06, 2011 Jun DISC @ 50MG A 091053 002 Jan 06, 2011 Jun DISC @ 100MG A 091053 003 Jan 06, 2011 Jun DISC AB ! STRIDES PHARMA 25MG A 090912 001 Jul 27, 2011 Oct CHRS PRECOSE + @ BAYER HLTHCARE 25MG N 020482 004 May 29, 1997 Oct DISC + @ 50MG N 020482 001 Sep 06, 1995 Oct DISC + @ 100MG N 020482 002 Sep 06, 1995 Oct DISC

ACEBUTOLOL HYDROCHLORIDE CAPSULE;ORAL ACEBUTOLOL HYDROCHLORIDE @ ANI PHARMS INC EQ 200MG BASE A 074007 001 Oct 18, 1995 Jul CAHN @ EQ 400MG BASE A 074007 002 Oct 18, 1995 Jul CAHN

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE TABLET;ORAL APADAZ + KEMPHARM 325MG;EQ 4.08MG BASE N 208653 002 Jan 04, 2019 Jan NEWA + 325MG;EQ 8.16MG BASE N 208653 003 Jan 04, 2019 Jan NEWA + KVK TECH INC 325MG;EQ 4.08MG BASE N 208653 002 Jan 04, 2019 Feb CAHN + 325MG;EQ 6.12MG BASE N 208653 001 Feb 23, 2018 Feb CAHN +! 325MG;EQ 8.16MG BASE N 208653 003 Jan 04, 2019 Aug CHRS + 325MG;EQ 8.16MG BASE N 208653 003 Jan 04, 2019 Feb CAHN

ACETAMINOPHEN; BUTALBITAL CAPSULE;ORAL BUTALBITAL AND ACETAMINOPHEN AA GRANULES PHARMS 300MG;50MG A 213115 001 Nov 22, 2019 Nov NFTG AA ! MAYNE PHARMA INC 300MG;50MG A 207313 001 Dec 27, 2017 Nov CFTG TABLET;ORAL ALLZITAL ! LARKEN LABS INC 325MG;25MG A 203484 001 Dec 04, 2015 Sep CHRS

ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> AA LANNETT CO INC 300MG;50MG;40MG A 212082 001 Dec 17, 2019 Dec NEWA >A> AA 325MG;50MG;40MG A 212083 001 Dec 17, 2019 Dec NEWA >A> AA MAYNE PHARMA INC 300MG;50MG;40MG A 210817 001 Dec 17, 2019 Dec NEWA

ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE @ LANNETT CO INC 120MG/5ML;12MG/5ML A 091238 001 Nov 10, 2011 Jan DISC TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE AA ELITE LABS INC 300MG;15MG A 212418 001 Sep 10, 2019 Aug NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -2

TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE AA 300MG;30MG A 212418 002 Sep 10, 2019 Aug NEWA AA 300MG;60MG A 212418 003 Sep 10, 2019 Aug NEWA AA EYWA 300MG;15MG A 211610 001 Jun 27, 2019 Sep CAHN AA 300MG;30MG A 211610 002 Jun 27, 2019 Sep CAHN AA 300MG;60MG A 211610 003 Jun 27, 2019 Sep CAHN AA WES PHARMA INC 300MG;15MG A 211610 001 Jun 27, 2019 Jun NEWA AA 300MG;30MG A 211610 002 Jun 27, 2019 Jun NEWA AA 300MG;60MG A 211610 003 Jun 27, 2019 Jun NEWA

ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION;ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN AA WES PHARMA INC 325MG/15ML;7.5MG/15ML A 211023 001 Mar 08, 2019 Feb NEWA TABLET;ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN @ ALVOGEN PINE BROOK 300MG;5MG A 208540 001 Nov 08, 2018 Apr DISC @ 300MG;7.5MG A 208540 002 Nov 08, 2018 Apr DISC @ 300MG;10MG A 208540 003 Nov 08, 2018 Apr DISC @ 325MG;2.5MG A 209958 001 Oct 24, 2018 Apr DISC @ 325MG;5MG A 209958 002 Oct 24, 2018 Apr DISC @ 325MG;7.5MG A 209958 003 Oct 24, 2018 Apr DISC @ 325MG;10MG A 209958 004 Oct 24, 2018 Apr DISC >D> @ ELITE LABS INC 325MG;2.5MG A 209924 001 Nov 16, 2018 Dec CAHN @ 325MG;2.5MG A 209924 001 Nov 16, 2018 May DISC >D> @ 325MG;5MG A 209924 002 Nov 16, 2018 Dec CAHN @ 325MG;5MG A 209924 002 Nov 16, 2018 May DISC >D> @ 325MG;7.5MG A 209924 003 Nov 16, 2018 Dec CAHN @ 325MG;7.5MG A 209924 003 Nov 16, 2018 May DISC >D> @ 325MG;10MG A 209924 004 Nov 16, 2018 Dec CAHN @ 325MG;10MG A 209924 004 Nov 16, 2018 May DISC >A> AA GRANULES PHARMS 325MG;5MG A 211729 001 Jan 03, 2020 Dec NEWA >A> AA 325MG;7.5MG A 211729 002 Jan 03, 2020 Dec NEWA >A> AA 325MG;10MG A 211729 003 Jan 03, 2020 Dec NEWA @ LANNETT CO INC 300MG;5MG A 207171 001 Jun 20, 2017 Sep DISC @ 300MG;7.5MG A 207171 002 Jun 20, 2017 Sep DISC @ 300MG;10MG A 207171 003 Jun 20, 2017 Sep DISC @ 325MG;5MG A 207172 001 Jun 22, 2017 Sep DISC @ 325MG;7.5MG A 207172 002 Jun 22, 2017 Sep DISC @ 325MG;10MG A 207172 003 Jun 22, 2017 Sep DISC >A> @ NOSTRUM LABS INC 325MG;2.5MG A 209924 001 Nov 16, 2018 Dec CAHN >A> @ 325MG;5MG A 209924 002 Nov 16, 2018 Dec CAHN >A> @ 325MG;7.5MG A 209924 003 Nov 16, 2018 Dec CAHN >A> @ 325MG;10MG A 209924 004 Nov 16, 2018 Dec CAHN @ UPSHER SMITH LABS 325MG;5MG A 206484 001 Mar 24, 2017 Jan DISC @ 325MG;7.5MG A 206484 002 Mar 24, 2017 Jan DISC @ 325MG;10MG A 206484 003 Mar 24, 2017 Jan DISC

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SOLUTION;ORAL OXYCODONE AND ACETAMINOPHEN @ MIKART INC 300MG/5ML;10MG/5ML A 202142 001 Nov 27, 2018 May DISC TABLET;ORAL OXYCODONE AND ACETAMINOPHEN AA ANDA REPOSITORY 325MG;5MG A 207834 001 Aug 15, 2019 Sep CAHN AA 325MG;7.5MG A 207834 002 Aug 15, 2019 Sep CAHN AA 325MG;10MG A 207834 003 Aug 15, 2019 Sep CAHN >D> AA ELITE LABS INC 325MG;5MG A 209385 001 Jul 02, 2018 Dec CAHN >D> AA 325MG;7.5MG A 209385 002 Jul 02, 2018 Dec CAHN >D> AA 325MG;10MG A 209385 003 Jul 02, 2018 Dec CAHN AA GRANULES PHARMS 325MG;2.5MG A 211708 001 Oct 31, 2019 Oct NEWA AA 325MG;5MG A 211708 002 Oct 31, 2019 Oct NEWA AA 325MG;7.5MG A 211708 003 Oct 31, 2019 Oct NEWA AA 325MG;10MG A 211708 004 Oct 31, 2019 Oct NEWA AA HALO PHARM CANADA 325MG;5MG A 207834 001 Aug 15, 2019 Aug NEWA AA 325MG;7.5MG A 207834 002 Aug 15, 2019 Aug NEWA AA 325MG;10MG A 207834 003 Aug 15, 2019 Aug NEWA >A> AA NOSTRUM LABS INC 325MG;5MG A 209385 001 Jul 02, 2018 Dec CAHN >A> AA 325MG;7.5MG A 209385 002 Jul 02, 2018 Dec CAHN >A> AA 325MG;10MG A 209385 003 Jul 02, 2018 Dec CAHN AA XIROMED 325MG;5MG A 207574 001 Dec 13, 2016 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -3

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN @ PAR PHARM 325MG;37.5MG A 076475 001 Apr 21, 2005 Nov DISC

ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL ACETAZOLAMIDE @ ACCORD HLTHCARE 500MG A 207659 001 Oct 18, 2018 Apr DISC AB ALEMBIC PHARMS LTD 500MG A 210423 001 Feb 19, 2019 Feb NEWA AB CADILA 500MG A 205301 001 Jan 16, 2019 Mar CAHN AB HERITAGE PHARMA 500MG A 040904 001 Dec 10, 2008 Jul CAHN AB ! HERITAGE PHARMS INC 500MG A 090779 001 Jul 14, 2011 Jul CHRS MY LAN@ MYLAN@ 500MG A 203917 001 Jun 18, 2019 Jul DISC AB 500MG A 203917 001 Jun 18, 2019 Jun NEWA DIAMOX + @ TEVA BRANDED PHARM 500MG N 012945 001 Jul DISC INJECTABLE;INJECTION ACETAZOLAMIDE SODIUM AP ZYDUS PHARMS EQ 500MG BASE/VIAL A 206533 001 Apr 15, 2019 Apr NEWA TABLET;ORAL ACETAZOLAMIDE AB EYWA PHARMA 125MG A 211556 001 Oct 18, 2019 Oct NEWA AB 250MG A 211556 002 Oct 18, 2019 Oct NEWA AB NOVITIUM PHARMA 125MG A 210588 001 Oct 17, 2019 Oct NEWA AB 250MG A 210588 002 Oct 17, 2019 Oct NEWA @ SUN PHARM INDUSTRIES 125MG A 089753 002 Jun 22, 1988 Oct DISC

ACETAZOLAMIDE SODIUM INJECTABLE;INJECTION ACETAZOLAMIDE SODIUM @ EMCURE PHARMS LTD EQ 500MG BASE/VIAL A 202693 001 Dec 19, 2014 Nov DISC @ PAR STERILE PRODUCTS EQ 500MG BASE/VIAL A 205358 001 Jun 20, 2017 Apr DISC AP ZYDUS PHARMS EQ 500MG BASE/VIAL A 206533 001 Apr 15, 2019 Jun CAIN

ACETIC ACID, GLACIAL SOLUTION/DROPS;OTIC ACETIC ACID AT MLV 2% A 040607 001 Feb 24, 2005 Sep CAHN AT SAPTALIS PHARMS 2% A 040607 001 Feb 24, 2005 May CAHN

ACETIC ACID, GLACIAL; HYDROCORTISONE SOLUTION/DROPS;OTIC ACETASOL HC @ ACTAVIS MID ATLANTIC 2%;1% A 087143 001 Jan 13, 1982 Jun DISC

ACETYLCYSTEINE INJECTABLE;INTRAVENOUS ACETYLCYSTEINE @ MYLAN INSTITUTIONAL 6GM/30ML (200MG/ML) A 203624 001 Jun 19, 2015 Mar DISC TABLET, EFFERVESCENT;ORAL CETYLEV + @ ARBOR PHARMS LLC 500MG N 207916 001 Jan 29, 2016 Mar DISC + @ 2.5GM N 207916 002 Jan 29, 2016 Mar DISC

ACITRETIN CAPSULE;ORAL SORIATANE + @ STIEFEL LABS INC 17.5MG N 019821 003 Aug 06, 2009 Jan DISC + @ 22.5MG N 019821 004 Aug 06, 2009 Jan DISC

ACLIDINIUM BROMIDE POWDER, METERED;INHALATION TUDORZA PRESSAIR +! CIRCASSIA 0.4MG/INH N 202450 001 Jul 23, 2012 Jun CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -4

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE POWDER, METERED;INHALATION DUAKLIR PRESSAIR ASTRAZENECA PHARMS 0.4MG/INH;0.012MG/INH N 210595 001 Mar 29, 2019 Mar NEWA CIRCASSIA 0.4MG/INH;0.012MG/INH N 210595 001 Mar 29, 2019 Apr CAHN

ACYCLOVIR CAPSULE;ORAL ACYCLOVIR AB CADILA 200MG A 204313 001 Mar 25, 2016 Aug CAHN AB KENTON 200MG A 075090 001 Jan 26, 1999 Mar CAHN ZOVIRAX + MYLAN@ 200MG N 018828 001 Jan 25, 1985 Nov DISC CREAM;TOPICAL ACYCLOVIR AB PERRIGO UK FINCO 5% A 208702 001 Feb 04, 2019 Jan NFTG ZOVIRAX AB +! BAUSCH 5% N 021478 001 Dec 30, 2002 Feb CAHN AB +! VIB 5% N 021478 001 Dec 30, 2002 Jan CFTG OINTMENT;OPHTHALMIC AVACLYR + @ FERA PHARMS LLC 3% N 202408 001 Mar 29, 2019 Aug DISC +! 3% N 202408 001 Mar 29, 2019 Mar NEWA OINTMENT;TOPICAL ACYCLOVIR AB APOTEX 5% A 210774 001 Sep 06, 2019 Aug NEWA AB CADILA 5% A 205974 001 Mar 15, 2019 Oct CAHN AB CIPLA 5% A 211794 001 Jan 18, 2019 Jan NEWA AB GLENMARK PHARMS SA 5% A 205510 001 Jul 31, 2017 Jun CAHN @ PERRIGO UK FINCO 5% A 205659 001 Feb 20, 2019 Aug DISC AB 5% A 205659 001 Feb 20, 2019 Feb NEWA AB ZYDUS PHARMS 5% A 205974 001 Mar 15, 2019 Mar NEWA ZOVIRAX AB +! BAUSCH 5% N 018604 001 Mar 29, 1982 Feb CAHN TABLET;ORAL ACYCLOVIR AB SQUARE PHARMS LTD 400MG A 209366 001 Oct 07, 2019 Sep NEWA AB 800MG A 209366 002 Oct 07, 2019 Sep NEWA

ACYCLOVIR SODIUM INJECTABLE;INJECTION ACYCLOVIR SODIUM ! ZYDUS PHARMS EQ 500MG BASE/VIAL A 206535 001 Aug 31, 2018 Jan CHRS ! EQ 1GM BASE/VIAL A 206535 002 Aug 31, 2018 Jan CHRS

ACYCLOVIR; HYDROCORTISONE CREAM;TOPICAL XERESE +! BAUSCH 5%;1% N 022436 001 Jul 31, 2009 Feb CAHN

ADAPALENE GEL;TOPICAL ADAPALENE AB P AND L 0.1% A 090962 001 Jun 02, 2010 Jul CAHN

ADAPALENE; BENZOYL PEROXIDE GEL;TOPICAL ADAPALENE AND BENZOYL PEROXIDE AB GLENMARK PHARMS LTD 0.1%;2.5% A 208108 001 Nov 08, 2019 Oct NEWA AB PERRIGO UK FINCO 0.1%;2.5% A 205033 001 Jan 23, 2018 May CAHN @ TARO 0.3%;2.5% A 209148 001 Oct 17, 2018 May DISC

ADENOSINE INJECTABLE;INJECTION ADENOSINE @ LUITPOLD 3MG/ML A 090010 001 Apr 28, 2009 Mar DISC SOLUTION;INTRAVENOUS ADENOSINE @ EMCURE PHARMS LTD 60MG/20ML (3MG/ML) A 202313 001 Sep 15, 2014 Nov DISC @ 90MG/30ML (3MG/ML) A 202313 002 Sep 15, 2014 Nov DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -5

AFAMELANOTIDE IMPLANT;SUBCUTANEOUS SCENESSE +! CLIVUNEL INC 16MG N 210797 001 Oct 08, 2019 Oct NEWA

AIR POLYMER-TYPE A FOAM;INTRAUTERINE EXEM FOAM KIT +! GISKIT 10ML N 212279 001 Nov 07, 2019 Nov NEWA

ALBENDAZOLE TABLET;ORAL ALBENDAZOLE AB ACTAVIS ELIZABETH 200MG A 208094 001 May 20, 2019 May NEWA AB EDENBRIDGE PHARMS 200MG A 211117 001 May 14, 2019 Apr NEWA AB STRIDES PHARMA 200MG A 210011 001 Dec 07, 2018 Aug CAHN

ALBUTEROL SULFATE POWDER, METERED;INHALATION PROAIR DIGIHALER + TEVA BRANDED PHARM EQ 0.09MG BASE/INH N 205636 002 Dec 21, 2018 Jan NEWA PROAIR RESPICLICK +! TEVA BRANDED PHARM EQ 0.09MG BASE/INH N 205636 001 Mar 31, 2015 Jan CPOT SYRUP;ORAL ALBUTEROL SULFATE AA COSETTE EQ 2MG BASE/5ML A 074454 001 Sep 25, 1995 Nov CAHN AA QUAGEN EQ 2MG BASE/5ML A 212197 001 Sep 06, 2019 Aug NEWA TABLET;ORAL ALBUTEROL SULFATE AB AIZANT EQ 2MG BASE A 210948 001 Mar 15, 2019 Mar NEWA AB EQ 4MG BASE A 210948 002 Mar 15, 2019 Mar NEWA AB APPCO EQ 2MG BASE A 207046 001 Jun 29, 2018 Feb CAHN AB EQ 4MG BASE A 207046 002 Jun 29, 2018 Feb CAHN AB ARISE EQ 2MG BASE A 210948 001 Mar 15, 2019 Sep CAHN AB EQ 4MG BASE A 210948 002 Mar 15, 2019 Sep CAHN

ALENDRONATE SODIUM TABLET;ORAL ALENDRONATE SODIUM MY LAN@ MYLAN@ EQ 5MG BASE A 076584 001 Aug 04, 2008 Jul DISC @ EQ 10MG BASE A 076584 002 Aug 04, 2008 Jul DISC TABLET, EFFERVESCENT;ORAL BINOSTO +! ASCEND THERAPS US EQ 70MG BASE N 202344 001 Mar 12, 2012 Sep CAHN

ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL ALFUZOSIN HYDROCHLORIDE @ HERITAGE PHARMA 10MG A 079056 001 Jul 18, 2011 Sep DISC AB 10MG A 079056 001 Jul 18, 2011 May CAHN @ MYLAN 10MG A 079014 001 Jul 18, 2011 Oct DISC

ALISKIREN HEMIFUMARATE TABLET;ORAL ALISKIREN HEMIFUMARATE AB ANCHEN PHARMS EQ 150MG BASE A 206665 001 Mar 22, 2019 Mar NFTG AB EQ 300MG BASE A 206665 002 Mar 22, 2019 Mar NFTG TEKTURNA AB + NODEN PHARMA EQ 150MG BASE N 021985 001 Mar 05, 2007 Mar CFTG AB +! EQ 300MG BASE N 021985 002 Mar 05, 2007 Mar CFTG

ALITRETINOIN GEL;TOPICAL PANRETIN +! CONCORDIA EQ 0.1% BASE N 020886 001 Feb 02, 1999 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -6

ALLOPURINOL TABLET;ORAL ALLOPURINOL @ SUN PHARM INDS INC 100MG A 078390 001 Aug 30, 2007 Oct DISC @ 300MG A 078390 002 Aug 30, 2007 Oct DISC AB UNICHEM LABS LTD 100MG A 211820 001 Mar 12, 2019 Feb NEWA AB 300MG A 211820 002 Mar 12, 2019 Feb NEWA

ALLOPURINOL; LESINURAD TABLET;ORAL DUZALLO + @ IRONWOOD PHARMS INC 200MG;200MG N 209203 001 Aug 18, 2017 Apr DISC + @ 300MG;200MG N 209203 002 Aug 18, 2017 Apr DISC

ALMOTRIPTAN MALATE TABLET;ORAL ALMOTRIPTAN MALATE AB ! AJANTA PHARMA LTD EQ 12.5MG BASE A 205523 002 Mar 03, 2016 Sep CHRS AXERT + @ JANSSEN PHARMS EQ 6.25MG BASE N 021001 001 May 07, 2001 Sep DISC + @ EQ 12.5MG BASE N 021001 002 May 07, 2001 Sep DISC

ALOSETRON HYDROCHLORIDE TABLET;ORAL ALOSETRON HYDROCHLORIDE AB EYWA PHARMA EQ 0.5MG BASE A 211621 001 Sep 16, 2019 Sep NEWA AB EQ 1MG BASE A 211621 002 Sep 16, 2019 Sep NEWA

ALPELISIB TABLET;ORAL PIQRAY + NOVARTIS 50MG N 212526 001 May 24, 2019 May NEWA + 150MG N 212526 002 May 24, 2019 May NEWA +! 200MG N 212526 003 May 24, 2019 May NEWA

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K SOLUTION;INTRAVENOUS INFUVITE ADULT +! SANDOZ CANADA INC 2 IU/ML;40MG/ML;12MCG/ML;40 N 021163 001 May 18, 2000 Jul CAHN IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG /ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;66 0 IU/ML;0.03MG/ML +! 2 IU/ML;40MG/ML;12MCG/ML;40 N 021163 002 Jun 16, 2003 Sep CMS1 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG /ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;66 0 IU/ML;30MCG/ML

ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL ALPRAZOLAM >D> AB ANI PHARMS INC 0.5MG A 077725 001 Jul 31, 2006 Dec DISC >A> @ 0.5MG A 077725 001 Jul 31, 2006 Dec DISC >D> AB 1MG A 077725 002 Jul 31, 2006 Dec DISC >A> @ 1MG A 077725 002 Jul 31, 2006 Dec DISC >D> AB 2MG A 077725 004 Jul 31, 2006 Dec DISC >A> @ 2MG A 077725 004 Jul 31, 2006 Dec DISC >D> AB 3MG A 077725 003 Jul 31, 2006 Dec DISC >A> @ 3MG A 077725 003 Jul 31, 2006 Dec DISC >D> AB HERITAGE PHARMS INC 0.5MG A 078489 001 Oct 17, 2008 Dec DISC >A> @ 0.5MG A 078489 001 Oct 17, 2008 Dec DISC >D> AB 1MG A 078489 002 Oct 17, 2008 Dec DISC >A> @ 1MG A 078489 002 Oct 17, 2008 Dec DISC >D> AB 2MG A 078489 003 Oct 17, 2008 Dec DISC >A> @ 2MG A 078489 003 Oct 17, 2008 Dec DISC >D> AB 3MG A 078489 004 Oct 17, 2008 Dec DISC >A> @ 3MG A 078489 004 Oct 17, 2008 Dec DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -7

ALTRETAMINE CAPSULE;ORAL HEXALEN + @ EISAI INC 50MG N 019926 001 Dec 26, 1990 Feb DISC

ALVIMOPAN CAPSULE;ORAL >A> ALVIMOPAN >A> AB WATSON LABS TEVA 12MG A 208295 001 Dec 19, 2019 Dec NFTG ENTEREG >D> +! CUBIST PHARMS 12MG N 021775 001 May 20, 2008 Dec CFTG >A> AB +! 12MG N 021775 001 May 20, 2008 Dec CFTG

AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE AB INVAGEN PHARMS 100MG A 207570 001 Sep 30, 2016 Sep CAHN AB UPSHER SMITH LABS 100MG A 070589 001 Aug 05, 1986 Jul CAHN TABLET;ORAL AMANTADINE HYDROCHLORIDE AB INVAGEN PHARMS 100MG A 207571 001 Jan 31, 2017 Sep CAHN AB ! UPSHER SMITH LABS 100MG A 076186 001 Dec 16, 2002 Jul CAHN

AMBRISENTAN TABLET;ORAL AMBRISENTAN AB CIPLA 5MG A 210715 001 Apr 26, 2019 Apr NEWA AB 10MG A 210715 002 Apr 26, 2019 Apr NEWA AB MYLAN 5MG A 208441 001 Mar 28, 2019 Mar NFTG AB 10MG A 208441 002 Mar 28, 2019 Mar NFTG AB PAR PHARM INC 5MG A 209509 001 Apr 10, 2019 Mar NEWA AB 10MG A 209509 002 Apr 10, 2019 Mar NEWA AB SIGMAPHARM LABS LLC 5MG A 208354 001 Apr 10, 2019 Mar NEWA AB 10MG A 208354 002 Apr 10, 2019 Mar NEWA AB SUN PHARM 5MG A 210784 001 Mar 28, 2019 Mar NFTG AB 10MG A 210784 002 Mar 28, 2019 Mar NFTG AB WATSON LABS INC 5MG A 208252 001 Mar 28, 2019 Mar NFTG AB 10MG A 208252 002 Mar 28, 2019 Mar NFTG AB ZYDUS PHARMS 5MG A 210058 001 Mar 28, 2019 Mar NFTG AB 10MG A 210058 002 Mar 28, 2019 Mar NFTG LETAIRIS AB + GILEAD 5MG N 022081 001 Jun 15, 2007 Mar CFTG AB +! 10MG N 022081 002 Jun 15, 2007 Mar CFTG

AMIFAMPRIDINE TABLET;ORAL RUZURGI +! JACOBUS PHARM CO INC 10MG N 209321 001 May 06, 2019 May NEWA

AMIFOSTINE INJECTABLE;INJECTION ETHYOL >A> @ CLINIGEN 375MG/VIAL N 020221 002 Sep 10, 1999 Dec CAHN >A> AP +! 500MG/VIAL N 020221 001 Dec 08, 1995 Dec CAHN >D> @ CLINIGEN HLTHCARE 375MG/VIAL N 020221 002 Sep 10, 1999 Dec CAHN >D> AP +! 500MG/VIAL N 020221 001 Dec 08, 1995 Dec CAHN

AMIKACIN SULFATE INJECTABLE;INJECTION AMIKACIN SULFATE @ TEVA PHARMS USA EQ 250MG BASE/ML A 064045 002 Sep 28, 1993 Sep DISC

AMILORIDE HYDROCHLORIDE TABLET;ORAL AMILORIDE HYDROCHLORIDE AB WINDLAS HLTHCARE 5MG A 204180 001 Aug 07, 2015 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -8

AMINO ACIDS INJECTABLE;INJECTION AMINOSYN 10% @ ICU MEDICAL INC 10% (10GM/100ML) N 017673 003 Jul DISC AMINOSYN 8.5% @ ICU MEDICAL INC 8.5% (8.5GM/100ML) N 017673 004 Jul DISC

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION AMINOSYN 3.5% M @ ICU MEDICAL INC 3.5%;21MG/100ML;40MG/100ML;128MG/1 N 017789 003 Jul DISC 00ML;234MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC INJECTABLE;INJECTION AMINOSYN 8.5% W/ELECTROLYTES @ ICU MEDICAL INC 8.5%;102MG/100ML;487MG/100ML;28MG/ N 017673 009 Oct 25, 2002 Jul DISC 100ML;425MG/100ML

AMINOCAPROIC ACID SYRUP;ORAL AMICAR AA +! CLOVER PHARMS 1.25GM/5ML N 015230 002 Aug CTEC AMINOCAPROIC ACID AA AMNEAL PHARMS LLC 1.25GM/5ML A 212780 001 Aug 23, 2019 Aug NEWA TABLET;ORAL AMICAR AB + CLOVER PHARMS 1GM N 015197 002 Jun 24, 2004 Feb CHRS AMINOCAPROIC ACID >A> AB AMNEAL 500MG A 212492 001 Nov 26, 2019 Dec CAHN >D> AB AMNEAL PHARMS CO 500MG A 212492 001 Nov 26, 2019 Dec CAHN AB 500MG A 212492 001 Nov 26, 2019 Nov NEWA AB ! SUNNY PHARMTECH INC 1GM A 209060 002 Nov 27, 2018 Feb CHRS

AMINOPHYLLINE INJECTABLE;INJECTION AMINOPHYLLINE ! HOSPIRA 25MG/ML A 087242 001 Oct 26, 1983 Feb CTEC @ LUITPOLD 25MG/ML A 087600 001 Feb DISC

AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION AMIODARONE HYDROCHLORIDE @ DR REDDYS 50MG/ML A 076163 001 Sep 05, 2003 May CAHN TABLET;ORAL AMIODARONE HYDROCHLORIDE AB RUBICON 200MG A 078578 001 Nov 06, 2008 Jul CAHN

AMLODIPINE BENZOATE SOLUTION;ORAL KATERZIA +! SILVERGATE PHARMS EQ 1MG BASE/ML N 211340 001 Jul 08, 2019 Jul NEWA SUSPENSION;ORAL KATERZIA +! SILVERGATE PHARMS EQ 1MG BASE/ML N 211340 001 Jul 08, 2019 Nov CDFR

AMLODIPINE BESYLATE TABLET;ORAL AMLODIPINE BESYLATE AB STRIDES PHARMA EQ 2.5MG BASE A 077516 001 Jul 11, 2007 Apr CAHN AB EQ 5MG BASE A 077516 002 Jul 11, 2007 Apr CAHN AB EQ 10MG BASE A 077516 003 Jul 11, 2007 Apr CAHN @ SUN PHARM INDS INC EQ 2.5MG BASE A 078231 001 Nov 30, 2007 Oct DISC @ EQ 5MG BASE A 078231 002 Nov 30, 2007 Oct DISC @ EQ 10MG BASE A 078231 003 Nov 30, 2007 Oct DISC @ TEVA EQ 2.5MG BASE A 076846 001 Jun 28, 2007 Oct DISC @ EQ 5MG BASE A 076846 002 Jun 28, 2007 Oct DISC @ EQ 10MG BASE A 076846 003 Jun 28, 2007 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -9

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TABLET;ORAL AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AB APOTEX EQ 5MG BASE;EQ 10MG BASE A 205199 001 Nov 18, 2019 Nov NEWA AB EQ 5MG BASE;EQ 20MG BASE A 205199 002 Nov 18, 2019 Nov NEWA AB EQ 5MG BASE;EQ 40MG BASE A 205199 003 Nov 18, 2019 Nov NEWA AB EQ 5MG BASE;EQ 80MG BASE A 205199 004 Nov 18, 2019 Nov NEWA AB EQ 10MG BASE;EQ 10MG BASE A 205199 005 Nov 18, 2019 Nov NEWA AB EQ 10MG BASE;EQ 20MG BASE A 205199 006 Nov 18, 2019 Nov NEWA AB EQ 10MG BASE;EQ 40MG BASE A 205199 007 Nov 18, 2019 Nov NEWA AB EQ 10MG BASE;EQ 80MG BASE A 205199 008 Nov 18, 2019 Nov NEWA @ ZYDUS PHARMS EQ 2.5MG BASE;EQ 10MG BASE A 207762 001 Jan 11, 2019 Jun DISC @ EQ 2.5MG BASE;EQ 20MG BASE A 207762 002 Jan 11, 2019 Jun DISC @ EQ 2.5MG BASE;EQ 40MG BASE A 207762 003 Jan 11, 2019 Jun DISC @ EQ 5MG BASE;EQ 10MG BASE A 207762 004 Jan 11, 2019 Jun DISC @ EQ 5MG BASE;EQ 20MG BASE A 207762 005 Jan 11, 2019 Jun DISC @ EQ 5MG BASE;EQ 40MG BASE A 207762 006 Jan 11, 2019 Jun DISC @ EQ 5MG BASE;EQ 80MG BASE A 207762 007 Jan 11, 2019 Jun DISC @ EQ 10MG BASE;EQ 10MG BASE A 207762 008 Jan 11, 2019 Jun DISC @ EQ 10MG BASE;EQ 20MG BASE A 207762 009 Jan 11, 2019 Jun DISC @ EQ 10MG BASE;EQ 40MG BASE A 207762 010 Jan 11, 2019 Jun DISC @ EQ 10MG BASE;EQ 80MG BASE A 207762 011 Jan 11, 2019 Jun DISC

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE @ CIPLA EQ 2.5MG BASE;10MG A 077215 001 Dec 07, 2018 May DISC @ EQ 5MG BASE;10MG A 077215 002 Dec 07, 2018 May DISC @ EQ 5MG BASE;20MG A 077215 003 Dec 07, 2018 May DISC @ EQ 10MG BASE;20MG A 077215 004 Dec 07, 2018 May DISC @ MYLAN EQ 2.5MG BASE;10MG A 077375 001 May 21, 2010 Feb DISC @ EQ 5MG BASE;10MG A 077375 002 May 21, 2010 Feb DISC @ EQ 5MG BASE;20MG A 077375 003 May 21, 2010 Feb DISC @ EQ 5MG BASE;40MG A 079047 001 Jul 05, 2011 Feb DISC @ EQ 10MG BASE;20MG A 077375 004 May 21, 2010 Feb DISC @ EQ 10MG BASE;40MG A 079047 002 Jul 05, 2011 Feb DISC @ TEVA PHARMS EQ 2.5MG BASE;10MG A 077179 001 May 18, 2007 Jun DISC @ EQ 5MG BASE;10MG A 077179 002 May 18, 2007 Jun DISC @ EQ 5MG BASE;20MG A 077179 003 May 18, 2007 Jun DISC @ EQ 5MG BASE;40MG A 077179 005 Jul 05, 2011 Jun DISC @ EQ 10MG BASE;20MG A 077179 004 May 18, 2007 Jun DISC @ EQ 10MG BASE;40MG A 077179 006 Jul 05, 2011 Jun DISC

AMLODIPINE BESYLATE; CELECOXIB TABLET;ORAL CONSENSI + COEPTIS EQ 2.5MG BASE;200MG N 210045 001 May 31, 2018 Mar CAHN + EQ 5MG BASE;200MG N 210045 002 May 31, 2018 Mar CAHN +! EQ 10MG BASE;200MG N 210045 003 May 31, 2018 Mar CAHN

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE @ TEVA PHARMS USA EQ 5MG BASE;12.5MG;20MG A 202491 001 Nov 03, 2016 Jul DISC @ EQ 5MG BASE;12.5MG;40MG A 202491 002 Nov 03, 2016 Jul DISC @ EQ 5MG BASE;25MG;40MG A 202491 003 Nov 03, 2016 Jul DISC @ EQ 10MG BASE;12.5MG;40MG A 202491 004 Nov 03, 2016 Jul DISC @ EQ 10MG BASE;25MG;40MG A 202491 005 Nov 03, 2016 Jul DISC

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE @ TEVA PHARMS 5MG;12.5MG;160MG A 200435 001 Sep 25, 2012 Jul DISC @ 5MG;25MG;160MG A 200435 002 Sep 25, 2012 Jul DISC @ 10MG;12.5MG;160MG A 200435 005 Sep 25, 2012 Jul DISC @ 10MG;25MG;160MG A 200435 003 Sep 25, 2012 Jul DISC @ 10MG;25MG;320MG A 200435 004 Sep 25, 2012 Jul DISC @ TORRENT 5MG;12.5MG;160MG A 201593 001 Jun 03, 2015 Nov DISC @ 5MG;25MG;160MG A 201593 002 Jun 03, 2015 Nov DISC @ 10MG;12.5MG;160MG A 201593 003 Jun 03, 2015 Nov DISC @ 10MG;25MG;160MG A 201593 004 Jun 03, 2015 Nov DISC @ 10MG;25MG;320MG A 201593 005 Jun 03, 2015 Nov DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -10

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL AMLODIPINE AND OLMESARTAN MEDOXOMIL @ ACCORD HLTHCARE INC EQ 5MG BASE;20MG A 209600 001 Aug 30, 2018 Mar DISC @ EQ 5MG BASE;40MG A 209600 003 Aug 30, 2018 Mar DISC @ EQ 10MG BASE;20MG A 209600 002 Aug 30, 2018 Mar DISC @ EQ 10MG BASE;40MG A 209600 004 Aug 30, 2018 Mar DISC @ TEVA PHARMS USA EQ 5MG BASE;20MG A 091154 001 Oct 26, 2016 Jun DISC @ EQ 5MG BASE;40MG A 091154 002 Oct 26, 2016 Jun DISC @ EQ 10MG BASE;20MG A 091154 003 Oct 26, 2016 Jun DISC @ EQ 10MG BASE;40MG A 091154 004 Oct 26, 2016 Jun DISC

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE TABLET;ORAL PRESTALIA + ADHERA EQ 2.5MG BASE;3.5MG N 205003 001 Jan 21, 2015 Apr CAHN + EQ 5MG BASE;7MG N 205003 002 Jan 21, 2015 Apr CAHN +! EQ 10MG BASE;14MG N 205003 003 Jan 21, 2015 Apr CAHN

AMLODIPINE BESYLATE; VALSARTAN TABLET;ORAL AMLODIPINE BESYLATE AND VALSARTAN @ TEVA PHARMS USA EQ 5MG BASE;160MG A 091235 001 Mar 30, 2015 Jul DISC @ EQ 5MG BASE;320MG A 091235 003 Mar 30, 2015 Jul DISC @ EQ 10MG BASE;160MG A 091235 002 Mar 30, 2015 Jul DISC @ EQ 10MG BASE;320MG A 091235 004 Mar 30, 2015 Jul DISC @ TORRENT EQ 5MG BASE;160MG A 202377 001 Mar 30, 2015 Nov DISC @ EQ 5MG BASE;320MG A 202377 002 Mar 30, 2015 Nov DISC @ EQ 10MG BASE;160MG A 202377 003 Mar 30, 2015 Nov DISC @ EQ 10MG BASE;320MG A 202377 004 Mar 30, 2015 Nov DISC

AMMONIA N-13 INJECTABLE;INTRAVENOUS AMMONIA N 13 AP DECATUR 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A 204465 001 Oct 23, 2014 Apr CAHN AP UNIV TX SW MEDCTR 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A 209507 001 Nov 01, 2019 Oct NEWA

AMMONIUM LACTATE CREAM;TOPICAL AMMONIUM LACTATE AB ! PERRIGO ISRAEL EQ 12% BASE A 075774 001 May 01, 2002 May CAHN LOTION;TOPICAL AMMONIUM LACTATE AB ! PERRIGO ISRAEL EQ 12% BASE A 075570 001 Jun 23, 2004 May CAHN

AMOXICILLIN FOR SUSPENSION;ORAL AMOXICILLIN @ TEVA 125MG/5ML A 061931 001 Jun DISC

AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM AB AUROBINDO PHARMA LTD 125MG/5ML;EQ 31.25MG BASE/5ML A 209371 001 Apr 19, 2019 Apr NFTG AB 250MG/5ML;EQ 62.5MG BASE/5ML A 209371 002 Apr 19, 2019 Apr NEWA AUGMENTIN '125' AB + NEOPHARMA 125MG/5ML;EQ 31.25MG BASE/5ML N 050575 001 Aug 06, 1984 Apr CFTG TABLET;ORAL AUGMENTIN '875' AB + NEOPHARMA 875MG;EQ 125MG BASE N 050720 001 Feb 13, 1996 Feb CAHN

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN CAPSULE, DELAYED RELEASE;ORAL TALICIA +! REDHILL 250MG;EQ 10MG BASE;12.5MG N 213004 001 Nov 01, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -11

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AB AMERIGEN PHARMS LTD 1.25MG;1.25MG;1.25MG;1.25MG A 205401 001 Jan 22, 2019 Jan NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG A 205401 002 Jan 22, 2019 Jan NEWA AB 3.75MG;3.75MG;3.75MG;3.75MG A 205401 003 Jan 22, 2019 Jan NEWA AB 5MG;5MG;5MG;5MG A 205401 004 Jan 22, 2019 Jan NEWA AB 6.25MG;6.25MG;6.25MG;6.25MG A 205401 005 Jan 22, 2019 Jan NEWA AB 7.5MG;7.5MG;7.5MG;7.5MG A 205401 006 Jan 22, 2019 Jan NEWA AB PAR PHARM INC 1.25MG;1.25MG;1.25MG;1.25MG A 206159 001 May 31, 2019 Nov CTNA AB 1.25MG;1.25MG;1.25MG;1.25MG A 206159 001 May 31, 2019 May NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG A 206159 002 May 31, 2019 Nov CTNA AB 2.5MG;2.5MG;2.5MG;2.5MG A 206159 002 May 31, 2019 May NEWA AB 3.75MG;3.75MG;3.75MG;3.75MG A 206159 003 May 31, 2019 Nov CTNA AB 3.75MG;3.75MG;3.75MG;3.75MG A 206159 003 May 31, 2019 May NEWA AB 5MG;5MG;5MG;5MG A 206159 004 May 31, 2019 Nov CTNA AB 5MG;5MG;5MG;5MG A 206159 004 May 31, 2019 May NEWA AB 6.25MG;6.25MG;6.25MG;6.25MG A 206159 005 May 31, 2019 Nov CTNA AB 6.25MG;6.25MG;6.25MG;6.25MG A 206159 005 May 31, 2019 May NEWA AB 7.5MG;7.5MG;7.5MG;7.5MG A 206159 006 May 31, 2019 Nov CTNA AB 7.5MG;7.5MG;7.5MG;7.5MG A 206159 006 May 31, 2019 May NEWA AB RHODES PHARMS 1.25MG;1.25MG;1.25MG;1.25MG A 210651 001 May 17, 2019 May NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG A 210651 002 May 17, 2019 May NEWA AB 3.75MG;3.75MG;3.75MG;3.75MG A 210651 003 May 17, 2019 May NEWA AB 5MG;5MG;5MG;5MG A 210651 004 May 17, 2019 May NEWA AB 6.25MG;6.25MG;6.25MG;6.25MG A 210651 005 May 17, 2019 May NEWA AB 7.5MG;7.5MG;7.5MG;7.5MG A 210651 006 May 17, 2019 May NEWA AB SPECGX LLC 1.25MG;1.25MG;1.25MG;1.25MG A 211547 001 Apr 22, 2019 Apr NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG A 211547 002 Apr 22, 2019 Apr NEWA AB 3.75MG;3.75MG;3.75MG;3.75MG A 211547 003 Apr 22, 2019 Apr NEWA AB 5MG;5MG;5MG;5MG A 211547 004 Apr 22, 2019 Apr NEWA AB 6.25MG;6.25MG;6.25MG;6.25MG A 211547 005 Apr 22, 2019 Apr NEWA AB 7.5MG;7.5MG;7.5MG;7.5MG A 211547 006 Apr 22, 2019 Apr NEWA @ SUN PHARM INDUSTRIES 1.25MG;1.25MG;1.25MG;1.25MG A 211715 001 May 17, 2019 Nov DISC AB 1.25MG;1.25MG;1.25MG;1.25MG A 211715 001 May 17, 2019 May NEWA @ 2.5MG;2.5MG;2.5MG;2.5MG A 211715 002 May 17, 2019 Nov DISC AB 2.5MG;2.5MG;2.5MG;2.5MG A 211715 002 May 17, 2019 May NEWA @ 3.75MG;3.75MG;3.75MG;3.75MG A 211715 003 May 17, 2019 Nov DISC AB 3.75MG;3.75MG;3.75MG;3.75MG A 211715 003 May 17, 2019 May NEWA @ 5MG;5MG;5MG;5MG A 211715 004 May 17, 2019 Nov DISC AB 5MG;5MG;5MG;5MG A 211715 004 May 17, 2019 May NEWA @ 6.25MG;6.25MG;6.25MG;6.25MG A 211715 005 May 17, 2019 Nov DISC AB 6.25MG;6.25MG;6.25MG;6.25MG A 211715 005 May 17, 2019 May NEWA @ 7.5MG;7.5MG;7.5MG;7.5MG A 211715 006 May 17, 2019 Nov DISC AB 7.5MG;7.5MG;7.5MG;7.5MG A 211715 006 May 17, 2019 May NEWA AB SUNGEN PHARMA 1.25MG;1.25MG;1.25MG;1.25MG A 212037 001 Dec 11, 2019 Nov NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG A 212037 002 Dec 11, 2019 Nov NEWA AB 3.75MG;3.75MG;3.75MG;3.75MG A 212037 003 Dec 11, 2019 Nov NEWA AB 5MG;5MG;5MG;5MG A 212037 004 Dec 11, 2019 Nov NEWA AB 6.25MG;6.25MG;6.25MG;6.25MG A 212037 005 Dec 11, 2019 Nov NEWA AB 7.5MG;7.5MG;7.5MG;7.5MG A 212037 006 Dec 11, 2019 Nov NEWA

AMPHETAMINE SULFATE TABLET;ORAL AMPHETAMINE SULFATE AA AUROLIFE PHARMA LLC 5MG A 211639 001 Apr 17, 2019 Apr NEWA AA 10MG A 211639 002 Apr 17, 2019 Apr NEWA AA BIONPHARMA INC 5MG A 212919 001 Nov 22, 2019 Nov NEWA AA 10MG A 212919 002 Nov 22, 2019 Nov NEWA AA GRANULES PHARMS 5MG A 212619 001 Aug 05, 2019 Jul NEWA AA 10MG A 212619 002 Aug 05, 2019 Jul NEWA TABLET, ORALLY DISINTEGRATING;ORAL EVEKEO ODT + ARBOR PHARMS LLC 5MG N 209905 001 Jan 30, 2019 Jan NEWA + 10MG N 209905 002 Jan 30, 2019 Jan NEWA + 15MG N 209905 003 Jan 30, 2019 Jan NEWA + 20MG N 209905 004 Jan 30, 2019 Jan NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -12

AMPICILLIN SODIUM INJECTABLE;INJECTION AMPICILLIN SODIUM @ HOSPIRA INC EQ 250MG BASE/VIAL A 202864 001 Sep 04, 2015 Oct DISC @ EQ 500MG BASE/VIAL A 202864 002 Sep 04, 2015 Oct DISC @ EQ 1GM BASE/VIAL A 202864 003 Sep 04, 2015 Oct DISC @ EQ 2GM BASE/VIAL A 202864 004 Sep 04, 2015 Oct DISC @ EQ 10GM BASE/VIAL A 202865 001 Sep 04, 2015 Sep DISC

AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION AMPICILLIN AND SULBACTAM @ HOSPIRA INC EQ 1GM BASE/VIAL;EQ 500MG A 090375 001 Dec 21, 2011 Sep DISC BASE/VIAL @ EQ 1GM BASE/VIAL;EQ 500MG A 090653 001 Dec 21, 2011 Sep DISC BASE/VIAL @ EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A 090375 002 Dec 21, 2011 Sep DISC @ EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A 090653 002 Dec 21, 2011 Sep DISC @ EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A 090646 001 Dec 21, 2011 Sep DISC @ MUSTAFA NEVZAT ILAC EQ 1GM BASE/VIAL;EQ 500MG A 065316 001 Jun 29, 2007 Sep DISC BASE/VIAL @ EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A 065316 002 Jun 29, 2007 Sep DISC

AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL AMPICILLIN TRIHYDRATE @ HERITAGE PHARMA EQ 250MG BASE A 061502 001 May CAHN @ EQ 500MG BASE A 061502 002 May CAHN

ANASTROZOLE TABLET;ORAL ANASTROZOLE AB FRESENIUS KABI USA 1MG A 090088 001 Jun 28, 2010 Feb CAHN AB KENTON 1MG A 078944 001 Jun 28, 2010 Mar CAHN

APIXABAN TABLET;ORAL >A> APIXABAN >A> AB MICRO LABS 2.5MG A 210013 001 Dec 23, 2019 Dec NFTG >A> AB 5MG A 210013 002 Dec 23, 2019 Dec NFTG >A> AB MYLAN 2.5MG A 210128 001 Dec 23, 2019 Dec NFTG >A> AB 5MG A 210128 002 Dec 23, 2019 Dec NFTG ELIQUIS >D> + BRISTOL MYERS SQUIBB 2.5MG N 202155 001 Dec 28, 2012 Dec CFTG >A> AB + 2.5MG N 202155 001 Dec 28, 2012 Dec CFTG >D> +! 5MG N 202155 002 Dec 28, 2012 Dec CFTG >A> AB +! 5MG N 202155 002 Dec 28, 2012 Dec CFTG

APREMILAST TABLET;ORAL OTEZLA >A> + AMGEN INC 10MG N 205437 001 Mar 21, 2014 Dec CAHN >A> + 20MG N 205437 002 Mar 21, 2014 Dec CAHN >A> +! 30MG N 205437 003 Mar 21, 2014 Dec CAHN >D> + CELGENE CORP 10MG N 205437 001 Mar 21, 2014 Dec CAHN >D> + 20MG N 205437 002 Mar 21, 2014 Dec CAHN >D> +! 30MG N 205437 003 Mar 21, 2014 Dec CAHN

APREPITANT CAPSULE;ORAL EMEND + @ MERCK 40MG N 021549 003 Jun 30, 2006 Oct DISC

ARIPIPRAZOLE SOLUTION;ORAL ARIPIPRAZOLE AA AUROBINDO PHARMA LTD 1MG/ML A 210479 001 Jan 29, 2019 Jan NEWA >A> AA VISTAPHARM 1MG/ML A 212870 001 Dec 26, 2019 Dec NEWA TABLET;ORAL ARIPIPRAZOLE AB ALKEM LABS LTD 2MG A 207105 001 Feb 21, 2019 Feb NEWA AB 5MG A 207105 002 Feb 21, 2019 Feb NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -13

TABLET;ORAL ARIPIPRAZOLE AB 10MG A 207105 003 Feb 21, 2019 Feb NEWA AB 15MG A 207105 004 Feb 21, 2019 Feb NEWA AB 20MG A 207105 005 Feb 21, 2019 Feb NEWA AB 30MG A 207105 006 Feb 21, 2019 Feb NEWA @ TEVA PHARMS USA 2MG A 078607 001 Apr 28, 2015 Jun DISC @ 5MG A 078607 002 Apr 28, 2015 Jun DISC @ 10MG A 078608 001 Apr 28, 2015 May DISC @ 15MG A 078708 001 Apr 28, 2015 May DISC @ 20MG A 078708 002 Apr 28, 2015 May DISC @ 30MG A 078708 003 Apr 28, 2015 May DISC @ ZYDUS PHARMS 2MG A 090472 001 Jan 07, 2019 Jun DISC @ 5MG A 090472 002 Jan 07, 2019 Jun DISC @ 10MG A 090472 003 Jan 07, 2019 Jun DISC @ 15MG A 090472 004 Jan 07, 2019 Jun DISC @ 20MG A 090472 005 Jan 07, 2019 Jun DISC @ 30MG A 090472 006 Jan 07, 2019 Jun DISC

ARMODAFINIL TABLET;ORAL ARMODAFINIL @ APOTEX INC 50MG A 201514 001 Mar 25, 2019 Sep DISC AB 50MG A 201514 001 Mar 25, 2019 Mar NEWA @ 150MG A 201514 002 Mar 25, 2019 Sep DISC AB 150MG A 201514 002 Mar 25, 2019 Mar NEWA @ 250MG A 201514 003 Mar 25, 2019 Sep DISC AB 250MG A 201514 003 Mar 25, 2019 Mar NEWA AB AUROBINDO PHARMA LTD 200MG A 206069 004 Dec 07, 2018 Mar NEWA AB MYLAN PHARMS INC 100MG A 200043 004 May 09, 2019 Apr NEWA AB 200MG A 200043 005 May 09, 2019 Apr NEWA AB NATCO PHARMA LTD 100MG A 202768 004 Sep 28, 2017 Apr CTEC

ARSENIC TRIOXIDE INJECTABLE;INJECTION ARSENIC TRIOXIDE AP STI PHARMA LLC 1MG/ML A 209873 001 May 06, 2019 Apr NEWA AP ZYDUS PHARMS 2MG/ML A 206228 002 Aug 30, 2019 Aug NFTG TRISENOX AP +! CEPHALON 2MG/ML N 021248 002 Oct 13, 2017 Aug CFTG

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K INJECTABLE;INTRAVENOUS INFUVITE PEDIATRIC +! SANDOZ CANADA INC 80MG/VIAL;0.02MG/VIAL;400 N 021265 001 Feb 21, 2001 Jul CAHN IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14 MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/V IAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN K INJECTABLE;INTRAVENOUS INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) +! SANDOZ CANADA INC 80MG/VIAL;0.02MG/VIAL;400 N 021265 002 Jan 29, 2004 Sep CMS1 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14 MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/V IAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE FOR SOLUTION;ORAL MOVIPREP AA +! SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM; N 021881 001 Aug 02, 2006 Nov CTEC 7.5GM PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID AA NOVEL LABS INC 4.7GM;100GM;1.015GM;5.9GM;2.691GM; A 090145 001 Jan 25, 2012 Nov CMFD 7.5GM RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -14

ASENAPINE SYSTEM;TRANSDERMAL SECUADO + HISAMITSU 3.8MG/24HR N 212268 001 Oct 11, 2019 Oct NEWA + 5.7MG/24HR N 212268 002 Oct 11, 2019 Oct NEWA +! 7.6MG/24HR N 212268 003 Oct 11, 2019 Oct NEWA

ASENAPINE MALEATE TABLET;SUBLINGUAL SAPHRIS + ALLERGAN EQ 2.5 BASE N 022117 003 Mar 12, 2015 Oct CAHN + EQ 5MG BASE N 022117 001 Aug 13, 2009 Oct CAHN +! EQ 10MG BASE N 022117 002 Aug 13, 2009 Oct CAHN + FOREST LABS LLC EQ 5MG BASE N 022117 001 Aug 13, 2009 Feb CTEC +! EQ 10MG BASE N 022117 002 Aug 13, 2009 Feb CTEC

ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL BUTALBITAL, ASPIRIN AND CAFFEINE >D> AA BRECKENRIDGE 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Dec CAHN AA 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Aug CAHN >A> AA PII 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Dec CAHN

>D> ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE >D> TABLET;ORAL >D> ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE >D> SANDOZ 385MG;30MG;25MG A 074654 001 Dec 31, 1996 Dec DISC >A> @ 385MG;30MG;25MG A 074654 001 Dec 31, 1996 Dec DISC >D> AB ! 770MG;60MG;50MG A 074654 002 Dec 31, 1996 Dec DISC >A> @ 770MG;60MG;50MG A 074654 002 Dec 31, 1996 Dec DISC AB ! 770MG;60MG;50MG A 074654 002 Dec 31, 1996 May CTEC >D> ORPHENGESIC FORTE >D> AB GALT PHARMS 770MG;60MG;50MG A 075141 002 May 29, 1998 Dec DISC >A> @ 770MG;60MG;50MG A 075141 002 May 29, 1998 Dec DISC AB 770MG;60MG;50MG A 075141 002 May 29, 1998 May CMFD

ASPIRIN; DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE;ORAL ASPIRIN AND DIPYRIDAMOLE >D> AB ANI PHARMS INC 25MG;200MG A 206964 001 Jan 18, 2017 Dec DISC >A> @ 25MG;200MG A 206964 001 Jan 18, 2017 Dec DISC AB GLENMARK PHARMS LTD 25MG;200MG A 210318 001 May 24, 2019 May NEWA AB GLENMARK PHARMS SA 25MG;200MG A 210318 001 May 24, 2019 Jun CAHN AB LANNETT CO INC 25MG;200MG A 204552 001 Mar 20, 2019 Mar NEWA

ATENOLOL TABLET;ORAL ATENOLOL AB HLTHCARE 25MG A 074052 001 May 01, 1992 Sep CAHN AB 50MG A 073025 001 Sep 17, 1991 Sep CAHN AB 100MG A 073026 001 Sep 17, 1991 Sep CAHN >A> @ INVATECH 25MG A 074265 001 Feb 28, 1994 Dec CAHN >A> @ 50MG A 074265 002 Feb 28, 1994 Dec CAHN >A> @ 100MG A 074265 003 Feb 28, 1994 Dec CAHN >D> @ SANDOZ 25MG A 074265 001 Feb 28, 1994 Dec CAHN >D> @ 50MG A 074265 002 Feb 28, 1994 Dec CAHN >D> @ 100MG A 074265 003 Feb 28, 1994 Dec CAHN @ SUN PHARM INDS INC 25MG A 078210 001 Jul 10, 2007 Oct DISC @ 50MG A 078210 002 Jul 10, 2007 Oct DISC @ 100MG A 078210 003 Jul 10, 2007 Oct DISC @ SUN PHARM INDUSTRIES 25MG A 074499 001 Jul 30, 1997 Oct DISC @ 50MG A 073475 001 Mar 30, 1993 Oct DISC @ 100MG A 073476 001 Mar 30, 1993 Oct DISC AB UNICHEM LABS LTD 25MG A 213136 001 Nov 21, 2019 Nov NEWA AB 50MG A 213136 002 Nov 21, 2019 Nov NEWA AB 100MG A 213136 003 Nov 21, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -15

ATENOLOL; CHLORTHALIDONE TABLET;ORAL ATENOLOL AND CHLORTHALIDONE @ SUN PHARM INDUSTRIES 50MG;25MG A 073582 002 Apr 29, 1993 Oct DISC @ 100MG;25MG A 073582 001 Apr 29, 1993 Oct DISC AB ZYDUS PHARMS 50MG;25MG A 210028 001 Mar 08, 2019 Feb NEWA AB 100MG;25MG A 210028 002 Mar 08, 2019 Feb NEWA

ATOMOXETINE HYDROCHLORIDE CAPSULE;ORAL ATOMOXETINE HYDROCHLORIDE AB ZYDUS PHARMS USA INC 18MG A 079017 001 Sep 17, 2010 Mar CMFD AB 25MG A 079017 002 Sep 17, 2010 Mar CMFD AB 40MG A 079017 003 Sep 17, 2010 Mar CMFD AB 60MG A 079017 004 Sep 17, 2010 Mar CMFD AB 80MG A 079017 005 Sep 17, 2010 Mar CMFD AB 100MG A 079017 006 Sep 17, 2010 Mar CMFD

ATORVASTATIN CALCIUM TABLET;ORAL ATORVASTATIN CALCIUM AB MICRO LABS LTD INDIA EQ 10MG BASE A 205945 001 Nov 07, 2019 Oct NEWA AB EQ 20MG BASE A 205945 002 Nov 07, 2019 Oct NEWA AB EQ 40MG BASE A 205945 003 Nov 07, 2019 Oct NEWA AB EQ 80MG BASE A 205945 004 Nov 07, 2019 Oct NEWA AB MSN EQ 10MG BASE A 211933 001 Feb 08, 2019 Feb NEWA AB EQ 20MG BASE A 211933 002 Feb 08, 2019 Feb NEWA AB EQ 40MG BASE A 211933 003 Feb 08, 2019 Feb NEWA AB EQ 80MG BASE A 211933 004 Feb 08, 2019 Feb NEWA

ATOVAQUONE SUSPENSION;ORAL ATOVAQUONE AB ABHAI LLC 750MG/5ML A 210510 001 May 31, 2019 May NEWA

ATRACURIUM BESYLATE INJECTABLE;INJECTION ATRACURIUM BESYLATE AP HONG KONG 10MG/ML A 091489 001 Feb 17, 2012 Feb CAHN AP MEITHEAL 10MG/ML A 091489 001 Feb 17, 2012 Nov CAHN @ MYLAN LABS LTD 10MG/ML A 206096 001 Jun 22, 2017 Sep DISC ATRACURIUM BESYLATE PRESERVATIVE FREE AP HONG KONG 10MG/ML A 091488 001 Feb 17, 2012 Feb CAHN AP MEITHEAL 10MG/ML A 091488 001 Feb 17, 2012 Nov CAHN @ MYLAN LABS LTD 10MG/ML A 206001 001 Apr 07, 2017 Sep DISC

ATROPINE SOLUTION;INTRAMUSCULAR ATROPEN +! MERIDIAN MEDCL TECHN EQ 0.25MG SULFATE/0.3ML N 017106 004 Sep 17, 2004 Mar CPOT +! EQ 0.5MG SULFATE/0.7ML N 017106 003 Jun 19, 2003 Mar CPOT +! EQ 1MG SULFATE/0.7ML N 017106 002 Jun 19, 2003 Mar CPOT +! EQ 2MG SULFATE/0.7ML N 017106 001 Mar CPOT ATROPINE AB BVI E@ ABBVIE@ EQ 2MG SULFATE/0.7ML A 071295 001 Jan 30, 1987 Mar CDFR

ATROPINE SULFATE SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL ATROPINE SULFATE +! FRESENIUS KABI USA 8MG/20ML (0.4MG/ML) N 209260 001 Jan 26, 2018 May CDFR

AZACITIDINE POWDER;INTRAVENOUS, SUBCUTANEOUS AZACITIDINE @ LUPIN LTD 100MG/VIAL A 210748 001 Feb 27, 2019 Sep DISC AP 100MG/VIAL A 210748 001 Feb 27, 2019 Feb NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -16

AZELAIC ACID CREAM;TOPICAL AZELEX +! ALMIRALL 20% N 020428 001 Sep 13, 1995 Apr CAHN GEL;TOPICAL AZELAIC ACID AB TARO 15% A 210549 001 Aug 23, 2019 Aug NEWA

AZELASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC AZELASTINE HYDROCHLORIDE AT ALEMBIC PHARMS LTD 0.05% A 209620 001 Mar 20, 2019 Mar NEWA AT SOMERSET THERAPS LLC 0.05% A 207411 001 Mar 29, 2019 Mar NEWA SPRAY, METERED;NASAL AZELASTINE HYDROCHLORIDE AB HI TECH EQ 0.125MG BASE/SPRAY A 207610 001 May 17, 2019 May NEWA AB EQ 0.1876MG BASE/SPRAY A 210032 001 Aug 23, 2019 Aug NEWA

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE SPRAY, METERED;NASAL AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE >D> @ APOTEX EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY A 207712 001 Apr 28, 2017 Dec CMFD >A> AB EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY A 207712 001 Apr 28, 2017 Dec CMFD DYMISTA >D> +! MYLAN SPECIALITY LP EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY N 202236 001 May 01, 2012 Dec CTEC >A> AB +! EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY N 202236 001 May 01, 2012 Dec CTEC

AZITHROMYCIN FOR SUSPENSION;ORAL AZITHROMYCIN >D> AB LUPIN LTD EQ 100MG BASE/5ML A 065488 001 May 15, 2015 Dec DISC >A> @ EQ 100MG BASE/5ML A 065488 001 May 15, 2015 Dec DISC >D> AB EQ 200MG BASE/5ML A 065488 002 May 15, 2015 Dec DISC >A> @ EQ 200MG BASE/5ML A 065488 002 May 15, 2015 Dec DISC AB TARO EQ 200MG BASE/5ML A 211521 001 Dec 11, 2019 Nov NEWA TABLET;ORAL AZITHROMYCIN AB BIONPHARMA INC EQ 250MG BASE A 210000 001 Feb 26, 2019 Feb NEWA AB EQ 500MG BASE A 210001 001 Feb 26, 2019 Feb NEWA AB CSPC OUYI EQ 250MG BASE A 208250 001 Apr 17, 2019 Apr NEWA AB ! PLIVA EQ 600MG BASE A 065218 001 Nov 14, 2005 Jul CHRS @ TEVA EQ 250MG BASE A 065153 001 Nov 14, 2005 Jul DISC @ EQ 600MG BASE A 065150 001 Nov 14, 2005 Jul DISC

AZTREONAM INJECTABLE;INJECTION AZACTAM IN PLASTIC CONTAINER + @ BRISTOL MYERS SQUIBB 20MG/ML N 050632 002 May 24, 1989 Jul DISC + @ 40MG/ML N 050632 001 May 24, 1989 Jul DISC

BACLOFEN INJECTABLE;INTRATHECAL BACLOFEN AP MAIA PHARMS INC 0.5MG/ML A 210048 001 Sep 11, 2019 Aug NEWA AP 1MG/ML A 210315 001 Jul 30, 2019 Jul NEWA AP 2MG/ML A 210048 002 Sep 11, 2019 Aug NEWA GABLOFEN AP PIRAMAL CRITICAL 0.05MG/ML N 022462 001 Nov 19, 2010 Aug CAHN AP 0.5MG/ML N 022462 002 Nov 19, 2010 Aug CAHN AP +! 1MG/ML N 022462 004 Jun 22, 2012 Aug CAHN AP 2MG/ML N 022462 003 Nov 19, 2010 Aug CAHN SOLUTION;ORAL OZOBAX +! METACEL PHARMS LLC 5MG/5ML N 208193 001 Sep 18, 2019 Sep NEWA TABLET;ORAL BACLOFEN AB EYWA PHARMA 10MG A 211555 001 Feb 01, 2019 Jan NEWA AB 20MG A 211555 002 Feb 01, 2019 Jan NEWA @ SUN PHARM INDS INC 10MG A 077862 001 Aug 14, 2006 Oct DISC @ 20MG A 077862 002 Aug 14, 2006 Oct DISC AB UPSHER SMITH LABS 10MG A 074584 001 Aug 19, 1996 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -17

TABLET;ORAL BACLOFEN AB 20MG A 074584 002 Aug 19, 1996 Jul CAHN

BALSALAZIDE DISODIUM CAPSULE;ORAL BALSALAZIDE DISODIUM @ MYLAN 750MG A 077807 001 Dec 28, 2007 Feb DISC TABLET;ORAL BALSALAZIDE DISODIUM @ PAR PHARM INC 1.1GM A 206336 001 Sep 08, 2015 Apr DISC GIAZO + @ VALEANT PHARMS INTL 1.1GM N 022205 001 Feb 03, 2012 Apr DISC

BARICITINIB TABLET;ORAL OLUMIANT + ELI LILLY AND CO 1MG N 207924 002 Oct 08, 2019 Oct NEWA

BARIUM SULFATE FOR SUSPENSION;ORAL VARIBAR THIN LIQUID +! BRACCO 81% (120GM/BOT) N 208036 004 Apr 30, 2019 May NEWA SUSPENSION;ORAL READI-CAT 2 SMOOTHIE +! BRACCO 2% (9GM/BOT) N 208143 002 Jan 15, 2016 Sep CMS1

BELINOSTAT POWDER;INTRAVENOUS BELEODAQ +! ACROTECH 500MG/VIAL N 206256 001 Jul 03, 2014 Mar CAHN

BENAZEPRIL HYDROCHLORIDE TABLET;ORAL BENAZEPRIL HYDROCHLORIDE >D> AB ANI PHARMS INC 5MG A 076333 001 Feb 11, 2004 Dec DISC >A> @ 5MG A 076333 001 Feb 11, 2004 Dec DISC >D> AB 10MG A 076333 002 Feb 11, 2004 Dec DISC >A> @ 10MG A 076333 002 Feb 11, 2004 Dec DISC >D> AB 20MG A 076333 003 Feb 11, 2004 Dec DISC >A> @ 20MG A 076333 003 Feb 11, 2004 Dec DISC >D> AB 40MG A 076333 004 Feb 11, 2004 Dec DISC >A> @ 40MG A 076333 004 Feb 11, 2004 Dec DISC @ HERITAGE PHARMA 5MG A 076267 001 Feb 11, 2004 Feb CAHN @ 10MG A 076267 002 Feb 11, 2004 Feb CAHN @ 20MG A 076267 003 Feb 11, 2004 Feb CAHN @ 40MG A 076267 004 Feb 11, 2004 Feb CAHN

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET;ORAL BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE @ ANI PHARMS INC 5MG;6.25MG A 076342 001 Feb 11, 2004 May CAHN @ 10MG;12.5MG A 076342 002 Feb 11, 2004 May CAHN @ 20MG;12.5MG A 076342 003 Feb 11, 2004 May CAHN @ 20MG;25MG A 076342 004 Feb 11, 2004 May CAHN

BENDAMUSTINE HYDROCHLORIDE POWDER;IV (INFUSION) TREANDA +! CEPHALON 25MG/VIAL N 022249 002 May 01, 2009 Feb CTEC +! 100MG/VIAL N 022249 001 Mar 20, 2008 Feb CTEC

BENZONATATE CAPSULE;ORAL BENZONATATE AA ASCENT PHARMS INC 100MG A 211518 001 Feb 22, 2019 Feb NEWA AA 150MG A 211518 002 Feb 22, 2019 Feb NEWA AA 200MG A 211518 003 Feb 22, 2019 Feb NEWA AA CSPC OUYI 100MG A 202765 002 Aug 25, 2017 Feb CAHN AA 200MG A 202765 001 Jul 31, 2015 Feb CAHN AA QINGDAO BAHEAL PHARM 100MG A 210562 001 Nov 09, 2018 May CAHN AA 150MG A 210562 002 Nov 09, 2018 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -18

CAPSULE;ORAL BENZONATATE AA 200MG A 210562 003 Nov 09, 2018 May CAHN @ SUN PHARM INDS INC 100MG A 040587 001 Mar 19, 2008 Oct DISC @ 200MG A 040587 002 Mar 19, 2008 Oct DISC

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL ACANYA AB +! BAUSCH 2.5%;EQ 1.2% BASE N 050819 001 Oct 23, 2008 Aug CAHN BENZACLIN AB +! BAUSCH 5%;EQ 1% BASE N 050756 001 Dec 21, 2000 Aug CAHN @ 5%;EQ 1% BASE N 050756 002 Apr 20, 2007 Aug CAHN CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE @ ANDA REPOSITORY 2.5%;EQ 1.2% BASE A 207194 001 Aug 19, 2019 Oct DISC AB 2.5%;EQ 1.2% BASE A 207194 001 Aug 19, 2019 Aug NEWA AB GLENMARK PHARMS 5%;EQ 1% BASE A 209252 001 Mar 14, 2019 Jun CMS1 AB 5%;1% BASE A 209252 001 Mar 14, 2019 Mar NEWA AB PERRIGO ISRAEL 2.5%;EQ 1.2% BASE A 205397 001 Sep 09, 2019 Aug NEWA AB PERRIGO UK FINCO 5%;EQ 1% BASE A 202440 001 Sep 21, 2015 May CAHN AB TARO 2.5%;EQ 1.2% BASE A 206575 001 Aug 19, 2019 Aug NEWA @ 3.75%;EQ 1.2% BASE A 208683 001 Jun 05, 2018 May DISC ONEXTON +! BAUSCH 3.75%;EQ 1.2% BASE N 050819 002 Nov 24, 2014 Aug CAHN +! DOW PHARM 3.75%;EQ 1.2% BASE N 050819 002 Nov 24, 2014 May CTEC

BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL AKTIPAK + @ BIOFRONTERA 5%;3% N 050769 001 Nov 27, 2000 Aug DISC +! 5%;3% N 050769 001 Nov 27, 2000 May CAHN

BENZTROPINE MESYLATE INJECTABLE;INJECTION BENZTROPINE MESYLATE @ LUITPOLD 1MG/ML A 091152 001 Mar 29, 2010 Feb DISC TABLET;ORAL BENZTROPINE MESYLATE AA ! ASPEN GLOBAL INC 0.5MG A 204713 001 Apr 14, 2015 Apr CHRS AA ! 1MG A 204713 002 Apr 14, 2015 Apr CHRS AA ! 2MG A 204713 003 Apr 14, 2015 Apr CHRS @ OXFORD PHARMS 0.5MG A 040706 002 Feb 14, 2008 Mar DISC @ 1MG A 040706 003 Feb 14, 2008 Mar DISC @ UPSHER SMITH LABS 0.5MG A 040103 001 Dec 12, 1996 Jul CAHN @ 1MG A 040103 002 Dec 12, 1996 Jul CAHN @ 2MG A 040103 003 Dec 12, 1996 Jul CAHN @ USL PHARMA 0.5MG A 040103 001 Dec 12, 1996 Apr DISC @ 1MG A 040103 002 Dec 12, 1996 Apr DISC @ 2MG A 040103 003 Dec 12, 1996 Apr DISC

BENZYL ALCOHOL LOTION;TOPICAL ULESFIA + @ SHIONOGI INC 5% N 022129 001 Apr 09, 2009 Sep DISC

BEPOTASTINE BESILATE SOLUTION/DROPS;OPHTHALMIC BEPOTASTINE BESILATE AP OTE X@ APOTEX@ 1.5% A 206066 001 Mar 05, 2019 Sep DISC AT APOTEX INC 1.5% A 206066 001 Mar 05, 2019 Feb NFTG AT MICRO LABS 1.5% A 206220 001 Mar 18, 2019 Mar NEWA AT MYLAN 1.5% A 206220 001 Mar 18, 2019 Apr CAHN BEPREVE AT +! BAUSCH AND LOMB INC 1.5% N 022288 001 Sep 08, 2009 Feb CFTG

BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL BETAMETHASONE DIPROPIONATE AB PERRIGO ISRAEL EQ 0.05% BASE A 076592 001 Dec 09, 2003 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -19

LOTION, AUGMENTED;TOPICAL BETAMETHASONE DIPROPIONATE AB HI TECH EQ 0.05% BASE A 208849 001 Oct 11, 2019 Sep NEWA OINTMENT, AUGMENTED;TOPICAL BETAMETHASONE DIPROPIONATE >A> AB LUPIN LTD EQ 0.05% BASE A 209106 001 Dec 18, 2019 Dec NEWA SPRAY;TOPICAL SERNIVO +! ENCORE DERMAT EQ 0.05% BASE/SPRAY N 208079 001 Feb 05, 2016 Mar CAHN

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE OINTMENT;TOPICAL CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE AB PERRIGO ISRAEL 0.064%;0.005% A 200174 001 Dec 12, 2014 Mar CAIN AB PERRIGO UK FINCO 0.064%;0.005% A 200174 001 Dec 12, 2014 May CAHN AB TOLMAR 0.064%;0.005% A 201615 001 Jan 14, 2013 Mar CAIN TACLONEX AB +! LEO PHARMA AS 0.064%;0.005% N 021852 001 Jan 09, 2006 Mar CAIN SUSPENSION;TOPICAL TACLONEX +! LEO PHARMA AS 0.064%;0.005% N 022185 001 May 09, 2008 Mar CAIN

BETAMETHASONE VALERATE LOTION;TOPICAL BETAMETHASONE VALERATE AB ANIMA EQ 0.1% BASE A 070052 001 Jul 31, 1985 Sep CAHN

BETHANECHOL CHLORIDE TABLET;ORAL BETHANECHOL CHLORIDE >A> AA ECI PHARMS LLC 5MG A 040728 002 Oct 26, 2007 Dec CMS1 >A> AA 10MG A 040728 003 Oct 26, 2007 Dec CMS1 >A> AA 25MG A 040728 004 Oct 26, 2007 Dec CMS1 DUVOID AA CHARTWELL RX 10MG A 086262 001 Mar CAHN AA 25MG A 086263 001 Mar CAHN AA 50MG A 085882 003 Mar CAHN

BEXAROTENE GEL;TOPICAL TARGRETIN +! BAUSCH 1% N 021056 001 Jun 28, 2000 Jun CAHN

BICALUTAMIDE TABLET;ORAL BICALUTAMIDE @ FRESENIUS KABI USA 50MG A 079045 001 May 13, 2010 Oct DISC AB 50MG A 079045 001 May 13, 2010 Feb CAHN AB KENTON 50MG A 091011 001 Jun 10, 2015 Jun CAHN @ TEVA 50MG A 076932 001 Jul 06, 2009 Sep DISC

BIMATOPROST SOLUTION/DROPS;OPHTHALMIC BIMATOPROST AT ALEMBIC PHARMS LTD 0.03% A 210263 001 Apr 12, 2019 Apr NEWA AT GLAND PHARMA LTD 0.03% A 210126 001 Mar 22, 2019 Mar NEWA @ HI-TECH PHARMA CO 0.03% A 203299 001 Nov 08, 2018 Jul DISC AT SOMERSET THERAPS LLC 0.03% A 207601 001 Jun 19, 2019 Jun NEWA

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL PYLERA +! ALLERGAN 140MG;125MG;125MG N 050786 001 Sep 28, 2006 Nov CAIN

BISOPROLOL FUMARATE TABLET;ORAL BISOPROLOL FUMARATE AB FRONTIDA BIOPHARM 5MG A 075474 001 Oct 25, 2002 Jul CMFD @ 5MG A 075474 001 Oct 25, 2002 Jan CAHN AB 10MG A 075474 002 Oct 25, 2002 Jul CMFD @ 10MG A 075474 002 Oct 25, 2002 Jan CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -20

TABLET;ORAL BISOPROLOL FUMARATE @ MYLAN 5MG A 075831 001 Dec 14, 2005 Nov DISC @ 10MG A 075831 002 Dec 14, 2005 Nov DISC AB 10MG A 075831 002 Dec 14, 2005 Jul CHRS AB ! UNICHEM PHARMS (USA) 10MG A 078635 002 Aug 18, 2009 Jul CHRS

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET;ORAL BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE @ MYLAN 2.5MG;6.25MG A 075768 001 Sep 25, 2000 Jul DISC @ 5MG;6.25MG A 075768 002 Sep 25, 2000 Jul DISC @ 10MG;6.25MG A 075768 003 Sep 25, 2000 Jul DISC

BIVALIRUDIN SOLUTION;INTRAVENOUS ANGIOMAX RTU +! MAIA PHARMS INC 250MG/50ML (5MG/ML) N 211215 001 Jul 25, 2019 Jul NEWA

BLEOMYCIN SULFATE INJECTABLE;INJECTION BLEOMYCIN SULFATE AP CIPLA EQ 15 UNITS BASE/VIAL A 209439 001 Mar 11, 2019 Feb NEWA AP MEITHEAL EQ 15 UNITS BASE/VIAL A 205030 001 Apr 20, 2018 Nov CAHN AP EQ 30 UNITS BASE/VIAL A 205030 002 Apr 20, 2018 Nov CAHN

BORTEZOMIB POWDER;INTRAVENOUS BORTEZOMIB DR REDDYS LABS LTD 3.5MG/VIAL N 206927 001 Oct 04, 2019 Oct NEWA POWDER;INTRAVENOUS, SUBCUTANEOUS BORTEZOMIB + @ HOSPIRA INC 1MG/VIAL N 209191 002 Dec 28, 2018 Mar DISC

BOSENTAN TABLET;ORAL BOSENTAN @ ALVOGEN PINE BROOK 62.5MG A 206002 001 Apr 26, 2019 Oct DISC AB 62.5MG A 206002 001 Apr 26, 2019 Apr NFTG @ 125MG A 206002 002 Apr 26, 2019 Oct DISC AB 125MG A 206002 002 Apr 26, 2019 Apr NFTG AB AMNEAL PHARMS CO 62.5MG A 209742 001 Apr 26, 2019 Apr NFTG AB 125MG A 209742 002 Apr 26, 2019 Apr NFTG >A> AB CIPLA 62.5MG A 210342 001 Jan 03, 2020 Dec NEWA >A> AB 125MG A 210342 002 Jan 03, 2020 Dec NEWA >A> AB MYLAN 62.5MG A 205173 001 Jan 15, 2020 Dec NEWA >A> AB 125MG A 205173 002 Jan 15, 2020 Dec NEWA AB NATCO PHARMA LTD 62.5MG A 206987 001 Apr 26, 2019 Apr NFTG AB 125MG A 206987 002 Apr 26, 2019 Apr NFTG AB PAR PHARM INC 62.5MG A 205699 001 Apr 26, 2019 Apr NFTG AB 125MG A 205699 002 Apr 26, 2019 Apr NFTG AB SUN PHARM 62.5MG A 209324 001 Apr 26, 2019 Apr NFTG AB 125MG A 209324 002 Apr 26, 2019 Apr NFTG AB WATSON LABS INC 62.5MG A 207110 001 Apr 26, 2019 Apr NFTG AB 125MG A 207110 002 Apr 26, 2019 Apr NFTG AB ZYDUS PHARMS 62.5MG A 207760 001 Apr 26, 2019 Apr NFTG AB 125MG A 207760 002 Apr 26, 2019 Apr NFTG TRACLEER AB + ACTELION PHARMS LTD 62.5MG N 021290 001 Nov 20, 2001 Apr CFTG AB +! 125MG N 021290 002 Nov 20, 2001 Apr CFTG

BREMELANOTIDE ACETATE SOLUTION;SUBCUTANEOUS VYLEESI (AUTOINJECTOR) +! AMAG PHARMS INC EQ 1.75MG BASE/0.3ML (EQ 1.75MG N 210557 001 Jun 21, 2019 Jun NEWA BASE/0.3 ML) RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -21

BRETYLIUM TOSYLATE INJECTABLE;INJECTION BRETYLIUM TOSYLATE ! BAS ANDA 50MG/ML A 204386 001 Dec 21, 2018 Jun CAHN ! BRECKENRIDGE 50MG/ML A 204386 001 Dec 21, 2018 Aug CAHN

BREXANOLONE SOLUTION;INTRAVENOUS ZULRESSO +! SAGE THERAP 100MG/20ML (5MG/ML) N 211371 001 Jun 17, 2019 Jun NEWA

>A> BRILLIANT BLUE G >A> SOLUTION;OPHTHALMIC >A> TISSUEBLUE >A> +! DUTCH OPHTHALMIC 0.025% N 209569 001 Dec 20, 2019 Dec NEWA

BRIMONIDINE TARTRATE SOLUTION/DROPS;OPHTHALMIC BRIMONIDINE TARTRATE AT SOMERSET THERAPS LLC 0.2% A 208992 001 Mar 11, 2019 Feb NEWA

BROMFENAC SODIUM SOLUTION/DROPS;OPHTHALMIC BROMFENAC SODIUM AT2 ALEMBIC PHARMS LTD EQ 0.09% ACID A 210560 001 Jun 21, 2019 Jun NEWA AT2 ! HI TECH EQ 0.09% ACID A 203395 001 Jan 22, 2014 May CTEC AT2 INNOPHARMA LICENSING EQ 0.09% ACID A 203368 001 Jun 03, 2019 May NEWA AT2 MYLAN EQ 0.09% ACID A 203368 001 Jun 03, 2019 Nov CAHN @ VISTAPHARM EQ 0.09% ACID A 201941 001 Feb 10, 2015 Nov CAHN

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE @ VINTAGE PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A 202940 001 Jul 21, 2014 Nov DISC

BUDESONIDE CAPSULE;ORAL BUDESONIDE AB APPCO 3MG A 207367 001 Apr 07, 2017 Feb CAHN CAPSULE, EXTENDED RELEASE;ORAL ORTIKOS + SUN PHARMA GLOBAL 6MG N 211929 001 Jun 13, 2019 Jun NEWA +! 9MG N 211929 002 Jun 13, 2019 Jun NEWA SUSPENSION;INHALATION BUDESONIDE AN NEPHRON 0.25MG/2ML A 078202 001 Mar 30, 2009 Sep CAHN AN 0.5MG/2ML A 078202 002 Mar 30, 2009 Sep CAHN TABLET, EXTENDED RELEASE;ORAL UCERIS AB +! SALIX 9MG N 203634 001 Jan 14, 2013 Mar CAHN

BUMETANIDE TABLET;ORAL BUMETANIDE >A> AB CEYONE 0.5MG A 212019 001 Dec 12, 2019 Dec NEWA >A> AB 1MG A 212019 002 Dec 12, 2019 Dec NEWA >A> AB 2MG A 212019 003 Dec 12, 2019 Dec NEWA AB HERITAGE PHARMA 0.5MG A 074225 001 Apr 24, 1995 Feb CAHN AB 1MG A 074225 002 Apr 24, 1995 Feb CAHN AB 2MG A 074225 003 Apr 24, 1995 Feb CAHN

BUPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION BUPIVACAINE HYDROCHLORIDE @ MYLAN ASI 0.25% A 091503 001 Oct 18, 2011 Sep DISC @ 0.5% A 091503 002 Oct 18, 2011 Sep DISC @ NOVOCOL HEALTHCARE 0.5% A 211096 001 Feb 19, 2019 Jun DISC AP 0.5% A 211096 001 Feb 19, 2019 Feb NEWA BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE @ MYLAN ASI 0.25% A 091487 002 Oct 18, 2011 Sep DISC @ 0.5% A 091487 001 Oct 18, 2011 Sep DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -22

INJECTABLE;INJECTION BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE @ 0.75% A 091487 003 Oct 18, 2011 Sep DISC INJECTABLE;SPINAL BUPIVACAINE HYDROCHLORIDE AP B BRAUN MEDICAL INC 0.75% A 209087 001 Apr 02, 2019 Mar NEWA >A> AP HUONS 0.75% A 212822 001 Dec 30, 2019 Dec NEWA

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE + @ HOSPIRA 0.5%;0.0091MG/ML N 022046 001 Jul 13, 1983 Sep CMS1 ! SEPTODONT 0.5%;0.0091MG/ML A 077250 001 Sep 27, 2006 Sep CHRS 0.5%;0.0091MG/ML A 077250 001 Sep 27, 2006 Sep CTEC BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE + @ HOSPIRA 0.5%;0.0091MG/ML N 022046 001 Jul 13, 1983 Sep DISC

BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE @ BARR EQ 2MG BASE A 090360 001 May 07, 2010 Jul DISC @ EQ 8MG BASE A 090360 002 May 07, 2010 Jul DISC @ MYLAN EQ 2MG BASE A 201066 001 Mar 06, 2015 Sep DISC @ EQ 8MG BASE A 201066 002 Mar 06, 2015 Sep DISC

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE AB ALVOGEN PINE BROOK EQ 2MG BASE;EQ 0.5MG BASE A 205954 001 Jan 24, 2019 Jan NEWA AB EQ 4MG BASE;EQ 1MG BASE A 205954 002 Jan 24, 2019 Jan NEWA AB EQ 8MG BASE;EQ 2MG BASE A 205954 003 Jan 24, 2019 Jan NEWA AB EQ 12MG BASE;EQ 3MG BASE A 205954 004 Jan 24, 2019 Jan NEWA FILM;SUBLINGUAL CASSIPA + @ TEVA PHARMS USA EQ 16MG BASE;EQ 4MG BASE N 208042 001 Sep 07, 2018 Mar DISC TABLET;SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE @ TEVA PHARMS USA EQ 2MG BASE;EQ 0.5MG BASE A 091149 001 Sep 08, 2014 Jan DISC @ EQ 8MG BASE;EQ 2MG BASE A 091149 002 Sep 08, 2014 Jan DISC

BUPROPION HYDROCHLORIDE TABLET;ORAL BUPROPION HYDROCHLORIDE AB APNAR PHARMA LP 75MG A 075584 001 Feb 07, 2000 Jun CAHN AB 100MG A 075584 002 Feb 07, 2000 Jun CAHN @ HERITAGE PHARMA 75MG A 075310 001 Nov 29, 1999 May CAHN @ 100MG A 075310 002 Nov 29, 1999 May CAHN >A> @ INVATECH 75MG A 075613 002 Oct 10, 2000 Dec CAHN >A> @ 100MG A 075613 001 Oct 10, 2000 Dec CAHN >D> @ SANDOZ 75MG A 075613 002 Oct 10, 2000 Dec CAHN >D> @ 100MG A 075613 001 Oct 10, 2000 Dec CAHN TABLET, EXTENDED RELEASE;ORAL BUPROPION HYDROCHLORIDE AB2 ! ACTAVIS LABS FL INC 150MG A 079094 001 Mar 24, 2009 Jul CHRS AB3 GRAVITI PHARMS 150MG A 211020 001 Jan 28, 2019 Jan NEWA AB3 300MG A 211020 002 Jan 28, 2019 Jan NEWA @ MYLAN 100MG A 090325 001 Apr 08, 2010 Nov DISC @ 150MG A 090325 002 Apr 08, 2010 Nov DISC @ 150MG A 090941 001 May 03, 2010 Nov DISC @ 150MG A 090942 001 Jul 14, 2010 Jul DISC @ 200MG A 090325 003 Apr 08, 2010 Nov DISC @ 300MG A 090942 002 Jul 14, 2010 Oct DISC @ SUN PHARM 150MG A 200695 001 Dec 18, 2014 Sep DISC @ YICHANG HUMANWELL 100MG A 211347 001 Oct 16, 2018 Apr DISC @ 150MG A 211347 002 Oct 16, 2018 Apr DISC @ 200MG A 211347 003 Oct 16, 2018 Apr DISC AB3 ZHEJIANG JUTAI PHARM 300MG A 211200 001 Sep 05, 2019 Aug NEWA ZYBAN + @ GLAXOSMITHKLINE 150MG N 020711 003 May 14, 1997 Jul DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -23

BUSPIRONE HYDROCHLORIDE TABLET;ORAL BUSPIRONE HYDROCHLORIDE AB EPIC PHARMA LLC 5MG A 208972 001 Apr 16, 2019 Apr NEWA AB 7.5MG A 208972 002 Apr 16, 2019 Apr NEWA AB 10MG A 208972 003 Apr 16, 2019 Apr NEWA AB 15MG A 208972 004 Apr 16, 2019 Apr NEWA AB 30MG A 208972 005 Apr 16, 2019 Apr NEWA @ RUBICON 5MG A 075521 001 Apr 05, 2002 Aug CAHN @ 10MG A 075521 002 Apr 05, 2002 Aug CAHN @ 15MG A 075521 003 Apr 05, 2002 Aug CAHN AB UNICHEM LABS LTD 5MG A 210907 001 Nov 14, 2019 Oct NEWA AB 10MG A 210907 002 Nov 14, 2019 Oct NEWA AB 15MG A 210907 003 Nov 14, 2019 Oct NEWA AB 30MG A 210907 004 Nov 14, 2019 Oct NEWA

BUSULFAN INJECTABLE;INJECTION BUSULFAN AP ACCORD HLTHCARE INC 6MG/ML A 210148 001 Feb 22, 2019 Feb NEWA AP APOTEX 6MG/ML A 210448 001 May 07, 2019 Apr NEWA AP ATHENEX INC 6MG/ML A 205106 001 Sep 21, 2018 Jan CAHN AP HOSPIRA INC 6MG/ML A 205672 001 Jul 31, 2018 Sep CMFD @ 6MG/ML A 205672 001 Jul 31, 2018 Feb DISC AP SHILPA MEDICARE LTD 6MG/ML A 210931 001 Apr 18, 2019 Apr NEWA MYLERAN AP MYLAN INSTITUTIONAL 6MG/ML A 208536 001 Nov 20, 2017 Jul CAHN

CABERGOLINE TABLET;ORAL CABERGOLINE @ ACTAVIS LABS FL INC 0.5MG A 078035 001 Apr 21, 2008 Aug DISC

CAFFEINE CITRATE SOLUTION;INTRAVENOUS CAFCIT AP +! HIKMA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N 020793 001 Sep 21, 1999 Aug CAHN SOLUTION;ORAL CAFCIT AA +! HIKMA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N 020793 002 Apr 12, 2000 Aug CAHN CAFFEINE CITRATE @ LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A 090064 001 Nov 20, 2009 Mar DISC >A> AA MICRO LABS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A 213202 001 Dec 16, 2019 Dec NEWA

CAFFEINE; ERGOTAMINE TARTRATE SUPPOSITORY;RECTAL MIGERGOT ! COSETTE 100MG;2MG A 086557 001 Oct 04, 1983 Jul CAHN

CALCITONIN SALMON INJECTABLE;INJECTION MIACALCIN + @ MYLAN IRELAND LTD 100 IU/ML N 017808 001 Jul 03, 1986 Aug CRLD

CALCITRIOL CAPSULE;ORAL CALCITRIOL @ SUN PHARM 0.25MCG A 204556 001 Feb 21, 2019 Jul DISC AB 0.25MCG A 204556 001 Feb 21, 2019 Feb NEWA @ 0.5MCG A 204556 002 Feb 21, 2019 Jul DISC AB 0.5MCG A 204556 002 Feb 21, 2019 Feb NEWA SOLUTION;ORAL CALCITRIOL AA ELYSIUM 1MCG/ML A 209798 001 Nov 21, 2018 Sep CAHN

CALCIUM ACETATE TABLET;ORAL CALCIUM ACETATE AB CHARTWELL MOLECULAR 667MG A 202420 001 Feb 05, 2013 Jan CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -24

CALCIUM CHLORIDE INJECTABLE;INJECTION CALCIUM CHLORIDE 10% AP MEDEFIL INC 100MG/ML A 211553 001 May 01, 2019 Apr NEWA

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/10 N 020183 001 Dec 04, 1992 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/10 N 020183 002 Dec 04, 1992 Aug CTEC 0ML;538MG/100ML;448MG/100ML + 18.3MG/100ML;2.5GM/100ML;5.08MG/10 N 020183 002 Dec 04, 1992 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER + @ BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/10 N 020183 003 Dec 04, 1992 Sep DISC 0ML;538MG/100ML;448MG/100ML + 18.3MG/100ML;3.5GM/100ML;5.08MG/10 N 020183 003 Dec 04, 1992 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/1 N 020183 004 Dec 04, 1992 Aug CTEC 00ML;538MG/100ML;448MG/100ML + 18.3MG/100ML;4.25GM/100ML;5.08MG/1 N 020183 004 Dec 04, 1992 Jun CRLD 00ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/10 N 017512 012 Jan 10, 1989 Aug NEWA 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/10 N 017512 013 Jul 11, 1990 Aug NEWA 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/10 N 017512 014 Jul 11, 1990 Aug NEWA 0ML;538MG/100ML;448MG/100ML DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/1 N 017512 015 Jul 11, 1990 Aug NEWA 00ML;538MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/10 N 017512 004 Jun CRLD 0ML;538MG/100ML;448MG/100ML AT + 25.7MG/100ML;1.5GM/100ML;5.08MG/10 N 017512 004 Aug CPOT 0ML;538MG/100ML;448MG/100ML AT + 25.7MG/100ML;1.5GM/100ML;5.08MG/10 N 020163 001 Dec 04, 1992 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/10 N 017512 005 Jun CRLD 0ML;538MG/100ML;448MG/100ML AT + 25.7MG/100ML;2.5GM/100ML;5.08MG/10 N 020163 002 Dec 04, 1992 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER + @ BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/10 N 017512 011 Nov 18, 1985 Jun CRLD 0ML;538MG/100ML;448MG/100ML DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER AT + BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/1 N 017512 006 Jun CRLD 00ML;538MG/100ML;448MG/100ML AT + 25.7MG/100ML;4.25GM/100ML;5.08MG/1 N 020163 003 Dec 04, 1992 Jun CRLD 00ML;538MG/100ML;448MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION LACTATED RINGER'S IN PLASTIC CONTAINER AP FRESENIUS KABI USA 20MG/100ML;30MG/100ML;600MG/100ML; A 209338 001 Jan 28, 2019 Jan NEWA 310MG/100ML

CAPECITABINE TABLET;ORAL CAPECITABINE AB SUN PHARM 150MG A 204668 001 Jun 21, 2019 Jun NEWA AB 500MG A 204668 002 Jun 21, 2019 Jun NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -25

CAPTOPRIL TABLET;ORAL CAPTOPRIL >A> AB AJANTA PHARMA LTD 12.5MG A 212809 001 Dec 13, 2019 Dec NEWA >A> AB 25MG A 212809 002 Dec 13, 2019 Dec NEWA >A> AB 50MG A 212809 003 Dec 13, 2019 Dec NEWA >A> AB 100MG A 212809 004 Dec 13, 2019 Dec NEWA AB BOSCOGEN 12.5MG A 074677 004 May 30, 1997 Jun CMFD AB 25MG A 074677 002 May 30, 1997 Jun CMFD AB 50MG A 074677 001 May 30, 1997 Jun CMFD AB 100MG A 074677 003 May 30, 1997 Jun CMFD AB SETON PHARMS 12.5MG A 212223 001 Oct 30, 2019 Oct NEWA AB 25MG A 212223 002 Oct 30, 2019 Oct NEWA AB 50MG A 212223 003 Oct 30, 2019 Oct NEWA AB 100MG A 212223 004 Oct 30, 2019 Oct NEWA

CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL CARBAMAZEPINE >D> @ MYLAN IRELAND LTD 100MG A 076697 001 May 20, 2011 Dec CAHN @ 100MG A 076697 001 May 20, 2011 Jul DISC >D> @ 200MG A 076697 002 May 20, 2011 Dec CAHN @ 200MG A 076697 002 May 20, 2011 Jul DISC >D> @ 300MG A 076697 003 May 20, 2011 Dec CAHN @ 300MG A 076697 003 May 20, 2011 Jul DISC >A> @ NOSTRUM LABS INC 100MG A 076697 001 May 20, 2011 Dec CAHN >A> @ 200MG A 076697 002 May 20, 2011 Dec CAHN >A> @ 300MG A 076697 003 May 20, 2011 Dec CAHN CARBATROL AB + SHIRE DEV LLC 100MG N 020712 003 Sep 30, 1997 Jan CAHN AB + 200MG N 020712 001 Sep 30, 1997 Jan CAHN AB +! 300MG N 020712 002 Sep 30, 1997 Jan CAHN TABLET, EXTENDED RELEASE;ORAL CARBAMAZEPINE AB ZYDUS PHARMS 100MG A 205571 001 Feb 07, 2019 Jan NEWA AB 200MG A 205571 002 Feb 07, 2019 Jan NEWA AB 400MG A 205571 003 Feb 07, 2019 Jan NEWA

CARBIDOPA TABLET;ORAL CARBIDOPA AB AUROBINDO PHARMA LTD 25MG A 211055 001 Oct 21, 2019 Oct NEWA

CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL CARBIDOPA, LEVODOPA AND ENTACAPONE @ WOCKHARDT LTD 18.75MG;200MG;75MG A 090833 001 Nov 20, 2012 Aug DISC @ 25MG;200MG;100MG A 090833 002 Nov 20, 2012 Aug DISC @ 31.25MG;200MG;125MG A 090833 003 Nov 20, 2012 Aug DISC @ 37.5MG;200MG;150MG A 090833 004 Nov 20, 2012 Aug DISC @ 50MG;200MG;200MG A 090833 005 Nov 20, 2012 Aug DISC STALEVO 125 + ORION PHARMA 31.25MG;200MG;125MG N 021485 006 Aug 29, 2008 Aug CTEC STALEVO 200 +! ORION PHARMA 50MG;200MG;200MG N 021485 004 Aug 02, 2007 Aug CTEC STALEVO 50 +! ORION PHARMA 12.5MG;200MG;50MG N 021485 001 Jun 11, 2003 Aug CTEC STALEVO 75 + ORION PHARMA 18.75MG;200MG;75MG N 021485 005 Aug 29, 2008 Aug CTEC

CARBIDOPA; LEVODOPA TABLET, EXTENDED RELEASE;ORAL CARBIDOPA AND LEVODOPA AB ALEMBIC PHARMS LTD 25MG;100MG A 210341 001 Jun 05, 2019 May NEWA AB 50MG;200MG A 210341 002 Jun 05, 2019 May NEWA AB ! SUN PHARM INDS 50MG;200MG A 077828 002 Aug 23, 2007 Oct CHRS SINEMET CR + @ MERCK SHARP DOHME 50MG;200MG N 019856 001 May 30, 1991 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -26

CARBINOXAMINE MALEATE SOLUTION;ORAL CARBINOXAMINE MALEATE ! MIKART 4MG/5ML A 040458 001 Apr 25, 2003 Jun CTEC @ VINTAGE PHARMS 4MG/5ML A 040814 001 Feb 26, 2008 Jun DISC SUSPENSION, EXTENDED RELEASE;ORAL KARBINAL ER >A> +! AYTU 4MG/5ML N 022556 001 Mar 28, 2013 Dec CAHN >D> +! TRIS PHARMA INC 4MG/5ML N 022556 001 Mar 28, 2013 Dec CAHN TABLET;ORAL CARBINOXAMINE MALEATE ! MIKART 6MG A 207484 001 May 31, 2016 Mar CHRS @ VINTAGE PHARMS 4MG A 040639 002 May 30, 2008 Nov DISC

CARBOPLATIN INJECTABLE;INTRAVENOUS CARBOPLATIN AP ACCORD HLTHCARE 50MG/5ML (10MG/ML) A 206775 001 Feb 09, 2017 May CDFR AP 150MG/15ML (10MG/ML) A 206775 002 Feb 09, 2017 May CDFR AP 450MG/45ML (10MG/ML) A 206775 003 Feb 09, 2017 May CDFR AP 600MG/60ML (10MG/ML) A 206775 004 Feb 09, 2017 May CDFR @ ACTAVIS TOTOWA 50MG/5ML (10MG/ML) A 078732 001 Feb 06, 2012 Mar CDFR @ 150MG/15ML (10MG/ML) A 078732 002 Feb 06, 2012 Mar CDFR @ 450MG/45ML (10MG/ML) A 078732 003 Feb 06, 2012 Mar CDFR @ 600MG/60ML (10MG/ML) A 078732 004 Feb 06, 2012 Mar CDFR AP AKORN 50MG/5ML (10MG/ML) A 090475 001 Jul 29, 2009 May CDFR AP 150MG/15ML (10MG/ML) A 090475 002 Jul 29, 2009 May CDFR AP 450MG/45ML (10MG/ML) A 090475 003 Jul 29, 2009 May CDFR AP 600MG/60ML (10MG/ML) A 091268 002 Jul 28, 2010 May CDFR AP CIPLA LTD 50MG/5ML (10MG/ML) A 077861 001 Jan 18, 2007 May CDFR AP 150MG/15ML (10MG/ML) A 077861 002 Jan 18, 2007 May CDFR AP 450MG/45ML (10MG/ML) A 077861 003 Jan 18, 2007 May CDFR AP 600MG/60ML (10MG/ML) A 077861 004 Jan 18, 2007 May CDFR AP EUGIA PHARMA 50MG/5ML (10MG/ML) A 205487 001 Mar 28, 2016 May CDFR AP 150MG/15ML (10MG/ML) A 205487 002 Mar 28, 2016 May CDFR AP 450MG/45ML (10MG/ML) A 205487 003 Mar 28, 2016 May CDFR @ FRESENIUS KABI USA 50MG/5ML (10MG/ML) A 077432 001 Sep 29, 2006 Oct DISC AP 50MG/5ML (10MG/ML) A 077432 001 Sep 29, 2006 May CDFR @ 150MG/15ML (10MG/ML) A 077432 002 Sep 29, 2006 Oct DISC AP 150MG/15ML (10MG/ML) A 077432 002 Sep 29, 2006 May CDFR @ 450MG/45ML (10MG/ML) A 077432 003 Sep 29, 2006 Oct DISC AP 450MG/45ML (10MG/ML) A 077432 003 Sep 29, 2006 May CDFR @ 50MG/5ML (10MG/ML) A 077247 001 Oct 21, 2004 Mar CDFR @ 50MG/5ML (10MG/ML) A 077266 001 Feb 15, 2006 Mar CDFR @ 150MG/15ML (10MG/ML) A 077247 002 Oct 21, 2004 Mar CDFR @ 150MG/15ML (10MG/ML) A 077266 002 Feb 15, 2006 Mar CDFR AP 450MG/45ML (10MG/ML) A 077247 003 Oct 21, 2004 Mar CDFR AP 450MG/45ML (10MG/ML) A 077266 003 Feb 15, 2006 May CDFR AP 600MG/60ML (10MG/ML) A 077266 004 Feb 15, 2006 May CDFR AP GLAND PHARMA LTD 150MG/15ML (10MG/ML) A 207324 002 Feb 15, 2017 May CDFR AP 450MG/45ML (10MG/ML) A 207324 003 Feb 15, 2017 May CDFR AP 600MG/60ML (10MG/ML) A 207324 004 Feb 15, 2017 May CDFR AP HONG KONG 50MG/5ML (10MG/ML) A 077096 001 Jun 14, 2005 May CDFR AP 150MG/15ML (10MG/ML) A 077096 002 Jun 14, 2005 May CDFR AP 450MG/45ML (10MG/ML) A 077096 003 Jun 14, 2005 May CDFR AP 600MG/60ML (10MG/ML) A 077096 004 Jun 03, 2013 May CDFR AP HOSPIRA 50MG/5ML (10MG/ML) A 076517 001 Oct 14, 2004 May CDFR AP 150MG/15ML (10MG/ML) A 076517 002 Oct 14, 2004 May CDFR AP 450MG/45ML (10MG/ML) A 076517 003 Oct 14, 2004 May CDFR AP 600MG/60ML (10MG/ML) A 077059 001 Nov 23, 2004 May CDFR AP INGENUS PHARMS LLC 50MG/5ML (10MG/ML) A 208487 001 Apr 26, 2017 May CDFR AP 150MG/15ML (10MG/ML) A 208487 002 Apr 26, 2017 May CDFR AP 450MG/45ML (10MG/ML) A 208487 003 Apr 26, 2017 May CDFR AP 600MG/60ML (10MG/ML) A 208487 004 Apr 26, 2017 May CDFR AP MEITHEAL 50MG/5ML (10MG/ML) A 077096 001 Jun 14, 2005 Nov CAHN AP 150MG/15ML (10MG/ML) A 077096 002 Jun 14, 2005 Nov CAHN AP 450MG/45ML (10MG/ML) A 077096 003 Jun 14, 2005 Nov CAHN AP 600MG/60ML (10MG/ML) A 077096 004 Jun 03, 2013 Nov CAHN @ MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A 077998 001 Apr 24, 2007 Apr CDFR @ 150MG/15ML (10MG/ML) A 077998 002 Apr 24, 2007 Apr CDFR @ 450MG/45ML (10MG/ML) A 077998 003 Apr 24, 2007 Apr CDFR @ MYLAN LABS LTD 50MG/5ML (10MG/ML) A 091063 001 Nov 09, 2011 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -27

INJECTABLE;INTRAVENOUS CARBOPLATIN AP 50MG/5ML (10MG/ML) A 091063 001 Nov 09, 2011 May CDFR @ 150MG/15ML (10MG/ML) A 091063 002 Nov 09, 2011 Oct DISC AP 150MG/15ML (10MG/ML) A 091063 002 Nov 09, 2011 May CDFR @ 450MG/45ML (10MG/ML) A 091063 003 Nov 09, 2011 Oct DISC AP 450MG/45ML (10MG/ML) A 091063 003 Nov 09, 2011 May CDFR @ 600MG/60ML (10MG/ML) A 091063 004 Nov 09, 2011 Oct DISC AP 600MG/60ML (10MG/ML) A 091063 004 Nov 09, 2011 May CDFR @ 1GM/100ML (10MG/ML) A 091478 001 Nov 23, 2011 Mar CDFR AP ! PHARMACHEMIE BV 50MG/5ML (10MG/ML) A 077269 001 Oct 14, 2004 May CDFR @ 50MG/5ML (10MG/ML) A 077679 001 Feb 25, 2009 Mar CDFR AP ! 150MG/15ML (10MG/ML) A 077269 002 Oct 14, 2004 May CDFR @ 150MG/15ML (10MG/ML) A 077679 002 Feb 25, 2009 Mar CDFR AP ! 450MG/45ML (10MG/ML) A 077269 003 Oct 14, 2004 May CDFR @ 450MG/45ML (10MG/ML) A 077679 003 Feb 25, 2009 Mar CDFR AP ! 600MG/60ML (10MG/ML) A 077269 004 Dec 28, 2007 May CDFR AP PLIVA LACHEMA 50MG/5ML (10MG/ML) A 078631 001 Dec 02, 2008 May CDFR AP 150MG/15ML (10MG/ML) A 078631 002 Dec 02, 2008 May CDFR AP 450MG/45ML (10MG/ML) A 078631 003 Dec 02, 2008 May CDFR AP 600MG/60ML (10MG/ML) A 078631 004 Dec 02, 2008 May CDFR AP SANDOZ INC 50MG/5ML (10MG/ML) A 078280 001 May 08, 2008 May CDFR AP 150MG/15ML (10MG/ML) A 078280 002 May 08, 2008 May CDFR AP 450MG/45ML (10MG/ML) A 078280 003 May 08, 2008 May CDFR AP SUN PHARM 50MG/5ML (10MG/ML) A 077926 001 Sep 19, 2008 May CDFR AP 150MG/15ML (10MG/ML) A 077926 002 Sep 19, 2008 May CDFR AP 450MG/45ML (10MG/ML) A 077926 003 Sep 19, 2008 May CDFR @ TEVA PARENTERAL 50MG/5ML (10MG/ML) A 077389 001 Mar 30, 2007 Mar CDFR @ 150MG/15ML (10MG/ML) A 077389 002 Mar 30, 2007 Mar CDFR @ 450MG/45ML (10MG/ML) A 077389 003 Mar 30, 2007 Mar CDFR AP ! TEVA PHARMS USA 50MG/5ML (10MG/ML) A 077139 001 Sep 21, 2005 May CDFR AP ! 150MG/15ML (10MG/ML) A 077139 002 Sep 21, 2005 May CDFR AP ! 450MG/45ML (10MG/ML) A 077139 003 Sep 21, 2005 May CDFR AP ! 600MG/60ML (10MG/ML) A 077139 004 Sep 21, 2005 May CDFR AP WEST-WARD PHARMS INT 50MG/5ML (10MG/ML) A 077244 001 Oct 15, 2004 May CDFR AP 150MG/15ML (10MG/ML) A 077244 002 Oct 15, 2004 May CDFR AP 450MG/45ML (10MG/ML) A 077244 003 Oct 15, 2004 May CDFR AP 600MG/60ML (10MG/ML) A 077244 004 Jan 20, 2006 May CDFR PARAPLATIN + @ CORDENPHARMA 50MG/5ML (10MG/ML) N 020452 001 Jul 14, 2003 Mar CDFR + @ 150MG/15ML (10MG/ML) N 020452 002 Jul 14, 2003 Mar CDFR + @ 450MG/45ML (10MG/ML) N 020452 003 Jul 14, 2003 Mar CDFR + @ 600MG/60ML (10MG/ML) N 020452 004 Jan 15, 2004 Mar CDFR INJECTABLE;IV (INFUSION) CARBOPLATIN AP GLAND PHARMA LTD 50MG/5ML (10MG/ML) A 207324 001 Feb 15, 2017 May CDFR AP HONG KONG 50MG/5ML (10MG/ML) A 077096 001 Jun 14, 2005 Feb CAHN AP 150MG/15ML (10MG/ML) A 077096 002 Jun 14, 2005 Feb CAHN AP 450MG/45ML (10MG/ML) A 077096 003 Jun 14, 2005 Feb CAHN AP 600MG/60ML (10MG/ML) A 077096 004 Jun 03, 2013 Feb CAHN @ MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A 077998 001 Apr 24, 2007 Mar DISC @ 150MG/15ML (10MG/ML) A 077998 002 Apr 24, 2007 Mar DISC @ 450MG/45ML (10MG/ML) A 077998 003 Apr 24, 2007 Mar DISC

CARBOPROST TROMETHAMINE INJECTABLE;INJECTION CARBOPROST TROMETHAMINE AP DR REDDYS LABS LTD EQ 0.25MG BASE/ML A 211941 001 Jul 02, 2019 Jun NFTG HEMABATE AP +! PHARMACIA AND UPJOHN EQ 0.25MG BASE/ML N 017989 001 Jun CFTG

CARFILZOMIB POWDER;INTRAVENOUS CARFILZOMIB AP DR REDDYS 60MG/VIAL A 209422 001 Sep 09, 2019 Aug NFTG KYPROLIS AP +! ONYX THERAP 60MG/VIAL N 202714 001 Jul 20, 2012 Aug CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -28

CARGLUMIC ACID TABLET;ORAL CARBAGLU +! RECORDATI RARE 200MG N 022562 001 Mar 18, 2010 May CAHN

CARISOPRODOL TABLET;ORAL CARISOPRODOL AA ALLIED 350MG A 040245 001 Sep 08, 1997 Aug CMFD @ 350MG A 040245 001 Sep 08, 1997 Jun CAHN @ SUN PHARM INDUSTRIES 350MG A 089346 001 Oct 17, 1991 Oct DISC @ VINTAGE PHARMS 350MG A 040245 001 Sep 08, 1997 Feb DISC

CARMUSTINE INJECTABLE;INJECTION CARMUSTINE AP STI PHARMA LLC 100MG/VIAL A 209278 001 Apr 02, 2019 Mar NEWA

CARTEOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC CARTEOLOL HYDROCHLORIDE @ BAUSCH AND LOMB 1% A 075546 001 Jan 20, 2000 May DISC ! SANDOZ INC 1% A 075476 001 Jan 03, 2000 May CTEC

CARVEDILOL TABLET;ORAL CARVEDILOL AB RUBICON 3.125MG A 078165 001 Sep 05, 2007 Aug CAHN AB 6.25MG A 078165 002 Sep 05, 2007 Aug CAHN AB 12.5MG A 078165 003 Sep 05, 2007 Aug CAHN AB 25MG A 078165 004 Sep 05, 2007 Aug CAHN @ SUN PHARM INDS INC 3.125MG A 077346 004 Sep 05, 2007 Oct DISC @ 6.25MG A 077346 001 Sep 05, 2007 Oct DISC @ 12.5MG A 077346 002 Sep 05, 2007 Oct DISC @ 25MG A 077346 003 Sep 05, 2007 Oct DISC

CASPOFUNGIN ACETATE POWDER;INTRAVENOUS CASPOFUNGIN ACETATE @ CIPLA 50MG/VIAL A 209489 001 Jul 12, 2018 Jan DISC @ 70MG/VIAL A 209489 002 Jul 12, 2018 Jan DISC >A> AP JIANGSU HENGRUI MED 50MG/VIAL A 200833 001 Jun 28, 2018 Dec CAHN >A> AP 70MG/VIAL A 200833 002 Jun 28, 2018 Dec CAHN >D> AP SANDOZ INC 50MG/VIAL A 200833 001 Jun 28, 2018 Dec CAHN >D> AP 70MG/VIAL A 200833 002 Jun 28, 2018 Dec CAHN

CEFAZOLIN SODIUM INJECTABLE;INJECTION ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER + @ BAXTER HLTHCARE EQ 10MG BASE/ML N 050566 003 Jun 08, 1983 Aug CRLD + @ EQ 20MG BASE/ML N 050566 004 Jun 08, 1983 Aug CRLD ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER + @ BAXTER HLTHCARE EQ 10MG BASE/ML N 050566 001 Jun 08, 1983 Aug CRLD + @ EQ 20MG BASE/ML N 050566 002 Jun 08, 1983 Aug CRLD CEFAZOLIN SODIUM AP ! HIKMA FARMACEUTICA EQ 500MG BASE/VIAL A 065047 001 Sep 18, 2001 Nov CHRS AP ! EQ 1GM BASE/VIAL A 065047 002 Sep 18, 2001 Nov CHRS @ HOSPIRA INC EQ 500MG BASE/VIAL A 065226 001 Apr 21, 2005 Nov DISC @ EQ 1GM BASE/VIAL A 065226 002 Apr 21, 2005 Nov DISC @ EQ 1GM BASE/VIAL A 065244 001 Aug 12, 2005 Oct DISC @ EQ 1GM BASE/VIAL A 201654 001 Feb 03, 2016 Oct DISC >D> AP ! EQ 10GM BASE/VIAL A 065247 001 Aug 12, 2005 Dec DISC >A> @ EQ 10GM BASE/VIAL A 065247 001 Aug 12, 2005 Dec DISC >D> AP QILU EQ 10GM BASE/VIAL A 209217 001 Oct 17, 2018 Dec CHRS >A> AP ! EQ 10GM BASE/VIAL A 209217 001 Oct 17, 2018 Dec CHRS RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -29

CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION CEFEPIME HYDROCHLORIDE @ HOSPIRA INC EQ 500MG BASE/VIAL A 065369 001 Jun 18, 2007 Sep DISC @ EQ 1GM BASE/VIAL A 065369 002 Jun 18, 2007 Sep DISC @ EQ 1GM BASE/VIAL A 202268 001 Jul 30, 2012 Sep DISC @ EQ 2GM BASE/VIAL A 065369 003 Jun 18, 2007 Sep DISC @ EQ 2GM BASE/VIAL A 202268 002 Jul 30, 2012 Sep DISC

CEFIDEROCOL SULFATE TOSYLATE POWDER;INTRAVENOUS FETROJA +! SHIONOGI INC EQ 1GM BASE/VIAL N 209445 001 Nov 14, 2019 Nov NEWA

CEFIXIME FOR SUSPENSION;ORAL CEFIXIME @ SANDOZ INC 100MG/5ML A 206144 001 Nov 17, 2017 Feb DISC @ 200MG/5ML A 206144 002 Nov 17, 2017 Feb DISC SUPRAX AB ! LUPIN PHARMS 200MG/5ML A 065355 001 Apr 10, 2007 Apr CHRS

CEFOTAXIME SODIUM INJECTABLE;INJECTION CEFOTAXIME ! HIKMA EQ 500MG BASE/VIAL A 065072 001 Nov 20, 2002 Nov CTEC ! EQ 1GM BASE/VIAL A 065072 002 Nov 20, 2002 Nov CTEC ! EQ 2GM BASE/VIAL A 065072 003 Nov 20, 2002 Nov CTEC ! EQ 10GM BASE/VIAL A 065071 001 Nov 20, 2002 Nov CTEC @ WOCKHARDT EQ 1GM BASE/VIAL A 065197 001 Aug 29, 2006 Nov DISC CEFOTAXIME SODIUM @ HOSPIRA INC EQ 500MG BASE/VIAL A 065290 001 Aug 11, 2006 Sep DISC @ EQ 1GM BASE/VIAL A 065290 002 Aug 11, 2006 Sep DISC @ EQ 1GM BASE/VIAL A 065293 001 Aug 10, 2006 Sep DISC @ EQ 1GM BASE/VIAL A 203132 001 Feb 19, 2016 Sep DISC @ EQ 2GM BASE/VIAL A 065290 003 Aug 11, 2006 Sep DISC @ EQ 2GM BASE/VIAL A 065293 002 Aug 10, 2006 Sep DISC @ EQ 2GM BASE/VIAL A 203132 002 Feb 19, 2016 Sep DISC @ EQ 10GM BASE/VIAL A 065292 001 Aug 10, 2006 Nov DISC @ WOCKHARDT EQ 500MG BASE/VIAL A 065197 002 Jun 20, 2008 Nov DISC @ EQ 2GM BASE/VIAL A 065197 003 Jun 20, 2008 Nov DISC

CEFOTETAN DISODIUM INJECTABLE;INJECTION CEFOTETAN @ FRESENIUS KABI USA EQ 10GM BASE/VIAL A 065375 001 Aug 09, 2007 Nov DISC @ WEST-WARD PHARM CORP EQ 10GM BASE/VIAL A 091030 001 Oct 26, 2011 Nov DISC

CEFOXITIN SODIUM INJECTABLE;INJECTION CEFOXITIN @ HOSPIRA INC EQ 1GM BASE/VIAL A 065313 001 Jan 23, 2006 Sep DISC @ EQ 2GM BASE/VIAL A 065313 002 Jan 23, 2006 Sep DISC @ EQ 10GM BASE/VIAL A 065312 001 Feb 13, 2006 Sep DISC

CEFPODOXIME PROXETIL FOR SUSPENSION;ORAL CEFPODOXIME PROXETIL AUROBINDO PHARMA LTD EQ 50MG BASE/5ML A 065409 001 Jun 08, 2007 Jan CTEC ! EQ 100MG BASE/5ML A 065409 002 Jun 08, 2007 Jan CHRS EQ 100MG BASE/5ML A 065409 002 Jun 08, 2007 Jan CTEC @ SANDOZ EQ 50MG BASE/5ML A 090031 001 Jan 14, 2009 Jan DISC @ EQ 100MG BASE/5ML A 090031 002 Jan 14, 2009 Jan DISC

CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS CEFTRIAXONE >D> AP HOSPIRA INC EQ 250MG BASE/VIAL A 065230 001 Aug 02, 2005 Dec DISC >A> @ EQ 250MG BASE/VIAL A 065230 001 Aug 02, 2005 Dec DISC >D> AP EQ 500MG BASE/VIAL A 065230 002 Aug 02, 2005 Dec DISC >A> @ EQ 500MG BASE/VIAL A 065230 002 Aug 02, 2005 Dec DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -30

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS CEFTRIAXONE >D> AP EQ 1GM BASE/VIAL A 065230 003 Aug 02, 2005 Dec DISC >A> @ EQ 1GM BASE/VIAL A 065230 003 Aug 02, 2005 Dec DISC >D> AP EQ 2GM BASE/VIAL A 065230 004 Aug 02, 2005 Dec DISC >A> @ EQ 2GM BASE/VIAL A 065230 004 Aug 02, 2005 Dec DISC

CEFUROXIME AXETIL TABLET;ORAL CEFUROXIME AXETIL >D> AB ANI PHARMS INC EQ 250MG BASE A 065190 001 Oct 18, 2004 Dec DISC >A> @ EQ 250MG BASE A 065190 001 Oct 18, 2004 Dec DISC >D> AB EQ 500MG BASE A 065190 002 Oct 18, 2004 Dec DISC >A> @ EQ 500MG BASE A 065190 002 Oct 18, 2004 Dec DISC

CEFUROXIME SODIUM INJECTABLE;INJECTION CEFUROXIME SODIUM @ HOSPIRA INC EQ 1.5GM BASE/VIAL A 065483 002 Oct 15, 2008 Sep DISC @ EQ 1.5GM BASE/VIAL A 065503 001 Oct 15, 2008 Sep DISC @ EQ 7.5GM BASE/VIAL A 065484 001 Oct 15, 2008 Sep DISC INJECTABLE;INTRAMUSCULAR, INTRAVENOUS CEFUROXIME SODIUM @ HOSPIRA INC EQ 750MG BASE/VIAL A 065483 001 Oct 15, 2008 Sep DISC

CELECOXIB CAPSULE;ORAL CELECOXIB AB CADILA PHARMS LTD 50MG A 208701 001 Nov 14, 2019 Nov NEWA AB 100MG A 208701 002 Nov 14, 2019 Nov NEWA AB 200MG A 208701 003 Nov 14, 2019 Nov NEWA AB 400MG A 208701 004 Nov 14, 2019 Nov NEWA AB QINGDAO BAHEAL PHARM 50MG A 208856 001 Aug 07, 2019 Jul NEWA AB 100MG A 208856 002 Aug 07, 2019 Jul NEWA AB 200MG A 208856 003 Aug 07, 2019 Jul NEWA AB 400MG A 208856 004 Aug 07, 2019 Jul NEWA TABLET;ORAL CELECOXIB AB UMEDICA LABS PVT LTD 50MG A 210628 001 Nov 27, 2019 Nov NEWA AB 100MG A 210628 002 Nov 27, 2019 Nov NEWA AB 200MG A 210628 003 Nov 27, 2019 Nov NEWA AB 400MG A 210628 004 Nov 27, 2019 Nov NEWA

CEPHALEXIN CAPSULE;ORAL CEPHALEXIN @ SUN PHARM INDS (IN) EQ 250MG BASE A 062791 001 Jun 11, 1987 Oct DISC @ EQ 500MG BASE A 062791 002 Jun 11, 1987 Oct DISC FOR SUSPENSION;ORAL CEPHALEXIN AB ALKEM LABS LTD EQ 125MG BASE/5ML A 210221 001 Mar 26, 2019 Mar NEWA AB EQ 250MG BASE/5ML A 210221 002 Mar 26, 2019 Mar NEWA

CERITINIB CAPSULE;ORAL ZYKADIA + @ NOVARTIS 150MG N 205755 001 Apr 29, 2014 Jun DISC TABLET;ORAL ZYKADIA +! NOVARTIS 150MG N 211225 001 Mar 18, 2019 Mar NEWA

CETIRIZINE HYDROCHLORIDE SOLUTION;INTRAVENOUS QUZYTTIR +! JDP 10MG/ML (10MG/ML) N 211415 001 Oct 04, 2019 Oct NEWA SYRUP;ORAL CETIRIZINE HYDROCHLORIDE @ LANNETT CO INC 5MG/5ML A 078496 001 Sep 25, 2009 May DISC AA MLV 5MG/5ML A 090191 001 Nov 12, 2009 Aug CAHN AA ! PERRIGO PHARMS CO 5MG/5ML A 078398 001 Jun 17, 2008 May CAHN @ TORRENT 5MG/5ML A 078870 001 Apr 27, 2009 Nov DISC AA 5MG/5ML A 078870 001 Apr 27, 2009 Jan CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -31

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN OINTMENT;TOPICAL ELASE-CHLOROMYCETIN + @ PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM N 050294 001 Aug CRLD

CHLORDIAZEPOXIDE HYDROCHLORIDE INJECTABLE;INJECTION LIBRIUM @ BAUSCH 100MG/AMP N 012301 001 Mar CAHN

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE SOLUTION;ORAL HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE @ ACELLA 4MG/5ML;5MG/5ML A 206891 001 Jun 09, 2017 Aug DISC VITUZ + @ PERSION 4MG/5ML;5MG/5ML N 204307 001 Feb 20, 2013 Aug DISC AA +! 4MG/5ML;5MG/5ML N 204307 001 Feb 20, 2013 Apr CAHN

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION;ORAL HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE >D> AA MAYNE PHARMA INC 4MG/5ML;5MG/5ML;60MG/5ML A 205657 001 Aug 03, 2015 Dec DISC >A> @ 4MG/5ML;5MG/5ML;60MG/5ML A 205657 001 Aug 03, 2015 Dec DISC >D> AA ! PADDOCK LLC 4MG/5ML;5MG/5ML;60MG/5ML A 204627 001 Apr 29, 2014 Dec CTEC >A> ! 4MG/5ML;5MG/5ML;60MG/5ML A 204627 001 Apr 29, 2014 Dec CTEC AA ! 4MG/5ML;5MG/5ML;60MG/5ML A 204627 001 Apr 29, 2014 Jun CHRS @ TORRENT 4MG/5ML;5MG/5ML;60MG/5ML A 206660 001 May 15, 2017 Jan CAHN ZUTRIPRO + @ PERSION 4MG/5ML;5MG/5ML;60MG/5ML N 022439 001 Jun 08, 2011 Jul DISC AA +! 4MG/5ML;5MG/5ML;60MG/5ML N 022439 001 Jun 08, 2011 Apr CAHN

CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE;ORAL CHLORPROMAZINE HYDROCHLORIDE INTENSOL @ HIKMA 30MG/ML A 088157 001 Apr 27, 1983 Sep CAHN @ 100MG/ML A 088158 001 Apr 27, 1983 Sep CAHN TABLET;ORAL CHLORPROMAZINE HYDROCHLORIDE AB UPSHER SMITH LABS 10MG A 083386 001 Jul CAHN AB ! 25MG A 084112 001 Jul CAHN AB 50MG A 084113 001 Jul CAHN AB ! 100MG A 084114 001 Jul CAHN AB 200MG A 084115 001 Jul CAHN

CHLORPROPAMIDE TABLET;ORAL CHLORPROPAMIDE @ MYLAN 100MG A 088549 002 Jun 01, 1984 May DISC @ 250MG A 088549 001 Jun 01, 1984 May DISC

CHLORTHALIDONE TABLET;ORAL CHLORTHALIDONE AB AMNEAL PHARMS CO 25MG A 207204 001 Jul 01, 2019 Jun NEWA AB 50MG A 207204 002 Jul 01, 2019 Jun NEWA AB ARISE 25MG A 210742 001 Oct 12, 2018 Sep CAHN AB 50MG A 210742 002 Oct 12, 2018 Sep CAHN AB UNICHEM LABS LTD 25MG A 211627 001 Aug 06, 2019 Jul NEWA AB 50MG A 211627 002 Aug 06, 2019 Jul NEWA AB ZYDUS PHARMS 25MG A 207813 001 May 10, 2019 Apr NEWA AB 50MG A 207813 002 May 10, 2019 Apr NEWA

CHLORZOXAZONE TABLET;ORAL CHLORZOXAZONE AB ! MIKART 375MG A 040861 001 Jun 01, 2010 Nov CTEC AB ! 750MG A 040861 002 Jun 01, 2010 Nov CTEC AB NOVITIUM PHARMA 375MG A 212253 001 Nov 27, 2019 Nov NEWA AA 500MG A 212254 001 Sep 12, 2019 Sep NEWA AB 750MG A 212253 002 Nov 27, 2019 Nov NEWA AA ! WATSON LABS 500MG A 089859 001 May 04, 1988 Sep CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -32

CHOLESTYRAMINE POWDER;ORAL LOCHOLEST LIGHT >A> @ INVATECH EQ 4GM RESIN/PACKET A 074562 001 Aug 15, 1996 Dec CAHN >A> @ EQ 4GM RESIN/SCOOPFUL A 074562 002 Aug 15, 1996 Dec CAHN >D> @ SANDOZ EQ 4GM RESIN/PACKET A 074562 001 Aug 15, 1996 Dec CAHN >D> @ EQ 4GM RESIN/SCOOPFUL A 074562 002 Aug 15, 1996 Dec CAHN

CHOLINE C-11 INJECTABLE;INTRAVENOUS CHOLINE C-11 AP DECATUR 4-33.1mCi/ML A 206319 001 Nov 13, 2015 Apr CAHN

CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL FENOFIBRIC ACID AB AUROBINDO PHARMA LTD EQ 45MG FENOFIBRIC ACID A 212598 001 Jul 25, 2019 Jul NEWA AB EQ 135MG FENOFIBRIC ACID A 212598 002 Jul 25, 2019 Jul NEWA AB GRAVITI PHARMS EQ 45MG FENOFIBRIC ACID A 211626 001 Jul 18, 2019 Jul NEWA AB EQ 135MG FENOFIBRIC ACID A 211626 002 Jul 18, 2019 Jul NEWA @ MYLAN PHARMS INC EQ 45MG FENOFIBRIC ACID A 200913 001 Mar 25, 2013 May DISC @ EQ 135MG FENOFIBRIC ACID A 200913 002 Mar 25, 2013 May DISC >D> AB TWI PHARMS EQ 45MG FENOFIBRIC ACID A 210469 001 Jul 05, 2019 Dec DISC >A> @ EQ 45MG FENOFIBRIC ACID A 210469 001 Jul 05, 2019 Dec DISC AB EQ 45MG FENOFIBRIC ACID A 210469 001 Jul 05, 2019 Jun NEWA >D> AB EQ 135MG FENOFIBRIC ACID A 210469 002 Jul 05, 2019 Dec DISC >A> @ EQ 135MG FENOFIBRIC ACID A 210469 002 Jul 05, 2019 Dec DISC AB EQ 135MG FENOFIBRIC ACID A 210469 002 Jul 05, 2019 Jun NEWA

CHROMIC PHOSPHATE P-32 INJECTABLE;INJECTION PHOSPHOCOL P32 @ CURIUM 5mCi/ML N 017084 001 Jan CAHN

CICLESONIDE AEROSOL, METERED;INHALATION ALVESCO +! COVIS PHARMA BV 0.08MG/INH N 021658 002 Jan 10, 2008 Mar CAHN +! 0.16MG/INH N 021658 003 Jan 10, 2008 Mar CAHN AEROSOL, METERED;NASAL ZETONNA +! COVIS PHARMA BV 0.037MG/INH N 202129 001 Jan 20, 2012 Mar CAHN SPRAY, METERED;NASAL OMNARIS +! COVIS PHARMA BV 0.05MG/INH N 022004 001 Oct 20, 2006 Mar CAHN

CICLOPIROX CREAM;TOPICAL CICLOPIROX AB PERRIGO ISRAEL 0.77% A 077364 001 Mar 03, 2006 May CAHN SHAMPOO;TOPICAL LOPROX AT +! BAUSCH 1% N 021159 001 Feb 28, 2003 Apr CAHN SOLUTION;TOPICAL CICLOPIROX AT ACELLA 8% A 078172 001 Sep 18, 2007 May CAHN AT ANDA REPOSITORY 8% A 077687 001 Sep 18, 2007 Aug CAHN AT NOVAST LABS 8% A 078124 001 Sep 18, 2007 Sep CAHN

CILASTATIN SODIUM; IMIPENEM POWDER;INTRAVENOUS IMIPENEM AND CILASTATIN @ HOSPIRA INC EQ 500MG BASE/VIAL;500MG/VIAL A 090825 002 Nov 16, 2011 Sep DISC @ EQ 500MG BASE/VIAL;500MG/VIAL A 091007 001 Nov 16, 2011 Sep DISC >A> AP HQ SPCLT PHARMA EQ 500MG BASE/VIAL;500MG/VIAL A 207594 001 Dec 12, 2019 Dec NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -33

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM POWDER;INTRAVENOUS RECARBRIO +! MSD MERCK CO EQ 500MG N 212819 001 Jul 16, 2019 Jul NEWA BASE/VIAL;500MG/VIAL;250MG/VIAL

CILOSTAZOL TABLET;ORAL CILOSTAZOL AB SLATE 50MG A 077208 002 Mar 29, 2006 Aug CAHN AB 100MG A 077208 001 Mar 29, 2006 Aug CAHN

CIMETIDINE HYDROCHLORIDE SOLUTION;ORAL CIMETIDINE HYDROCHLORIDE >D> AA ANI PHARMS INC EQ 300MG BASE/5ML A 074610 001 Sep 26, 1996 Dec DISC >A> @ EQ 300MG BASE/5ML A 074610 001 Sep 26, 1996 Dec DISC

CINACALCET HYDROCHLORIDE TABLET;ORAL CINACALCET HYDROCHLORIDE AB ALKEM LABS LTD EQ 30MG BASE A 210570 001 May 17, 2019 May NEWA AB EQ 60MG BASE A 210570 002 May 17, 2019 May NEWA AB EQ 90MG BASE A 210570 003 May 17, 2019 May NEWA

CIPROFLOXACIN FOR SUSPENSION;ORAL CIPRO >D> AB + BAYER HLTHCARE 250MG/5ML N 020780 001 Sep 26, 1997 Dec CTEC >A> + 250MG/5ML N 020780 001 Sep 26, 1997 Dec CTEC >D> AB +! 500MG/5ML N 020780 002 Sep 26, 1997 Dec CTEC >A> +! 500MG/5ML N 020780 002 Sep 26, 1997 Dec CTEC >D> CIPROFLOXACIN >D> AB LUPIN LTD 250MG/5ML A 200563 001 Mar 05, 2014 Dec DISC >A> @ 250MG/5ML A 200563 001 Mar 05, 2014 Dec DISC >D> AB 500MG/5ML A 200563 002 Mar 05, 2014 Dec DISC >A> @ 500MG/5ML A 200563 002 Mar 05, 2014 Dec DISC INJECTABLE;INJECTION CIPROFLOXACIN @ DR REDDYS 200MG/20ML (10MG/ML) A 077782 001 Aug 28, 2006 May CAHN @ 400MG/40ML (10MG/ML) A 077782 002 Aug 28, 2006 May CAHN

CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC CIPROFLOXACIN HYDROCHLORIDE @ RUBICON EQ 0.3% BASE A 075928 001 Jun 09, 2004 Jul CAHN TABLET;ORAL CIPROFLOXACIN HYDROCHLORIDE AB CHARTWELL EQ 250MG BASE A 076896 001 Nov 04, 2004 Sep CAHN AB EQ 500MG BASE A 076896 002 Nov 04, 2004 Sep CAHN AB EQ 750MG BASE A 076896 003 Nov 04, 2004 Sep CAHN AB CHARTWELL MOLECULES EQ 250MG BASE A 076896 001 Nov 04, 2004 Jul CAHN AB EQ 500MG BASE A 076896 002 Nov 04, 2004 Jul CAHN AB EQ 750MG BASE A 076896 003 Nov 04, 2004 Jul CAHN

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL CIPROFLOXACIN EXTENDED RELEASE ! ANCHEN PHARMS 212.6MG;EQ 287.5MG BASE A 078166 002 Nov 27, 2007 May CTEC AB ! 212.6MG;EQ 287.5MG BASE A 078166 002 Nov 27, 2007 May CHRS AB ! 425.2MG;EQ 574.9MG BASE A 078166 001 Nov 27, 2007 May CHRS @ ANI PHARMS INC 212.6MG;EQ 287.5MG BASE A 077417 001 Nov 30, 2010 May CAHN @ 425.2MG;EQ 574.9MG BASE A 077809 001 Nov 30, 2010 May CAHN @ MYLAN PHARMS INC 212.6MG;EQ 287.5MG BASE A 078183 001 Mar 22, 2007 May DISC @ 425.2MG;EQ 574.9MG BASE A 078183 002 Mar 22, 2007 May DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -34

CISATRACURIUM BESYLATE INJECTABLE;INJECTION CISATRACURIUM BESYLATE @ ACCORD HLTHCARE EQ 2MG BASE/ML A 205873 001 Jun 16, 2017 Feb DISC AP ANDA REPOSITORY EQ 2MG BASE/ML A 209132 001 Apr 24, 2019 Sep CAHN AP HOSPIRA INC EQ 2MG BASE/ML A 203236 001 Mar 30, 2018 Nov CMFD AP EQ 10MG BASE/ML A 203236 002 Mar 30, 2018 Nov CMFD AP MEITHEAL EQ 2MG BASE/ML A 211668 001 Apr 25, 2019 Nov CAHN AP EQ 2MG BASE/ML A 211669 001 Apr 25, 2019 Nov CAHN AP EQ 10MG BASE/ML A 211668 002 Apr 25, 2019 Nov CAHN AP NANJING KING-FRIEND EQ 2MG BASE/ML A 211668 001 Apr 25, 2019 Apr NEWA AP EQ 2MG BASE/ML A 211669 001 Apr 25, 2019 Apr NEWA AP EQ 10MG BASE/ML A 211668 002 Apr 25, 2019 Apr NEWA AP SOMERSET EQ 2MG BASE/ML A 209132 001 Apr 24, 2019 Oct CAHN AP SOMERSET THERAPS LLC EQ 2MG BASE/ML A 209132 001 Apr 24, 2019 Apr NEWA AP ZYDUS PHARMS EQ 2MG BASE/ML A 212171 001 Nov 04, 2019 Oct NEWA AP EQ 10MG BASE/ML A 212171 002 Nov 04, 2019 Oct NEWA CISATRACURIUM BESYLATE PRESERVATIVE FREE @ ACCORD HLTHCARE EQ 2MG BASE/ML A 205872 001 Jun 16, 2017 Feb DISC @ EQ 10MG BASE/ML A 205872 002 Jun 16, 2017 Feb DISC AP SOMERSET THERAPS LLC EQ 2MG BASE/ML A 206791 001 Feb 20, 2019 Feb NEWA AP EQ 10MG BASE/ML A 206791 002 Feb 20, 2019 Feb NEWA NIMBEX PRESERVATIVE FREE AP +! ABBVIE EQ 10MG BASE/ML N 020551 002 Dec 15, 1995 Feb CTEC

CISPLATIN INJECTABLE;INJECTION CISPLATIN @ MYLAN LABS LTD 1MG/ML A 091062 001 Apr 18, 2012 Oct DISC

CITALOPRAM HYDROBROMIDE TABLET;ORAL CITALOPRAM HYDROBROMIDE @ HERITAGE PHARMA EQ 10MG BASE A 077033 001 Oct 28, 2004 May CAHN @ EQ 10MG BASE A 077213 001 Mar 31, 2006 May CAHN >D> AB EQ 10MG BASE A 077232 001 Oct 31, 2005 Dec DISC >A> @ EQ 10MG BASE A 077232 001 Oct 31, 2005 Dec DISC AB EQ 10MG BASE A 077232 001 Oct 31, 2005 May CAHN @ EQ 20MG BASE A 077033 002 Oct 28, 2004 May CAHN @ EQ 20MG BASE A 077213 002 Mar 31, 2006 May CAHN >D> AB EQ 20MG BASE A 077232 002 Oct 31, 2005 Dec DISC >A> @ EQ 20MG BASE A 077232 002 Oct 31, 2005 Dec DISC AB EQ 20MG BASE A 077232 002 Oct 31, 2005 May CAHN @ EQ 40MG BASE A 077033 003 Oct 28, 2004 May CAHN @ EQ 40MG BASE A 077213 003 Mar 31, 2006 May CAHN >D> AB EQ 40MG BASE A 077232 003 Oct 31, 2005 Dec DISC >A> @ EQ 40MG BASE A 077232 003 Oct 31, 2005 Dec DISC AB EQ 40MG BASE A 077232 003 Oct 31, 2005 May CAHN @ SUN PHARM INDS INC EQ 10MG BASE A 077032 001 Nov 12, 2004 Oct DISC @ EQ 20MG BASE A 077032 002 Nov 12, 2004 Oct DISC @ EQ 40MG BASE A 077032 003 Nov 12, 2004 Oct DISC

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FOR SOLUTION;ORAL PREPOPIK + @ FERRING PHARMS INC 12GM/PACKET;3.5GM/PACKET;10MG/PACK N 202535 001 Jul 16, 2012 Sep DISC ET +! 12GM/PACKET;3.5GM/PACKET;10MG/PACK N 202535 001 Jul 16, 2012 Jun CMFD ET + @ 12GM/PACKET;3.5GM/PACKET;10MG/PACK N 202535 001 Jul 16, 2012 Apr DISC ET

CLADRIBINE INJECTABLE;INJECTION CLADRIBINE AP HISUN PHARM HANGZHOU 1MG/ML A 210856 001 Nov 25, 2019 Nov NEWA TABLET;ORAL MAVENCLAD +! EMD SERONO INC 10MG N 022561 001 Mar 29, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -35

CLARITHROMYCIN TABLET;ORAL CLARITHROMYCIN @ AJANTA PHARMA LTD 250MG A 206714 001 Apr 25, 2019 Sep DISC AB 250MG A 206714 001 Apr 25, 2019 Apr NEWA @ 500MG A 206714 002 Apr 25, 2019 Sep DISC AB 500MG A 206714 002 Apr 25, 2019 Apr NEWA AB CHARTWELL 250MG A 065384 001 Aug 20, 2007 Aug CAHN AB 500MG A 065384 002 Aug 20, 2007 Aug CAHN AB STRIDES PHARMA 250MG A 202710 001 Jun 10, 2013 Feb CAHN AB 500MG A 202710 002 Jun 10, 2013 Feb CAHN TABLET, EXTENDED RELEASE;ORAL CLARITHROMYCIN >D> AB LUPIN LTD 500MG A 202532 001 Sep 15, 2015 Dec DISC >A> @ 500MG A 202532 001 Sep 15, 2015 Dec DISC AB NOSTRUM LABS INC 500MG A 203243 001 Feb 29, 2016 Jul CAHN

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR SOLUTION;ORAL CLINDAMYCIN PALMITATE HYDROCHLORIDE @ MYLAN EQ 75MG BASE/5ML A 203063 001 May 25, 2016 Mar DISC

CLINDAMYCIN PHOSPHATE GEL;TOPICAL CLINDAGEL BT +! BAUSCH EQ 1% BASE N 050782 001 Nov 27, 2000 May CAHN SOLUTION;TOPICAL CLINDAMYCIN PHOSPHATE AT CADILA EQ 1% BASE A 208767 001 Jul 16, 2018 Oct CAHN AT ENCUBE ETHICALS EQ 1% BASE A 209914 001 Jan 28, 2019 Jan NEWA

CLINDAMYCIN PHOSPHATE; TRETINOIN GEL;TOPICAL VELTIN BX +! ALMIRALL 1.2%;0.025% N 050803 001 Jul 16, 2010 Feb CAHN

CLOBAZAM SUSPENSION;ORAL CLOBAZAM TA RO@ TARO@ 2.5MG/ML A 210978 001 Apr 15, 2019 Sep DISC AB 2.5MG/ML A 210978 001 Apr 15, 2019 Apr NEWA AB VISTAPHARM 2.5MG/ML A 210746 001 Jul 10, 2019 Jun NEWA TABLET;ORAL CLOBAZAM >D> AB ACCORD HLTHCARE 10MG A 212398 001 May 23, 2019 Dec DISC >A> @ 10MG A 212398 001 May 23, 2019 Dec DISC AB 10MG A 212398 001 May 23, 2019 May NEWA >D> AB 20MG A 212398 002 May 23, 2019 Dec DISC >A> @ 20MG A 212398 002 May 23, 2019 Dec DISC AB 20MG A 212398 002 May 23, 2019 May NEWA AB ALKEM LABS LTD 10MG A 212714 001 Sep 06, 2019 Aug NEWA AB 20MG A 212714 002 Sep 06, 2019 Aug NEWA AB LANNETT CO INC 10MG A 212092 001 Oct 30, 2019 Oct NEWA AB 20MG A 212092 002 Oct 30, 2019 Oct NEWA AB MICRO LABS 10MG A 211711 001 Jan 30, 2019 Jan NEWA AB 20MG A 211711 002 Jan 30, 2019 Jan NEWA TA RO@ TARO@ 10MG A 209440 001 Oct 22, 2018 Jul DISC @ 20MG A 209440 002 Oct 22, 2018 Jul DISC

CLOBETASOL PROPIONATE AEROSOL, FOAM;TOPICAL CLOBETASOL PROPIONATE AB1 GLENMARK PHARMS LTD 0.05% A 210809 001 Feb 15, 2019 Feb NEWA AB2 0.05% A 211450 001 Sep 09, 2019 Aug NEWA AB2 PERRIGO UK FINCO 0.05% A 201402 001 Aug 14, 2012 May CAHN CREAM;TOPICAL CLOBETASOL PROPIONATE AB1 RISING 0.05% A 211401 001 Jan 11, 2019 Sep CAHN >A> AB1 TORRENT 0.05% A 211836 001 Dec 30, 2019 Dec NEWA AB1 XIROMED 0.05% A 210034 001 Jun 15, 2018 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -36

CREAM;TOPICAL CLOBETASOL PROPIONATE (EMOLLIENT) >D> @ NOVAST LABS 0.05% A 075733 001 Aug 22, 2001 Dec CMFD >A> AB2 0.05% A 075733 001 Aug 22, 2001 Dec CMFD LOTION;TOPICAL CLOBETASOL PROPIONATE >A> AB CADILA 0.05% A 205249 001 Sep 24, 2019 Dec CAHN @ HI TECH 0.05% A 211348 001 Oct 26, 2018 Jul DISC >D> AB ZYDUS PHARMS 0.05% A 205249 001 Sep 24, 2019 Dec CAHN AB 0.05% A 205249 001 Sep 24, 2019 Sep NEWA OINTMENT;TOPICAL CLOBETASOL PROPIONATE AB ALEOR DERMACEUTICALS 0.05% A 211800 001 Mar 04, 2019 Feb NEWA @ AMNEAL PHARMS LLC 0.05% A 210551 001 Aug 21, 2018 Feb DISC AB ENCUBE 0.05% A 211295 001 Nov 15, 2019 Nov NEWA AB TELIGENT PHARMA INC 0.05% A 208589 001 Jan 23, 2019 Jan NEWA AB TORRENT 0.05% A 212926 001 Oct 25, 2019 Oct NEWA AB XIROMED 0.05% A 209701 001 Apr 17, 2018 Aug CAHN SOLUTION;TOPICAL CLOBETASOL PROPIONATE AT ALEOR DERMACEUTICALS 0.05% A 212881 001 Oct 21, 2019 Oct NEWA AT SAPTALIS PHARMS 0.05% A 211494 001 Oct 02, 2019 Sep NEWA SPRAY;TOPICAL CLOBETASOL PROPIONATE AT ALEOR DERMACEUTICALS 0.05% A 211191 001 Oct 02, 2019 Sep NEWA AT GLENMARK PHARMS 0.05% A 209004 001 Mar 26, 2018 Aug CAHN

CLOFARABINE SOLUTION;INTRAVENOUS CLOFARABINE AP ACCORD HLTHCARE 20MG/20ML (1MG/ML) A 212034 001 Feb 22, 2019 Feb NEWA @ HOSPIRA INC 20MG/20ML (1MG/ML) A 210283 001 Dec 27, 2018 Feb DISC

CLOMIPRAMINE HYDROCHLORIDE CAPSULE;ORAL CLOMIPRAMINE HYDROCHLORIDE AB JUBILANT CADISTA 25MG A 212218 001 Oct 21, 2019 Oct NEWA AB 50MG A 212218 002 Oct 21, 2019 Oct NEWA AB 75MG A 212218 003 Oct 21, 2019 Oct NEWA @ MANKIND PHARMA 25MG A 211767 001 Apr 08, 2019 Oct DISC AB 25MG A 211767 001 Apr 08, 2019 Mar NEWA @ 50MG A 211767 002 Apr 08, 2019 Oct DISC AB 50MG A 211767 002 Apr 08, 2019 Mar NEWA @ 75MG A 211767 003 Apr 08, 2019 Oct DISC AB 75MG A 211767 003 Apr 08, 2019 Mar NEWA

CLONAZEPAM TABLET;ORAL CLONAZEPAM @ RUBICON 0.5MG A 075468 001 Oct 06, 2000 Aug CAHN @ 1MG A 075468 002 Oct 06, 2000 Aug CAHN @ 2MG A 075468 003 Oct 06, 2000 Aug CAHN @ SUN PHARM INDS INC 0.5MG A 075423 001 Apr 27, 2001 Oct DISC @ 1MG A 075423 002 Apr 27, 2001 Oct DISC @ 2MG A 075423 003 Apr 27, 2001 Oct DISC TABLET, ORALLY DISINTEGRATING;ORAL CLONAZEPAM AB ALEMBIC PHARMS LTD 0.125MG A 211033 001 Jun 28, 2019 Jun NEWA AB 0.25MG A 211033 002 Jun 28, 2019 Jun NEWA AB 0.5MG A 211033 003 Jun 28, 2019 Jun NEWA AB 1MG A 211033 004 Jun 28, 2019 Jun NEWA AB 2MG A 211033 005 Jun 28, 2019 Jun NEWA

CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION CLONIDINE HYDROCHLORIDE @ LUITPOLD 1MG/10ML (0.1MG/ML) A 091104 001 Oct 08, 2009 Feb DISC @ 5MG/10ML (0.5MG/ML) A 091104 002 Oct 08, 2009 Feb DISC TABLET;ORAL CLONIDINE HYDROCHLORIDE AB FRONTIDA BIOPHARM 0.1MG A 070923 003 Sep 04, 1987 Apr CMS1 AB 0.2MG A 070923 002 Sep 04, 1987 Apr CMS1 RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -37

TABLET;ORAL CLONIDINE HYDROCHLORIDE @ SUN PHARM INDS INC 0.1MG A 090329 001 Jul 03, 2014 Oct DISC @ 0.2MG A 090329 002 Jul 03, 2014 Oct DISC @ 0.3MG A 090329 003 Jul 03, 2014 Oct DISC TABLET, EXTENDED RELEASE;ORAL CLONIDINE HYDROCHLORIDE AB1 NOVAST LABS 0.1MG A 209675 001 Mar 05, 2019 Feb NEWA @ UPSHER SMITH LABS 0.1MG A 211433 001 Oct 12, 2018 May DISC

CLOPIDOGREL BISULFATE TABLET;ORAL CLOPIDOGREL BISULFATE >D> AB ANI PHARMS INC EQ 300MG BASE A 090625 001 May 17, 2012 Dec DISC >A> @ EQ 300MG BASE A 090625 001 May 17, 2012 Dec DISC >D> AB EQ 300MG BASE A 091216 001 May 17, 2012 Dec DISC >A> @ EQ 300MG BASE A 091216 001 May 17, 2012 Dec DISC AB EQ 300MG BASE A 091216 001 May 17, 2012 May CAHN @ CADILA EQ 75MG BASE A 201686 001 Oct 10, 2012 Jun DISC AB EQ 75MG BASE A 201686 001 Oct 10, 2012 Apr CAHN AB CELLTRION EQ 75MG BASE A 202266 001 Aug 14, 2012 Aug CAHN AB EQ 300MG BASE A 202266 002 Nov 20, 2012 Aug CAHN @ MYLAN PHARMS INC EQ 75MG BASE A 077665 001 May 17, 2012 Sep DISC @ EQ 300MG BASE A 077665 002 May 17, 2012 Feb DISC @ SUN PHARM INDUSTRIES EQ 75MG BASE A 078133 001 Jun 10, 2013 Oct DISC

CLORAZEPATE DIPOTASSIUM TABLET;ORAL CLORAZEPATE DIPOTASSIUM @ AUROLIFE PHARMA LLC 3.75MG A 072514 002 May 11, 1990 Jan CMS1 @ 7.5MG A 072514 003 May 11, 1990 Jan CMS1

CLOTRIMAZOLE SOLUTION;TOPICAL CLOTRIMAZOLE AT NOVITIUM PHARMA 1% A 209815 001 Feb 14, 2019 Feb NEWA AT TASMAN PHARMA 1% A 212281 001 Jul 25, 2019 Jul NEWA

CLOZAPINE TABLET;ORAL CLOZARIL AB + HERITAGE LIFE 50MG N 019758 003 May 20, 2019 May NEWA AB + 200MG N 019758 004 May 20, 2019 May NEWA TABLET, ORALLY DISINTEGRATING;ORAL CLOZAPINE BARR LABS INC 12.5MG A 090308 003 Apr 09, 2018 Nov CTEC AB ! 100MG A 090308 002 Nov 25, 2015 Nov CHRS TEVA PHARMS USA 150MG A 203039 001 Nov 25, 2015 Nov CTEC 200MG A 203039 002 Nov 25, 2015 Nov CTEC FAZACLO ODT + @ JAZZ 12.5MG N 021590 004 May 30, 2007 Nov DISC AB + 12.5MG N 021590 004 May 30, 2007 Jun CAHN + @ 25MG N 021590 001 Feb 10, 2004 Nov DISC AB + 25MG N 021590 001 Feb 10, 2004 Jun CAHN @ 50MG N 021590 003 Jun 03, 2005 Jun CAHN + @ 100MG N 021590 002 Feb 10, 2004 Nov DISC AB +! 100MG N 021590 002 Feb 10, 2004 Jun CAHN + @ 150MG N 021590 005 Jul 09, 2010 Nov DISC AB + 150MG N 021590 005 Jul 09, 2010 Jun CAHN + @ 200MG N 021590 006 Jul 09, 2010 Nov DISC AB + 200MG N 021590 006 Jul 09, 2010 Jun CAHN

COBICISTAT; DARUNAVIR TABLET;ORAL PREZCOBIX +! JANSSEN PRODS 150MG;800MG N 205395 001 Jan 29, 2015 Sep CAIN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -38

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE TABLET;ORAL SYMTUZA +! JANSSEN PRODS 150MG;800MG;200MG;EQ 10MG BASE N 210455 001 Jul 17, 2018 Oct CAIN +! 150MG;EQ 800MG BASE;200MG;EQ 10MG N 210455 001 Jul 17, 2018 Oct CAIN BASE

COLCHICINE CAPSULE;ORAL COLCHICINE @ PAR PHARM INC 0.6MG A 208678 001 Nov 29, 2018 May DISC MITIGARE +! HIKMA INTL PHARMS 0.6MG N 204820 001 Sep 26, 2014 May CTEC SOLUTION;ORAL GLOPERBA +! AVION PHARMS 0.6MG/5ML N 210942 001 Jan 30, 2019 Jul CAHN +! ROMEG THERAPS LLC 0.6MG/5ML N 210942 001 Jan 30, 2019 Jan NEWA TABLET;ORAL COLCHICINE AB ALKEM LABS LTD 0.6MG A 211250 001 Feb 08, 2019 Feb NEWA AB DR REDDYS 0.6MG A 209876 001 Sep 06, 2019 Aug NEWA AB MYLAN 0.6MG A 209470 001 Sep 16, 2019 Sep NEWA AB WATSON LABS INC 0.6MG A 204461 001 Jul 31, 2019 Jul NEWA @ ZYDUS PHARMS 0.6MG A 211519 001 Feb 19, 2019 Jul DISC AB 0.6MG A 211519 001 Feb 19, 2019 Feb NEWA COLCRYS AB +! TAKEDA PHARMS USA 0.6MG N 022352 001 Jul 29, 2009 Jan CTEC

COLESEVELAM HYDROCHLORIDE BAR, CHEWABLE;ORAL WELCHOL +! DAIICHI SANKYO INC 3.75GM N 210895 001 Apr 03, 2019 Apr NEWA FOR SUSPENSION;ORAL COLESEVELAM HYDROCHLORIDE AB ALKEM LABS LTD 3.75GM/PACKET A 210316 001 May 06, 2019 Apr NEWA GLENMARK PHARMS LTD 1.875GM/PACKET A 202190 001 Jul 16, 2018 Mar CTEC WELCHOL + @ DAIICHI SANKYO 1.875GM/PACKET N 022362 001 Oct 02, 2009 Mar DISC TABLET;ORAL COLESEVELAM HYDROCHLORIDE AB BIONPHARMA INC 625MG A 208670 001 Sep 13, 2019 Sep NEWA AB ZYDUS PHARMS 625MG A 207765 001 Oct 07, 2019 Sep NEWA

CROMOLYN SODIUM SOLUTION;INHALATION CROMOLYN SODIUM @ MYLAN SPECIALITY LP 10MG/ML A 074209 001 Apr 26, 1994 Mar DISC

CROTAMITON CREAM;TOPICAL EURAX + @ SUN PHARM INDS INC 10% N 006927 001 Aug DISC

CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL AMRIX AB + TEVA PHARMS INTL 15MG N 021777 001 Feb 01, 2007 Mar CTEC + 15MG N 021777 001 Feb 01, 2007 Jan CTEC AB +! 30MG N 021777 002 Feb 01, 2007 Mar CTEC +! 30MG N 021777 002 Feb 01, 2007 Jan CTEC CYCLOBENZAPRINE HYDROCHLORIDE AB APOTEX 15MG A 206703 001 Jul 24, 2018 Feb CMFD AB 30MG A 206703 002 Jul 24, 2018 Feb CMFD @ APOTEX INC 15MG A 206703 001 Jul 24, 2018 Jan DISC @ 30MG A 206703 002 Jul 24, 2018 Jan DISC AB TWI PHARMS INC 15MG A 091281 001 Jan 31, 2013 Mar CMFD AB 30MG A 091281 002 Jan 31, 2013 Mar CMFD TABLET;ORAL CYCLOBENZAPRINE HYDROCHLORIDE AB ANDA REPOSITORY 5MG A 073541 002 Apr 06, 2006 Aug CAHN AB 10MG A 073541 001 May 23, 1995 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -39

CYCLOPHOSPHAMIDE CAPSULE;ORAL CYCLOPHOSPHAMIDE AB CIPLA 25MG A 211608 001 Jan 18, 2019 Jan NEWA AB 50MG A 211608 002 Jan 18, 2019 Jan NEWA AB + HIKMA 25MG N 203856 001 Sep 16, 2013 Oct CAHN AB +! 50MG N 203856 002 Sep 16, 2013 Oct CAHN

CYCLOSERINE CAPSULE;ORAL SEROMYCIN ! PURDUE 250MG A 060593 001 Aug CAHN

CYCLOSPORINE CAPSULE;ORAL CYCLOSPORINE AB1 APOTEX 25MG A 210721 001 Jul 10, 2019 Jun NEWA AB1 50MG A 210721 002 Jul 10, 2019 Jun NEWA AB1 100MG A 210721 003 Jul 10, 2019 Jun NEWA AB1 IVAX SUB TEVA PHARMS 50MG A 065110 001 Mar 29, 2005 Jun CTEC

CYPROHEPTADINE HYDROCHLORIDE SYRUP;ORAL CYPROHEPTADINE HYDROCHLORIDE AA ANDA REPOSITORY 2MG/5ML A 204823 001 Dec 27, 2016 Sep CAHN AA ELYSIUM 2MG/5ML A 209108 001 Oct 16, 2018 Sep CAHN AA PATRIN PHARMA INC 2MG/5ML A 204823 001 Dec 27, 2016 Jul CAHN AA QUAGEN 2MG/5ML A 212423 001 May 22, 2019 May NEWA AA TORRENT 2MG/5ML A 204823 001 Dec 27, 2016 Jan CAHN TABLET;ORAL CYPROHEPTADINE HYDROCHLORIDE AA BEXIMCO PHARMS USA 4MG A 206676 001 Apr 12, 2019 Apr NEWA AA ELYSIUM 4MG A 207555 001 Jan 31, 2017 Sep CAHN AA ! HERITAGE PHARMA 4MG A 087056 001 Feb CAHN

CYSTEINE HYDROCHLORIDE SOLUTION;INTRAVENOUS ELCYS +! EXELA PHARMA SCS LLC 500MG/10ML (50MG/ML) N 210660 001 Apr 16, 2019 Apr NEWA >A> NOURESS >A> AVADEL LEGACY 500MG/10ML (50MG/ML) N 212535 001 Dec 13, 2019 Dec NEWA

CYTARABINE INJECTABLE;INJECTION CYTARABINE >A> AP GLAND PHARMA LTD 100MG/VIAL A 211937 001 Dec 23, 2019 Dec NEWA >A> AP 2GM/VIAL A 211938 001 Dec 23, 2019 Dec NEWA AP MEITHEAL 20MG/ML A 206190 001 Nov 09, 2017 Nov CAHN AP 100MG/ML A 205696 001 Jul 17, 2018 Nov CAHN @ MYLAN LABS LTD 20MG/ML A 200916 001 Dec 13, 2011 Sep DISC >D> WEST-WARD PHARMS INT 100MG/VIAL A 071471 001 Aug 02, 1989 Dec CTEC >A> AP 100MG/VIAL A 071471 001 Aug 02, 1989 Dec CTEC >D> ! 2GM/VIAL A 074245 002 Aug 31, 1994 Dec CTEC >A> AP ! 2GM/VIAL A 074245 002 Aug 31, 1994 Dec CTEC

DACLATASVIR DIHYDROCHLORIDE TABLET;ORAL DAKLINZA + @ BRISTOL-MYERS SQUIBB EQ 30MG BASE N 206843 001 Jul 24, 2015 Jun DISC + @ EQ 60MG BASE N 206843 002 Jul 24, 2015 Jun DISC + @ EQ 90MG BASE N 206843 003 Apr 13, 2016 Feb DISC

DACTINOMYCIN INJECTABLE;INJECTION DACTINOMYCIN AP HISUN PHARM HANGZHOU 0.5MG/VIAL A 207232 001 Jul 16, 2019 Jul NEWA AP X-GEN PHARMS INC 0.5MG/VIAL A 203999 001 May 20, 2019 May NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -40

DALFAMPRIDINE TABLET, EXTENDED RELEASE;ORAL DALFAMPRIDINE AB MICRO LABS 10MG A 210158 001 Mar 11, 2019 Feb NEWA AB SUN PHARM 10MG A 208292 001 May 21, 2019 May NEWA

DANTROLENE SODIUM INJECTABLE;INJECTION DANTROLENE SODIUM @ MYLAN INSTITUTIONAL 20MG/VIAL A 205239 001 Feb 18, 2016 Mar DISC

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL QTERNMET XR + ASTRAZENECA AB 2.5MG;1GM;EQ 2.5MG BASE N 210874 001 May 02, 2019 May NEWA + 5MG;1GM;EQ 2.5MG BASE N 210874 002 May 02, 2019 May NEWA + 5MG;1GM;EQ 5MG BASE N 210874 003 May 02, 2019 May NEWA +! 10MG;1GM;EQ 5MG BASE N 210874 004 May 02, 2019 May NEWA

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL QTERN + ASTRAZENECA AB 5MG;EQ 5MG BASE N 209091 002 May 02, 2019 May NEWA

DAPIPRAZOLE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC DAPIPRAZOLE HYDROCHLORIDE @ BARADAINA LLC 0.5% A 204902 001 May 30, 2019 Oct DISC 0.5% A 204902 001 May 30, 2019 May NEWA

DAPSONE GEL;TOPICAL ACZONE +! ALMIRALL 7.5% N 207154 001 Feb 24, 2016 Nov CTEC AB +! 7.5% N 207154 001 Feb 24, 2016 Jun CFTG +! 7.5% N 207154 001 Feb 24, 2016 Feb CAHN DAPSONE @ TARO PHARMS 7.5% A 210191 001 Jun 26, 2019 Nov DISC AB 7.5% A 210191 001 Jun 26, 2019 Jun NFTG TABLET;ORAL DAPSONE AB SAI LIFE SCIENCES 100MG A 207165 001 May 08, 2019 Apr NEWA @ TARO 25MG A 209430 001 Mar 01, 2019 May DISC @ 100MG A 209430 002 Mar 01, 2019 May DISC AB TARO PHARM 25MG A 209430 001 Mar 01, 2019 Feb NEWA AB 100MG A 209430 002 Mar 01, 2019 Feb NEWA

DAPTOMYCIN POWDER;INTRAVENOUS CUBICIN @ CUBIST PHARMS LLC 250MG/VIAL N 021572 001 Sep 12, 2003 Oct CDFR DAPTOMYCIN AP ACCORD HLTHCARE 500MG/VIAL A 211961 001 Jun 24, 2019 Jun NEWA AP BE PHARMS 500MG/VIAL A 212513 001 Jun 26, 2019 Jun NEWA AP DR REDDYS 500MG/VIAL A 208375 001 May 01, 2019 Apr NEWA AP JIANGSU HENGRUI MED 500MG/VIAL A 212022 001 Aug 22, 2019 Aug NEWA AP SAGENT PHARMS INC 500MG/VIAL A 207104 001 Nov 15, 2019 Nov NEWA AP XELLIA PHARMS APS 500MG/VIAL A 206005 001 Jun 15, 2016 Mar CAHN POWDER;IV (INFUSION) DAPTOMYCIN AP ACCORD HLTHCARE 350MG/VIAL A 212667 001 Jul 12, 2019 Jul NFTG AP +! SAGENT PHARMS INC 350MG/VIAL N 208385 001 Sep 12, 2017 Jul CTEC

DARIFENACIN HYDROBROMIDE TABLET, EXTENDED RELEASE;ORAL DARIFENACIN HYDROBROMIDE AB ALAN LABS INC EQ 7.5MG BASE A 209571 002 Oct 22, 2019 Oct NEWA AB EQ 15MG BASE A 209571 001 Oct 22, 2019 Oct NEWA >A> AB POLYGEN PHARMS EQ 7.5MG BASE A 211045 001 Jan 06, 2020 Dec NEWA >A> AB EQ 15MG BASE A 211045 002 Jan 06, 2020 Dec NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -41

DAROLUTAMIDE TABLET;ORAL NUBEQA +! BAYER HEALTHCARE 300MG N 212099 001 Jul 30, 2019 Jul NEWA

DARUNAVIR SUSPENSION;ORAL PREZISTA +! JANSSEN PRODS 100MG/ML N 202895 001 Dec 16, 2011 Sep CAIN TABLET;ORAL DARUNAVIR AB TEVA PHARMS USA 600MG A 202118 001 Nov 21, 2017 Oct CTNA AB 600MG A 202118 001 Nov 21, 2017 Sep CAIN PREZISTA + JANSSEN PRODS 75MG N 021976 004 Dec 18, 2008 Sep CAIN + 150MG N 021976 005 Dec 18, 2008 Sep CAIN + @ 300MG N 021976 001 Jun 23, 2006 Sep CAIN + @ 400MG N 021976 003 Oct 21, 2008 Sep CAIN AB + 600MG N 021976 002 Feb 25, 2008 Sep CAIN +! 800MG N 021976 006 Nov 09, 2012 Sep CAIN

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR TABLET, EXTENDED RELEASE;ORAL VIEKIRA XR + @ ABBVIE INC EQ 200MG BASE;8.33MG;50MG;33.33MG N 208624 001 Jul 22, 2016 Apr DISC

DAUNORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION DAUNORUBICIN HYDROCHLORIDE AP HISUN PHARM HANGZHOU EQ 5MG BASE/ML A 208759 001 Apr 12, 2019 Apr NEWA @ EQ 20MG BASE/VIAL A 206195 001 Apr 25, 2019 Oct DISC AP EQ 20MG BASE/VIAL A 206195 001 Apr 25, 2019 Apr NEWA

DECITABINE INJECTABLE;INTRAVENOUS DECITABINE AP INGENUS PHARMS LLC 50MG/VIAL A 210984 001 Sep 16, 2019 Sep NEWA AP MSN 50MG/VIAL A 212265 001 Aug 28, 2019 Aug NEWA AP WOCKHARDT BIO AG 50MG/VIAL A 209056 001 Apr 09, 2019 Mar NEWA

DEFERASIROX TABLET;ORAL DEFERASIROX >A> AB ACTAVIS ELIZABETH 90MG A 208697 001 Dec 13, 2019 Dec NEWA >A> AB 180MG A 208697 002 Dec 13, 2019 Dec NFTG >A> AB 360MG A 208697 003 Dec 13, 2019 Dec NEWA AB ALEMBIC PHARMS LTD 90MG A 211824 001 Nov 20, 2019 Nov NFTG AB 360MG A 211824 002 Nov 20, 2019 Nov NFTG >A> AB AMNEAL PHARMS CO 90MG A 210727 001 Dec 27, 2019 Dec NEWA >A> AB 360MG A 210727 002 Dec 27, 2019 Dec NEWA AB MSN 90MG A 210945 001 Nov 20, 2019 Nov NFTG AB 360MG A 210945 002 Nov 20, 2019 Nov NFTG >A> AB PIRAMAL HLTHCARE UK 90MG A 212995 001 Dec 30, 2019 Dec NEWA >A> AB 360MG A 212995 002 Dec 30, 2019 Dec NEWA >A> AB SUN PHARM 90MG A 211641 001 Jan 02, 2020 Dec NEWA >A> AB 360MG A 211641 002 Jan 02, 2020 Dec NEWA AB TEVA PHARMS USA 90MG A 209223 001 Nov 25, 2019 Nov NEWA AB 360MG A 209223 002 Nov 25, 2019 Nov NEWA AB ZYDUS PHARMS 90MG A 211383 001 Nov 20, 2019 Nov NFTG AB 360MG A 211383 002 Nov 20, 2019 Nov NFTG JADENU AB + NOVARTIS PHARMS CORP 90MG N 206910 001 Mar 30, 2015 Nov CFTG >D> + 180MG N 206910 002 Mar 30, 2015 Dec CFTG >A> AB + 180MG N 206910 002 Mar 30, 2015 Dec CFTG AB +! 360MG N 206910 003 Mar 30, 2015 Nov CFTG TABLET, FOR SUSPENSION;ORAL DEFERASIROX AB ALEMBIC PHARMS LTD 125MG A 210060 001 Nov 20, 2019 Nov NEWA AB 250MG A 210060 002 Nov 20, 2019 Nov NEWA AB 500MG A 210060 003 Nov 20, 2019 Nov NEWA AB ALKEM LABS LTD 125MG A 210519 001 Nov 20, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -42

TABLET, FOR SUSPENSION;ORAL DEFERASIROX AB 250MG A 210519 002 Nov 20, 2019 Nov NEWA AB 500MG A 210519 003 Nov 20, 2019 Nov NEWA AB BIONPHARMA INC 125MG A 210920 001 Nov 20, 2019 Nov NEWA AB 250MG A 210920 002 Nov 20, 2019 Nov NEWA AB 500MG A 210920 003 Nov 20, 2019 Nov NEWA >A> AB ICHNOS 125MG A 209433 001 Jan 06, 2020 Dec NEWA >A> AB 250MG A 209433 002 Jan 06, 2020 Dec NEWA >A> AB 500MG A 209433 003 Jan 06, 2020 Dec NEWA AB MSN 125MG A 209878 001 Nov 20, 2019 Nov NEWA AB 250MG A 209878 002 Nov 20, 2019 Nov NEWA AB 500MG A 209878 003 Nov 20, 2019 Nov NEWA AB SUN PHARM 125MG A 209782 001 Nov 20, 2019 Nov NEWA AB 250MG A 209782 002 Nov 20, 2019 Nov NEWA AB 500MG A 209782 003 Nov 20, 2019 Nov NEWA

DEFERIPRONE TABLET;ORAL DEFERIPRONE @ TARO PHARM INDS LTD 500MG A 208800 001 Feb 08, 2019 May DISC AB 500MG A 208800 001 Feb 08, 2019 Feb NFTG FERRIPROX +! APOPHARMA INC 500MG N 021825 001 Oct 14, 2011 May CTEC AB +! 500MG N 021825 001 Oct 14, 2011 Feb CFTG + 1GM N 021825 002 Jul 25, 2019 Jul NEWA

DELAVIRDINE MESYLATE TABLET;ORAL RESCRIPTOR + @ VIIV HLTHCARE 100MG N 020705 001 Apr 04, 1997 Jun DISC

DESIPRAMINE HYDROCHLORIDE TABLET;ORAL DESIPRAMINE HYDROCHLORIDE AB NOVAST LABS 10MG A 204963 001 Dec 26, 2017 Sep CAHN AB 25MG A 204963 002 Dec 26, 2017 Sep CAHN AB 50MG A 204963 003 Dec 26, 2017 Sep CAHN AB 75MG A 204963 004 Dec 26, 2017 Sep CAHN AB 100MG A 204963 005 Dec 26, 2017 Sep CAHN AB 150MG A 204963 006 Dec 26, 2017 Sep CAHN

DESLORATADINE TABLET;ORAL DESLORATADINE @ MYLAN PHARMS INC 5MG A 078351 001 Feb 10, 2012 May DISC AB PERRIGO 5MG A 078361 001 Dec 22, 2011 Apr CAHN

DESMOPRESSIN ACETATE INJECTABLE;INJECTION DESMOPRESSIN ACETATE AP TEVA PHARMS USA 0.004MG/ML A 074888 001 Oct 15, 1997 Mar CMFD SOLUTION;NASAL DDAVP +! FERRING PHARMS INC 0.01% N 017922 001 Jul CTEC DESMOPRESSIN ACETATE @ SUN PHARM INDS 0.01% A 077212 001 Apr 12, 2012 Jul DISC SPRAY, METERED;NASAL NOCTIVA + @ ALYVANT 0.00083MG/SPRAY N 201656 001 Mar 03, 2017 Jun DISC + 0.00083MG/SPRAY N 201656 001 Mar 03, 2017 Apr CAHN + @ 0.00166MG/SPRAY N 201656 002 Mar 03, 2017 Jun DISC +! 0.00166MG/SPRAY N 201656 002 Mar 03, 2017 Apr CAHN TABLET;ORAL DESMOPRESSIN ACETATE AB ABHAI LLC 0.1MG A 210371 001 Jan 28, 2019 Jan NEWA AB 0.2MG A 210371 002 Jan 28, 2019 Jan NEWA AB NOVAST LABS 0.1MG A 208357 001 Jun 06, 2019 May NEWA AB 0.2MG A 208357 002 Jun 06, 2019 May NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -43

DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 DESOGESTREL AND ETHINYL ESTRADIOL @ ACCORD HLTHCARE 0.15MG;0.03MG A 207067 001 Sep 13, 2018 Mar DISC ISIBLOOM AB XIROMED 0.15MG;0.03MG A 202789 001 Aug 12, 2015 Aug CAHN VOLNEA AB XIROMED 0.15MG,N/A;0.02MG,0.01MG A 202689 001 Sep 09, 2016 Aug CAHN

DESONIDE AEROSOL, FOAM;TOPICAL VERDESO +! ALMIRALL 0.05% N 021978 001 Sep 19, 2006 Feb CAHN CREAM;TOPICAL DESONIDE >A> AB CADILA 0.05% A 210198 001 Nov 20, 2019 Dec CAHN >D> AB ZYDUS PHARMS 0.05% A 210198 001 Nov 20, 2019 Dec CAHN AB 0.05% A 210198 001 Nov 20, 2019 Nov NEWA OINTMENT;TOPICAL DESONIDE AB ALEOR DERMACEUTICALS 0.05% A 212473 001 Oct 23, 2019 Oct NEWA AB ENCUBE ETHICALS 0.05% A 210998 001 Jan 30, 2019 Jan NEWA AB TELIGENT PHARMA INC 0.05% A 212002 001 Mar 12, 2019 Feb NEWA

DESOXIMETASONE CREAM;TOPICAL DESOXIMETASONE >D> AB ANDA REPOSITORY 0.25% A 205594 001 Jul 02, 2018 Dec CAHN >A> @ CADILA 0.25% A 205620 001 Sep 28, 2018 Dec CAHN >A> AB RISING 0.25% A 205594 001 Jul 02, 2018 Dec CAHN >D> @ ZYDUS PHARMS 0.25% A 205620 001 Sep 28, 2018 Dec CAHN @ 0.25% A 205620 001 Sep 28, 2018 Feb DISC

DESVENLAFAXINE TABLET, EXTENDED RELEASE;ORAL DESVENLAFAXINE +! ALEMBIC PHARMS LTD 50MG N 204150 001 Mar 04, 2013 May CTEC +! 100MG N 204150 002 Mar 04, 2013 May CTEC KHEDEZLA @ OSMOTICA PHARM CORP 50MG N 204683 001 Jul 10, 2013 May DISC @ 100MG N 204683 002 Jul 10, 2013 May DISC

DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL DESVENLAFAXINE SUCCINATE AB INTELLIPHARMACEUTICS EQ 50MG BASE A 204805 001 May 07, 2019 Apr NEWA AB EQ 100MG BASE A 204805 002 May 07, 2019 Apr NEWA AB MYLAN EQ 50MG BASE A 204095 001 Jun 29, 2015 Jul CMFD @ EQ 50MG BASE A 204095 001 Jun 29, 2015 May DISC @ EQ 100MG BASE A 204095 002 Jun 29, 2015 May DISC @ YICHANG HUMANWELL EQ 50MG BASE A 210014 001 Oct 01, 2018 Mar DISC @ EQ 100MG BASE A 210014 002 Oct 01, 2018 Mar DISC

DEXAMETHASONE ELIXIR;ORAL DEXAMETHASONE AA ! ANIMA 0.5MG/5ML A 084754 001 Sep CAHN TABLET;ORAL HEMADY +! DEXCEL PHARMA 20MG N 211379 001 Oct 03, 2019 Oct NEWA

DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION DEXAMETHASONE SODIUM PHOSPHATE AP ANDA REPOSITORY EQ 4MG PHOSPHATE/ML A 207521 001 Jun 08, 2018 Sep CAHN >D> AP AUROBINDO PHARMA LTD EQ 10MG PHOSPHATE/ML A 210967 001 Jun 07, 2019 Dec DISC >A> @ EQ 10MG PHOSPHATE/ML A 210967 001 Jun 07, 2019 Dec DISC AP EQ 10MG PHOSPHATE/ML A 210967 001 Jun 07, 2019 May NEWA AP ! FRESENIUS KABI USA EQ 4MG PHOSPHATE/ML A 084916 001 Feb CHRS @ LUITPOLD EQ 4MG PHOSPHATE/ML A 087440 001 Jul 21, 1982 Feb DISC AP SOMERSET EQ 4MG PHOSPHATE/ML A 207521 001 Jun 08, 2018 Oct CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -44

INJECTABLE;INJECTION DEXAMETHASONE SODIUM PHOSPHATE AP SOMERSET THERAPS LLC EQ 10MG PHOSPHATE/ML A 211036 001 May 10, 2019 Apr NEWA SOLUTION/DROPS;OPHTHALMIC, OTIC DECADRON + @ MERCK EQ 0.1% PHOSPHATE N 011984 001 Oct CRLD DEXAMETHASONE SODIUM PHOSPHATE ! BAUSCH AND LOMB EQ 0.1% PHOSPHATE A 040069 001 Jul 26, 1996 May CTEC @ SANDOZ INC EQ 0.1% PHOSPHATE A 088771 001 Jan 16, 1985 May DISC

DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION DEXMEDETOMIDINE HYDROCHLORIDE @ CIPLA EQ 200MCG BASE/2ML (EQ 100MCG A 204843 001 Jan 18, 2019 Jul DISC BASE/ML) AP EQ 200MCG BASE/2ML (EQ 100MCG A 204843 001 Jan 18, 2019 Jan NEWA BASE/ML) AP SLAYBACK PHARMA LLC EQ 200MCG BASE/50ML (EQ 4MCG A 212791 001 Dec 04, 2019 Nov NEWA BASE/ML) AP EQ 400MCG BASE/100ML (EQ 4MCG A 212791 002 Dec 04, 2019 Nov NEWA BASE/ML) SOLUTION;INTRAVENOUS DEXMEDETOMIDINE HYDROCHLORIDE + HQ SPCLT PHARMA EQ 200MCG BASE/50ML (EQ 4MCG N 206628 003 Jun 22, 2018 Mar CPOT BASE/ML) + EQ 400MCG BASE/100ML (EQ 4MCG N 206628 004 Jun 22, 2018 Mar CPOT BASE/ML)

DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL DEXMETHYLPHENIDATE HYDROCHLORIDE AB ALKEM LABS LTD 2.5MG A 212631 001 Jul 19, 2019 Jul NEWA AB 5MG A 212631 002 Jul 19, 2019 Jul NEWA AB 10MG A 212631 003 Jul 19, 2019 Jul NEWA >D> AB LANNETT CO INC 2.5MG A 209468 001 Sep 25, 2017 Dec DISC >A> @ 2.5MG A 209468 001 Sep 25, 2017 Dec DISC >D> AB 5MG A 209468 002 Sep 25, 2017 Dec DISC >A> @ 5MG A 209468 002 Sep 25, 2017 Dec DISC >D> AB 10MG A 209468 003 Sep 25, 2017 Dec DISC >A> @ 10MG A 209468 003 Sep 25, 2017 Dec DISC @ TEVA PHARMS 2.5MG A 077107 003 Jan 29, 2007 May DISC @ 5MG A 077107 001 Jan 29, 2007 May DISC @ 10MG A 077107 002 Jan 29, 2007 May DISC

DEXRAZOXANE HYDROCHLORIDE INJECTABLE;INJECTION DEXRAZOXANE HYDROCHLORIDE >A> AP GLAND PHARMA LTD EQ 250MG BASE/VIAL A 207321 002 Dec 16, 2019 Dec NEWA TOTECT >A> +! CLINIGEN EQ 500MG BASE/VIAL N 022025 001 Sep 06, 2007 Dec CAHN >D> +! CLINIGEN HLTHCARE EQ 500MG BASE/VIAL N 022025 001 Sep 06, 2007 Dec CAHN

DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL DEXTROAMPHETAMINE SULFATE >D> AB ANDA REPOSITORY 5MG A 205077 001 Jun 21, 2019 Dec CAHN AB 5MG A 205077 001 Jun 21, 2019 Aug CAHN >D> AB 10MG A 205077 002 Jun 21, 2019 Dec CAHN AB 10MG A 205077 002 Jun 21, 2019 Aug CAHN >D> AB 15MG A 205077 003 Jun 21, 2019 Dec CAHN AB 15MG A 205077 003 Jun 21, 2019 Aug CAHN @ MYLAN 5MG A 206735 001 Jan 27, 2016 Aug DISC @ 10MG A 206735 002 Jan 27, 2016 Aug DISC @ 15MG A 206735 003 Jan 27, 2016 Aug DISC >A> AB PII 5MG A 205077 001 Jun 21, 2019 Dec CAHN AB 5MG A 205077 001 Jun 21, 2019 Jun NEWA >A> AB 10MG A 205077 002 Jun 21, 2019 Dec CAHN AB 10MG A 205077 002 Jun 21, 2019 Jun NEWA >A> AB 15MG A 205077 003 Jun 21, 2019 Dec CAHN AB 15MG A 205077 003 Jun 21, 2019 Jun NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -45

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL PROMETHAZINE DM @ VINTAGE 15MG/5ML;6.25MG/5ML A 040649 001 Feb 14, 2006 May DISC

DEXTROSE INJECTABLE;INJECTION DEXTROSE 70% IN PLASTIC CONTAINER + @ BAXTER HLTHCARE 70GM/100ML N 017521 006 Mar 26, 1982 Sep DISC

DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;224MG/100ML N 018371 003 Jul DISC POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;298MG/100ML N 018371 002 Jul DISC

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER + @ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;225MG/100ML N 018365 002 Jul 05, 1983 Jul DISC + @ 5GM/100ML;149MG/100ML;225MG/100ML N 018365 006 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;300MG/100ML N 018876 001 Jan 17, 1986 Jul DISC @ 5GM/100ML;149MG/100ML;300MG/100ML N 018876 006 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;224MG/100ML;225MG/100ML N 018365 008 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;224MG/100ML;300MG/100ML N 018876 007 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER + @ ICU MEDICAL INC 5GM/100ML;298MG/100ML;225MG/100ML N 018365 009 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;298MG/100ML;300MG/100ML N 018876 008 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;149MG/100ML;300MG/100ML N 018876 002 Jan 17, 1986 Jul DISC POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;224MG/100ML;225MG/100ML N 018365 003 Jul 05, 1983 Jul DISC POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;224MG/100ML;300MG/100ML N 018876 003 Jan 17, 1986 Jul DISC POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;298MG/100ML;225MG/100ML N 018365 004 Jul 05, 1983 Jul DISC POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;298MG/100ML;300MG/100ML N 018876 004 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;225MG/100ML N 018365 005 Mar 28, 1988 Jul DISC @ 5GM/100ML;149MG/100ML;225MG/100ML N 018365 007 Mar 28, 1988 Jul DISC POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER @ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;300MG/100ML N 018876 005 Mar 28, 1988 Jul DISC @ 5GM/100ML;149MG/100ML;300MG/100ML N 018876 009 Mar 28, 1988 Jul DISC

DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER >A> AP FRESENIUS KABI USA 2.5GM/100ML;450MG/100ML A 211190 001 Dec 20, 2019 Dec NEWA

DIAZEPAM GEL;RECTAL DIASTAT + BAUSCH 2.5MG/0.5ML (5MG/ML) N 020648 001 Jul 29, 1997 Feb CAHN + @ 5MG/ML (5MG/ML) N 020648 002 Jul 29, 1997 Feb CAHN + @ 10MG/2ML (5MG/ML) N 020648 003 Jul 29, 1997 Feb CAHN + @ 15MG/3ML (5MG/ML) N 020648 004 Jul 29, 1997 Feb CAHN + @ 20MG/4ML (5MG/ML) N 020648 005 Jul 29, 1997 Feb CAHN DIASTAT ACUDIAL + BAUSCH 10MG/2ML (5MG/ML) N 020648 007 Sep 15, 2005 Feb CAHN +! 20MG/4ML (5MG/ML) N 020648 006 Sep 15, 2005 Feb CAHN INJECTABLE;INJECTION DIAZEPAM AP BELOTECA INC 10MG/2ML (5MG/ML) A 210363 001 Mar 18, 2019 Mar NEWA >A> AP 50MG/10ML (5MG/ML) A 211998 001 Dec 26, 2019 Dec NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -46

INJECTABLE;INJECTION DIAZEPAM AP ! HOSPIRA 10MG/2ML (5MG/ML) A 072079 001 Dec 20, 1988 Mar CTEC >D> ! 50MG/10ML (5MG/ML) A 071583 001 Oct 13, 1987 Dec CTEC >A> AP ! 50MG/10ML (5MG/ML) A 071583 001 Oct 13, 1987 Dec CTEC TABLET;ORAL DIAZEPAM >A> @ NUVO PHARM 10MG A 070464 001 Feb 25, 1986 Dec CAHN >D> @ VIRTUS PHARMS 10MG A 070464 001 Feb 25, 1986 Dec CAHN

DIAZOXIDE SUSPENSION;ORAL >A> DIAZOXIDE >A> AB E5 PHARMA INC 50MG/ML A 211050 001 Dec 20, 2019 Dec NFTG PROGLYCEM >D> +! TEVA BRANDED PHARM 50MG/ML N 017453 001 Dec CFTG >A> AB +! 50MG/ML N 017453 001 Dec CFTG

DICLOFENAC CAPSULE;ORAL ZORVOLEX + EGALET 18MG N 204592 001 Oct 18, 2013 Feb CAHN +! 35MG N 204592 002 Oct 18, 2013 Feb CAHN + ZYLA 18MG N 204592 001 Oct 18, 2013 Jul CAHN +! 35MG N 204592 002 Oct 18, 2013 Jul CAHN

DICLOFENAC EPOLAMINE SYSTEM;TOPICAL LICART + @ IBSA INST BIO 1.3% N 206976 001 Dec 19, 2018 Feb DISC

DICLOFENAC POTASSIUM CAPSULE;ORAL DICLOFENAC POTASSIUM AB STRIDES PHARMA 25MG A 210078 001 Dec 03, 2019 Nov NEWA TABLET;ORAL DICLOFENAC POTASSIUM AB AMICI 50MG A 076561 001 Mar 18, 2004 May CAHN

DICLOFENAC SODIUM GEL;TOPICAL DICLOFENAC SODIUM AB MYLAN 1% A 204306 001 May 06, 2019 Apr NEWA AB PERRIGO UK FINCO 1% A 211253 001 May 16, 2019 May NEWA SOLUTION;INTRAVENOUS DICLOFENAC SODIUM @ MYLAN LABS LTD 37.5MG/ML (37.5MG/ML) A 208786 001 Jun 18, 2019 Jul DISC 37.5MG/ML (37.5MG/ML) A 208786 001 Jun 18, 2019 Jun NEWA SOLUTION;TOPICAL DICLOFENAC SODIUM >A> AT CADILA 1.5% A 206411 001 Apr 17, 2018 Dec CAHN @ RICONPHARMA LLC 1.5% A 206715 001 Aug 07, 2017 Oct DISC >D> AT ZYDUS PHARMS 1.5% A 206411 001 Apr 17, 2018 Dec CAHN PENNSAID >A> +! HORIZON 2% N 204623 001 Jan 16, 2014 Dec CAHN >D> +! HZNP 2% N 204623 001 Jan 16, 2014 Dec CAHN TABLET, DELAYED RELEASE;ORAL DICLOFENAC SODIUM @ CASI PHARMS INC 25MG A 074376 001 Sep 28, 1995 Nov DISC @ 50MG A 074376 002 Sep 28, 1995 Nov DISC @ 75MG A 074394 001 Nov 30, 1995 Nov DISC AB ! UNIQUE PHARM LABS 25MG A 090066 001 Dec 01, 2010 Nov CHRS AB ! 50MG A 090066 002 Dec 01, 2010 Nov CHRS AB ! 75MG A 077863 003 Jun 08, 2007 Nov CHRS TABLET, EXTENDED RELEASE;ORAL DICLOFENAC SODIUM @ MYLAN 100MG A 076152 001 Dec 13, 2001 Jun DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -47

DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL DICLOFENAC SODIUM AND MISOPROSTOL @ EXELA HOLDINGS 50MG;0.2MG A 200540 001 Mar 14, 2014 Sep DISC @ 75MG;0.2MG A 200540 002 Mar 14, 2014 Sep DISC

DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL >D> BENTYL >D> AB +! ALLERGAN 10MG N 007409 003 Oct 15, 1984 Dec DISC >A> + @ 10MG N 007409 003 Oct 15, 1984 Dec DISC DICYCLOMINE HYDROCHLORIDE >D> AB LANNETT 10MG A 084285 001 Dec CHRS >A> AB ! 10MG A 084285 001 Dec CHRS INJECTABLE;INJECTION DICYCLOMINE HYDROCHLORIDE @ APC PHARMS LLC 10MG/ML A 210979 001 Jul 02, 2018 Feb DISC AP CUSTOPHARM INC 10MG/ML A 210788 001 Feb 11, 2019 Jan NEWA >D> @ FOSUN PHARMA 10MG/ML A 210979 001 Jul 02, 2018 Dec CMFD >A> AP 10MG/ML A 210979 001 Jul 02, 2018 Dec CMFD @ 10MG/ML A 210979 001 Jul 02, 2018 Sep CAHN AP FRESENIUS KABI USA 10MG/ML A 210257 001 Jan 25, 2019 Jan NEWA AP NEXUS PHARMS 10MG/ML A 206468 001 Feb 01, 2019 Jan NEWA AP SLATE 10MG/ML A 207076 001 Nov 02, 2018 Feb CAHN AP SUNGEN PHARMA 10MG/ML A 212058 001 Apr 26, 2019 Apr NEWA TABLET;ORAL >D> BENTYL >D> AB +! ALLERGAN 20MG N 007409 001 Oct 15, 1984 Dec DISC >A> + @ 20MG N 007409 001 Oct 15, 1984 Dec DISC DICYCLOMINE HYDROCHLORIDE >D> AB WATSON LABS 20MG A 085223 001 Jul 30, 1986 Dec CHRS >A> AB ! 20MG A 085223 001 Jul 30, 1986 Dec CHRS

DIETHYLPROPION HYDROCHLORIDE TABLET;ORAL DIETHYLPROPION HYDROCHLORIDE AA ! LANNETT CO INC 25MG A 200177 001 Jul 18, 2011 Jul CHRS TENUATE + @ TEVA BRANDED PHARM 25MG N 011722 002 Jul DISC TABLET, EXTENDED RELEASE;ORAL DIETHYLPROPION HYDROCHLORIDE AB ! LANNETT CO INC 75MG A 091680 001 Oct 24, 2011 Jul CHRS TENUATE DOSPAN + @ TEVA BRANDED PHARM 75MG N 012546 001 Jul DISC

DIGOXIN ELIXIR;ORAL DIGOXIN AA NOVITIUM PHARMA 0.05MG/ML A 213000 001 Oct 04, 2019 Sep NFTG AA VISTAPHARM 0.05MG/ML A 213000 001 Oct 04, 2019 Nov CAHN

DIHYDROERGOTAMINE MESYLATE INJECTABLE;INJECTION D.H.E. 45 AP +! BAUSCH 1MG/ML N 005929 001 Apr CAHN DIHYDROERGOTAMINE MESYLATE >A> AP APOLLO 1MG/ML A 212046 001 Jan 07, 2020 Dec CAHN >A> AP 1MG/ML A 212046 001 Jan 07, 2020 Dec NEWA SPRAY, METERED;NASAL MIGRANAL +! BAUSCH 0.5MG/SPRAY N 020148 001 Dec 08, 1997 Apr CAHN +! VALEANT 0.5MG/SPRAY N 020148 001 Dec 08, 1997 Jan CPOT

DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL CARDIZEM CD AB3 + BAUSCH 120MG N 020062 001 Aug 10, 1992 Feb CAHN AB3 + 180MG N 020062 002 Dec 27, 1991 Feb CAHN AB3 + 240MG N 020062 003 Dec 27, 1991 Feb CAHN AB3 + 300MG N 020062 004 Dec 27, 1991 Feb CAHN AB3 +! 360MG N 020062 005 Aug 24, 1999 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -48

CAPSULE, EXTENDED RELEASE;ORAL DILTIAZEM HYDROCHLORIDE APOTEX 120MG A 074943 003 Dec 19, 2000 Aug CTEC AB2 ! 240MG A 074943 001 Aug 06, 1998 May CHRS MY LAN@ MYLAN@ 120MG A 075124 002 Mar 18, 1998 Aug DISC @ 180MG A 075124 003 Mar 18, 1998 Oct DISC @ 240MG A 075124 001 Mar 18, 1998 Oct DISC AB2 240MG A 075124 001 Mar 18, 1998 May CHRS AB3 NOVAST LABS 120MG A 208783 001 Jun 14, 2019 Jun NEWA AB3 180MG A 208783 002 Jun 14, 2019 Jun NEWA AB3 240MG A 208783 003 Jun 14, 2019 Jun NEWA AB3 300MG A 208783 004 Jun 14, 2019 Jun NEWA AB3 360MG A 208783 005 Jun 14, 2019 Jun NEWA @ PAR PHARM 360MG A 209766 001 May 30, 2018 Mar DISC TIAZAC AB4 + BAUSCH 120MG N 020401 001 Sep 11, 1995 Feb CAHN AB4 + 180MG N 020401 002 Sep 11, 1995 Feb CAHN AB4 + 240MG N 020401 003 Sep 11, 1995 Feb CAHN AB4 + 300MG N 020401 004 Sep 11, 1995 Feb CAHN AB4 + 360MG N 020401 005 Sep 11, 1995 Feb CAHN AB4 +! 420MG N 020401 006 Oct 16, 1998 Feb CAHN INJECTABLE;INJECTION DILTIAZEM HYDROCHLORIDE @ DR REDDYS 5MG/ML A 074894 001 Aug 26, 1997 May CAHN TABLET;ORAL CARDIZEM AB + BAUSCH 30MG N 018602 001 Nov 05, 1982 Mar CAHN AB + 60MG N 018602 002 Nov 05, 1982 Mar CAHN AB + 90MG N 018602 003 Dec 08, 1986 Mar CAHN AB +! 120MG N 018602 004 Dec 08, 1986 Mar CAHN DILTIAZEM HYDROCHLORIDE AB EDENBRIDGE PHARMS 30MG A 211596 001 Nov 18, 2019 Nov NEWA AB 60MG A 211596 002 Nov 18, 2019 Nov NEWA AB 90MG A 211596 003 Nov 18, 2019 Nov NEWA AB 120MG A 211596 004 Nov 18, 2019 Nov NEWA TABLET, EXTENDED RELEASE;ORAL CARDIZEM LA AB + BAUSCH 120MG N 021392 001 Feb 06, 2003 Mar CAHN AB + 180MG N 021392 002 Feb 06, 2003 Mar CAHN AB + 240MG N 021392 003 Feb 06, 2003 Mar CAHN AB + 300MG N 021392 004 Feb 06, 2003 Mar CAHN AB + 360MG N 021392 005 Feb 06, 2003 Mar CAHN AB +! 420MG N 021392 006 Feb 06, 2003 Mar CAHN

DIMETHYL SULFOXIDE SOLUTION;INTRAVESICAL DIMETHYL SULFOXIDE @ MYLAN INSTITUTIONAL 50% A 076185 001 Nov 29, 2002 Mar DISC RIMSO-50 +! MYLAN INSTITUTIONAL 50% N 017788 001 Mar CTEC

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE;ORAL DIPHENHYDRAMINE HYDROCHLORIDE @ HERITAGE PHARMA 50MG A 080738 001 Oct DISC ! 50MG A 080738 001 May CAHN INJECTABLE;INJECTION DIPHENHYDRAMINE HYDROCHLORIDE @ DR REDDYS 10MG/ML A 080873 001 May CAHN @ 50MG/ML A 080873 002 May CAHN DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE @ DR REDDYS 50MG/ML A 080873 003 May CAHN

DIPYRIDAMOLE INJECTABLE;INJECTION DIPYRIDAMOLE @ DR REDDYS 5MG/ML A 074952 001 Nov 26, 1997 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -49

DIROXIMEL FUMARATE CAPSULE, DELAYED RELEASE;ORAL VUMERITY +! BIOGEN 231MG N 211855 001 Oct 29, 2019 Oct NEWA

DISULFIRAM TABLET;ORAL DISULFIRAM @ MYLAN 250MG A 203916 001 Mar 04, 2015 Oct DISC @ 500MG A 203916 002 Mar 04, 2015 Oct DISC

DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL DIVALPROEX SODIUM AB CELLTRION EQ 125MG VALPROIC ACID A 077296 001 Jul 31, 2008 Aug CAHN AB EQ 250MG VALPROIC ACID A 077296 002 Jul 31, 2008 Aug CAHN AB EQ 500MG VALPROIC ACID A 077296 003 Jul 31, 2008 Aug CAHN >A> AB INVATECH EQ 125MG VALPROIC ACID A 078290 003 Jul 29, 2008 Dec CAHN >A> AB EQ 250MG VALPROIC ACID A 078290 002 Jul 29, 2008 Dec CAHN >A> AB EQ 500MG VALPROIC ACID A 078290 001 Jul 29, 2008 Dec CAHN >D> AB SANDOZ EQ 125MG VALPROIC ACID A 078290 003 Jul 29, 2008 Dec CAHN >D> AB EQ 250MG VALPROIC ACID A 078290 002 Jul 29, 2008 Dec CAHN >D> AB EQ 500MG VALPROIC ACID A 078290 001 Jul 29, 2008 Dec CAHN @ TEVA EQ 125MG VALPROIC ACID A 076941 001 Jul 29, 2008 Sep DISC @ EQ 250MG VALPROIC ACID A 076941 002 Jul 29, 2008 Sep DISC @ EQ 500MG VALPROIC ACID A 076941 003 Jul 29, 2008 Sep DISC TABLET, EXTENDED RELEASE;ORAL DIVALPROEX SODIUM @ ANCHEN PHARMS EQ 250MG VALPROIC ACID A 078445 001 Feb 26, 2009 Sep DISC @ EQ 500MG VALPROIC ACID A 078445 002 Aug 04, 2009 Sep DISC AB LUPIN LTD EQ 250MG VALPROIC ACID A 209286 001 Oct 18, 2019 Oct NEWA AB EQ 500MG VALPROIC ACID A 209286 002 Oct 18, 2019 Oct NEWA

DOCETAXEL INJECTABLE;INJECTION DOCETAXEL AP ACTAVIS LLC 160MG/8ML (20MG/ML) N 203551 004 Sep 21, 2015 Jun NEWA CI PLA@ CIPLA@ 20MG/2ML (10MG/ML) A 209634 001 Aug 24, 2018 Mar DISC @ 80MG/8ML (10MG/ML) A 209634 002 Aug 24, 2018 Mar DISC @ 160MG/16ML (10MG/ML) A 209634 003 Aug 24, 2018 Mar DISC AP MYLAN LABS LTD 160MG/8ML (20MG/ML) A 208137 001 Apr 01, 2019 Mar NEWA @ SHILPA MEDICARE LTD 20MG/ML (20MG/ML) A 210327 001 May 16, 2019 Oct DISC AP 20MG/ML (20MG/ML) A 210327 001 May 16, 2019 May NEWA @ 80MG/4ML (20MG/ML) A 210327 002 May 16, 2019 Oct DISC AP 80MG/4ML (20MG/ML) A 210327 002 May 16, 2019 May NEWA @ 160MG/8ML (20MG/ML) A 210327 003 May 16, 2019 Oct DISC AP 160MG/8ML (20MG/ML) A 210327 003 May 16, 2019 May NEWA AP TEIKOKU PHARMA 20MG/ML (20MG/ML) N 205934 001 Dec 22, 2015 Mar CAHN AP 80MG/4ML (20MG/ML) N 205934 002 Dec 22, 2015 Mar CAHN AP 160MG/8ML (20MG/ML) N 205934 003 Dec 22, 2015 Mar CAHN @ TEVA PHARMS USA 20MG/ML (20MG/ML) A 203877 001 Sep 16, 2015 Nov DISC @ 80MG/4ML (20MG/ML) A 203877 002 Sep 16, 2015 Nov DISC SOLUTION;INTRAVENOUS DOCETAXEL AP SUN PHARMA GLOBAL 20MG/ML (20MG/ML) N 022534 003 Jan 08, 2019 Jan NEWA AP 80MG/4ML (20MG/ML) N 022534 004 Jan 08, 2019 Jan NEWA AP 160MG/8ML (20MG/ML) N 022534 005 Jan 08, 2019 Jan NEWA

DOFETILIDE CAPSULE;ORAL DOFETILDE AB AUROBINDO PHARMA LTD 0.125MG A 210740 001 Jan 22, 2019 Jan NEWA AB 0.25MG A 210740 002 Jan 22, 2019 Jan NEWA AB 0.5MG A 210740 003 Jan 22, 2019 Jan NEWA DOFETILIDE >A> AB PRINSTON INC 0.125MG A 211223 001 Dec 17, 2019 Dec NEWA >A> AB 0.25MG A 211223 002 Dec 17, 2019 Dec NEWA >A> AB 0.5MG A 211223 003 Dec 17, 2019 Dec NEWA >A> AB RICONPHARMA LLC 0.125MG A 212410 001 Dec 27, 2019 Dec NEWA >A> AB 0.25MG A 212410 002 Dec 27, 2019 Dec NEWA >A> AB 0.5MG A 212410 003 Dec 27, 2019 Dec NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -50

DOLUTEGRAVIR SODIUM; LAMIVUDINE TABLET;ORAL DOVATO +! VIIV HLTHCARE EQ 50MG BASE;300MG N 211994 001 Apr 08, 2019 Apr NEWA

DONEPEZIL HYDROCHLORIDE TABLET;ORAL DONEPEZIL HYDROCHLORIDE AB CADILA 5MG A 090100 001 Oct 24, 2012 Mar CAHN AB 10MG A 090100 002 Oct 24, 2012 Mar CAHN AB HERITAGE PHARMA 5MG A 077344 001 May 31, 2011 May CAHN AB 10MG A 077344 002 May 31, 2011 May CAHN @ OSMOTICA PHARM US 23MG A 203114 001 Jan 26, 2016 Mar DISC @ PAR PHARM 23MG A 202542 001 Jul 24, 2013 Nov DISC AB STRIDES PHARMA 5MG A 090551 001 May 31, 2011 Apr CAHN AB 10MG A 090551 002 May 31, 2011 Apr CAHN @ SUN PHARM 23MG A 204293 001 Jun 05, 2015 Jul DISC TABLET, ORALLY DISINTEGRATING;ORAL DONEPEZIL HYDROCHLORIDE @ HERITAGE PHARMA 5MG A 078388 002 Nov 26, 2010 May CAHN @ 10MG A 078388 001 Nov 26, 2010 May CAHN

DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC DORZOLAMIDE HYDROCHLORIDE AT ALEMBIC PHARMS LTD EQ 2% BASE A 212639 001 Aug 09, 2019 Jul NEWA AT FDC LTD EQ 2% BASE A 205294 001 Jan 24, 2019 Jan NEWA @ LUITPOLD EQ 2% BASE A 079186 001 Nov 18, 2009 Mar DISC AT MICRO LABS EQ 2% BASE A 204778 001 Nov 08, 2019 Oct NEWA @ RUBICON EQ 2% BASE A 078395 001 Oct 28, 2008 Aug CAHN

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE AT ANDA REPOSITORY EQ 2% BASE;EQ 0.5% BASE A 207523 001 Jun 25, 2019 Sep CAHN >D> AT FDC LTD EQ 2% BASE;EQ 0.5% BASE A 205295 001 Jun 13, 2019 Dec DISC >A> @ EQ 2% BASE;EQ 0.5% BASE A 205295 001 Jun 13, 2019 Dec DISC AT EQ 2% BASE;EQ 0.5% BASE A 205295 001 Jun 13, 2019 Jun NEWA @ RUBICON EQ 2% BASE;EQ 0.5% BASE A 078201 001 Oct 28, 2008 Jul CAHN AT SOMERSET EQ 2% BASE;EQ 0.5% BASE A 207523 001 Jun 25, 2019 Oct CAHN AT SOMERSET THERAPS LLC EQ 2% BASE;EQ 0.5% BASE A 207523 001 Jun 25, 2019 Jun NEWA

DOXAPRAM HYDROCHLORIDE INJECTABLE;INJECTION DOPRAM AP +! HIKMA 20MG/ML N 014879 001 Mar CAHN

DOXEPIN HYDROCHLORIDE CAPSULE;ORAL DOXEPIN HYDROCHLORIDE AB AJANTA PHARMA LTD EQ 10MG BASE A 212624 001 Sep 13, 2019 Sep NEWA AB EQ 25MG BASE A 212624 002 Sep 13, 2019 Sep NEWA AB EQ 50MG BASE A 212624 003 Sep 13, 2019 Sep NEWA AB EQ 75MG BASE A 212624 004 Sep 13, 2019 Sep NEWA AB EQ 100MG BASE A 212624 005 Sep 13, 2019 Sep NEWA AB AUROBINDO PHARMA LTD EQ 10MG BASE A 211603 001 Mar 27, 2019 Mar NEWA AB EQ 25MG BASE A 211603 002 Mar 27, 2019 Mar NEWA AB EQ 50MG BASE A 211603 003 Mar 27, 2019 Mar NEWA AB EQ 75MG BASE A 211603 004 Mar 27, 2019 Mar NEWA AB EQ 100MG BASE A 211603 005 Mar 27, 2019 Mar NEWA AB PAR PHARM EQ 10MG BASE A 071422 002 Nov 09, 1987 Aug CMS1 AB EQ 25MG BASE A 071422 003 Nov 09, 1987 Aug CMS1 AB EQ 50MG BASE A 071422 004 Nov 09, 1987 Aug CMS1 AB EQ 75MG BASE A 071422 005 Nov 09, 1987 Aug CMS1 ! EQ 150MG BASE A 071422 006 Nov 09, 1987 Nov CHRS AB EQ 150MG BASE A 071422 006 Nov 09, 1987 Aug CMS1 TABLET;ORAL DOXEPIN HYDROCHLORIDE >D> @ ACTAVIS ELIZABETH EQ 3MG BASE A 201951 001 Jul 26, 2013 Dec CMFD >A> AB EQ 3MG BASE A 201951 001 Jul 26, 2013 Dec CMFD >D> @ EQ 6MG BASE A 201951 002 Jul 26, 2013 Dec CMFD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -51

TABLET;ORAL DOXEPIN HYDROCHLORIDE >A> AB EQ 6MG BASE A 201951 002 Jul 26, 2013 Dec CMFD SILENOR >D> + CURRAX EQ 3MG BASE N 022036 001 Mar 17, 2010 Dec CTEC >A> AB + EQ 3MG BASE N 022036 001 Mar 17, 2010 Dec CTEC + EQ 3MG BASE N 022036 001 Mar 17, 2010 Apr CAHN >D> +! EQ 6MG BASE N 022036 002 Mar 17, 2010 Dec CTEC >A> AB +! EQ 6MG BASE N 022036 002 Mar 17, 2010 Dec CTEC +! EQ 6MG BASE N 022036 002 Mar 17, 2010 Apr CAHN + PERNIX EQ 3MG BASE N 022036 001 Mar 17, 2010 Feb CAHN +! EQ 6MG BASE N 022036 002 Mar 17, 2010 Feb CAHN

DOXERCALCIFEROL INJECTABLE;INJECTION DOXERCALCIFEROL AP GLAND PHARMA LTD 4MCG/2ML (2MCG/ML) A 210452 001 Sep 26, 2019 Sep NEWA + @ HOSPIRA INC 10MCG/5ML (2MCG/ML) N 208614 002 Jul 24, 2018 Jun DISC AP SUN PHARM 2MCG/ML (2MCG/ML) A 203875 001 Nov 14, 2019 Nov NEWA AP 4MCG/2ML (2MCG/ML) A 203875 002 Nov 14, 2019 Nov NEWA

DOXORUBICIN HYDROCHLORIDE INJECTABLE;INJECTION DOXORUBICIN HYDROCHLORIDE @ HISUN PHARM HANGZHOU 20MG/VIAL A 206062 001 May 13, 2019 Oct DISC AP 20MG/VIAL A 206062 001 May 13, 2019 Apr NEWA @ HLTHCARE 2MG/ML A 200146 001 Jul 18, 2012 Sep CAHN @ MYLAN LABS LTD 2MG/ML A 200901 001 Feb 14, 2012 Sep DISC INJECTABLE, LIPOSOMAL;INJECTION DOXIL (LIPOSOMAL) AB + BAXTER HLTHCARE CORP 20MG/10ML (2MG/ML) N 050718 001 Nov 17, 1995 Aug CAHN AB + 50MG/25ML (2MG/ML) N 050718 002 Jun 13, 2000 Aug CAHN

DOXYCYCLINE CAPSULE;ORAL DOXYCYCLINE AB ! SUN PHARM INDS LTD EQ 100MG BASE A 065053 002 Nov 22, 2000 Oct CHRS MONODOX + @ ALMIRALL EQ 50MG BASE N 050641 002 Feb 10, 1992 Oct DISC AB + EQ 50MG BASE N 050641 002 Feb 10, 1992 Feb CAHN + @ EQ 75MG BASE N 050641 003 Oct 18, 2006 Oct DISC AB + EQ 75MG BASE N 050641 003 Oct 18, 2006 Feb CAHN + @ EQ 100MG BASE N 050641 001 Dec 29, 1989 Oct DISC AB +! EQ 100MG BASE N 050641 001 Dec 29, 1989 Feb CAHN TABLET;ORAL DOXYCYCLINE >D> AB HERITAGE PHARMS INC EQ 150MG BASE A 091605 004 Dec 20, 2011 Dec CHRS >A> AB ! EQ 150MG BASE A 091605 004 Dec 20, 2011 Dec CHRS MY LAN@ MYLAN@ EQ 50MG BASE A 065377 001 Nov 07, 2006 Apr DISC @ EQ 75MG BASE A 065377 002 Nov 07, 2006 Apr DISC @ EQ 100MG BASE A 065377 003 Nov 07, 2006 May DISC @ EQ 150MG BASE A 065427 001 Jun 07, 2007 May DISC >D> AB PAR PHARM EQ 50MG BASE A 065070 001 Dec 15, 2000 Dec DISC >A> @ EQ 50MG BASE A 065070 001 Dec 15, 2000 Dec DISC >D> AB EQ 75MG BASE A 065070 003 Dec 30, 2002 Dec DISC >A> @ EQ 75MG BASE A 065070 003 Dec 30, 2002 Dec DISC >D> AB EQ 100MG BASE A 065070 002 Dec 15, 2000 Dec DISC >A> @ EQ 100MG BASE A 065070 002 Dec 15, 2000 Dec DISC >D> AB ! EQ 150MG BASE A 065070 004 Jul 14, 2005 Dec DISC >A> @ EQ 150MG BASE A 065070 004 Jul 14, 2005 Dec DISC

DOXYCYCLINE HYCLATE CAPSULE;ORAL ACTICLATE CAP + @ ALMIRALL EQ 75MG BASE N 208253 001 Apr 26, 2016 Feb CAHN DOXYCYCLINE HYCLATE @ AJANTA PHARMA LTD EQ 50MG BASE A 211012 001 Sep 24, 2018 Mar DISC @ EQ 100MG BASE A 211012 002 Sep 24, 2018 Mar DISC AB CHANGZHOU PHARM EQ 100MG BASE A 209402 001 Oct 07, 2019 Sep NEWA @ MYLAN EQ 50MG BASE A 062337 001 Mar 29, 1982 Apr DISC @ EQ 100MG BASE A 062337 002 Mar 29, 1982 Apr DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -52

TABLET;ORAL ACTICLATE AB + ALMIRALL EQ 75MG BASE N 205931 001 Jul 25, 2014 Feb CAHN AB +! EQ 150MG BASE N 205931 002 Jul 25, 2014 Feb CAHN DOXYCYCLINE HYCLATE AB APOTEX EQ 75MG BASE A 209243 001 Apr 15, 2019 Apr NEWA AB EQ 150MG BASE A 209243 002 Apr 15, 2019 Apr NEWA AB CADILA EQ 100MG BASE A 207773 001 Oct 30, 2017 Feb CAHN AB CHANGZHOU PHARM EQ 100MG BASE A 211343 001 Oct 09, 2019 Sep NEWA AB EPIC PHARMA LLC EQ 20MG BASE A 065182 001 May 13, 2005 Aug CMFD AB HERITAGE PHARMA EQ 20MG BASE A 065163 001 May 13, 2005 May CAHN TABLET, DELAYED RELEASE;ORAL DOXYCYCLINE HYCLATE @ MYLAN EQ 75MG BASE A 090431 001 Dec 28, 2010 Jul DISC @ EQ 100MG BASE A 090431 002 Dec 28, 2010 Jul DISC @ EQ 200MG BASE A 090431 005 May 19, 2016 Jul DISC @ MYLAN PHARMS INC EQ 150MG BASE A 091052 001 Feb 08, 2012 Sep DISC @ ZYDUS PHARMS EQ 75MG BASE A 206772 001 Dec 21, 2018 May DISC @ EQ 100MG BASE A 206772 002 Dec 21, 2018 May DISC @ EQ 150MG BASE A 206772 003 Dec 21, 2018 May DISC

DROSPIRENONE TABLET;ORAL SLYND +! EXELTIS USA INC 4MG N 211367 001 May 23, 2019 May NEWA

DROSPIRENONE; ETHINYL ESTRADIOL TABLET;ORAL DROSPIRENONE AND ETHINYL ESTRADIOL AB ANDA REPOSITORY 3MG;0.02MG A 203291 001 Jul 18, 2017 Aug CAHN AB HETERO LABS LTD 3MG;0.02MG A 211944 001 Mar 22, 2019 Mar NEWA KYRA AB SUN PHARM 3MG;0.02MG A 202318 001 Jul 23, 2019 Jul NEWA LORYNA AB XIROMED 3MG;0.02MG A 079221 001 Mar 28, 2011 Aug CAHN TABLET;ORAL-28 KEMEYA AB SUN PHARM 3MG;0.03MG A 202138 001 Mar 13, 2019 Feb NEWA SYEDA AB XIROMED 3MG;0.03MG A 090114 001 Mar 28, 2011 Aug CAHN

DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED REL PELLETS;ORAL DULOXETINE HYDROCHLORIDE AB AJANTA PHARMA LTD EQ 40MG BASE A 208706 004 Mar 11, 2019 Feb NEWA AB INVENTIA EQ 20MG BASE A 202336 001 Oct 28, 2015 Aug CAHN AB EQ 30MG BASE A 202336 002 Oct 28, 2015 Aug CAHN AB EQ 60MG BASE A 202336 003 Oct 28, 2015 Aug CAHN AB QINGDAO BAHEAL PHARM EQ 20MG BASE A 210599 001 Apr 17, 2019 Apr NEWA AB EQ 30MG BASE A 210599 002 Apr 17, 2019 Apr NEWA AB EQ 60MG BASE A 210599 003 Apr 17, 2019 Apr NEWA @ TEVA PHARMS USA EQ 20MG BASE A 090783 001 Dec 11, 2013 Aug DISC @ EQ 30MG BASE A 090783 002 Dec 11, 2013 Aug DISC @ EQ 60MG BASE A 090783 003 Dec 11, 2013 Aug DISC AB YAOPHARMA CO LTD EQ 20MG BASE A 207219 001 Aug 16, 2019 Aug NEWA AB EQ 30MG BASE A 207219 002 Aug 16, 2019 Aug NEWA AB EQ 60MG BASE A 207219 003 Aug 16, 2019 Aug NEWA CAPSULE, DELAYED RELEASE;ORAL DRIZALMA SPRINKLE + SUN PHARMA GLOBAL EQ 20MG BASE N 212516 001 Jul 19, 2019 Jul NEWA + EQ 30MG BASE N 212516 002 Jul 19, 2019 Jul NEWA + EQ 40MG BASE N 212516 003 Jul 19, 2019 Jul NEWA +! EQ 60MG BASE N 212516 004 Jul 19, 2019 Jul NEWA

DUTASTERIDE CAPSULE;ORAL DUTASTERIDE @ BRECKENRIDGE 0.5MG A 204705 001 Nov 20, 2015 Jun DISC >D> @ 0.5MG A 208227 001 Jun 22, 2018 Dec CAHN @ 0.5MG A 208227 001 Jun 22, 2018 Jun DISC AB CADILA 0.5MG A 204373 001 Oct 04, 2017 Feb CAHN >A> PII@ 0.5MG A 208227 001 Jun 22, 2018 Dec CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -53

ECONAZOLE NITRATE CREAM;TOPICAL ECONAZOLE NITRATE @ CASI PHARMS INC 1% A 076075 001 Nov 26, 2002 Jun DISC AB ! PERRIGO ISRAEL 1% A 076479 001 Jun 23, 2004 May CAHN

EFAVIRENZ TABLET;ORAL EFAVIRENZ >D> @ AUROBINDO PHARMA LTD 600MG A 077673 001 Sep 21, 2018 Dec CMFD >A> AB 600MG A 077673 001 Sep 21, 2018 Dec CMFD @ 600MG A 077673 001 Sep 21, 2018 Feb DISC

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE AB CIPLA 600MG;200MG;300MG A 206894 001 Jun 03, 2019 May NEWA @ TEVA PHARMS USA 600MG;200MG;300MG A 091215 001 Nov 09, 2018 May DISC

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE @ MACLEODS PHARMS LTD 400MG;300MG;300MG N 210649 001 Mar 15, 2019 Jun DISC 400MG;300MG;300MG N 210649 001 Mar 15, 2019 Mar NEWA

EFINACONAZOLE SOLUTION;TOPICAL JUBLIA +! BAUSCH 10% N 203567 001 Jun 06, 2014 Feb CAHN

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TABLET, TABLET;ORAL TRIKAFTA (COPACKAGED) +! VERTEX PHARMS INC 100MG,75MG,50MG;N/A,150MG,N/A N 212273 001 Oct 21, 2019 Oct NEWA

ELTROMBOPAG OLAMINE TABLET;ORAL PROMACTA + @ NOVARTIS EQ 100MG ACID N 022291 005 Nov 16, 2012 Feb DISC

EMEDASTINE DIFUMARATE SOLUTION/DROPS;OPHTHALMIC EMADINE + @ NOVARTIS 0.05% N 020706 001 Dec 29, 1997 Jul DISC

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE @ AMNEAL PHARMS CO 100MG;150MG A 209721 001 Aug 22, 2018 Feb DISC @ 133MG;200MG A 209721 002 Aug 22, 2018 Feb DISC @ 167MG;250MG A 209721 003 Aug 22, 2018 Feb DISC @ 200MG;300MG A 209721 004 Aug 22, 2018 Feb DISC @ LAURUS LABS LTD 200MG;300MG A 212114 001 Jul 26, 2019 Aug DISC AB 200MG;300MG A 212114 001 Jul 26, 2019 Jul NEWA TRUVADA + GILEAD 100MG;150MG N 021752 002 Mar 10, 2016 Feb CTEC + 133MG;200MG N 021752 003 Mar 10, 2016 Feb CTEC + 167MG;250MG N 021752 004 Mar 10, 2016 Feb CTEC

ENALAPRIL MALEATE FOR SOLUTION;ORAL EPANED KIT + @ SILVERGATE PHARMS 1MG/ML N 204308 001 Aug 13, 2013 Mar DISC TABLET;ORAL ENALAPRIL MALEATE @ BEXIMCO PHARMS USA 2.5MG A 075621 001 Aug 22, 2000 Feb CAHN @ 5MG A 075621 002 Aug 22, 2000 Feb CAHN @ 10MG A 075621 003 Aug 22, 2000 Feb CAHN @ 20MG A 075621 004 Aug 22, 2000 Feb CAHN AB HERITAGE PHARMA 2.5MG A 075479 001 Aug 22, 2000 Feb CAHN AB 5MG A 075479 002 Aug 22, 2000 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -54

TABLET;ORAL ENALAPRIL MALEATE AB 10MG A 075479 003 Aug 22, 2000 Feb CAHN AB 20MG A 075479 004 Aug 22, 2000 Feb CAHN @ MYLAN 5MG A 075480 002 Aug 22, 2000 Jun DISC @ 10MG A 075480 003 Aug 22, 2000 Feb DISC AB NOSTRUM LABS INC 2.5MG A 075178 002 Mar 23, 2001 Oct CAHN AB 5MG A 075178 001 Mar 23, 2001 Oct CAHN AB 10MG A 075178 003 Mar 23, 2001 Oct CAHN AB 20MG A 075178 004 Mar 23, 2001 Oct CAHN VASOTEC AB + BAUSCH 2.5MG N 018998 005 Jul 26, 1988 Mar CAHN AB + 5MG N 018998 001 Dec 24, 1985 Mar CAHN AB + 10MG N 018998 002 Dec 24, 1985 Mar CAHN AB +! 20MG N 018998 003 Dec 24, 1985 Mar CAHN

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE AB NOSTRUM LABS INC 5MG;12.5MG A 076486 001 Oct 27, 2004 Oct CAHN AB 10MG;25MG A 076486 002 Oct 27, 2004 Oct CAHN VASERETIC AB + BAUSCH 5MG;12.5MG N 019221 003 Jul 12, 1995 Mar CAHN AB +! 10MG;25MG N 019221 001 Oct 31, 1986 Mar CAHN

ENALAPRILAT INJECTABLE;INJECTION ENALAPRILAT AP DR REDDYS 1.25MG/ML A 075578 001 Aug 22, 2000 May CAHN

ENCORAFENIB CAPSULE;ORAL BRAFTOVI + @ ARRAY BIOPHARMA INC 50MG N 210496 001 Jun 27, 2018 Jul DISC

ENOXAPARIN SODIUM INJECTABLE;INTRAVENOUS, SUBCUTANEOUS ENOXAPARIN SODIUM AB AMPHASTAR PHARMS INC 300MG/3ML (100MG/ML) A 208600 001 Mar 14, 2019 Mar NEWA INJECTABLE;SUBCUTANEOUS ENOXAPARIN SODIUM (PRESERVATIVE FREE) AP NANJING KING-FRIEND 30MG/0.3ML (100MG/ML) A 206834 001 Nov 29, 2019 Nov NEWA AP 40MG/0.4ML (100MG/ML) A 206834 002 Nov 29, 2019 Nov NEWA AP 60MG/0.6ML (100MG/ML) A 206834 003 Nov 29, 2019 Nov NEWA AP 80MG/0.8ML (100MG/ML) A 206834 004 Nov 29, 2019 Nov NEWA AP 100MG/ML (100MG/ML) A 206834 005 Nov 29, 2019 Nov NEWA AP 120MG/0.8ML (150MG/ML) A 206834 006 Nov 29, 2019 Nov NEWA AP 150MG/ML (150MG/ML) A 206834 007 Nov 29, 2019 Nov NEWA

ENTECAVIR TABLET;ORAL ENTECAVIR AB BRIGHTGENE 0.5MG A 212126 001 Sep 25, 2019 Sep NEWA AB 1MG A 212126 002 Sep 25, 2019 Sep NEWA AB MYLAN 0.5MG A 206226 001 Mar 26, 2019 Mar NEWA AB 1MG A 206226 002 Mar 26, 2019 Mar NEWA @ PAR PHARM INC 0.5MG A 206294 001 Nov 23, 2016 Nov DISC @ 1MG A 206294 002 Nov 23, 2016 Nov DISC AB YAOPHARMA CO LTD 0.5MG A 212201 001 Nov 04, 2019 Oct NEWA AB 1MG A 212201 002 Nov 04, 2019 Oct NEWA

ENTRECTINIB CAPSULE;ORAL ROZLYTREK + GENENTECH INC 100MG N 212725 001 Aug 15, 2019 Aug NEWA +! 200MG N 212725 002 Aug 15, 2019 Aug NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -55

EPHEDRINE SULFATE SOLUTION;INTRAVENOUS AKOVAZ AP +! AVADEL LEGACY 50MG/ML (50MG/ML) N 208289 001 Apr 29, 2016 Nov CAHN EPHEDRINE SULFATE AP AMNEAL 50MG/ML (50MG/ML) A 212932 001 Oct 23, 2019 Nov CAHN AP AMNEAL PHARMS CO 50MG/ML (50MG/ML) A 212932 001 Oct 23, 2019 Oct NEWA

EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EPINASTINE HYDROCHLORIDE @ CASI PHARMS INC 0.05% A 203384 001 Dec 07, 2016 Jun DISC @ SUN PHARM INDS 0.05% A 091626 001 Oct 31, 2011 Jul DISC

EPINEPHRINE INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS EPINEPHRINE (AUTOINJECTOR) AB TEVA PHARMS USA 0.15MG/DELIVERY A 090589 002 Aug 16, 2018 Jul CMFD @ 0.15MG/DELIVERY A 090589 002 Aug 16, 2018 Mar DISC EPIPEN JR. AB +! MYLAN SPECIALITY LP 0.15MG/DELIVERY N 019430 002 Dec 22, 1987 Jul CTEC +! 0.15MG/DELIVERY N 019430 002 Dec 22, 1987 Mar CTEC SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS ADRENALIN +! PAR STERILE PRODUCTS EQ 1MG BASE/ML (EQ 1MG BASE/ML) N 204200 001 Dec 07, 2012 Aug CTEC AP +! EQ 1MG BASE/ML (EQ 1MG BASE/ML) N 204200 001 Dec 07, 2012 Jan CDFR +! EQ 30MG BASE/30ML (EQ 1MG BASE/ML) N 204640 001 Dec 18, 2013 Jan CDFR SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS EPINEPHRINE @ AM REGENT EQ 1MG BASE/ML (EQ 1MG BASE/ML) A 207568 001 Jul 06, 2018 Aug DISC SOLUTION;INTRAVENOUS EPINEPHRINE (COPACKAGED) +! HOSPIRA INC 1MG/10ML (0.1MG/ML) N 209359 001 Nov 05, 2019 Nov NEWA SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS EPINEPHRINE +! BELCHER PHARMS LLC EQ 1MG BASE/ML (EQ 1MG BASE/ML) N 205029 001 Jul 29, 2014 May CDFR

EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION EPIRUBICIN HYDROCHLORIDE @ ACTAVIS TOTOWA 10MG/5ML (2MG/ML) A 065445 001 Sep 18, 2008 Sep DISC FRESENIUS KABI USA 10MG/5ML (2MG/ML) A 065408 001 Oct 15, 2007 Sep CTEC 150MG/75ML (2MG/ML) A 065408 003 Oct 15, 2007 Mar CTEC @ 200MG/100ML (2MG/ML) A 065411 001 Aug 20, 2007 Oct DISC @ 50MG/25ML (2MG/ML) A 065411 002 Aug 20, 2007 Oct DISC @ MYLAN LABS LTD 50MG/25ML (2MG/ML) A 091599 001 Mar 12, 2012 Sep DISC @ 200MG/100ML (2MG/ML) A 091599 002 Mar 12, 2012 Sep DISC @ ZENNOVA 50MG/25ML (2MG/ML) A 090266 001 Apr 15, 2011 Sep CAHN @ 200MG/100ML (2MG/ML) A 090266 002 Apr 15, 2011 Sep CAHN

EPTIFIBATIDE INJECTABLE;INJECTION EPTIFIBATIDE AP BAXTER HLTHCARE CORP 2MG/ML A 208554 001 Nov 23, 2018 Jan CAHN AP 75MG/100ML A 208554 002 Nov 23, 2018 Jan CAHN AP HAINAN POLY PHARM 2MG/ML A 209864 001 Jan 25, 2019 Jan NEWA AP 75MG/100ML A 209864 002 Jan 25, 2019 Jan NEWA @ USV 2MG/ML A 204361 001 Mar 14, 2019 Oct DISC AP 2MG/ML A 204361 001 Mar 14, 2019 Mar NEWA @ 2MG/ML A 204362 001 Mar 11, 2019 Oct DISC AP 2MG/ML A 204362 001 Mar 11, 2019 Feb NEWA @ 75MG/100ML A 204361 002 Mar 14, 2019 Oct DISC AP 75MG/100ML A 204361 002 Mar 14, 2019 Mar NEWA

ERDAFITINIB TABLET;ORAL BALVERSA + JANSSEN BIOTECH 3MG N 212018 001 Apr 12, 2019 Apr NEWA + 4MG N 212018 002 Apr 12, 2019 Apr NEWA +! 5MG N 212018 003 Apr 12, 2019 Apr NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -56

ERGOCALCIFEROL CAPSULE;ORAL ERGOCALCIFEROL >D> AA PURACAP PHARM LLC 50000IU A 204276 001 Dec 07, 2018 Dec CPOT >A> AA 50,000 IU A 204276 001 Dec 07, 2018 Dec CPOT

ERLOTINIB HYDROCHLORIDE TABLET;ORAL ERLOTINIB HYDROCHLORIDE AB APOTEX EQ 25MG BASE A 208396 001 Nov 05, 2019 Oct NEWA AB EQ 100MG BASE A 208396 002 Nov 05, 2019 Oct NEWA AB EQ 150MG BASE A 208396 003 Nov 05, 2019 Oct NEWA AB MYLAN EQ 25MG BASE A 091002 001 Jun 11, 2014 Feb CMFD AB EQ 100MG BASE A 091002 002 Jun 11, 2014 Feb CMFD AB EQ 150MG BASE A 091002 003 Jun 11, 2014 Feb CMFD AB NATCO PHARMA LTD EQ 25MG BASE A 208488 001 Nov 05, 2019 Oct NEWA AB EQ 100MG BASE A 208488 002 Nov 05, 2019 Oct NEWA AB EQ 150MG BASE A 208488 003 Nov 05, 2019 Oct NEWA AB SHILPA MEDICARE LTD EQ 25MG BASE A 211960 001 Nov 05, 2019 Oct NEWA AB EQ 100MG BASE A 211960 002 Nov 05, 2019 Oct NEWA AB EQ 150MG BASE A 211960 003 Nov 05, 2019 Oct NEWA AB SUN PHARM EQ 25MG BASE A 210300 001 Nov 05, 2019 Oct NEWA AB EQ 100MG BASE A 210300 002 Nov 05, 2019 Oct NEWA AB EQ 150MG BASE A 210300 003 Nov 05, 2019 Oct NEWA AB TEVA PHARMS USA EQ 100MG BASE A 091059 002 Aug 28, 2015 Mar CMFD AB EQ 150MG BASE A 091059 003 Aug 28, 2015 Mar CMFD TARCEVA AB + OSI PHARMS EQ 25MG BASE N 021743 001 Nov 18, 2004 Mar CAHN AB + EQ 25MG BASE N 021743 001 Nov 18, 2004 Feb CTEC AB + EQ 100MG BASE N 021743 002 Nov 18, 2004 Mar CAHN AB + EQ 100MG BASE N 021743 002 Nov 18, 2004 Feb CTEC AB +! EQ 150MG BASE N 021743 003 Nov 18, 2004 Mar CAHN AB +! EQ 150MG BASE N 021743 003 Nov 18, 2004 Feb CTEC

ERTAPENEM SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS ERTAPENEM SODIUM AP SAVIOR LIFETEC CORP EQ 1GM BASE/VIAL A 207647 001 Mar 19, 2019 Mar NEWA

ERYTHROMYCIN OINTMENT;TOPICAL AKNE-MYCIN + BAUSCH@ 2% N 050584 001 Jan 10, 1985 Apr CAHN SOLUTION;TOPICAL ERYTHRA-DERM ML V@ MLV@ 2% A 062687 001 Feb 05, 1988 Aug CAHN @ SAPTALIS PHARMS 2% A 062687 001 Feb 05, 1988 Feb CAHN TABLET, DELAYED RELEASE;ORAL ERY-TAB AB ARBOR PHARMS LLC 250MG A 062298 001 Jun CTEC AB 333MG A 062298 003 Mar 29, 1982 Jun CTEC AB ! 500MG A 062298 002 Jun CTEC ERYTHROMYCIN AB AMNEAL PHARMS CO 250MG A 210954 001 Jul 02, 2019 Jun NEWA AB 333MG A 210954 002 Jul 02, 2019 Jun NEWA AB 500MG A 210954 003 Jul 02, 2019 Jun NEWA

ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL E.E.S. AB + ARBOR PHARMS LLC EQ 200MG BASE/5ML N 050207 001 Sep CTEC ERYPED AB + ARBOR PHARMS LLC EQ 200MG BASE/5ML N 050207 003 Mar 30, 1987 Sep CTEC ERYTHROMYCIN ETHYLSUCCINATE AB AMNEAL PHARMS EQ 200MG BASE/5ML A 211204 001 Nov 01, 2019 Oct NEWA AB EQ 400MG BASE/5ML A 211204 002 Nov 01, 2019 Oct NEWA AB ANI PHARMS INC EQ 200MG BASE/5ML A 062055 001 Sep CTEC AB EQ 200MG BASE/5ML A 062055 003 Nov 02, 2018 Sep CTEC AB PAR PHARM INC EQ 200MG BASE/5ML A 211991 001 Oct 23, 2019 Oct NEWA AB EQ 400MG BASE/5ML A 211991 002 Oct 23, 2019 Oct NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -57

ESCITALOPRAM OXALATE SOLUTION;ORAL ESCITALOPRAM OXALATE AA ALLIED EQ 5MG BASE/5ML A 203967 001 May 26, 2015 Sep CAHN TABLET;ORAL ESCITALOPRAM OXALATE AB CADILA EQ 5MG BASE A 077734 001 Sep 11, 2012 Apr CAHN AB EQ 10MG BASE A 077734 002 Sep 11, 2012 Apr CAHN AB EQ 20MG BASE A 077734 003 Sep 11, 2012 Apr CAHN AB GRAVITI PHARMS EQ 5MG BASE A 078777 001 Sep 11, 2012 Nov CAHN AB EQ 10MG BASE A 078777 002 Sep 11, 2012 Nov CAHN AB EQ 20MG BASE A 078777 003 Sep 11, 2012 Nov CAHN

ESKETAMINE HYDROCHLORIDE SPRAY;NASAL SPRAVATO +! JANSSEN PHARMS EQ 28MG BASE N 211243 001 Mar 05, 2019 Mar NEWA

ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION ESMOLOL HYDROCHLORIDE AP GLAND PHARMA LTD 10MG/ML A 208538 001 Aug 14, 2019 Jul NEWA

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED REL PELLETS;ORAL ESOMEPRAZOLE MAGNESIUM @ AMNEAL PHARMS NY EQ 20MG BASE A 209647 001 Apr 10, 2019 Jun DISC AB EQ 20MG BASE A 209647 001 Apr 10, 2019 Mar NEWA @ EQ 40MG BASE A 209647 002 Apr 10, 2019 Jun DISC AB EQ 40MG BASE A 209647 002 Apr 10, 2019 Mar NEWA AB GLENMARK PHARMS EQ 20MG BASE A 209495 001 May 10, 2019 Apr NEWA AB EQ 40MG BASE A 209495 002 May 10, 2019 Apr NEWA @ HEC PHARM EQ 20MG BASE A 207265 002 May 18, 2018 Mar DISC @ EQ 40MG BASE A 207265 001 May 18, 2018 Mar DISC AB HETERO LABS LTD III EQ 20MG BASE A 202784 001 Sep 21, 2015 Jun CTEC AB EQ 40MG BASE A 202784 002 Sep 21, 2015 Jun CTEC AB ZYDUS PHARMS EQ 20MG BASE A 206296 001 May 22, 2019 May NEWA AB EQ 40MG BASE A 206296 002 May 22, 2019 May NEWA

ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE;ORAL ESOMEPRAZOLE STRONTIUM + @ R2 PHARMA LLC 49.3MG N 202342 002 Aug 06, 2013 Aug DISC

ESTRADIOL FILM, EXTENDED RELEASE;TRANSDERMAL ESTRADIOL AB1 AMNEAL PHARMS LLC 0.025MG/24HR A 211293 001 Feb 04, 2019 Jan NEWA AB1 0.0375MG/24HR A 211293 002 Feb 04, 2019 Jan NEWA AB1 0.05MG/24HR A 211293 003 Feb 04, 2019 Jan NEWA AB1 0.075MG/24HR A 211293 004 Feb 04, 2019 Jan NEWA AB1 0.1MG/24HR A 211293 005 Feb 04, 2019 Jan NEWA GEL;TRANSDERMAL DIVIGEL +! VERTICAL PHARMS LLC 0.1% N 022038 001 Jun 04, 2007 Jan CHRS

ESTRADIOL VALERATE INJECTABLE;INJECTION ESTRADIOL VALERATE @ DR REDDYS 40MG/ML A 083714 001 May CAHN

ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL ESTRADIOL AND NORETHINDRONE ACETATE @ ACCORD HLTHCARE 1MG;0.5MG A 210233 001 Feb 28, 2018 Mar DISC AB NOVAST LABS 0.5MG;0.1MG A 210612 001 Apr 03, 2019 Mar NEWA AB 1MG;0.5MG A 210612 002 Apr 03, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -58

ESTROGENS, CONJUGATED SYNTHETIC A TABLET;ORAL CENESTIN + @ ASPEN 0.3MG N 020992 001 Jun 21, 2002 Feb CAHN + @ 0.45MG N 020992 005 Feb 05, 2004 Feb CAHN + @ 0.625MG N 020992 002 Mar 24, 1999 Feb CAHN + @ 0.9MG N 020992 003 Mar 24, 1999 Feb CAHN + @ 1.25MG N 020992 004 Mar 13, 2000 Feb CAHN

ESTROGENS, CONJUGATED SYNTHETIC B TABLET;ORAL ENJUVIA @ ASPEN 0.3MG N 021443 001 Dec 20, 2004 Feb CAHN @ 0.45MG N 021443 002 Dec 20, 2004 Feb CAHN @ 0.625MG N 021443 003 May 10, 2004 Feb CAHN @ 0.9MG N 021443 005 Apr 27, 2007 Feb CAHN @ 1.25MG N 021443 004 May 10, 2004 Feb CAHN

ESZOPICLONE TABLET;ORAL ESZOPICLONE @ BRECKENRIDGE 1MG A 203087 001 May 08, 2019 May DISC @ 2MG A 203087 002 May 08, 2019 May DISC @ 3MG A 203087 003 May 08, 2019 May DISC AB BRECKENRIDGE PHARM 1MG A 203087 001 May 08, 2019 Apr NEWA AB 2MG A 203087 002 May 08, 2019 Apr NEWA AB 3MG A 203087 003 May 08, 2019 Apr NEWA

ETHACRYNATE SODIUM INJECTABLE;INJECTION EDECRIN AP +! BAUSCH EQ 50MG BASE/VIAL N 016093 001 Mar CAHN AP +! VALEANT PHARMS INTL EQ 50MG BASE/VIAL N 016093 001 Jan CAHN

ETHACRYNIC ACID TABLET;ORAL EDECRIN AB +! BAUSCH 25MG N 016092 001 Mar CAHN @ 50MG N 016092 002 Mar CAHN AB +! VALEANT PHARMS INTL 25MG N 016092 001 Jan CAHN @ 50MG N 016092 002 Jan CAHN ETHACRYNIC ACID AB AGNITIO 25MG A 211809 001 Jul 12, 2019 Jul NEWA AB LUPIN LTD 25MG A 211719 001 Sep 06, 2019 Aug NEWA AB SCIEGEN PHARMS INC 25MG A 211232 001 Aug 27, 2019 Aug NEWA

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE TABLET;ORAL-28 LO-MALMOREDE AB NOVAST LABS 0.035MG;1MG A 209548 001 Feb 11, 2019 Jan NEWA

ETHINYL ESTRADIOL; ETONOGESTREL RING;VAGINAL ELURYNG AB AMNEAL PHARMS LLC 0.015MG/24HR;0.12MG/24HR A 210830 001 Dec 11, 2019 Nov NFTG NUVARING AB +! ORGANON SUB MERCK 0.015MG/24HR;0.12MG/24HR N 021187 001 Oct 03, 2001 Nov CFTG

ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL INTROVALE AB XIROMED 0.03MG;0.15MG A 079064 001 Sep 27, 2010 Aug CAHN JAIMIESS AB XIROMED 0.03MG,0.01MG;0.15MG,N/A A 203770 001 Dec 27, 2017 Aug CAHN LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AB XIROMED 0.02MG,0.1MG;0.01MG,N/A A 205131 001 Dec 14, 2017 Aug CAHN SYLEVIA AB SUN PHARM 0.03MG;0.15MG A 202988 001 Feb 06, 2019 Jan NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -59

TABLET;ORAL-28 ALTAVERA AB XIROMED 0.03MG;0.15MG A 079102 001 Aug 03, 2010 Aug CAHN ELIFEMME AB XIROMED 0.03MG,0.04MG,0.03MG;0.05MG,0.075M A 202507 001 Dec 04, 2015 Aug CAHN G,0.125MG LEVONORGESTREL AND ETHINYL ESTRADIOL @ MYLAN LABS LTD 0.02MG;0.1MG A 202247 001 Dec 08, 2014 Jun DISC VIENVA AB1 XIROMED 0.02MG;0.1MG A 201088 001 May 21, 2015 Aug CAHN

ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 NORETHINDRONE AND ETHINYL ESTRADIOL @ MYLAN LABS LTD 0.05MG;1MG A 203006 001 Aug 05, 2013 Sep DISC NORTREL 1/35-28 AB ! BARR 0.035MG;1MG A 072696 001 Feb 28, 1992 Mar CHRS ORTHO-NOVUM 1/35-28 + @ JANSSEN PHARMS 0.035MG;1MG N 017919 002 Mar DISC TABLET, CHEWABLE;ORAL NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE AB ! MYLAN LABS LTD 0.035MG;0.4MG A 202086 001 Apr 01, 2015 Mar CHRS

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 HAILEY 1.5/30 AB GLENMARK PHARMS 0.03MG;1.5MG A 209297 001 Jun 05, 2018 Jan CDFR LOESTRIN 21 1.5/30 AB + APIL 0.03MG;1.5MG N 017875 001 Jan CRLD LOESTRIN 21 1/20 AB + APIL 0.02MG;1MG N 017876 001 Jan CRLD TABLET, CHEWABLE;ORAL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE @ MYLAN LABS LTD 0.02MG;1MG A 206120 001 Sep 12, 2017 Oct DISC AB XIROMED 0.02MG;1MG A 209609 001 Jul 16, 2018 Aug CAHN

ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 ESTARYLLA AB XIROMED 0.035MG;0.25MG A 090794 001 Jan 30, 2013 Aug CAHN NORGESTIMATE AND ETHINYL ESTRADIOL @ MYLAN LABS LTD 0.025MG,0.025MG,0.025MG;0.18MG,0.2 A 202132 001 Sep 09, 2015 Jan DISC 15MG,0.25MG AB NAARI PTE LTD 0.035MG;0.035MG;0.035MG;0.18MG;0.2 A 200383 001 Apr 07, 2015 Sep CAHN 15MG;0.25MG AB 0.035MG;0.25MG A 200384 001 Apr 07, 2015 Sep CAHN ORTHO CYCLEN-28 + @ JANSSEN PHARMS 0.035MG;0.25MG N 019653 002 Dec 29, 1989 Apr DISC SPRINTEC AB ! BARR 0.035MG;0.25MG A 075804 001 Sep 25, 2002 Apr CHRS TRI-ESTARYLLA AB XIROMED 0.035MG,0.035MG,0.035MG;0.18MG,0.2 A 090793 001 Jan 30, 2013 Aug CAHN 15MG,0.25MG TRI-LO-ESTARYLLA AB XIROMED 0.025MG,0.025MG,0.025MG;0.18MG,0.2 A 091232 001 Jun 29, 2015 Aug CAHN 15MG,0.25MG

ETHINYL ESTRADIOL; SEGESTERONE ACETATE RING;VAGINAL ANNOVERA +! THERAPEUTICSMD INC 0.013MG/24HR;0.15MG/24HR N 209627 001 Aug 10, 2018 May CMFD + @ 0.013MG/24HR;0.15MG/24HR N 209627 001 Aug 10, 2018 Feb DISC

ETHOSUXIMIDE CAPSULE;ORAL ETHOSUXIMIDE AB STRIDES PHARMA 250MG A 211928 001 Feb 19, 2019 Feb NEWA SYRUP;ORAL ETHOSUXIMIDE @ TEVA PHARMS 250MG/5ML A 081306 001 Jul 30, 1993 May DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -60

ETIDRONATE DISODIUM TABLET;ORAL ETIDRONATE DISODIUM @ MYLAN 200MG A 075800 001 Jan 24, 2003 Nov DISC @ 400MG A 075800 002 Jan 24, 2003 Nov DISC

ETODOLAC TABLET;ORAL ETODOLAC >A> @ INVATECH 400MG A 074839 001 Jul 11, 1997 Dec CAHN >A> @ 400MG A 074846 001 Feb 28, 1997 Dec CAHN >D> @ SANDOZ 400MG A 074839 001 Jul 11, 1997 Dec CAHN >D> @ 400MG A 074846 001 Feb 28, 1997 Dec CAHN

ETOMIDATE INJECTABLE;INJECTION ETOMIDATE @ LUITPOLD 2MG/ML A 078867 001 Dec 22, 2009 Feb DISC @ PAR STERILE PRODUCTS 2MG/ML A 091297 001 Jun 20, 2012 Apr DISC

ETOPOSIDE PHOSPHATE INJECTABLE;INJECTION ETOPOPHOS PRESERVATIVE FREE +! CHEPLAPHARM EQ 100MG BASE/VIAL N 020457 001 May 17, 1996 May CAHN

EVEROLIMUS TABLET;ORAL AFINITOR AB + NOVARTIS 2.5MG N 022334 003 Jul 09, 2010 Nov CFTG AB +! 5MG N 022334 001 Mar 30, 2009 Nov CFTG +! 5MG N 022334 001 Mar 30, 2009 Apr CHRS AB + 7.5MG N 022334 004 Mar 30, 2012 Nov CFTG AB + 10MG N 022334 002 Mar 30, 2009 Nov CFTG + 10MG N 022334 002 Mar 30, 2009 Apr CHRS EVEROLIMUS AB PAR PHARM 2.5MG A 207934 001 Dec 09, 2019 Nov NFTG AB 5MG A 207934 002 Dec 09, 2019 Nov NFTG AB 7.5MG A 207934 003 Dec 09, 2019 Nov NFTG AB TEVA PHARMS USA 2.5MG A 210050 001 Dec 09, 2019 Nov NFTG AB 5MG A 210050 002 Dec 09, 2019 Nov NFTG AB 7.5MG A 210050 003 Dec 09, 2019 Nov NFTG AB 10MG A 210050 004 Dec 09, 2019 Nov NFTG ZORTRESS + NOVARTIS 1MG N 021560 004 Aug 10, 2018 Mar NEWA TABLET, FOR SUSPENSION;ORAL AFINITOR DISPERZ + NOVARTIS PHARM 2MG N 203985 001 Aug 29, 2012 Apr CTEC AB + 2MG N 203985 001 Aug 29, 2012 Apr CFTG + 3MG N 203985 002 Aug 29, 2012 Apr CTEC AB + 3MG N 203985 002 Aug 29, 2012 Apr CFTG +! 5MG N 203985 003 Aug 29, 2012 Apr CTEC AB +! 5MG N 203985 003 Aug 29, 2012 Apr CFTG EVEROLIMUS MY LAN@ MYLAN@ 2MG A 210130 001 Apr 19, 2019 Apr NFTG @ 3MG A 210130 002 Apr 19, 2019 Apr NFTG @ 5MG A 210130 003 Apr 19, 2019 Apr NFTG

EXEMESTANE TABLET;ORAL EXEMESTANE @ AMNEAL PHARMS 25MG A 206421 001 Dec 28, 2018 Jul DISC >D> @ BRECKENRIDGE 25MG A 211031 001 Feb 21, 2019 Dec CMFD >A> AB 25MG A 211031 001 Feb 21, 2019 Dec CMFD @ 25MG A 211031 001 Feb 21, 2019 May DISC AB BRECKENRIDGE PHARM 25MG A 211031 001 Feb 21, 2019 Feb NEWA AB MAYNE PHARMA INC 25MG A 208764 001 Aug 08, 2019 Jul NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -61

EZETIMIBE TABLET;ORAL EZETIMIBE AB ACCORD HLTHCARE 10MG A 211550 001 Oct 26, 2018 Nov CMFD @ 10MG A 211550 001 Oct 26, 2018 Apr DISC AB MYLAN 10MG A 201790 001 Apr 26, 2019 Apr NEWA

EZETIMIBE; SIMVASTATIN TABLET;ORAL EZETIMIBE AND SIMVASTATIN AB GLENMARK PHARMS LTD 10MG;10MG A 208699 001 Jun 27, 2019 Jun NEWA AB 10MG;20MG A 208699 002 Jun 27, 2019 Jun NEWA AB 10MG;40MG A 208699 003 Jun 27, 2019 Jun NEWA AB 10MG;80MG A 208699 004 Jun 27, 2019 Jun NEWA

FAMOTIDINE FOR SUSPENSION;ORAL FAMOTIDINE AB ! LUPIN LTD 40MG/5ML A 090440 001 Jun 29, 2010 Nov CHRS PEPCID + @ SALIX PHARMS 40MG/5ML N 019527 001 Feb 02, 1987 Nov DISC TABLET;ORAL FAMOTIDINE AB CELLTRION 20MG A 075786 001 Apr 16, 2001 Aug CAHN AB 40MG A 075786 002 Apr 16, 2001 Aug CAHN MY LAN@ MYLAN@ 40MG A 075704 002 Apr 16, 2001 Apr DISC

FEBUXOSTAT TABLET;ORAL FEBUXOSTAT AB ALEMBIC PHARMS LTD 40MG A 205421 001 Jul 01, 2019 Jun NFTG AB 80MG A 205421 002 Jul 01, 2019 Jun NFTG AB HIKMA 40MG A 205414 001 Oct 15, 2019 Nov CAHN AB 80MG A 205414 002 Oct 15, 2019 Nov CAHN >A> AB INDOCO REMEDIES 40MG A 210292 001 Dec 30, 2019 Dec NEWA >A> AB 80MG A 210292 002 Dec 30, 2019 Dec NEWA >A> AB MSN 40MG A 210461 001 Dec 30, 2019 Dec NEWA >A> AB 80MG A 210461 002 Dec 30, 2019 Dec NEWA AB MYLAN 40MG A 205385 001 Jul 01, 2019 Jun NFTG AB 80MG A 205385 002 Jul 01, 2019 Jun NFTG AB SUN PHARM 40MG A 205467 001 Jul 01, 2019 Jun NFTG AB 80MG A 205467 002 Jul 01, 2019 Jun NFTG AB WEST-WARD PHARMS INT 40MG A 205414 001 Oct 15, 2019 Sep NEWA AB 80MG A 205414 002 Oct 15, 2019 Sep NEWA ULORIC AB + TAKEDA PHARMS USA 40MG N 021856 001 Feb 13, 2009 Jun CFTG AB +! 80MG N 021856 002 Feb 13, 2009 Jun CFTG

FEDRATINIB HYDROCHLORIDE CAPSULE;ORAL INREBIC +! IMPACT EQ 100MG BASE N 212327 001 Aug 16, 2019 Aug NEWA

FELBAMATE SUSPENSION;ORAL FELBAMATE AB VISTAPHARM 600MG/5ML A 211333 001 May 31, 2019 May NEWA TABLET;ORAL FELBAMATE AB CADILA 400MG A 208970 001 May 30, 2017 Jul CAHN AB 600MG A 208970 002 May 30, 2017 Jul CAHN

FELODIPINE TABLET, EXTENDED RELEASE;ORAL FELODIPINE @ MYLAN 2.5MG A 078855 001 Apr 17, 2008 Oct DISC @ 5MG A 078855 002 Apr 17, 2008 Oct DISC @ 10MG A 078855 003 Apr 17, 2008 Oct DISC AB ! TORRENT PHARMS LTD 10MG A 202170 003 Nov 28, 2011 Oct CHRS AB YUNG SHIN PHARM 2.5MG A 204800 001 Apr 29, 2019 Apr NEWA AB 5MG A 204800 002 Apr 29, 2019 Apr NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -62

TABLET, EXTENDED RELEASE;ORAL FELODIPINE AB 10MG A 204800 003 Apr 29, 2019 Apr NEWA

FENOFIBRATE CAPSULE;ORAL FENOFIBRATE (MICRONIZED) AB AUSTARPHARMA 67MG A 207805 001 Nov 16, 2017 Jan CAHN AB 134MG A 207805 002 Nov 16, 2017 Jan CAHN AB 200MG A 207805 003 Nov 16, 2017 Jan CAHN AB INGENUS PHARMS LLC 67MG A 207564 001 Apr 19, 2019 Apr NEWA AB 134MG A 207564 002 Apr 19, 2019 Apr NEWA AB 200MG A 207564 003 Apr 19, 2019 Apr NEWA @ NOVAST LABS 67MG A 207564 001 Apr 19, 2019 Oct DISC AB 67MG A 207564 001 Apr 19, 2019 Sep CAHN @ 134MG A 207564 002 Apr 19, 2019 Oct DISC AB 134MG A 207564 002 Apr 19, 2019 Sep CAHN @ 200MG A 207564 003 Apr 19, 2019 Oct DISC AB 200MG A 207564 003 Apr 19, 2019 Sep CAHN TABLET;ORAL FENOFIBRATE AB ALEMBIC PHARMS LTD 48MG A 210476 001 Aug 09, 2019 Jul NEWA AB 145MG A 210476 002 Aug 09, 2019 Jul NEWA AB APPCO PHARMA LLC 54MG A 210670 001 Sep 06, 2019 Aug NEWA AB 160MG A 210670 002 Sep 06, 2019 Aug NEWA AB AUSTARPHARMA 54MG A 207803 001 Dec 19, 2017 Jan CAHN AB 160MG A 207803 002 Dec 19, 2017 Jan CAHN AB NUVO PHARM 54MG A 210670 001 Sep 06, 2019 Sep CAHN AB 160MG A 210670 002 Sep 06, 2019 Sep CAHN AB ORIT LABS LLC 54MG A 209660 001 Feb 11, 2019 Jan NEWA AB 160MG A 209660 002 Feb 11, 2019 Jan NEWA FENOGLIDE AB + SALIX 40MG N 022118 001 Aug 10, 2007 Mar CAHN AB +! 120MG N 022118 002 Aug 10, 2007 Mar CAHN TRIGLIDE BX + SKYEPHARMA AG 160MG N 021350 002 May 07, 2005 Oct CMFD + @ 160MG N 021350 002 May 07, 2005 Sep DISC

FENOFIBRIC ACID TABLET;ORAL FIBRICOR + ATHENA 35MG N 022418 001 Aug 14, 2009 Feb CAHN +! 105MG N 022418 002 Aug 14, 2009 Feb CAHN

FENOPROFEN CALCIUM TABLET;ORAL FENOPROFEN CALCIUM @ ANI PHARMS INC EQ 600MG BASE A 072274 001 May 02, 1988 May CAHN

FENTANYL SPRAY;SUBLINGUAL SUBSYS + BTCP PHARMA 0.1MG N 202788 001 Jan 04, 2012 Sep CAHN + 0.2MG N 202788 002 Jan 04, 2012 Sep CAHN +! 0.4MG N 202788 003 Jan 04, 2012 Sep CAHN + 0.6MG N 202788 004 Jan 04, 2012 Sep CAHN + 0.8MG N 202788 005 Jan 04, 2012 Sep CAHN + 1.2MG N 202788 006 Aug 30, 2012 Sep CAHN + 1.6MG N 202788 007 Aug 30, 2012 Sep CAHN

FENTANYL CITRATE INJECTABLE;INJECTION FENTANYL CITRATE PRESERVATIVE FREE AP FRESENIUS KABI USA EQ 0.05MG BASE/ML A 210762 001 May 03, 2019 Apr NEWA SPRAY, METERED;NASAL LAZANDA + BTCP PHARMA EQ 0.1MG BASE N 022569 001 Jun 30, 2011 Sep CAHN + @ EQ 0.3MG BASE N 022569 003 Dec 21, 2015 Sep DISC + @ EQ 0.3MG BASE N 022569 003 Dec 21, 2015 Sep CAHN +! EQ 0.4MG BASE N 022569 002 Jun 30, 2011 Sep CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -63

TABLET;SUBLINGUAL ABSTRAL + @ SENTYNL THERAPS INC EQ 0.1MG BASE N 022510 001 Jan 07, 2011 Oct DISC + @ EQ 0.2MG BASE N 022510 002 Jan 07, 2011 Oct DISC + @ EQ 0.3MG BASE N 022510 003 Jan 07, 2011 Oct DISC + @ EQ 0.4MG BASE N 022510 004 Jan 07, 2011 Oct DISC + @ EQ 0.6MG BASE N 022510 005 Jan 07, 2011 Oct DISC + @ EQ 0.8MG BASE N 022510 006 Jan 07, 2011 Oct DISC FENTANYL CITRATE @ ACTAVIS LABS FL INC EQ 0.1MG BASE A 207338 001 Nov 17, 2017 Oct DISC @ EQ 0.2MG BASE A 207338 002 Nov 17, 2017 Oct DISC @ EQ 0.3MG BASE A 207338 003 Nov 17, 2017 Oct DISC @ EQ 0.4MG BASE A 207338 004 Nov 17, 2017 Oct DISC @ EQ 0.6MG BASE A 207338 005 Nov 17, 2017 Oct DISC @ EQ 0.8MG BASE A 207338 006 Nov 17, 2017 Oct DISC

FERRIC CARBOXYMALTOSE INJECTABLE;INTRAVENOUS INJECTAFER +! AM REGENT 750MG IRON/15ML (50MG IRON/ML) N 203565 001 Jul 25, 2013 Jun CAHN

FERRIC MALTOL CAPSULE;ORAL ACCRUFER +! SHIELD TX 30MG IRON N 212320 001 Jul 25, 2019 Jul NEWA

FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE;ORAL FESOTERODINE FUMARATE AB DR REDDYS LABS LTD 4MG A 204975 001 Aug 13, 2019 Jul NEWA AB 8MG A 204975 002 Aug 13, 2019 Jul NEWA

FEXOFENADINE HYDROCHLORIDE SUSPENSION;ORAL FEXOFENADINE HYDROCHLORIDE @ P AND L 30MG/5ML A 201311 001 Jul 25, 2012 Aug CAHN TABLET;ORAL FEXOFENADINE HYDROCHLORIDE @ MYLAN 30MG A 077081 002 Apr 11, 2008 Jul DISC

FINAFLOXACIN SUSPENSION/DROPS;OTIC XTORO + @ MERLION PHARMS GMBH 0.3% N 206307 001 Dec 17, 2014 Apr DISC

FINASTERIDE TABLET;ORAL FINASTERIDE @ MYLAN 5MG A 077578 001 Dec 18, 2006 Jul DISC

FINGOLIMOD HYDROCHLORIDE CAPSULE;ORAL FINGOLIMOD HYDROCHLORIDE AB BIOCON LTD EQ 0.5MG BASE A 207979 001 Dec 04, 2019 Nov NFTG AB HEC PHARM CO LTD EQ 0.5MG BASE A 207939 001 Dec 04, 2019 Nov NFTG AB SUN PHARM EQ 0.5MG BASE A 208014 001 Dec 04, 2019 Nov NFTG GILENYA AB +! NOVARTIS EQ 0.5MG BASE N 022527 001 Sep 21, 2010 Nov CFTG

FLOXURIDINE INJECTABLE;INJECTION FLOXURIDINE @ LUITPOLD 500MG/VIAL A 203008 001 Nov 22, 2017 Mar DISC

FLUCONAZOLE INJECTABLE;INJECTION FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER AP WOODWARD 200MG/100ML (2MG/ML) A 077988 001 May 26, 2010 Oct CAHN AP 400MG/200ML (2MG/ML) A 077988 002 May 26, 2010 Oct CAHN FLUCONAZOLE IN SODIUM CHLORIDE 0.9% @ DR REDDYS 200MG/100ML (2MG/ML) A 076653 001 Jul 29, 2004 May CAHN @ 400MG/200ML (2MG/ML) A 076653 002 Jul 29, 2004 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -64

INJECTABLE;INJECTION FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER @ DR REDDYS 200MG/100ML (2MG/ML) A 076837 001 Jan 13, 2005 May CAHN @ 400MG/200ML (2MG/ML) A 076837 002 Jan 13, 2005 May CAHN WOODWARD 100MG/50ML (2MG/ML) A 077909 003 Apr 20, 2015 Oct CAHN AP 200MG/100ML (2MG/ML) A 077909 001 May 26, 2010 Oct CAHN AP 400MG/200ML (2MG/ML) A 077909 002 May 26, 2010 Oct CAHN TABLET;ORAL FLUCONAZOLE AB CHARTWELL 50MG A 076665 001 Jul 29, 2004 Jun CAHN AB 100MG A 076665 002 Jul 29, 2004 Jun CAHN AB 150MG A 076665 003 Jul 29, 2004 Jun CAHN AB 200MG A 076665 004 Jul 29, 2004 Jun CAHN

FLUCYTOSINE CAPSULE;ORAL ANCOBON AB + BAUSCH 250MG N 017001 001 Feb CAHN AB +! 500MG N 017001 002 Feb CAHN

FLUDARABINE PHOSPHATE INJECTABLE;INJECTION FLUDARABINE PHOSPHATE @ MYLAN LABS LTD 50MG/2ML (25MG/ML) A 200647 001 Dec 21, 2011 Oct DISC

FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS FLUDEOXYGLUCOSE F18 AP DECATUR 20-300mCi/ML A 204463 001 Oct 21, 2014 Apr CAHN

FLUMAZENIL INJECTABLE;INJECTION FLUMAZENIL @ DR REDDYS 0.5MG/5ML (0.1MG/ML) A 076589 002 Oct 12, 2004 May CAHN @ 1MG/10ML (0.1MG/ML) A 076589 001 Oct 12, 2004 May CAHN AP ! HIKMA FARMACEUTICA 1MG/10ML (0.1MG/ML) A 078527 002 Mar 23, 2009 Aug CHRS @ MYLAN LABS LTD 1MG/10ML (0.1MG/ML) A 078595 002 May 13, 2008 Aug DISC

FLUNISOLIDE AEROSOL, METERED;INHALATION AEROSPAN HFA + @ MYLAN SPECIALITY LP 0.078MG/INH N 021247 001 Jan 27, 2006 Jul DISC SPRAY, METERED;NASAL FLUNISOLIDE @ APOTEX 0.029MG/SPRAY A 077436 001 Aug 09, 2007 Nov DISC 0.029MG/SPRAY A 077436 001 Aug 09, 2007 Jun CMFD AB APOTEX INC 0.029MG/SPRAY A 077436 001 Aug 09, 2007 Jun CMFD

FLUOCINOLONE ACETONIDE CREAM;TOPICAL FLUOCINOLONE ACETONIDE >A> @ INVATECH 0.01% A 088047 001 Dec 16, 1982 Dec CAHN >A> @ 0.025% A 088045 001 Dec 16, 1982 Dec CAHN >D> @ PHARMADERM 0.01% A 088047 001 Dec 16, 1982 Dec CAHN >D> @ 0.025% A 088045 001 Dec 16, 1982 Dec CAHN OIL/DROPS;OTIC FLAC AT ANDA REPOSITORY 0.01% A 210736 001 Apr 11, 2018 Sep CAHN SOLUTION;TOPICAL FLUOCINOLONE ACETONIDE @ ACTAVIS LABS UT INC 0.01% A 208386 001 Oct 21, 2016 Mar DISC AT ENCUBE ETHICALS 0.01% A 209913 001 Feb 13, 2019 Jan NEWA AT GLASSHOUSE PHARMS 0.01% A 209596 001 Dec 26, 2017 Jan CMFD >A> @ INVATECH 0.01% A 088048 001 Dec 16, 1982 Dec CAHN AT LUPIN 0.01% A 206422 001 Sep 02, 2015 Feb CAHN >D> @ PHARMADERM 0.01% A 088048 001 Dec 16, 1982 Dec CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -65

FLUOCINONIDE CREAM;TOPICAL FLUOCINONIDE @ AMNEAL PHARMS LLC 0.05% A 210554 001 Aug 21, 2018 Feb DISC AB TELIGENT PHARMA INC 0.1% A 211758 001 Apr 03, 2019 Mar NEWA OINTMENT;TOPICAL FLUOCINONIDE >D> AB CHEMO RESEARCH SL 0.05% A 212976 001 Nov 26, 2019 Dec CAHN AB 0.05% A 212976 001 Nov 26, 2019 Nov NEWA >A> AB XIROMED 0.05% A 212976 001 Nov 26, 2019 Dec CAHN SOLUTION;TOPICAL FLUOCINONIDE AT TELIGENT PHARMA INC 0.05% A 207554 001 Mar 18, 2019 Mar NEWA

FLUORODOPA F-18 SOLUTION;INTRAVENOUS FLUORODOPA F18 +! FEINSTEIN 0.42-8.33mCi/ML N 200655 001 Oct 10, 2019 Oct NEWA

FLUOROMETHOLONE SUSPENSION/DROPS;OPHTHALMIC FML FORTE +! ALLERGAN 0.25% N 019216 001 Apr 23, 1986 Jun CHRS + 0.25% N 019216 001 Apr 23, 1986 Jun CRLD

FLUOROMETHOLONE ACETATE SUSPENSION/DROPS;OPHTHALMIC FLAREX +! EYEVANCE 0.1% N 019079 001 Feb 11, 1986 Feb CAHN

FLUOROMETHOLONE ACETATE; TOBRAMYCIN SUSPENSION/DROPS;OPHTHALMIC TOBRASONE @ EYEVANCE 0.1%;0.3% N 050628 001 Jul 21, 1989 May CAHN

FLUOROURACIL CREAM;TOPICAL EFUDEX AB +! BAUSCH 5% N 016831 003 Aug CAHN FLUOROPLEX +! ALMIRALL 1% N 016988 001 Feb CAHN INJECTABLE;INJECTION ADRUCIL >D> @ PHARMACIA AND UPJOHN 50MG/ML N 017959 001 Dec CRLD >A> + @ 50MG/ML N 017959 001 Dec CRLD FLUOROURACIL >A> AP INGENUS PHARMS LLC 500MG/10ML (50MG/ML) A 209219 001 Dec 12, 2019 Dec NEWA AP 500MG/10ML (50MG/ML) A 209271 001 Dec 11, 2019 Nov NEWA >A> AP 1GM/20ML (50MG/ML) A 209219 002 Dec 12, 2019 Dec NEWA AP 2.5GM/50ML (50MG/ML) A 209271 002 Dec 11, 2019 Nov NEWA @ MYLAN LABS LTD 500MG/10ML (50MG/ML) A 202668 001 Jul 17, 2012 Sep DISC @ 1GM/20ML (50MG/ML) A 202668 002 Jul 17, 2012 Sep DISC SOLUTION;TOPICAL EFUDEX AT +! BAUSCH 2% N 016831 001 Aug CAHN AT +! 5% N 016831 002 Aug CAHN

FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL FLUOXETINE HYDROCHLORIDE AB1 APNAR PHARMA LP EQ 10MG BASE A 075049 001 Aug 02, 2001 Jun CAHN AB1 EQ 20MG BASE A 075049 002 Jan 29, 2002 Jun CAHN AB EQ 40MG BASE A 075049 003 Jan 29, 2002 Jun CAHN @ BEXIMCO PHARMS USA EQ 10MG BASE A 075807 001 Jan 29, 2002 Feb CAHN @ EQ 20MG BASE A 075807 002 Jan 29, 2002 Feb CAHN AB1 CADILA PHARMS LTD EQ 10MG BASE A 206993 001 May 23, 2019 May NEWA AB1 EQ 20MG BASE A 206993 002 May 23, 2019 May NEWA AB EQ 40MG BASE A 206993 003 May 23, 2019 May NEWA @ CELLTRION EQ 10MG BASE A 078143 001 Jan 16, 2008 Aug CAHN @ EQ 20MG BASE A 078143 002 Jan 16, 2008 Aug CAHN @ EQ 40MG BASE A 078143 003 Jan 16, 2008 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -66

CAPSULE;ORAL FLUOXETINE HYDROCHLORIDE >D> AB1 HERITAGE PHARMS INC EQ 10MG BASE A 201336 001 Oct 01, 2012 Dec DISC >A> @ EQ 10MG BASE A 201336 001 Oct 01, 2012 Dec DISC >D> AB1 EQ 20MG BASE A 201336 002 Oct 01, 2012 Dec DISC >A> @ EQ 20MG BASE A 201336 002 Oct 01, 2012 Dec DISC >D> AB EQ 40MG BASE A 201336 003 Oct 01, 2012 Dec DISC >A> @ EQ 40MG BASE A 201336 003 Oct 01, 2012 Dec DISC @ MYLAN EQ 10MG BASE A 078045 001 Nov 17, 2008 Oct DISC @ EQ 20MG BASE A 078045 002 Nov 17, 2008 Oct DISC @ PAR PHARM EQ 40MG BASE A 076922 003 Dec 16, 2004 Mar DISC CAPSULE, DELAYED REL PELLETS;ORAL FLUOXETINE HYDROCHLORIDE @ BARR EQ 90MG BASE A 076237 001 Mar 24, 2010 Apr DISC ! DR REDDYS LABS LTD EQ 90MG BASE A 078572 001 Mar 22, 2010 Apr CTEC AB ! EQ 90MG BASE A 078572 001 Mar 22, 2010 Apr CHRS SOLUTION;ORAL FLUOXETINE HYDROCHLORIDE @ NOSTRUM LABS INC EQ 20MG BASE/5ML A 075292 001 Feb 07, 2002 May CAHN TABLET;ORAL FLUOXETINE HYDROCHLORIDE AB APPCO PHARMA LLC EQ 10MG BASE A 211696 001 Jan 30, 2019 Jan NEWA AB EQ 20MG BASE A 211696 002 Jan 30, 2019 Jan NEWA AB DR REDDYS LABS LTD EQ 60MG BASE A 211721 001 Jan 25, 2019 Jan NEWA AB G AND W LABS INC EQ 60MG BASE A 212191 001 Jul 05, 2019 Jun NEWA AB LUPIN LTD EQ 10MG BASE A 211653 001 Apr 15, 2019 Apr NEWA AB EQ 20MG BASE A 211653 002 Apr 15, 2019 Apr NEWA AB EQ 60MG BASE A 211632 001 Feb 08, 2019 Feb NEWA AB SCIEGEN PHARMS INC EQ 10MG BASE A 210935 001 Mar 20, 2019 Mar NEWA AB EQ 20MG BASE A 210935 002 Mar 20, 2019 Mar NEWA AB TARO EQ 60MG BASE A 211477 001 Nov 21, 2018 Sep CAHN AB UPSHER SMITH LABS EQ 10MG BASE A 211696 001 Jan 30, 2019 May CAHN AB EQ 20MG BASE A 211696 002 Jan 30, 2019 May CAHN

FLUOXYMESTERONE TABLET;ORAL FLUOXYMESTERONE ! UPSHER SMITH LABS 10MG A 088342 001 Oct 21, 1983 Jul CAHN

FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL FLUPHENAZINE HYDROCHLORIDE AB ! LANNETT CO INC 10MG A 089743 001 Aug 25, 1988 May CHRS AB MYLAN 10MG A 089804 001 Aug 12, 1988 May CHRS

FLURANDRENOLIDE CREAM;TOPICAL CORDRAN SP +! ALMIRALL 0.025% N 012806 003 Feb CAHN AT +! 0.05% N 012806 002 Feb CAHN LOTION;TOPICAL CORDRAN AT +! ALMIRALL 0.05% N 013790 001 Feb CAHN OINTMENT;TOPICAL CORDRAN + @ ALMIRALL 0.025% N 012806 004 Feb CAHN AT +! 0.05% N 012806 001 Feb CAHN TAPE;TOPICAL CORDRAN +! ALMIRALL 0.004MG/SQ CM N 016455 001 Feb CAHN

FLURBIPROFEN TABLET;ORAL FLURBIPROFEN MYLAN 50MG A 074358 001 Jun 20, 1994 Oct CTEC @ SUN PHARM INDS INC 50MG A 075058 001 Apr 27, 2001 Oct DISC @ 100MG A 075058 002 Apr 27, 2001 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -67

FLUTAMIDE CAPSULE;ORAL FLUTAMIDE @ ACTAVIS LABS FL INC 125MG A 075820 001 Sep 18, 2001 Apr DISC

FLUTICASONE PROPIONATE CREAM;TOPICAL FLUTICASONE PROPIONATE AB ! PERRIGO ISRAEL 0.05% A 076793 001 May 14, 2004 May CAHN POWDER;INHALATION ARMONAIR RESPICLICK + @ TEVA PHARM 0.055MG/INH N 208798 001 Jan 27, 2017 Sep DISC + @ 0.113MG/INH N 208798 002 Jan 27, 2017 Jul DISC + @ 0.232MG/INH N 208798 003 Jan 27, 2017 Sep DISC

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE POWDER;INHALATION ADVAIR DISKUS 100/50 AB +! GLAXO GRP LTD 0.1MG/INH;EQ 0.05MG BASE/INH N 021077 001 Aug 24, 2000 Jan CFTG ADVAIR DISKUS 250/50 AB +! GLAXO GRP LTD 0.25MG/INH;EQ 0.05MG BASE/INH N 021077 002 Aug 24, 2000 Jan CFTG ADVAIR DISKUS 500/50 AB +! GLAXO GRP LTD 0.5MG/INH;EQ 0.05MG BASE/INH N 021077 003 Aug 24, 2000 Jan CFTG AIRDUO DIGIHALER + TEVA PHARM 0.055MG/INH;EQ 0.014MG BASE/INH N 208799 004 Jul 12, 2019 Jul NEWA + 0.113MG/INH;EQ 0.014MG BASE/INH N 208799 005 Jul 12, 2019 Jul NEWA + 0.232MG/INH;EQ 0.014MG BASE/INH N 208799 006 Jul 12, 2019 Jul NEWA AIRDUO RESPICLICK +! TEVA PHARM 0.232MG/INH;EQ 0.014MG BASE/INH N 208799 003 Jan 27, 2017 Jul CMS1 WIXELA INHUB AB MYLAN 0.1MG/INH;EQ 0.05MG BASE/INH A 208891 001 Jan 30, 2019 Jan NFTG AB 0.25MG/INH;EQ 0.05MG BASE/INH A 208891 002 Jan 30, 2019 Jan NFTG AB 0.5MG/INH;EQ 0.05MG BASE/INH A 208891 003 Jan 30, 2019 Jan NFTG

FLUVASTATIN SODIUM TABLET, EXTENDED RELEASE;ORAL FLUVASTATIN SODIUM @ MYLAN EQ 80MG BASE A 202458 001 Sep 11, 2015 Jun DISC

FLUVOXAMINE MALEATE TABLET;ORAL FLUVOXAMINE MALEATE >D> AB ANI PHARMS INC 25MG A 075897 001 Jan 25, 2001 Dec DISC >A> @ 25MG A 075897 001 Jan 25, 2001 Dec DISC >D> AB 50MG A 075897 002 Jan 25, 2001 Dec DISC >A> @ 50MG A 075897 002 Jan 25, 2001 Dec DISC >D> AB 100MG A 075897 003 Jan 25, 2001 Dec DISC >A> @ 100MG A 075897 003 Jan 25, 2001 Dec DISC @ MYLAN 25MG A 075889 001 Nov 29, 2000 May DISC @ 50MG A 075889 002 Nov 29, 2000 May DISC @ 100MG A 075889 003 Nov 29, 2000 May DISC

FOLIC ACID INJECTABLE;INJECTION FOLIC ACID AP EXELA PHARMA SCS LLC 5MG/ML A 202522 001 Nov 06, 2019 Oct NEWA AP ! FRESENIUS KABI USA 5MG/ML A 089202 001 Feb 18, 1986 Oct CTEC FOLVITE + @ WYETH PHARMS INC 5MG/ML N 005897 008 Nov CRLD TABLET;ORAL FOLIC ACID AA QINGDAO BAHEAL PHARM 1MG A 091145 001 Jul 12, 2013 May CAHN

FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS GONAL-F RFF REDI-JECT +! EMD SERONO 150 IU/0.25ML N 021684 004 Nov 25, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -68

FOMEPIZOLE INJECTABLE;INJECTION ANTIZOL + @ PAR PHARM INC 1.5GM/1.5ML (1GM/ML) N 020696 001 Dec 04, 1997 Jun DISC FOMEPIZOLE AP ! MYLAN INSTITUTIONAL 1.5GM/1.5ML (1GM/ML) A 078639 001 Mar 03, 2008 Jun CHRS

FORMOTEROL FUMARATE; MOMETASONE FUROATE AEROSOL, METERED;INHALATION DULERA + MERCK SHARP DOHME 0.005MG/INH;0.05MG/INH N 022518 003 Aug 12, 2019 Aug NEWA

FOSAMPRENAVIR CALCIUM TABLET;ORAL FOSAMPRENAVIR CALCIUM AB SUN PHARM EQ 700MG BASE A 204024 001 Nov 20, 2019 Nov NEWA

FOSAPREPITANT POWDER;INTRAVENOUS FOSAPREPITANT DIMEGLUMINE TEVA PHARMS USA 150MG/VIAL N 210064 001 Sep 05, 2019 Sep NEWA

FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS FOSAPREPITANT DIMEGLUMINE AP APOTEX EQ 150MG BASE/VIAL A 205020 001 Sep 05, 2019 Aug NEWA AP BAXTER HLTHCARE CORP EQ 150MG BASE/VIAL A 211860 001 Sep 05, 2019 Aug NEWA AP BE PHARMS EQ 150MG BASE/VIAL A 212309 001 Sep 05, 2019 Aug NEWA AP LUPIN LTD EQ 150MG BASE/VIAL A 210689 001 Sep 05, 2019 Aug NEWA AP MSN EQ 150MG BASE/VIAL A 209965 001 Sep 05, 2019 Aug NEWA MYLAN LABS LTD EQ 115MG BASE/VIAL A 204015 001 Sep 05, 2019 Aug NFTG AP EQ 150MG BASE/VIAL A 204015 002 Sep 05, 2019 Aug NEWA AP SUNGEN PHARMA EQ 150MG BASE/VIAL A 211624 001 Sep 05, 2019 Aug NEWA TEVA PHARMS USA EQ 150MG BASE/VIAL N 210064 001 Sep 05, 2019 Oct CPOT 150MG/VIAL N 210064 001 Sep 05, 2019 Oct CAIN

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE TABLET;ORAL FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE @ ANI PHARMS INC 10MG;12.5MG A 076608 001 Dec 03, 2004 May CAHN @ 20MG;12.5MG A 076608 002 Dec 03, 2004 May CAHN

FOSPHENYTOIN SODIUM INJECTABLE;INJECTION FOSPHENYTOIN SODIUM @ DR REDDYS EQ 50MG PHENYTOIN NA/ML A 076886 001 Aug 06, 2007 May CAHN @ LUITPOLD EQ 50MG PHENYTOIN NA/ML A 078277 001 Aug 06, 2007 Feb DISC @ EQ 50MG PHENYTOIN NA/ML A 090099 001 May 13, 2010 Feb DISC

FROVATRIPTAN SUCCINATE TABLET;ORAL FROVATRIPTAN SUCCINATE AB AMNEAL PHARMS CO EQ 2.5MG BASE A 211292 001 Nov 06, 2018 Aug CMFD @ EQ 2.5MG BASE A 211292 001 Nov 06, 2018 May DISC

FULVESTRANT INJECTABLE;INTRAMUSCULAR FASLODEX AO +! ASTRAZENECA 50MG/ML N 021344 001 Apr 25, 2002 Apr CMS1 AP +! 50MG/ML N 021344 001 Apr 25, 2002 Feb CFTG FULVESTRANT AO GLENMARK PHARMS INC 50MG/ML A 207754 001 Aug 22, 2019 Aug NEWA AO HBT LABS INC 50MG/ML A 209714 001 Nov 21, 2019 Nov NEWA AO MYLAN INSTITUTIONAL 50MG/ML A 208811 001 Jul 23, 2019 Jul NEWA AO SAGENT PHARMS INC 50MG/ML A 205871 001 Aug 22, 2019 Aug NEWA AO SANDOZ INC 50MG/ML A 205935 001 May 14, 2019 Apr NEWA SOLUTION;INTRAMUSCULAR FULVESTRANT FRESENIUS KABI USA 250MG/5ML (50MG/ML) N 210326 001 May 20, 2019 May NEWA TEVA PHARMS USA INC 250MG/5ML (50MG/ML) N 210063 001 Aug 19, 2019 Aug NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -69

FUROSEMIDE INJECTABLE;INJECTION FUROSEMIDE AP AUROBINDO PHARMA LTD 10MG/ML A 212174 001 May 03, 2019 Apr NEWA TABLET;ORAL FUROSEMIDE @ ANI PHARMS INC 20MG A 071379 001 Jan 02, 1987 Jul CAHN @ 40MG A 070413 001 Feb 26, 1986 Sep CAHN AB AVET 20MG N 018413 001 Nov 30, 1983 Oct CAHN AB 40MG N 018413 002 Nov 30, 1983 Oct CAHN AB HERITAGE PHARMA 20MG N 018413 001 Nov 30, 1983 Feb CAHN AB 40MG N 018413 002 Nov 30, 1983 Feb CAHN

GABAPENTIN CAPSULE;ORAL GABAPENTIN AB GRANULES INDIA LTD 100MG A 075360 001 Apr 06, 2005 Jun CAHN AB 300MG A 075360 002 Apr 06, 2005 Jun CAHN AB 400MG A 075360 003 Apr 06, 2005 Jun CAHN SOLUTION;ORAL GABAPENTIN AA VISTAPHARM 250MG/5ML A 211330 001 Dec 03, 2019 Nov NEWA TABLET;ORAL GABAPENTIN >A> @ INVATECH 600MG A 076877 001 Jul 06, 2006 Dec CAHN >A> @ 800MG A 076877 002 Jul 06, 2006 Dec CAHN @ IVAX SUB TEVA PHARMS 600MG A 076017 004 Apr 29, 2005 Jul DISC @ 800MG A 076017 005 Apr 29, 2005 Jul DISC @ LUPIN LTD 600MG A 209306 001 Aug 24, 2018 Mar DISC @ 800MG A 209306 002 Aug 24, 2018 Mar DISC AB RUBICON 600MG A 077661 004 Sep 13, 2006 Aug CAHN AB 800MG A 077661 005 Sep 13, 2006 Aug CAHN >D> SANDOZ@ 600MG A 076877 001 Jul 06, 2006 Dec CAHN >D> @ 800MG A 076877 002 Jul 06, 2006 Dec CAHN

GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS CLARISCAN AP GE HEALTHCARE 7.538GM/20ML (376.9MG/ML) A 210016 003 Nov 01, 2019 Oct NFTG AP 3.769GM/10ML (376.9MG/ML) A 210016 001 Nov 01, 2019 Oct NFTG AP 5.6535GM/15ML (376.9MG/ML) A 210016 002 Nov 01, 2019 Oct NFTG DOTAREM AP +! GUERBET 3.769GM/10ML (376.9MG/ML) N 204781 002 Mar 20, 2013 Oct CFTG AP +! 5.6535GM/15ML (376.9MG/ML) N 204781 003 Mar 20, 2013 Oct CFTG AP +! 7.538GM/20ML (376.9MG/ML) N 204781 004 Mar 20, 2013 Oct CFTG

GALANTAMINE HYDROBROMIDE TABLET;ORAL GALANTAMINE HYDROBROMIDE @ HERITAGE PHARMA EQ 4MG BASE A 077585 001 Sep 15, 2009 May CAHN @ EQ 4MG BASE A 077587 001 Jul 09, 2009 Sep DISC AB EQ 4MG BASE A 077587 001 Jul 09, 2009 May CAHN @ EQ 8MG BASE A 077585 002 Sep 15, 2009 May CAHN @ EQ 8MG BASE A 077587 002 Jul 09, 2009 Sep DISC AB EQ 8MG BASE A 077587 002 Jul 09, 2009 May CAHN @ EQ 12MG BASE A 077585 003 Sep 15, 2009 May CAHN @ EQ 12MG BASE A 077587 003 Jul 09, 2009 Sep DISC AB EQ 12MG BASE A 077587 003 Jul 09, 2009 May CAHN >D> AB MYLAN EQ 4MG BASE A 077590 001 May 29, 2009 Dec DISC >A> @ EQ 4MG BASE A 077590 001 May 29, 2009 Dec DISC >D> AB EQ 8MG BASE A 077590 002 May 29, 2009 Dec DISC >A> @ EQ 8MG BASE A 077590 002 May 29, 2009 Dec DISC >D> AB EQ 12MG BASE A 077590 003 May 29, 2009 Dec DISC >A> @ EQ 12MG BASE A 077590 003 May 29, 2009 Dec DISC

GALLIUM CITRATE GA-67 INJECTABLE;INJECTION GALLIUM CITRATE GA 67 BS CURIUM 2mCi/ML N 018058 001 Jan CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -70

GALLIUM DOTATOC GA-68 SOLUTION;INTRAVENOUS GALLIUM DOTATOC GA 68 +! UIHC PET IMAGING 0.5-4mCi/ML N 210828 001 Aug 21, 2019 Aug NEWA

GALLIUM NITRATE INJECTABLE;INJECTION GANITE @ CHEPLAPHARM 25MG/ML N 019961 002 Jan 17, 1991 Aug CAHN

GANCICLOVIR SOLUTION;INTRAVENOUS GANZYK-RTU +! EXELA PHARMA SCS LLC 500MG/250ML (2MG/ML) N 209347 001 Feb 17, 2017 Sep CTNA

GANCICLOVIR SODIUM INJECTABLE;INJECTION CYTOVENE AP +! CHEPLAPHARM EQ 500MG BASE/VIAL N 019661 001 Jun 23, 1989 Aug CAHN GANCICLOVIR SODIUM >D> AP CUSTOPHARM INC EQ 500MG BASE/VIAL A 212001 001 Jun 20, 2019 Dec DISC >A> @ EQ 500MG BASE/VIAL A 212001 001 Jun 20, 2019 Dec DISC AP EQ 500MG BASE/VIAL A 212001 001 Jun 20, 2019 Jun NEWA AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A 090658 001 Jun 21, 2010 Jul CTNA AP HAINAN POLY PHARM EQ 500MG BASE/VIAL A 204204 001 Nov 08, 2018 Jul CTNA @ LUITPOLD EQ 500MG BASE/VIAL A 202624 001 Sep 18, 2013 Jul CTNA @ EQ 500MG BASE/VIAL A 202624 001 Sep 18, 2013 Feb DISC AP MYLAN LABS LTD EQ 500MG BASE/VIAL A 204560 001 Nov 17, 2017 Jul CTNA AP PAR STERILE PRODUCTS EQ 500MG BASE/VIAL A 204950 001 Dec 06, 2016 Jul CTNA

GANIRELIX ACETATE INJECTABLE;INJECTION GANIRELIX ACETATE AP +! ORGANON USA INC 250MCG/0.5ML N 021057 001 Jul 29, 1999 Mar CPOT AP SUN PHARM 250MCG/0.5ML A 204246 001 Nov 30, 2018 Mar CPOT

GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION GEMCITABINE HYDROCHLORIDE >D> AP ACTAVIS INC 200MG/5.26ML (38MG/ML) A 204549 001 Apr 11, 2016 Dec DISC >A> @ 200MG/5.26ML (38MG/ML) A 204549 001 Apr 11, 2016 Dec DISC >D> AP 1GM/26.3ML (38MG/ML) A 204549 002 Apr 11, 2016 Dec DISC >A> @ 1GM/26.3ML (38MG/ML) A 204549 002 Apr 11, 2016 Dec DISC >D> AP 2GM/52.6ML (38MG/ML) A 204549 003 Apr 11, 2016 Dec DISC >A> @ 2GM/52.6ML (38MG/ML) A 204549 003 Apr 11, 2016 Dec DISC >D> AP ACTAVIS TOTOWA EQ 200MG BASE/VIAL A 079160 001 Jul 25, 2011 Dec DISC >A> @ EQ 200MG BASE/VIAL A 079160 001 Jul 25, 2011 Dec DISC >D> AP EQ 1GM BASE/VIAL A 079160 002 Jul 25, 2011 Dec DISC >A> @ EQ 1GM BASE/VIAL A 079160 002 Jul 25, 2011 Dec DISC >D> AP EQ 2GM BASE/VIAL A 079160 003 Jul 28, 2016 Dec DISC >A> @ EQ 2GM BASE/VIAL A 079160 003 Jul 28, 2016 Dec DISC AP FRESENIUS KABI USA EQ 200MG BASE/VIAL A 090799 001 Jul 25, 2011 Jan CAHN AP EQ 1GM BASE/VIAL A 090799 002 Jul 25, 2011 Jan CAHN AP EQ 2GM BASE/VIAL A 090799 003 May 16, 2011 Jan CAHN @ INGENUS PHARMS LLC 200MG/5.26ML (38MG/ML) A 210383 001 Feb 14, 2019 Oct DISC AP 200MG/5.26ML (38MG/ML) A 210383 001 Feb 14, 2019 Feb NEWA @ 1GM/26.3ML (38MG/ML) A 210383 002 Feb 14, 2019 Oct DISC AP 1GM/26.3ML (38MG/ML) A 210383 002 Feb 14, 2019 Feb NEWA @ 2GM/52.6ML (38MG/ML) A 210383 003 Feb 14, 2019 Oct DISC AP 2GM/52.6ML (38MG/ML) A 210383 003 Feb 14, 2019 Feb NEWA @ LUITPOLD EQ 200MG BASE/VIAL A 202031 001 May 07, 2013 Feb DISC @ EQ 1GM BASE/VIAL A 202031 002 May 07, 2013 Feb DISC @ SHILPA MEDICARE LTD EQ 200MG BASE/VIAL A 207575 001 Feb 22, 2019 Oct DISC AP EQ 200MG BASE/VIAL A 207575 001 Feb 22, 2019 Feb NEWA AP 200MG/5.26ML (38MG/ML) A 210991 001 Oct 04, 2019 Sep NEWA @ EQ 1GM BASE/VIAL A 207575 002 Feb 22, 2019 Oct DISC AP EQ 1GM BASE/VIAL A 207575 002 Feb 22, 2019 Feb NEWA AP 1GM/26.3ML (38MG/ML) A 210991 002 Oct 04, 2019 Sep NEWA AP 2GM/52.6ML (38MG/ML) A 210991 003 Oct 04, 2019 Sep NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -71

GEMFIBROZIL TABLET;ORAL GEMFIBROZIL @ SUN PHARM INDS INC 600MG A 079239 001 Dec 29, 2008 Oct DISC

GENTAMICIN SULFATE CREAM;TOPICAL GENTAMICIN SULFATE AT TELIGENT PHARMA INC EQ 0.1% BASE A 209304 001 Oct 18, 2019 Oct NEWA INJECTABLE;INJECTION GENTAMICIN SULFATE AP ! FRESENIUS KABI USA EQ 10MG BASE/ML A 062366 002 Feb 06, 1986 Jul CHRS OINTMENT;OPHTHALMIC GENTAMICIN SULFATE AT FERA PHARMS LLC EQ 0.3% BASE A 065024 001 Jul 30, 2004 Sep CAHN

GIVOSIRAN SODIUM SOLUTION;SUBCUTANEOUS GIVLAARI +! ALNYLAM PHARMS INC EQ 189MG BASE/ML (EQ 189MG N 212194 001 Nov 20, 2019 Nov NEWA BASE/ML)

GLASDEGIB MALEATE TABLET;ORAL DAURISMO + PFIZER INC EQ 25MG BASE N 210656 001 Nov 21, 2018 Feb CAIN +! EQ 100MG BASE N 210656 002 Nov 21, 2018 Feb CAIN

GLIMEPIRIDE TABLET;ORAL GLIMEPIRIDE AB MICRO LABS 1MG A 091220 001 Jun 29, 2012 Mar CAHN AB 2MG A 091220 002 Jun 29, 2012 Mar CAHN 3MG A 091220 003 Jun 29, 2012 Mar CAHN AB 4MG A 091220 004 Jun 29, 2012 Mar CAHN 6MG A 091220 005 Jun 29, 2012 Mar CAHN AB 8MG A 091220 006 Jun 29, 2012 Mar CAHN @ TEVA 1MG A 076802 001 Oct 06, 2005 Oct DISC @ 2MG A 076802 002 Oct 06, 2005 Oct DISC @ 4MG A 076802 003 Oct 06, 2005 Oct DISC

GLIPIZIDE TABLET;ORAL GLIPIZIDE >D> AB ANI PHARMS INC 5MG A 074497 001 Aug 31, 1995 Dec DISC >A> @ 5MG A 074497 001 Aug 31, 1995 Dec DISC >D> AB 10MG A 074497 002 Aug 31, 1995 Dec DISC >A> @ 10MG A 074497 002 Aug 31, 1995 Dec DISC @ BEXIMCO PHARMS USA 5MG A 074542 001 Jun 20, 1995 Feb CAHN @ 10MG A 074542 002 Jun 20, 1995 Feb CAHN TABLET, EXTENDED RELEASE;ORAL GLIPIZIDE @ MYLAN 2.5MG A 202298 001 May 19, 2015 Feb DISC @ 5MG A 202298 002 May 19, 2015 Feb DISC @ 10MG A 202298 003 May 19, 2015 Feb DISC

GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL GLIPIZIDE AND METFORMIN HYDROCHLORIDE @ MYLAN 2.5MG;250MG A 078083 001 Apr 12, 2007 Apr DISC @ 2.5MG;500MG A 078083 002 Apr 12, 2007 Nov DISC @ 5MG;500MG A 078083 003 Apr 12, 2007 Nov DISC @ SUN PHARM INDS INC 2.5MG;250MG A 077620 001 Jan 11, 2008 Oct DISC @ 2.5MG;500MG A 077620 002 Jan 11, 2008 Oct DISC @ 5MG;500MG A 077620 003 Jan 11, 2008 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -72

GLUCAGON POWDER;NASAL BAQSIMI +! ELI LILLY AND CO 3MG N 210134 001 Jul 24, 2019 Jul NEWA SOLUTION;SUBCUTANEOUS GVOKE HYPOPEN +! XERIS 0.5MG/0.1ML (0.5MG/0.1ML) N 212097 003 Sep 10, 2019 Sep NEWA +! 1MG/0.2ML (1MG/0.2ML) N 212097 004 Sep 10, 2019 Sep NEWA GVOKE PFS +! XERIS 0.5MG/0.1ML (0.5MG/0.1ML) N 212097 001 Sep 10, 2019 Sep NEWA +! 1MG/0.2ML (1MG/0.2ML) N 212097 002 Sep 10, 2019 Sep NEWA

GLYBURIDE TABLET;ORAL GLYBURIDE @ ORIENT PHARMA CO LTD 1.25MG A 206483 001 Feb 22, 2019 Jul DISC AB1 1.25MG A 206483 001 Feb 22, 2019 Feb NEWA @ 2.5MG A 206483 002 Feb 22, 2019 Jul DISC AB1 2.5MG A 206483 002 Feb 22, 2019 Feb NEWA @ 5MG A 206483 003 Feb 22, 2019 Jul DISC AB1 5MG A 206483 003 Feb 22, 2019 Feb NEWA

GLYBURIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL GLYBURIDE AND METFORMIN HYDROCHLORIDE @ HERITAGE PHARMS INC 1.25MG;250MG A 079009 001 Jun 03, 2009 Aug DISC @ 2.5MG;500MG A 079009 002 Jun 03, 2009 Aug DISC @ 5MG;500MG A 079009 003 Jun 03, 2009 Aug DISC

GLYCEROL PHENYLBUTYRATE LIQUID;ORAL RAVICTI +! HORIZON THERAP 1.1GM/ML N 203284 001 Feb 01, 2013 Feb CAHN

GLYCOPYRROLATE INJECTABLE;INJECTION GLYCOPYRROLATE AP APOTEX 0.2MG/ML A 210246 001 Oct 29, 2019 Oct NEWA AP CAPLIN 0.2MG/ML A 211705 001 Mar 20, 2019 Mar NEWA AP GLAND PHARMA LTD 0.2MG/ML A 212612 001 Sep 30, 2019 Sep NEWA AP PIRAMAL CRITICAL 0.2MG/ML A 210842 001 Oct 25, 2018 Jun CAHN AP SANDOZ INC 0.2MG/ML A 211334 001 May 14, 2019 Apr NEWA ROBINUL + @ HIKMA 0.2MG/ML N 017558 001 Aug CAHN TABLET;ORAL GLYCOPYRROLATE AA AUROLIFE PHARMA LLC 2MG A 202675 002 Oct 30, 2018 May NEWA AA KENTON 1MG A 091182 001 Feb 03, 2014 Mar CAHN AA 2MG A 091182 002 Feb 03, 2014 Mar CAHN

>A> GOLODIRSEN >A> SOLUTION;INTRAVENOUS >A> VYONDYS 53 >A> +! SAREPTA THERAPS INC 100MG/2ML (50MG/ML) N 211970 001 Dec 12, 2019 Dec NEWA

GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION GRANISETRON HYDROCHLORIDE AP BIONPHARMA INC EQ 0.1MG BASE/ML (EQ 0.1MG A 078863 001 Jun 30, 2008 Apr CAHN BASE/ML) AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A 078880 001 Jun 30, 2008 Apr CAHN AP ! DR REDDYS EQ 0.1MG BASE/ML (EQ 0.1MG A 078392 001 Dec 31, 2007 May CAHN BASE/ML) AP ! EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A 077297 001 Jun 30, 2008 May CAHN @ LUITPOLD EQ 1MG BASE/ML (EQ 1MG BASE/ML) A 091274 001 Sep 22, 2010 Feb DISC GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE AP BIONPHARMA INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) A 078863 002 Jun 30, 2008 Apr CAHN @ DR REDDYS EQ 1MG BASE/ML (EQ 1MG BASE/ML) A 077165 001 Dec 31, 2007 May CAHN TABLET;ORAL GRANISETRON HYDROCHLORIDE @ TEVA PHARMS EQ 1MG BASE A 078080 001 Dec 31, 2007 Jan DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -73

GUAIFENESIN; HYDROCODONE BITARTRATE SOLUTION;ORAL OBREDON + @ SOVEREIGN PHARMS 200MG/5ML;2.5MG/5ML N 205474 001 Nov 14, 2014 Jun DISC TABLET;ORAL XTRELUS + @ ECI PHARMS LLC 400MG;5MG N 208085 001 Apr 25, 2018 Jun DISC

>D> GUANABENZ ACETATE >D> TABLET;ORAL >D> GUANABENZ ACETATE >D> ANI PHARMS INC EQ 4MG BASE A 074149 001 Apr 07, 1995 Dec DISC >A> @ EQ 4MG BASE A 074149 001 Apr 07, 1995 Dec DISC >D> ! EQ 8MG BASE A 074149 002 Apr 07, 1995 Dec DISC >A> @ EQ 8MG BASE A 074149 002 Apr 07, 1995 Dec DISC

GUANFACINE HYDROCHLORIDE TABLET;ORAL GUANFACINE HYDROCHLORIDE AB EPIC PHARMA LLC EQ 1MG BASE A 074673 001 Feb 28, 1997 Apr CMFD AB EQ 2MG BASE A 074673 002 Feb 28, 1997 Apr CMFD >D> AB ! MYLAN EQ 1MG BASE A 074796 001 Jan 27, 1997 Dec CHRS >A> AB EQ 1MG BASE A 074796 001 Jan 27, 1997 Dec CHRS TABLET, EXTENDED RELEASE;ORAL GUANFACINE HYDROCHLORIDE @ MYLAN EQ 1MG BASE A 202578 001 Jun 02, 2015 May DISC @ EQ 2MG BASE A 202578 002 Jun 02, 2015 May DISC @ EQ 3MG BASE A 202578 003 Jun 02, 2015 May DISC @ EQ 4MG BASE A 202578 004 Jun 02, 2015 May DISC

HALCINONIDE CREAM;TOPICAL HALCINONIDE AB MYLAN 0.1% A 211027 001 Aug 12, 2019 Jul NEWA HALOG AB +! SUN PHARM INDS INC 0.1% N 017556 001 Aug CFTG

HALOBETASOL PROPIONATE AEROSOL, FOAM;TOPICAL LEXETTE +! MAYNE PHARMA 0.05% N 210566 001 May 24, 2018 Sep CTNA CREAM;TOPICAL ULTRAVATE + @ SUN PHARM INDS INC 0.05% N 019967 001 Dec 27, 1990 Nov DISC LOTION;TOPICAL BRYHALI +! BAUSCH 0.01% N 209355 001 Nov 06, 2018 Apr CAHN +! DOW PHARM 0.01% N 209355 001 Nov 06, 2018 Jan CHRS + 0.01% N 209355 001 Nov 06, 2018 Jan CRLD

HALOBETASOL PROPIONATE; TAZAROTENE LOTION;TOPICAL DUOBRII +! BAUSCH 0.01%;0.045% N 209354 001 Apr 25, 2019 Apr NEWA

HALOPERIDOL TABLET;ORAL HALOPERIDOL >A> AB APPCO 0.5MG A 211061 001 Jan 08, 2020 Dec NEWA >A> AB 1MG A 211061 002 Jan 08, 2020 Dec NEWA >A> AB 2MG A 211061 003 Jan 08, 2020 Dec NEWA >A> AB 5MG A 211061 004 Jan 08, 2020 Dec NEWA >A> AB 10MG A 211061 005 Jan 08, 2020 Dec NEWA >A> AB 20MG A 211061 006 Jan 08, 2020 Dec NEWA AB INNOGENIX 0.5MG A 071173 002 Jan 02, 1987 Oct CMFD @ 0.5MG A 071173 002 Jan 02, 1987 May CMS1 AB 1MG A 071173 003 Jan 02, 1987 Oct CMFD @ 1MG A 071173 003 Jan 02, 1987 May CMS1 AB 2MG A 071173 004 Jan 02, 1987 Oct CMFD @ 2MG A 071173 004 Jan 02, 1987 May CMS1 AB 5MG A 071173 005 Jan 07, 1988 Oct CMFD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -74

TABLET;ORAL HALOPERIDOL @ 5MG A 071173 005 Jan 07, 1988 May CMS1 AB 10MG A 071173 001 Jan 07, 1988 Oct CMFD @ 10MG A 071173 001 Jan 07, 1988 Mar CAHN AB 20MG A 071173 006 Jan 07, 1988 Oct CMFD @ 20MG A 071173 006 Jan 07, 1988 May CMS1 >D> ! MYLAN 2MG A 070278 001 Jun 10, 1986 Dec CTEC >A> AB ! 2MG A 070278 001 Jun 10, 1986 Dec CTEC ! 2MG A 070278 001 Jun 10, 1986 Jan CTEC AB ! 2MG A 070278 001 Jun 10, 1986 Jan CHRS @ SANDOZ 2MG A 071208 001 Nov 17, 1986 Jan DISC

HALOPERIDOL DECANOATE INJECTABLE;INJECTION HALOPERIDOL DECANOATE AO ZYDUS PHARMS EQ 50MG BASE/ML A 211180 001 Oct 22, 2019 Oct NEWA AO EQ 100MG BASE/ML A 211180 002 Oct 22, 2019 Oct NEWA

HALOPERIDOL LACTATE CONCENTRATE;ORAL HALOPERIDOL AA ! PHARM ASSOC EQ 2MG BASE/ML A 073037 001 Feb 26, 1993 May CHRS @ TEVA PHARMS EQ 2MG BASE/ML A 071617 001 Dec 01, 1988 May DISC HALOPERIDOL INTENSOL @ HIKMA EQ 2MG BASE/ML A 072045 001 Apr 12, 1988 Sep CAHN INJECTABLE;INJECTION HALOPERIDOL >D> AP FRESENIUS KABI USA EQ 5MG BASE/ML A 210356 001 Jul 01, 2019 Dec DISC >A> @ EQ 5MG BASE/ML A 210356 001 Jul 01, 2019 Dec DISC AP EQ 5MG BASE/ML A 210356 001 Jul 01, 2019 Jun NEWA

HEPARIN SODIUM INJECTABLE;INJECTION HEPARIN SODIUM B BRAUN MEDICAL INC 5,000 UNITS/0.5ML A 208827 001 Nov 19, 2018 Aug CAHN AP +! HIKMA 1,000 UNITS/ML N 017037 001 Feb CAHN AP +! 5,000 UNITS/ML N 017037 002 Feb CAHN @ 5,000 UNITS/0.5ML N 017037 013 Apr 07, 1986 Feb CAHN AP +! 10,000 UNITS/ML N 017037 003 Feb CAHN AP NANJING KING-FRIEND 1,000 UNITS/ML A 211007 001 May 28, 2019 May NEWA AP 5,000 UNITS/ML A 211007 002 May 28, 2019 May NEWA AP 10,000 UNITS/ML A 211007 003 May 28, 2019 May NEWA

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL HYCODAN AA + GENUS 1.5MG/5ML;5MG/5ML N 005213 002 Jul 26, 1988 Jun CMFD HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE @ BRECKENRIDGE 1.5MG/5ML;5MG/5ML A 210663 001 Jun 11, 2019 Jul DISC AA BRECKENRIDGE PHARM 1.5MG/5ML;5MG/5ML A 210663 001 Jun 11, 2019 May NEWA @ TORRENT 1.5MG/5ML;5MG/5ML A 204765 001 Mar 06, 2017 Nov DISC AA 1.5MG/5ML;5MG/5ML A 204765 001 Mar 06, 2017 May CMFD @ 1.5MG/5ML;5MG/5ML A 204765 001 Mar 06, 2017 Jan CAHN

HYDRALAZINE HYDROCHLORIDE INJECTABLE;INJECTION HYDRALAZINE HYDROCHLORIDE @ LUITPOLD 20MG/ML A 040136 001 Jun 30, 1997 Feb DISC TABLET;ORAL HYDRALAZINE HYDROCHLORIDE AA UPSHER SMITH LABS 10MG A 209251 001 Jul 09, 2018 Jun CAHN AA 25MG A 209251 002 Jul 09, 2018 Jun CAHN AA 50MG A 209251 003 Jul 09, 2018 Jun CAHN AA 100MG A 209251 004 Jul 09, 2018 Jun CAHN

HYDROCHLOROTHIAZIDE TABLET;ORAL HYDROCHLOROTHIAZIDE AB ! ACCORD HLTHCARE 12.5MG A 202556 001 Sep 24, 2012 Nov CHRS @ SUN PHARM INDS INC 12.5MG A 040857 001 May 30, 2008 Oct DISC @ 25MG A 040810 001 Mar 27, 2007 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -75

TABLET;ORAL HYDROCHLOROTHIAZIDE @ 50MG A 040810 002 Mar 27, 2007 Oct DISC

HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL IRBESARTAN AND HYDROCHLOROTHIAZIDE @ APOTEX INC 12.5MG;150MG A 201505 001 Oct 15, 2012 Jul DISC @ 12.5MG;300MG A 201505 002 Oct 15, 2012 Jul DISC

HYDROCHLOROTHIAZIDE; LISINOPRIL TABLET;ORAL LISINOPRIL AND HYDROCHLOROTHIAZIDE @ HERITAGE PHARMA 12.5MG;10MG A 075776 001 Jul 01, 2002 Aug DISC AB 12.5MG;10MG A 075776 001 Jul 01, 2002 Feb CAHN @ 12.5MG;20MG A 075776 002 Jul 01, 2002 Aug DISC AB 12.5MG;20MG A 075776 002 Jul 01, 2002 Feb CAHN @ 25MG;20MG A 075776 003 Jul 01, 2002 Aug DISC AB 25MG;20MG A 075776 003 Jul 01, 2002 Feb CAHN >D> AB MYLAN 12.5MG;10MG A 076113 001 Jul 01, 2002 Dec DISC >A> @ 12.5MG;10MG A 076113 001 Jul 01, 2002 Dec DISC >D> AB 12.5MG;20MG A 076113 002 Jul 01, 2002 Dec DISC >A> @ 12.5MG;20MG A 076113 002 Jul 01, 2002 Dec DISC >D> AB 25MG;20MG A 076113 003 Jul 01, 2002 Dec DISC >A> @ 25MG;20MG A 076113 003 Jul 01, 2002 Dec DISC

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET;ORAL OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE @ ACCORD HLTHCARE 12.5MG;20MG A 209281 001 Feb 07, 2019 Aug DISC AB 12.5MG;20MG A 209281 001 Feb 07, 2019 Jan NEWA @ 12.5MG;40MG A 209281 002 Feb 07, 2019 Aug DISC AB 12.5MG;40MG A 209281 002 Feb 07, 2019 Jan NEWA @ 25MG;40MG A 209281 003 Feb 07, 2019 Aug DISC AB 25MG;40MG A 209281 003 Feb 07, 2019 Jan NEWA @ MYLAN 12.5MG;20MG A 078827 001 Oct 26, 2016 Nov DISC @ 12.5MG;40MG A 078827 002 Oct 26, 2016 Nov DISC @ 25MG;40MG A 078827 003 Oct 26, 2016 Nov DISC @ TEVA PHARMS USA 12.5MG;20MG A 200532 001 Apr 24, 2017 Jul DISC @ 25MG;40MG A 200532 003 Apr 24, 2017 Jul DISC AB UMEDICA LABS PVT LTD 12.5MG;20MG A 208847 001 Sep 17, 2019 Sep NEWA AB 12.5MG;40MG A 208847 003 Sep 17, 2019 Sep NEWA AB 25MG;40MG A 208847 002 Sep 17, 2019 Sep NEWA

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET;ORAL QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE @ MYLAN 12.5MG;EQ 10MG BASE A 077093 001 Mar 28, 2005 May DISC @ 12.5MG;EQ 20MG BASE A 077093 002 Mar 28, 2005 May DISC @ 25MG;EQ 20MG BASE A 077093 003 Mar 28, 2005 May DISC QUINARETIC AB LUPIN 12.5MG;EQ 10MG BASE A 076374 001 Mar 31, 2004 Feb CAHN AB 12.5MG;EQ 20MG BASE A 076374 002 Mar 31, 2004 Feb CAHN AB 25MG;EQ 20MG BASE A 076374 003 Mar 31, 2004 Feb CAHN

HYDROCHLOROTHIAZIDE; TELMISARTAN TABLET;ORAL TELMISARTAN AND HYDROCHLOROTHIAZIDE AB GLENMARK PHARMS LTD 12.5MG;40MG A 202544 001 Mar 04, 2019 Feb NEWA AB 12.5MG;80MG A 202544 002 Mar 04, 2019 Feb NEWA AB 25MG;80MG A 202544 003 Mar 04, 2019 Feb NEWA

HYDROCHLOROTHIAZIDE; TRIAMTERENE CAPSULE;ORAL TRIAMTERENE AND HYDROCHLOROTHIAZIDE @ ANI PHARMS INC 25MG;50MG A 074259 001 Mar 30, 1995 Jun DISC @ CASI PHARMS INC 25MG;50MG A 073191 001 Jul 31, 1991 Jun DISC AB ZYDUS PHARMS 25MG;37.5MG A 208358 001 Feb 11, 2019 Jan NEWA TABLET;ORAL TRIAMTERENE AND HYDROCHLOROTHIAZIDE >D> AB ANI PHARMS INC 50MG;75MG A 073467 001 Jan 31, 1996 Dec DISC >A> @ 50MG;75MG A 073467 001 Jan 31, 1996 Dec DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -76

HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL VALSARTAN AND HYDROCHLOROTHIAZIDE @ ZYDUS PHARMS 12.5MG;80MG A 203000 001 Mar 15, 2019 Aug DISC AB 12.5MG;80MG A 203000 001 Mar 15, 2019 Mar NEWA @ 12.5MG;160MG A 203000 002 Mar 15, 2019 Aug DISC AB 12.5MG;160MG A 203000 002 Mar 15, 2019 Mar NEWA @ 12.5MG;320MG A 203000 003 Mar 15, 2019 Aug DISC AB 12.5MG;320MG A 203000 003 Mar 15, 2019 Mar NEWA @ 25MG;160MG A 203000 004 Mar 15, 2019 Aug DISC AB 25MG;160MG A 203000 004 Mar 15, 2019 Mar NEWA @ 25MG;320MG A 203000 005 Mar 15, 2019 Aug DISC AB 25MG;320MG A 203000 005 Mar 15, 2019 Mar NEWA

HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE;ORAL ZOHYDRO ER +! PERSION 10MG N 202880 001 Oct 25, 2013 Apr CAHN + 15MG N 202880 002 Oct 25, 2013 Apr CAHN + 20MG N 202880 003 Oct 25, 2013 Apr CAHN + 30MG N 202880 004 Oct 25, 2013 Apr CAHN + 40MG N 202880 005 Oct 25, 2013 Apr CAHN + 50MG N 202880 006 Oct 25, 2013 Apr CAHN TABLET, EXTENDED RELEASE;ORAL HYSINGLA ER +! PURDUE PHARMA LP 20MG N 206627 001 Nov 20, 2014 Jul CMS1 + 30MG N 206627 002 Nov 20, 2014 Jul CMS1 + 40MG N 206627 003 Nov 20, 2014 Jul CMS1 + 60MG N 206627 004 Nov 20, 2014 Jul CMS1 + 80MG N 206627 005 Nov 20, 2014 Jul CMS1 + 100MG N 206627 006 Nov 20, 2014 Jul CMS1 + 120MG N 206627 007 Nov 20, 2014 Jul CMS1

HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL HYDROCODONE BITARTRATE AND IBUPROFEN @ ANI PHARMS INC 5MG;200MG A 077454 001 Jun 23, 2010 May CAHN @ SUN PHARM INDS INC 2.5MG;200MG A 091633 001 May 28, 2013 Oct DISC @ 5MG;200MG A 091633 002 May 28, 2013 Oct DISC @ 7.5MG;200MG A 091633 003 May 28, 2013 Oct DISC @ 10MG;200MG A 091633 004 May 28, 2013 Oct DISC REPREXAIN AMNEAL PHARMS NY 2.5MG;200MG A 076642 003 Oct 19, 2007 Oct CTEC

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION;ORAL HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE @ MAYNE PHARMA INC 5MG/5ML;60MG/5ML A 205658 001 Nov 17, 2015 Jun DISC @ PADDOCK LLC 5MG/5ML;60MG/5ML A 204658 001 Apr 29, 2014 Jun DISC @ TORRENT 5MG/5ML;60MG/5ML A 206661 001 Jan 23, 2019 Feb DISC AA 5MG/5ML;60MG/5ML A 206661 001 Jan 23, 2019 Jan NEWA REZIRA + @ PERSION 5MG/5ML;60MG/5ML N 022442 001 Jun 08, 2011 Jun DISC AA +! 5MG/5ML;60MG/5ML N 022442 001 Jun 08, 2011 Apr CAHN

HYDROCORTISONE CREAM;TOPICAL NUTRACORT @ BAUSCH 0.5% A 080442 002 Feb CAHN @ 1% A 080442 003 Feb CAHN LOTION;TOPICAL ALA-SCALP >D> CROWN LABS 2% A 083231 001 Dec CAHN >A> MARNEL PHARMS 2% A 083231 001 Dec CAHN CETACORT @ BAUSCH 0.5% A 080426 002 Feb CAHN @ 1% A 080426 001 Feb CAHN TABLET;ORAL HYDROCORTISONE >D> AB BRECKENRIDGE 5MG A 207029 001 Apr 27, 2017 Dec CAHN AB 5MG A 207029 001 Apr 27, 2017 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -77

TABLET;ORAL HYDROCORTISONE >D> AB 10MG A 207029 002 Apr 27, 2017 Dec CAHN AB 10MG A 207029 002 Apr 27, 2017 Aug CAHN >D> AB 20MG A 207029 003 Apr 27, 2017 Dec CAHN AB 20MG A 207029 003 Apr 27, 2017 Aug CAHN >A> AB PII 5MG A 207029 001 Apr 27, 2017 Dec CAHN >A> AB 10MG A 207029 002 Apr 27, 2017 Dec CAHN >A> AB 20MG A 207029 003 Apr 27, 2017 Dec CAHN

HYDROCORTISONE BUTYRATE CREAM;TOPICAL LOCOID AB1 +! BAUSCH 0.1% N 018514 001 Mar 31, 1982 May CAHN LOTION;TOPICAL LOCOID AB +! BAUSCH 0.1% N 022076 001 May 18, 2007 May CAHN SOLUTION;TOPICAL LOCOID AT +! BAUSCH 0.1% N 019116 001 Feb 25, 1987 May CAHN

HYDROCORTISONE VALERATE CREAM;TOPICAL HYDROCORTISONE VALERATE AB LUPIN LTD 0.2% A 210307 001 Aug 15, 2019 Aug NEWA AB PERRIGO ISRAEL 0.2% A 075666 001 May 24, 2000 May CAHN

HYDROGEN PEROXIDE SOLUTION;TOPICAL ESKATA + @ ACLARIS 40% N 209305 001 Dec 14, 2017 Aug DISC

HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EXALGO + @ SPECGX LLC 8MG N 021217 001 Mar 01, 2010 Mar DISC + @ 12MG N 021217 002 Mar 01, 2010 Mar DISC + @ 16MG N 021217 003 Mar 01, 2010 Mar DISC + @ 32MG N 021217 004 Aug 24, 2012 Mar DISC HYDROMORPHONE HYDROCHLORIDE AB ! OSMOTICA 32MG A 205629 004 Jul 07, 2016 Mar CHRS

HYDROXYCHLOROQUINE SULFATE TABLET;ORAL HYDROXYCHLOROQUINE SULFATE >A> @ INVATECH 200MG A 040150 001 Jan 27, 1996 Dec CAHN @ LAURUS LABS LTD 200MG A 210959 001 Jan 15, 2019 Sep DISC AB 200MG A 210959 001 Jan 15, 2019 Jan CAHN @ LUPIN LTD 200MG A 210543 001 Jul 06, 2018 Feb DISC >D> @ SANDOZ 200MG A 040150 001 Jan 27, 1996 Dec CAHN

HYDROXYPROGESTERONE CAPROATE SOLUTION;INTRAMUSCULAR HYDROXYPROGESTERON CAPROATE AP1 AM REGENT 1250MG/5ML (250MG/ML) A 210724 001 Aug 09, 2019 Jul NEWA HYDROXYPROGESTERONE CAPROATE AP ASPEN 250MG/ML (250MG/ML) A 211777 001 Aug 08, 2019 Jul NEWA ! ASPEN GLOBAL INC 1250MG/5ML (250MG/ML) A 200271 001 Aug 24, 2015 Nov CTEC AP2 ! 1250MG/5ML (250MG/ML) A 200271 001 Aug 24, 2015 Apr CPOT AP2 ! 250MG/ML (250MG/ML) A 200271 001 Aug 24, 2015 Apr CTEC AP EUGIA PHARMA 250MG/ML (250MG/ML) A 211071 001 Apr 16, 2019 Apr NEWA AP1 1250MG/5ML (250MG/ML) A 211070 001 Apr 16, 2019 Apr NEWA @ 1250MG/5ML (250MG/ML) A 211142 001 May 09, 2019 Nov DISC AP2 1250MG/5ML (250MG/ML) A 211142 001 May 09, 2019 Apr NEWA AP SLAYBACK PHARMA LLC 250MG/ML (250MG/ML) A 210877 001 Mar 22, 2019 Mar NEWA AP1 1250MG/5ML (250MG/ML) A 210618 001 Dec 28, 2018 Apr CTEC AP1 SUN PHARM 1250MG/5ML (250MG/ML) A 208381 001 Apr 09, 2019 Apr CTEC AP 1250MG/5ML (250MG/ML) A 208381 001 Apr 09, 2019 Mar NEWA MAKENA AP1 +! AMAG PHARMA USA 1250MG/5ML (250MG/ML) N 021945 001 Feb 03, 2011 Apr CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -78

HYDROXYPROPYL CELLULOSE INSERT;OPHTHALMIC LACRISERT +! VALEANT PHARMS INTL 5MG N 018771 001 Jan CAHN

HYDROXYZINE HYDROCHLORIDE INJECTABLE;INJECTION HYDROXYZINE HYDROCHLORIDE ! LUITPOLD 50MG/ML A 087408 002 Mar CMFD @ 50MG/ML A 087408 002 Feb DISC SYRUP;ORAL HYDROXYZINE HYDROCHLORIDE @ ANIMA 10MG/5ML A 086880 001 Sep CAHN @ TORRENT 10MG/5ML A 210634 001 Feb 26, 2019 Nov DISC AA 10MG/5ML A 210634 001 Feb 26, 2019 Feb NEWA TABLET;ORAL HYDROXYZINE HYDROCHLORIDE AB EPIC PHARMA LLC 10MG A 040604 002 Dec 28, 2004 Jan CAHN AB 25MG A 040604 003 Dec 28, 2004 Jan CAHN AB 50MG A 040604 001 Dec 28, 2004 Jan CAHN AB KVK TECH 25MG A 040786 002 Mar 20, 2007 Feb CMS1 AB 50MG A 040786 003 Mar 20, 2007 Feb CMS1 @ MYLAN 10MG A 091176 001 Jun 07, 2010 Aug DISC @ 25MG A 091176 002 Jun 07, 2010 Aug DISC @ 50MG A 091176 003 Jun 07, 2010 Aug DISC

HYDROXYZINE PAMOATE CAPSULE;ORAL HYDROXYZINE PAMOATE @ BEXIMCO PHARMS USA EQ 25MG HYDROCHLORIDE A 081127 001 Jun 28, 1991 Feb CAHN AB ! SANDOZ EQ 50MG HYDROCHLORIDE A 086183 001 Nov CHRS VISTARIL + @ PFIZER EQ 25MG HYDROCHLORIDE N 011459 002 Nov DISC + @ EQ 50MG HYDROCHLORIDE N 011459 004 Nov DISC

IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS IBANDRONATE SODIUM @ EMCURE PHARMS LTD EQ 3MG BASE/3ML A 203987 001 Sep 02, 2014 Nov DISC TABLET;ORAL IBANDRONATE SODIUM @ SUN PHARM INDUSTRIES EQ 150MG BASE A 078996 001 Aug 15, 2012 Oct DISC

IBUPROFEN SOLUTION;INTRAVENOUS CALDOLOR +! CUMBERLAND PHARMS 800MG/200ML (4MG/ML) N 022348 003 Jan 25, 2019 Jan NEWA SUSPENSION;ORAL CHILDREN'S ADVIL @ GLAXOSMITHKLINE 100MG/5ML N 019833 002 Sep 19, 1989 Nov CAHN IBUPROFEN AB L PERRIGO CO 100MG/5ML A 076925 001 Sep 23, 2004 May CAHN TABLET;ORAL IBUPROFEN @ HEC PHARM 400MG A 204062 001 Sep 10, 2018 Mar DISC @ 600MG A 204062 002 Sep 10, 2018 Mar DISC @ 800MG A 204062 003 Sep 10, 2018 Mar DISC AB PERRIGO PHARMS CO 400MG A 077114 001 Jul 18, 2005 May CAHN AB 600MG A 077114 002 Jul 18, 2005 May CAHN AB 800MG A 077114 003 Jul 18, 2005 May CAHN

IBUTILIDE FUMARATE INJECTABLE;INJECTION IBUTILIDE FUMARATE @ LUITPOLD 0.1MG/ML A 090240 001 Jan 11, 2010 Feb DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -79

ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS FIRAZYR AP +! SHIRE ORPHAN THERAP EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N 022150 001 Aug 25, 2011 Jul CFTG ICATIBANT ACETATE AP TEVA PHARMS USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A 210118 001 Jul 15, 2019 Jul NFTG

IDARUBICIN HYDROCHLORIDE INJECTABLE;INJECTION IDARUBICIN HYDROCHLORIDE @ MYLAN LABS LTD 1MG/ML A 200144 001 Oct 11, 2012 Oct DISC

IFOSFAMIDE INJECTABLE;INJECTION IFOSFAMIDE @ MYLAN LABS LTD 1GM/20ML (50MG/ML) A 201689 001 Nov 26, 2012 Sep DISC @ 3GM/60ML (50MG/ML) A 201689 002 Nov 26, 2012 Sep DISC

ILOPERIDONE TABLET;ORAL FANAPT +! VANDA PHARMS INC 1MG N 022192 001 May 06, 2009 Aug CTEC + 2MG N 022192 002 May 06, 2009 Aug CTEC + 4MG N 022192 003 May 06, 2009 Aug CTEC + 6MG N 022192 004 May 06, 2009 Aug CTEC + 8MG N 022192 005 May 06, 2009 Aug CTEC + 10MG N 022192 006 May 06, 2009 Aug CTEC + 12MG N 022192 007 May 06, 2009 Aug CTEC ILOPERIDONE @ INVENTIA 1MG A 207231 001 Nov 28, 2016 Aug CAHN @ 2MG A 207231 002 Nov 28, 2016 Aug CAHN @ 4MG A 207231 003 Nov 28, 2016 Aug CAHN @ 6MG A 207231 004 Nov 28, 2016 Aug CAHN @ 8MG A 207231 005 Nov 28, 2016 Aug CAHN @ 10MG A 207231 006 Nov 28, 2016 Aug CAHN @ 12MG A 207231 007 Nov 28, 2016 Aug CAHN @ INVENTIA HLTHCARE 1MG A 207231 001 Nov 28, 2016 Jul DISC @ 2MG A 207231 002 Nov 28, 2016 Jul DISC @ 4MG A 207231 003 Nov 28, 2016 Jul DISC @ 6MG A 207231 004 Nov 28, 2016 Jul DISC @ 8MG A 207231 005 Nov 28, 2016 Jul DISC @ 10MG A 207231 006 Nov 28, 2016 Jul DISC @ 12MG A 207231 007 Nov 28, 2016 Jul DISC @ TARO PHARM INDS LTD 1MG A 207098 001 Jul 22, 2019 Aug DISC AB 1MG A 207098 001 Jul 22, 2019 Jul NEWA @ 2MG A 207098 002 Jul 22, 2019 Aug DISC AB 2MG A 207098 002 Jul 22, 2019 Jul NEWA @ 4MG A 207098 003 Jul 22, 2019 Aug DISC AB 4MG A 207098 003 Jul 22, 2019 Jul NEWA @ 6MG A 207098 004 Jul 22, 2019 Aug DISC AB 6MG A 207098 004 Jul 22, 2019 Jul NEWA @ 8MG A 207098 005 Jul 22, 2019 Aug DISC AB 8MG A 207098 005 Jul 22, 2019 Jul NEWA @ 10MG A 207098 006 Jul 22, 2019 Aug DISC AB 10MG A 207098 006 Jul 22, 2019 Jul NEWA @ 12MG A 207098 007 Jul 22, 2019 Aug DISC AB 12MG A 207098 007 Jul 22, 2019 Jul NEWA

IMATINIB MESYLATE TABLET;ORAL IMATINIB MESYLATE @ AMNEAL PHARMS EQ 100MG BASE A 207495 001 Feb 08, 2019 Aug DISC AB EQ 100MG BASE A 207495 001 Feb 08, 2019 Feb NEWA @ EQ 400MG BASE A 207495 002 Feb 08, 2019 Aug DISC AB EQ 400MG BASE A 207495 002 Feb 08, 2019 Feb NEWA AB BRECKENRIDGE EQ 100MG BASE A 205990 001 Feb 08, 2019 Feb NEWA AB EQ 400MG BASE A 205990 002 Feb 08, 2019 Feb NEWA AB NATCO PHARMA LTD EQ 100MG BASE A 207818 001 Mar 01, 2019 Feb NEWA AB EQ 400MG BASE A 207818 002 Mar 01, 2019 Feb NEWA AB SHILPA MEDICARE LTD EQ 100MG BASE A 208302 001 Jan 17, 2019 Jan NEWA AB EQ 400MG BASE A 208302 002 Jan 17, 2019 Jan NEWA AB WOCKHARDT BIO AG EQ 100MG BASE A 208429 001 Jan 17, 2019 Jan NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -80

TABLET;ORAL IMATINIB MESYLATE AB EQ 400MG BASE A 208429 002 Jan 17, 2019 Jan NEWA

IMIPRAMINE HYDROCHLORIDE TABLET;ORAL IMIPRAMINE HYDROCHLORIDE >D> AB LUPIN LTD 10MG A 090441 002 Mar 11, 2010 Dec DISC >A> @ 10MG A 090441 002 Mar 11, 2010 Dec DISC >D> AB 25MG A 090441 003 Mar 11, 2010 Dec DISC >A> @ 25MG A 090441 003 Mar 11, 2010 Dec DISC >D> AB 50MG A 090441 001 Mar 11, 2010 Dec DISC >A> @ 50MG A 090441 001 Mar 11, 2010 Dec DISC @ OXFORD PHARMS 10MG A 040751 003 Feb 28, 2008 Mar DISC @ 25MG A 040751 002 Feb 28, 2008 Mar DISC

IMIQUIMOD CREAM;TOPICAL ALDARA AB +! BAUSCH 5% N 020723 001 Feb 27, 1997 Aug CAHN ZYCLARA +! BAUSCH 2.5% N 022483 002 Jul 15, 2011 Aug CAHN +! 3.75% N 022483 001 Mar 25, 2010 Aug CAHN

INDIUM IN-111 CHLORIDE INJECTABLE;INJECTION INDICLOR + @ GE HEALTHCARE 2mCi/0.2ML N 019862 001 Dec 29, 1992 Jun DISC INDIUM IN 111 CHLORIDE +! CURIUM 5mCi/0.5ML N 019841 001 Sep 27, 1994 Jan CAHN

INDIUM IN-111 OXYQUINOLINE INJECTABLE;INJECTION INDIUM IN 111 OXYQUINOLINE >D> @ BWXT ITG 1mCi/ML A 202586 001 Jul 25, 2018 Dec CMFD >A> AP 1mCi/ML A 202586 001 Jul 25, 2018 Dec CMFD >D> +! GE HEALTHCARE 1mCi/ML N 019044 001 Dec 24, 1985 Dec CTEC >A> AP +! 1mCi/ML N 019044 001 Dec 24, 1985 Dec CTEC

INDIUM IN-111 PENTETREOTIDE KIT INJECTABLE;INJECTION OCTREOSCAN +! CURIUM 3mCi/ML N 020314 001 Jun 02, 1994 Jan CAHN

INDOMETHACIN CAPSULE;ORAL INDOCIN + @ EGALET 25MG N 016059 001 Feb CAHN + @ 50MG N 016059 002 Feb CAHN INDOMETHACIN @ ANI PHARMS INC 25MG A 071148 001 Mar 18, 1987 May CAHN @ 50MG A 071149 001 Mar 18, 1987 May CAHN AB CADILA 25MG A 090403 001 Nov 15, 2010 May CAHN AB 50MG A 090403 002 Nov 15, 2010 May CAHN AB ! GLENMARK GENERICS 50MG A 091276 002 Dec 22, 2010 Aug CHRS AB HERITAGE PHARMA 25MG A 070719 001 Feb 12, 1986 Feb CAHN AB 50MG A 070756 001 Feb 12, 1986 Feb CAHN @ MYLAN 25MG N 018858 001 Apr 20, 1984 Aug DISC @ 50MG A 070624 001 Sep 04, 1985 Aug DISC @ SUN PHARM INDS INC 25MG A 091401 001 Mar 28, 2013 Oct DISC @ 50MG A 091401 002 Mar 28, 2013 Oct DISC TIVORBEX + EGALET 20MG N 204768 001 Feb 24, 2014 Feb CAHN +! 40MG N 204768 002 Feb 24, 2014 Feb CAHN + GENUS 20MG N 204768 001 Feb 24, 2014 Nov CAHN +! 40MG N 204768 002 Feb 24, 2014 Nov CAHN CAPSULE, EXTENDED RELEASE;ORAL INDOCIN SR + @ EGALET 75MG N 018185 001 Feb 23, 1982 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -81

SUPPOSITORY;RECTAL INDOCIN + EGALET@ 50MG N 017814 001 Aug 13, 1984 Feb CAHN SUSPENSION;ORAL INDOCIN +! EGALET 25MG/5ML N 018332 001 Oct 10, 1985 Feb CAHN INDOMETHACIN HI KMA@ HIKMA@ 25MG/5ML A 071412 001 Mar 18, 1987 Sep CAHN

INSULIN ASPART SOLUTION;SUBCUTANEOUS FIASP PENFILL +! NOVO 300 UNITS/3ML (100 UNITS/ML) N 208751 003 Sep 24, 2018 Jun NEWA

INSULIN ASPART; INSULIN DEGLUDEC SOLUTION;SUBCUTANEOUS RYZODEG 70/30 + @ NOVO 90 UNITS/3ML;210 UNITS/3ML (30 N 203313 001 Sep 25, 2015 Jun DISC UNITS/ML;70 UNITS/ML)

INSULIN DEGLUDEC SOLUTION;SUBCUTANEOUS TRESIBA NOVO 1000 UNITS/10ML (100 UNITS/ML) N 203314 003 Nov 21, 2018 Jun NEWA

INSULIN HUMAN SOLUTION;INTRAVENOUS MYXREDLIN +! BAXTER HLTHCARE CORP 100 UNITS/100ML (1 UNIT/ML) N 208157 001 Jun 20, 2019 Jul CAHN +! CELERITY PHARMS 100 UNITS/100ML (1 UNIT/ML) N 208157 001 Jun 20, 2019 Jun NEWA

INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION >A> HUMALOG KWIKPEN >A> +! LILLY 200UNITS/ML N 020563 004 Nov 15, 2019 Dec NEWA >A> HUMALOG TEMPO PEN >A> +! LILLY 100UNITS/ML N 020563 005 Nov 15, 2019 Dec NEWA

IOPROMIDE INJECTABLE;INJECTION ULTRAVIST (PHARMACY BULK) + @ BAYER HLTHCARE 49.9% N 021425 003 Mar 12, 2004 Aug DISC +! 49.9% N 021425 003 Mar 12, 2004 Apr CMFD + @ 49.9% N 021425 003 Mar 12, 2004 Feb DISC ULTRAVIST 240 + @ BAYER HLTHCARE 49.9% N 020220 003 May 10, 1995 Aug DISC +! 49.9% N 020220 003 May 10, 1995 Apr CMFD + @ 49.9% N 020220 003 May 10, 1995 Feb DISC

IOTHALAMATE MEGLUMINE INJECTABLE;INJECTION CONRAY 43 + @ LIEBEL-FLARSHEIM 43% N 013295 002 Jun DISC

IPRATROPIUM BROMIDE SPRAY, METERED;NASAL IPRATROPIUM BROMIDE @ MYLAN SPECIALITY LP 0.021MG/SPRAY A 075552 001 Mar 31, 2003 Mar DISC @ 0.042MG/SPRAY A 075553 001 Mar 31, 2003 Mar DISC

IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION IRINOTECAN HYDROCHLORIDE @ FRESENIUS KABI USA 40MG/2ML (20MG/ML) A 078188 001 Feb 27, 2008 Oct DISC AP 40MG/2ML (20MG/ML) A 078188 001 Feb 27, 2008 Jan CAHN @ 100MG/5ML (20MG/ML) A 078188 002 Feb 27, 2008 Oct DISC AP 100MG/5ML (20MG/ML) A 078188 002 Feb 27, 2008 Jan CAHN AP GLAND PHARMA LTD 40MG/2ML (20MG/ML) A 212993 001 Nov 18, 2019 Nov NEWA AP 100MG/5ML (20MG/ML) A 212993 002 Nov 18, 2019 Nov NEWA AP ZENNOVA 40MG/2ML (20MG/ML) A 090393 002 May 13, 2011 Sep CAHN AP 100MG/5ML (20MG/ML) A 090393 003 May 13, 2011 Sep CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -82

IRON DEXTRAN INJECTABLE;INJECTION DEXFERRUM @ LUITPOLD EQ 50MG IRON/ML N 040024 001 Feb 23, 1996 Mar DISC PROFERDEX @ NEW RIVER EQ 50MG IRON/ML N 017807 001 Mar DISC

IRON SUCROSE INJECTABLE;INTRAVENOUS VENOFER + AM REGENT EQ 50MG BASE/2.5ML (EQ 20MG N 021135 002 Mar 20, 2005 Apr CAHN BASE/ML) @ EQ 65MG BASE/3.25ML (EQ 20MG N 021135 005 Mar 29, 2013 Apr CAHN BASE/ML) @ EQ 75MG BASE/3.75ML (EQ 20MG N 021135 003 Mar 29, 2005 Apr CAHN BASE/ML) +! EQ 100MG BASE/5ML (EQ 20MG N 021135 001 Nov 06, 2000 Apr CAHN BASE/ML) + EQ 200MG BASE/10ML (EQ 20MG N 021135 004 Feb 09, 2007 Apr CAHN BASE/ML)

ISONIAZID TABLET;ORAL ISONIAZID AA ! BARR 100MG A 080936 001 Aug CHRS AA ! 300MG A 080937 002 Aug CHRS + SANDOZ@ 100MG N 008678 002 Aug DISC + @ 300MG N 008678 003 Aug DISC LANIAZID @ LANNETT 300MG A 089776 001 Jun 13, 1988 Oct DISC

ISOPROPYL ALCOHOL SOLUTION;TOPICAL ZURAGARD +! ZUREX PHARMA 70% (10.5ML) N 210872 001 Apr 26, 2019 Apr NEWA

ISOPROTERENOL HYDROCHLORIDE INJECTABLE;INJECTION ISOPROTERENOL HYDROCHLORIDE AP CIPLA 0.2MG/ML A 211738 001 Jun 28, 2019 Jun NEWA ISUPREL AP +! BAUSCH 0.2MG/ML N 010515 001 Mar CAHN

ISOSORBIDE DINITRATE TABLET;ORAL ISORDIL AB + BAUSCH 5MG N 012093 007 Jul 29, 1988 Mar CAHN + @ 10MG N 012093 002 Jul 29, 1988 Mar CAHN + @ 20MG N 012093 006 Jul 29, 1988 Mar CAHN + @ 30MG N 012093 005 Jul 29, 1988 Mar CAHN AB +! 40MG N 012093 001 Jul 29, 1988 Nov CTEC +! 40MG N 012093 001 Jul 29, 1988 Mar CAHN ISOSORBIDE DINITRATE AB ZYDUS 5MG A 213057 001 Nov 20, 2019 Nov NEWA AB 10MG A 213057 002 Nov 20, 2019 Nov NEWA AB 20MG A 213057 003 Nov 20, 2019 Nov NEWA AB 30MG A 213057 004 Nov 20, 2019 Nov NEWA AB 40MG A 213057 005 Nov 20, 2019 Nov NEWA

ISOSORBIDE MONONITRATE TABLET;ORAL ISOSORBIDE MONONITRATE >D> AB ANI PHARMS INC 20MG A 075147 001 Nov 27, 1998 Dec DISC >A> @ 20MG A 075147 001 Nov 27, 1998 Dec DISC TABLET, EXTENDED RELEASE;ORAL ISOSORBIDE MONONITRATE AB HIKMA INTL PHARMS 30MG A 076813 002 Mar 30, 2006 Mar CAHN AB 60MG A 076813 001 Jan 07, 2005 Mar CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -83

ISOSULFAN BLUE INJECTABLE;INJECTION ISOSULFAN BLUE AP ANDA REPOSITORY 1% A 210558 001 Jul 12, 2019 Sep CAHN @ BELOTECA INC 1% A 210714 001 Jan 16, 2019 Jul DISC >D> AP SOMERSET THERAPS LLC 1% A 210558 001 Jul 12, 2019 Dec DISC >A> @ 1% A 210558 001 Jul 12, 2019 Dec DISC AP 1% A 210558 001 Jul 12, 2019 Oct CAHN AP 1% A 210558 001 Jul 12, 2019 Jul NEWA

ISOTRETINOIN CAPSULE;ORAL ABSORICA LD + SUN PHARM 8MG N 211913 001 Nov 05, 2019 Nov NEWA + 16MG N 211913 002 Nov 05, 2019 Nov NEWA + 20MG N 211913 003 Nov 05, 2019 Nov NEWA + 24MG N 211913 004 Nov 05, 2019 Nov NEWA + 28MG N 211913 005 Nov 05, 2019 Nov NEWA +! 32MG N 211913 006 Nov 05, 2019 Nov NEWA

ISTRADEFYLLINE TABLET;ORAL NOURIANZ + KYOWA KIRIN 20MG N 022075 001 Aug 27, 2019 Aug NEWA +! 40MG N 022075 002 Aug 27, 2019 Aug NEWA

ITRACONAZOLE CAPSULE;ORAL ITRACONAZOLE >D> AB ANDA REPOSITORY 100MG A 206410 001 Jul 02, 2019 Dec CAHN AB 100MG A 206410 001 Jul 02, 2019 Aug CAHN >A> AB PII 100MG A 206410 001 Jul 02, 2019 Dec CAHN AB 100MG A 206410 001 Jul 02, 2019 Jun NEWA SOLUTION;ORAL ITRACONAZOLE AA APOTEX 10MG/ML A 208481 001 Aug 02, 2019 Jul NEWA

IVABRADINE SOLUTION;ORAL CORLANOR +! AMGEN INC 5MG/5ML (1MG/ML) N 209964 001 Apr 22, 2019 Apr NEWA

IVACAFTOR GRANULE;ORAL KALYDECO + VERTEX PHARMS INC 25MG/PACKET N 207925 003 Apr 29, 2019 May NEWA TABLET;ORAL KALYDECO + VERTEX PHARMS 75MG N 203188 002 May 20, 2019 May NEWA

IVACAFTOR; IVACAFTOR, TEZACAFTOR TABLET, TABLET;ORAL SYMDEKO (COPACKAGED) + VERTEX PHARMS INC 75MG,N/A;75MG, 50MG N 210491 002 Jun 21, 2019 Nov CHRS +! 75MG,N/A;75MG, 50MG N 210491 002 Jun 21, 2019 Jul NEWA

IVERMECTIN CREAM;TOPICAL IVERMECTIN AB TEVA PHARMS USA 1% A 210019 001 Sep 13, 2019 Sep NFTG SOOLANTRA AB +! GALDERMA LABS LP 1% N 206255 001 Dec 19, 2014 Sep CFTG

KETOCONAZOLE GEL;TOPICAL XOLEGEL +! ALMIRALL 2% N 021946 001 Jul 28, 2006 Feb CAHN SHAMPOO;TOPICAL KETOCONAZOLE AB PERRIGO ISRAEL 2% A 076419 001 Jan 07, 2004 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -84

TABLET;ORAL KETOCONAZOLE >D> @ APOTEX 200MG A 075912 001 Jan 10, 2002 Dec CAHN >A> @ HAVIX 200MG A 075912 001 Jan 10, 2002 Dec CAHN @ HERITAGE PHARMA 200MG A 074971 001 Jun 15, 1999 May CAHN @ 200MG A 075362 001 Jun 15, 1999 May CAHN AB ! TARO 200MG A 075319 001 Jun 15, 1999 Apr CHRS @ TEVA 200MG A 075273 001 Jun 15, 1999 Apr DISC

KETOROLAC TROMETHAMINE INJECTABLE;INJECTION KETOROLAC TROMETHAMINE AP WEST-WARD PHARMS INT 15MG/ML A 075772 001 Jul 21, 2004 Feb CMFD AP 30MG/ML A 075772 002 Jul 21, 2004 Feb CMFD SOLUTION/DROPS;OPHTHALMIC KETOROLAC TROMETHAMINE @ AUROBINDO PHARMA LTD 0.4% A 205191 001 Nov 15, 2018 May DISC AT MICRO LABS LTD INDIA 0.5% A 203410 001 Apr 05, 2019 Mar NEWA @ SANDOZ INC 0.4% A 078721 001 Nov 05, 2009 May DISC SPRAY, METERED;NASAL SPRIX +! ZYLA 15.75MG/SPRAY N 022382 001 May 14, 2010 Jul CAHN

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE SOLUTION;IRRIGATION KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE AT LUPIN LTD EQ 0.3% BASE;EQ 1% BASE A 210183 001 Jul 01, 2019 Jun NFTG OMIDRIA AT +! OMEROS EQ 0.3% BASE;EQ 1% BASE N 205388 001 May 30, 2014 Jun CFTG

L-GLUTAMINE FOR SOLUTION;ORAL NUTRESTORE + @ EMMAUS MEDCL 5GM/PACKET N 021667 001 Jun 10, 2004 Jun DISC

LABETALOL HYDROCHLORIDE INJECTABLE;INJECTION LABETALOL HYDROCHLORIDE @ MYLAN ASI 5MG/ML A 079134 001 Feb 03, 2010 Sep DISC TABLET;ORAL LABETALOL HYDROCHLORIDE AB CADILA PHARMS LTD 100MG A 211325 001 May 13, 2019 Apr NEWA AB 200MG A 211325 002 May 13, 2019 Apr NEWA AB 300MG A 211325 003 May 13, 2019 Apr NEWA @ HERITAGE PHARMA 100MG A 074787 001 Aug 03, 1998 Oct DISC AB 100MG A 074787 001 Aug 03, 1998 Feb CAHN @ 200MG A 074787 002 Aug 03, 1998 Oct DISC AB 200MG A 074787 002 Aug 03, 1998 Feb CAHN @ 300MG A 074787 003 Aug 03, 1998 Oct DISC AB 300MG A 074787 003 Aug 03, 1998 Feb CAHN TRANDATE AB + CNTY LINE PHARMS 100MG N 018716 001 May 24, 1985 Jan CRLD AB + 200MG N 018716 002 Aug 01, 1984 Jan CRLD AB + 300MG N 018716 003 Aug 01, 1984 Jan CRLD

LACTULOSE SOLUTION;ORAL LACTULOSE >D> AA ANI PHARMS 10GM/15ML A 078430 001 Nov 28, 2007 Dec DISC >A> @ 10GM/15ML A 078430 001 Nov 28, 2007 Dec DISC @ BAJAJ 10GM/15ML A 075911 001 Feb 21, 2002 Jan CAHN @ TORRENT 10GM/15ML A 207786 001 Jun 11, 2018 Nov DISC AA 10GM/15ML A 207786 001 Jun 11, 2018 Jan CAHN AA XTTRIUM LABS INC 10GM/15ML A 075911 001 Feb 21, 2002 Aug CMFD @ 10GM/15ML A 075911 001 Feb 21, 2002 Mar CAHN SOLUTION;ORAL, RECTAL LACTULOSE >D> AA ANI PHARMS 10GM/15ML A 090426 001 Nov 21, 2008 Dec DISC >A> @ 10GM/15ML A 090426 001 Nov 21, 2008 Dec DISC @ BAJAJ 10GM/15ML A 076645 001 Jul 28, 2003 Jan CAHN @ TORRENT 10GM/15ML A 203762 001 Mar 27, 2015 Nov DISC AA 10GM/15ML A 203762 001 Mar 27, 2015 Jan CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -85

LAMIVUDINE TABLET;ORAL LAMIVUDINE AB ANNORA 100MG A 211306 001 Mar 21, 2019 Mar NEWA AB MACLEODS PHARMS LTD 150MG A 090198 001 May 01, 2019 Apr NEWA AB 300MG A 090198 002 May 01, 2019 Apr NEWA @ MYLAN 100MG A 204002 001 Dec 31, 2014 Oct DISC @ 150MG A 204528 001 Mar 04, 2016 Apr DISC @ 300MG A 204528 002 Mar 04, 2016 Apr DISC AB MYLAN LABS LTD 150MG A 078545 001 Mar 05, 2019 Feb NEWA AB 300MG A 078545 002 Mar 05, 2019 Feb NEWA

LAMIVUDINE; ZIDOVUDINE TABLET;ORAL LAMIVUDINE AND ZIDOVUDINE AB ANDA REPOSITORY 150MG;300MG A 206375 001 Apr 10, 2018 Sep CAHN @ MYLAN 150MG;300MG A 079079 001 Aug 12, 2019 Aug DISC AB 150MG;300MG A 079079 001 Aug 12, 2019 Jul NEWA @ 150MG;300MG A 204005 001 Aug 28, 2014 Jan DISC

LAMOTRIGINE TABLET;ORAL LAMOTRIGINE @ CELLTRION 25MG A 078982 001 Jan 27, 2009 Aug CAHN @ 100MG A 078982 002 Jan 27, 2009 Aug CAHN @ 150MG A 078982 003 Jan 27, 2009 Aug CAHN @ 200MG A 078982 004 Jan 27, 2009 Aug CAHN AB RUBICON 25MG A 078625 001 Jan 27, 2009 Jul CAHN AB 100MG A 078625 002 Jan 27, 2009 Jul CAHN AB 150MG A 078625 003 Jan 27, 2009 Jul CAHN AB 200MG A 078625 004 Jan 27, 2009 Jul CAHN TE VA@ TEVA@ 25MG A 076388 001 Aug 30, 2006 Nov DISC @ 100MG A 076388 002 Aug 30, 2006 Nov DISC @ 150MG A 076388 003 Aug 30, 2006 Nov DISC @ 200MG A 076388 004 Aug 30, 2006 Nov DISC TABLET, CHEWABLE;ORAL LAMOTRIGINE @ TEVA 5MG A 076420 001 Jun 21, 2006 Jul DISC @ 25MG A 076420 002 Jun 21, 2006 Jul DISC TABLET, EXTENDED RELEASE;ORAL LAMOTRIGINE @ RUBICON 25MG A 202887 001 Jun 17, 2013 Mar CAHN @ 50MG A 202887 002 Jun 17, 2013 Mar CAHN AB 100MG A 202887 003 Jun 17, 2013 Mar CAHN AB 200MG A 202887 004 Jun 17, 2013 Mar CAHN

LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL LANSOPRAZOLE @ AJANTA PHARMA LTD 15MG A 203957 001 Oct 14, 2016 Sep DISC @ 30MG A 203957 002 Oct 14, 2016 Sep DISC AB ALKEM LABS LTD 15MG A 207394 001 Jan 18, 2019 Jan NEWA AB 30MG A 207394 002 Jan 18, 2019 Jan NEWA @ BRECKENRIDGE 15MG A 203964 001 Oct 17, 2018 May DISC @ 30MG A 203964 002 Oct 17, 2018 May DISC AB INVENTIA 15MG A 205868 001 Aug 30, 2017 Aug CAHN AB 30MG A 205868 002 Aug 30, 2017 Aug CAHN @ KRKA TOVARNA ZDRAVIL 15MG A 091212 001 Sep 16, 2013 Feb DISC @ 30MG A 091212 002 Sep 16, 2013 Feb DISC AB XIROMED 15MG A 203203 001 Jul 25, 2016 Aug CAHN AB 30MG A 203203 002 Jul 25, 2016 Aug CAHN

LAROTRECTINIB CAPSULE;ORAL VITRAKVI + BAYER HLTHCARE 25MG N 210861 001 Nov 26, 2018 Feb CAHN +! 100MG N 210861 002 Nov 26, 2018 Feb CAHN SOLUTION;ORAL VITRAKVI +! BAYER HEALTHCARE 20MG/ML N 211710 001 Nov 26, 2018 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -86

LAROTRECTINIB SULFATE CAPSULE;ORAL VITRAKVI + BAYER HLTHCARE EQ 25MG BASE N 210861 001 Nov 26, 2018 Jun CAIN + EQ 25MG BASE N 210861 001 Nov 26, 2018 Jun CPOT +! EQ 100MG BASE N 210861 002 Nov 26, 2018 Jun CAIN +! EQ 100MG BASE N 210861 002 Nov 26, 2018 Jun CPOT SOLUTION;ORAL VITRAKVI +! BAYER HEALTHCARE EQ 20MG BASE/ML N 211710 001 Nov 26, 2018 Jun CAIN +! EQ 20MG BASE/ML N 211710 001 Nov 26, 2018 Jun CPOT

LATANOPROST SOLUTION/DROPS;OPHTHALMIC LATANOPROST AT AUROBINDO PHARMA LTD 0.005% A 206519 001 Sep 03, 2019 Aug NEWA AT SOMERSET 0.005% A 201786 001 Mar 22, 2011 Oct CAHN

LATANOPROST; NETARSUDIL DIMESYLATE SOLUTION/DROPS;OPHTHALMIC ROCKLATAN +! AERIE PHARMS INC 0.005%;EQ 0.02% BASE N 208259 001 Mar 12, 2019 Mar NEWA

LEDIPASVIR; SOFOSBUVIR PELLETS;ORAL HARVONI + GILEAD SCIENCES INC 33.75MG;150MG/PACKET N 212477 001 Aug 28, 2019 Aug NEWA +! 45MG;200MG/PACKET N 212477 002 Aug 28, 2019 Aug NEWA TABLET;ORAL HARVONI + GILEAD SCIENCES INC 45MG;200MG N 205834 002 Aug 28, 2019 Aug NEWA

LEFAMULIN ACETATE SOLUTION;INTRAVENOUS XENLETA +! NABRIVA EQ 150MG BASE/15ML (EQ 10MG N 211673 001 Aug 19, 2019 Aug NEWA BASE/ML) TABLET;ORAL XENLETA +! NABRIVA EQ 600MG BASE N 211672 001 Aug 19, 2019 Aug NEWA

LEFLUNOMIDE TABLET;ORAL LEFLUNOMIDE AB ABHAI LLC 10MG A 212453 001 Jun 03, 2019 May NEWA AB 20MG A 212453 002 Jun 03, 2019 May NEWA AB ZYDUS 10MG A 212308 001 Apr 24, 2019 Apr NEWA AB 20MG A 212308 002 Apr 24, 2019 Apr NEWA

LESINURAD TABLET;ORAL ZURAMPIC + @ IRONWOOD PHARMS INC 200MG N 207988 001 Dec 22, 2015 Apr DISC

LETROZOLE TABLET;ORAL LETROZOLE AB EUGIA PHARMA 2.5MG A 211717 001 Jan 11, 2019 Sep CMFD @ 2.5MG A 211717 001 Jan 11, 2019 Jul DISC @ FRESENIUS KABI USA 2.5MG A 090491 001 Jun 03, 2011 Oct DISC AB 2.5MG A 090491 001 Jun 03, 2011 Feb CAHN

LEUCOVORIN CALCIUM INJECTABLE;INJECTION LEUCOVORIN CALCIUM @ INGENUS PHARMS LLC EQ 10MG BASE/ML A 210917 001 Nov 23, 2018 Oct DISC AP EQ 10MG BASE/ML A 210917 001 Nov 23, 2018 Feb CPOT RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -87

LEUPROLIDE ACETATE FOR SUSPENSION;INTRAMUSCULAR LUTRATE DEPOT KIT + @ GP-PHARM SA 22.5MG/VIAL N 205054 001 Aug 28, 2018 Jun DISC

LEVALBUTEROL HYDROCHLORIDE SOLUTION;INHALATION LEVALBUTEROL HYDROCHLORIDE @ MYLAN SPECIALITY LP EQ 0.0103% BASE A 077800 001 Mar 15, 2013 Oct DISC @ EQ 0.021% BASE A 077800 002 Mar 15, 2013 Oct DISC @ EQ 0.042% BASE A 077800 003 Mar 15, 2013 Oct DISC

>A> LEVAMLODIPINE MALEATE >A> TABLET;ORAL >A> CONJUPRI >A> + CSPC OUYI EQ 1.25MG BASE N 212895 001 Dec 19, 2019 Dec NEWA >A> + EQ 2.5MG BASE N 212895 002 Dec 19, 2019 Dec NEWA >A> +! EQ 5MG BASE N 212895 003 Dec 19, 2019 Dec NEWA

LEVETIRACETAM INJECTABLE;INTRAVENOUS KEPPRA AP +! UCB INC 500MG/5ML (100MG/ML) N 021872 001 Jul 31, 2006 Jun CDFR LEVETIRACETAM @ AKORN 500MG/5ML (100MG/ML) A 209934 001 May 04, 2018 Aug DISC AP 500MG/5ML (100MG/ML) A 209934 001 May 04, 2018 Jun CDFR AP AUROBINDO PHARMA LTD 500MG/5ML (100MG/ML) A 204312 001 Feb 01, 2016 Jun CDFR AP FRESENIUS KABI USA 500MG/5ML (100MG/ML) A 090813 001 May 26, 2010 Jun CDFR AP 500MG/5ML (100MG/ML) A 090876 001 Aug 13, 2015 Jun CDFR AP HAINAN POLY PHARM 500MG/5ML (100MG/ML) A 209781 001 Mar 20, 2018 Jun CDFR AP HIKMA FARMACEUTICA 500MG/5ML (100MG/ML) A 090981 001 Oct 13, 2011 Jun CDFR AP HOSPIRA INC 500MG/5ML (100MG/ML) A 202869 001 Apr 06, 2012 Jun CDFR AP JUBILANT GENERICS 500MG/5ML (100MG/ML) A 206838 001 Jun 02, 2016 Jun CDFR AP MICRO LABS 500MG/5ML (100MG/ML) A 211954 001 Aug 09, 2019 Jul NEWA AP MYLAN LABS LTD 500MG/5ML (100MG/ML) A 203308 001 Sep 16, 2016 Jun CDFR AP SAGENT PHARMS 500MG/5ML (100MG/ML) A 091627 001 Jun 26, 2013 Jun CDFR AP SUN PHARM INDS LTD 500MG/5ML (100MG/ML) A 090754 001 Jun 16, 2010 Jun CDFR AP X GEN PHARMS 500MG/5ML (100MG/ML) A 091485 001 Aug 05, 2011 Jun CDFR LEVETIRACETAM IN SODIUM CHLORIDE AP AUROBINDO PHARMA LTD 500MG/100ML (5MG/ML) A 207160 001 Jan 04, 2017 Jun CDFR AP 1000MG/100ML (10MG/ML) A 207160 002 Jan 04, 2017 Jun CDFR AP 1500MG/100ML (15MG/ML) A 207160 003 Jan 04, 2017 Jun CDFR AP GLAND PHARMA LTD 500MG/100ML (5MG/ML) A 206880 001 Oct 25, 2017 Jun CDFR AP 1000MG/100ML (10MG/ML) A 206880 002 Oct 25, 2017 Jun CDFR AP 1500MG/100ML (15MG/ML) A 206880 003 Oct 25, 2017 Jun CDFR AP +! HQ SPECIALITY PHARMA 500MG/100ML (5MG/ML) N 202543 001 Nov 09, 2011 Jun CDFR AP +! 1000MG/100ML (10MG/ML) N 202543 002 Nov 09, 2011 Jun CDFR AP +! 1500MG/100ML (15MG/ML) N 202543 003 Nov 09, 2011 Jun CDFR SOLUTION;ORAL LEVETIRACETAM AA ANDA REPOSITORY 100MG/ML A 079107 001 Jan 15, 2009 Aug CAHN TABLET;ORAL LEVETIRACETAM AB LOTUS PHARM CO LTD 250MG A 090906 002 Oct 31, 2016 Oct CTNA AB 500MG A 090906 001 Nov 05, 2010 Oct CTNA AB 750MG A 090906 003 Oct 31, 2016 Oct CTNA AB 1GM A 090906 004 Oct 31, 2016 Oct CTNA TABLET, EXTENDED RELEASE;ORAL LEVETIRACETAM AB ANDA REPOSITORY 500MG A 204511 001 Feb 23, 2016 Sep CAHN AB 750MG A 204511 002 Feb 23, 2016 Sep CAHN AB HISUN PHARM HANGZHOU 500MG A 207175 001 Sep 28, 2017 Sep CAHN AB 750MG A 207175 002 Sep 28, 2017 Sep CAHN @ SUN PHARM INDUSTRIES 500MG A 091285 001 Sep 12, 2011 Oct DISC @ 750MG A 091285 002 Sep 12, 2011 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -88

LEVOBUNOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC LEVOBUNOLOL HYDROCHLORIDE @ SANDOZ INC 0.5% A 074850 001 Oct 28, 1996 May DISC

LEVOCARNITINE SOLUTION;ORAL LEVOCARNITINE AA NOVITIUM PHARMA 1GM/10ML A 211676 001 Aug 14, 2019 Jul NEWA LEVOCARNITINE SF AA NOVITIUM PHARMA 1GM/10ML A 211676 002 Aug 14, 2019 Jul NEWA

LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION;ORAL LEVOCETIRIZINE HYDROCHLORIDE AA HETERO LABS LTD III 2.5MG/5ML A 210914 001 Apr 01, 2019 Mar NEWA

LEVOFLOXACIN INJECTABLE;INJECTION LEVOFLOXACIN AP AKORN EQ 500MG/20ML (EQ 25MG/ML) A 091644 001 Jun 20, 2011 Oct CMFD AP EQ 750MG/30ML (EQ 25MG/ML) A 091644 002 Jun 20, 2011 Oct CMFD SOLUTION/DROPS;OPHTHALMIC LEVOFLOXACIN MICRO LABS LTD INDIA 1.5% A 205600 001 Feb 27, 2019 Feb NEWA TABLET;ORAL LEVOFLOXACIN AB CELLTRION 250MG A 090367 001 Jun 20, 2011 Aug CAHN AB 500MG A 090367 002 Jun 20, 2011 Aug CAHN AB 750MG A 090367 003 Jun 20, 2011 Aug CAHN AB HEC PHARM 250MG A 204968 001 Feb 05, 2019 Jan NEWA AB 500MG A 204968 002 Feb 05, 2019 Jan NEWA AB 750MG A 204968 003 Feb 05, 2019 Jan NEWA

LEVOLEUCOVORIN POWDER;INTRAVENOUS KHAPZORY +! ACROTECH 175MG/VIAL N 211226 001 Oct 19, 2018 Mar CAHN +! 300MG/VIAL N 211226 002 Oct 19, 2018 Mar CAHN

LEVOLEUCOVORIN CALCIUM POWDER;INTRAVENOUS FUSILEV AP +! ACROTECH EQ 50MG BASE/VIAL N 020140 001 Mar 07, 2008 Mar CAHN LEVOLEUCOVORIN CALCIUM + @ ACTAVIS LLC EQ 175MG BASE/VIAL N 208723 001 Sep 29, 2016 Jun DISC AP MEITHEAL EQ 50MG BASE/VIAL A 211003 001 Aug 22, 2019 Nov CAHN AP NANJING KING-FRIEND EQ 50MG BASE/VIAL A 211003 001 Aug 22, 2019 Aug NEWA SOLUTION;INTRAVENOUS FUSILEV + @ ACROTECH EQ 175MG BASE/17.5ML (EQ 10MG N 020140 002 Apr 29, 2011 Mar CAHN BASE/ML) + @ EQ 250MG BASE/25ML (EQ 10MG N 020140 003 Apr 29, 2011 Mar CAHN BASE/ML) LEVOLEUCOVORIN CALCIUM AP MEITHEAL EQ 175MG BASE/17.5ML (EQ 10MG A 211002 001 Aug 16, 2019 Nov CAHN BASE/ML) AP EQ 250MG BASE/25ML (EQ 10MG A 211002 002 Aug 16, 2019 Nov CAHN BASE/ML) @ MYLAN TEORANTA EQ 175MG BASE/17.5ML (EQ 10MG A 203576 001 Oct 20, 2015 Aug DISC BASE/ML) @ EQ 250MG BASE/25ML (EQ 10MG A 203576 002 Oct 20, 2015 Aug DISC BASE/ML) AP NANJING KING-FRIEND EQ 175MG BASE/17.5ML (EQ 10MG A 211002 001 Aug 16, 2019 Aug NEWA BASE/ML) AP EQ 250MG BASE/25ML (EQ 10MG A 211002 002 Aug 16, 2019 Aug NEWA BASE/ML) RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -89

LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL FETZIMA + ALLERGAN EQ 20MG BASE N 204168 001 Jul 25, 2013 Jun CTEC + EQ 40MG BASE N 204168 002 Jul 25, 2013 Jun CTEC + EQ 80MG BASE N 204168 003 Jul 25, 2013 Jun CTEC

+! EQ 120MG BASE N 204168 004 Jul 25, 2013 Jun CTEC AB + ALLERGAN SALES LLC EQ 20MG BASE N 204168 001 Jul 25, 2013 Jan CFTG AB + EQ 40MG BASE N 204168 002 Jul 25, 2013 Jan CFTG AB + EQ 80MG BASE N 204168 003 Jul 25, 2013 Jan CFTG AB +! EQ 120MG BASE N 204168 004 Jul 25, 2013 Jan CFTG LEVOMILNACIPRAN HYDROCHLORIDE @ AMNEAL PHARMS CO EQ 20MG BASE A 210790 001 Feb 04, 2019 Jun DISC AB EQ 20MG BASE A 210790 001 Feb 04, 2019 Jan NFTG @ EQ 40MG BASE A 210790 002 Feb 04, 2019 Jun DISC AB EQ 40MG BASE A 210790 002 Feb 04, 2019 Jan NFTG

@ EQ 80MG BASE A 210790 003 Feb 04, 2019 Jun DISC AB EQ 80MG BASE A 210790 003 Feb 04, 2019 Jan NFTG @ EQ 120MG BASE A 210790 004 Feb 04, 2019 Jun DISC AB EQ 120MG BASE A 210790 004 Feb 04, 2019 Jan NFTG

LEVONORGESTREL

TABLET;ORAL LEVONORGESTREL AB ! L PERRIGO CO 0.75MG A 090740 001 Dec 30, 2010 May CAHN >D> AB LOTUS PHARM CO LTD 0.75MG A 202684 001 Sep 02, 2016 Dec DISC >A> @ 0.75MG A 202684 001 Sep 02, 2016 Dec DISC

LEVORPHANOL TARTRATE TABLET;ORAL LEVORPHANOL TARTRATE @ SENTYNL THERAPS INC 1MG A 074278 002 Jun 18, 2018 Feb DISC ! 3MG A 074278 003 Jun 18, 2018 May CMFD @ 3MG A 074278 003 Jun 18, 2018 Feb DISC >A> AB SPECGX LLC 2MG A 212024 001 Dec 13, 2019 Dec NEWA

LEVOTHYROXINE SODIUM POWDER;INTRAVENOUS LEVOTHYROXINE SODIUM @ PAR STERILE PRODUCTS 200MCG/VIAL A 205366 001 Dec 07, 2015 Apr DISC SOLUTION;INTRAVENOUS LEVOTHYROXINE SODIUM +! FRESENIUS KABI USA 100MCG/5ML (20MCG/ML) N 210632 001 Apr 11, 2019 Apr NEWA +! 200MCG/5ML (40MCG/ML) N 210632 002 Apr 11, 2019 Apr NEWA +! 500MCG/5ML (100MCG/ML) N 210632 003 Apr 11, 2019 Apr NEWA SOLUTION;ORAL TIROSINT-SOL + INSTITUT BIOCHIMIQUE 13MCG/ML N 206977 001 Dec 15, 2016 Jan CMFD + 25MCG/ML N 206977 002 Dec 15, 2016 Jan CMFD + 50MCG/ML N 206977 003 Dec 15, 2016 Jan CMFD + 75MCG/ML N 206977 004 Dec 15, 2016 Jan CMFD + 88MCG/ML N 206977 005 Dec 15, 2016 Jan CMFD + 100MCG/ML N 206977 006 Dec 15, 2016 Jan CMFD + 112MCG/ML N 206977 007 Dec 15, 2016 Jan CMFD + 125MCG/ML N 206977 008 Dec 15, 2016 Jan CMFD + 137MCG/ML N 206977 009 Dec 15, 2016 Jan CMFD + 150MCG/ML N 206977 010 Dec 15, 2016 Jan CMFD + 175MCG/ML N 206977 011 Dec 15, 2016 Jan CMFD +! 200MCG/ML N 206977 012 Dec 15, 2016 Jan CMFD LEVOTHYROXINE SODIUM ** **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL LEVO-T

>D> AB1, + CEDIPROF INC 0.025MG N 021342 001 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.025MG N 021342 001 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.05MG N 021342 002 Mar 01, 2002 Dec CRLD

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -90

TABLET;ORAL LEVO-T AB2, AB3 >A> AB1, 0.05MG N 021342 002 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.075MG N 021342 003 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.075MG N 021342 003 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.088MG N 021342 004 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.088MG N 021342 004 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.1MG N 021342 005 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.1MG N 021342 005 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.112MG N 021342 006 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.112MG N 021342 006 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.125MG N 021342 007 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.125MG N 021342 007 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.137MG N 021342 012 Dec 08, 2003 Dec CRLD AB2, AB3 >A> AB1, 0.137MG N 021342 012 Dec 08, 2003 Dec CRLD AB2, AB3 >D> AB1, + 0.15MG N 021342 008 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.15MG N 021342 008 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.175MG N 021342 009 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.175MG N 021342 009 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, + 0.2MG N 021342 010 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.2MG N 021342 010 Mar 01, 2002 Dec CRLD AB2, AB3 >D> AB1, +! 0.3MG N 021342 011 Mar 01, 2002 Dec CRLD AB2, AB3 >A> AB1, 0.3MG N 021342 011 Mar 01, 2002 Dec CHRS AB2, AB3 >A> AB1, ! 0.3MG N 021342 011 Mar 01, 2002 Dec CRLD AB2, AB3 LEVOTHYROXINE SODIUM @ AMNEAL PHARMS LLC 0.025MG A 210831 001 Feb 19, 2019 Jun DISC AB2 0.025MG A 210831 001 Feb 19, 2019 May CTEC AB1, 0.025MG A 210831 001 Feb 19, 2019 Feb NEWA AB2 @ 0.05MG A 210831 002 Feb 19, 2019 Jun DISC AB2 0.05MG A 210831 002 Feb 19, 2019 May CTEC AB1, 0.05MG A 210831 002 Feb 19, 2019 Feb NEWA AB2 @ 0.075MG A 210831 003 Feb 19, 2019 Jun DISC AB2 0.075MG A 210831 003 Feb 19, 2019 May CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -91

TABLET;ORAL LEVOTHYROXINE SODIUM AB1, 0.075MG A 210831 003 Feb 19, 2019 Feb NEWA AB2 @ 0.088MG A 210831 004 Feb 19, 2019 Jun DISC AB2 0.088MG A 210831 004 Feb 19, 2019 May CTEC AB1, 0.088MG A 210831 004 Feb 19, 2019 Feb NEWA AB2 @ 0.1MG A 210831 005 Feb 19, 2019 Jun DISC AB2 0.1MG A 210831 005 Feb 19, 2019 May CTEC AB1, 0.1MG A 210831 005 Feb 19, 2019 Feb NEWA AB2 @ 0.112MG A 210831 006 Feb 19, 2019 Jun DISC AB2 0.112MG A 210831 006 Feb 19, 2019 May CTEC AB1, 0.112MG A 210831 006 Feb 19, 2019 Feb NEWA AB2 @ 0.125MG A 210831 007 Feb 19, 2019 Jun DISC AB2 0.125MG A 210831 007 Feb 19, 2019 May CTEC AB1, 0.125MG A 210831 007 Feb 19, 2019 Feb NEWA AB2 @ 0.137MG A 210831 008 Feb 19, 2019 Jun DISC AB2 0.137MG A 210831 008 Feb 19, 2019 May CTEC AB1, 0.137MG A 210831 008 Feb 19, 2019 Feb NEWA AB2 @ 0.15MG A 210831 009 Feb 19, 2019 Jun DISC AB2 0.15MG A 210831 009 Feb 19, 2019 May CTEC AB1, 0.15MG A 210831 009 Feb 19, 2019 Feb NEWA AB2 @ 0.175MG A 210831 010 Feb 19, 2019 Jun DISC AB2 0.175MG A 210831 010 Feb 19, 2019 May CTEC AB1, 0.175MG A 210831 010 Feb 19, 2019 Feb NEWA AB2 @ 0.2MG A 210831 011 Feb 19, 2019 Jun DISC AB2 0.2MG A 210831 011 Feb 19, 2019 May CTEC AB1, 0.2MG A 210831 011 Feb 19, 2019 Feb NEWA AB2 @ 0.3MG A 210831 012 Feb 19, 2019 Jun DISC AB2 0.3MG A 210831 012 Feb 19, 2019 May CTEC AB1, 0.3MG A 210831 012 Feb 19, 2019 Feb NEWA AB2 AB1, LUPIN ATLANTIS 0.025MG A 209713 001 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.025MG A 209713 001 Jan 18, 2019 Sep CTEC AB2 AB2 0.025MG A 209713 001 Jan 18, 2019 Jan NEWA AB1, 0.05MG A 209713 002 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.05MG A 209713 002 Jan 18, 2019 Sep CTEC AB2 AB2 0.05MG A 209713 002 Jan 18, 2019 Jan NEWA AB1, 0.075MG A 209713 003 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.075MG A 209713 003 Jan 18, 2019 Sep CTEC AB2 AB2 0.075MG A 209713 003 Jan 18, 2019 Jan NEWA AB1, 0.088MG A 209713 004 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.088MG A 209713 004 Jan 18, 2019 Sep CTEC AB2 AB2 0.088MG A 209713 004 Jan 18, 2019 Jan NEWA AB1, 0.1MG A 209713 005 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.1MG A 209713 005 Jan 18, 2019 Sep CTEC AB2 AB2 0.1MG A 209713 005 Jan 18, 2019 Jan NEWA AB1, 0.112MG A 209713 006 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.112MG A 209713 006 Jan 18, 2019 Sep CTEC AB2 AB2 0.112MG A 209713 006 Jan 18, 2019 Jan NEWA AB1, 0.125MG A 209713 007 Jan 18, 2019 Oct CTEC AB2, AB3 RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -92

TABLET;ORAL LEVOTHYROXINE SODIUM AB1, 0.125MG A 209713 007 Jan 18, 2019 Sep CTEC AB2 AB2 0.125MG A 209713 007 Jan 18, 2019 Jan NEWA AB1, 0.137MG A 209713 008 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.137MG A 209713 008 Jan 18, 2019 Sep CTEC AB2 AB2 0.137MG A 209713 008 Jan 18, 2019 Jan NEWA AB1, 0.15MG A 209713 009 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.15MG A 209713 009 Jan 18, 2019 Sep CTEC AB2 AB2 0.15MG A 209713 009 Jan 18, 2019 Jan NEWA AB1, 0.175MG A 209713 010 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.175MG A 209713 010 Jan 18, 2019 Sep CTEC AB2 AB2 0.175MG A 209713 010 Jan 18, 2019 Jan NEWA AB1, 0.2MG A 209713 011 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.2MG A 209713 011 Jan 18, 2019 Sep CTEC AB2 AB2 0.2MG A 209713 011 Jan 18, 2019 Jan NEWA AB1, 0.3MG A 209713 012 Jan 18, 2019 Oct CTEC AB2, AB3 AB1, 0.3MG A 209713 012 Jan 18, 2019 Sep CTEC AB2 AB2 0.3MG A 209713 012 Jan 18, 2019 Jan NEWA THYRO-TABS AB2, + ALVOGEN 0.025MG N 021116 001 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.05MG N 021116 002 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.075MG N 021116 003 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.088MG N 021116 010 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.1MG N 021116 004 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.112MG N 021116 011 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.125MG N 021116 005 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.137MG N 021116 012 Dec 07, 2004 Mar CAHN AB4 AB2, + 0.15MG N 021116 006 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.175MG N 021116 007 Oct 24, 2002 Mar CAHN AB4 AB2, + 0.2MG N 021116 008 Oct 24, 2002 Mar CAHN AB4 AB2, +! 0.3MG N 021116 009 Oct 24, 2002 Mar CAHN AB4 AB2, + LLOYD 0.025MG N 021116 001 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.05MG N 021116 002 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.075MG N 021116 003 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.088MG N 021116 010 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.1MG N 021116 004 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.112MG N 021116 011 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.125MG N 021116 005 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.137MG N 021116 012 Dec 07, 2004 Feb CMFD AB4 AB2, + 0.15MG N 021116 006 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.175MG N 021116 007 Oct 24, 2002 Feb CMFD AB4 AB2, + 0.2MG N 021116 008 Oct 24, 2002 Feb CMFD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -93

TABLET;ORAL THYRO-TABS AB4 AB2, +! 0.3MG N 021116 009 Oct 24, 2002 Feb CMFD AB4

LIDOCAINE OINTMENT;TOPICAL LIDOCAINE AT NOVAST LABS 5% A 208604 001 Sep 20, 2017 Sep CAHN AT SUNGEN PHARMA 5.0% A 212486 001 Oct 17, 2019 Oct NEWA

LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION LIDOCAINE HYDROCHLORIDE AP FRESENIUS KABI USA 1% A 080404 002 Jun CTNA AP 2% A 080404 003 Jun CTNA AP ! HOSPIRA 1% A 083158 001 Sep CHRS AP ! 2% A 083158 002 Sep CHRS @ 20% A 083158 003 Sep DISC @ LUITPOLD 1% A 080850 001 Mar DISC @ 1% A 091564 001 Aug 14, 2015 Feb DISC XYLOCAINE PRESERVATIVE FREE + @ FRESENIUS KABI USA 1% N 016801 005 Jan 19, 1988 Sep DISC + @ 2% N 016801 001 Sep DISC + @ 4% N 016801 002 Sep DISC + @ 20% N 016801 004 Sep DISC JELLY;TOPICAL ANESTACON @ BIONPHARMA INC 2% A 080429 001 Apr CAHN SOLUTION;ORAL XYLOCAINE VISCOUS + @ FRESENIUS KABI USA 2% N 009470 001 Aug CRLD SOLUTION;TOPICAL LIDOCAINE HYDROCHLORIDE AT LANNETT CO INC 4% A 040710 001 Feb 27, 2007 Sep CMFD

LIDOCAINE; PRILOCAINE CREAM;TOPICAL EMLA AB +! TEVA BRANDED PHARM 2.5%;2.5% N 019941 001 Dec 30, 1992 Apr CAHN

LIFITEGRAST SOLUTION/DROPS;OPHTHALMIC XIIDRA +! NOVARTIS 5% N 208073 001 Jul 11, 2016 Sep CAHN

LINEZOLID TABLET;ORAL LINEZOLID AB CELLTRION 600MG A 210702 001 Apr 25, 2019 Apr NEWA @ MYLAN 600MG A 078845 001 Dec 21, 2015 Jun DISC

LIOTHYRONINE SODIUM TABLET;ORAL CYTOMEL AB + KING PHARMS EQ 0.05MG BASE N 010379 003 Jun CHRS LIOTHYRONINE SODIUM @ MYLAN EQ 0.005MG BASE A 090326 001 Jul 14, 2009 Mar DISC @ EQ 0.025MG BASE A 090326 002 Jul 14, 2009 Mar DISC @ EQ 0.05MG BASE A 090326 003 Jul 14, 2009 Mar DISC AB ! SIGMAPHARM LABS LLC EQ 0.05MG BASE A 200295 003 Nov 29, 2012 Jun CHRS @ SUN PHARM EQ 0.005MG BASE A 091382 001 Apr 20, 2016 Jun DISC @ EQ 0.025MG BASE A 091382 002 Apr 20, 2016 Jun DISC @ EQ 0.05MG BASE A 091382 003 Apr 20, 2016 Jun DISC @ TEVA PHARMS USA EQ 0.005MG BASE A 211510 001 Oct 26, 2018 Apr DISC @ EQ 0.025MG BASE A 211510 002 Oct 26, 2018 Apr DISC @ EQ 0.05MG BASE A 211510 003 Oct 26, 2018 Apr DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -94

LISINOPRIL TABLET;ORAL LISINOPRIL @ HERITAGE PHARMA 2.5MG A 075752 001 Jul 01, 2002 Aug DISC AB 2.5MG A 075752 001 Jul 01, 2002 Feb CAHN @ 5MG A 075752 002 Jul 01, 2002 Aug DISC AB 5MG A 075752 002 Jul 01, 2002 Feb CAHN @ 10MG A 075752 003 Jul 01, 2002 Aug DISC AB 10MG A 075752 003 Jul 01, 2002 Feb CAHN @ 20MG A 075752 004 Jul 01, 2002 Aug DISC AB 20MG A 075752 004 Jul 01, 2002 Feb CAHN @ 30MG A 075752 005 Jul 01, 2002 Aug DISC AB 30MG A 075752 005 Jul 01, 2002 Feb CAHN @ 40MG A 075752 006 Jul 01, 2002 Aug DISC AB 40MG A 075752 006 Jul 01, 2002 Feb CAHN >D> AB HIKMA INTL PHARMS 2.5MG A 076063 001 Jul 01, 2002 Dec DISC >A> @ 2.5MG A 076063 001 Jul 01, 2002 Dec DISC >D> AB 5MG A 076063 002 Jul 01, 2002 Dec DISC >A> @ 5MG A 076063 002 Jul 01, 2002 Dec DISC >D> AB 10MG A 076063 003 Jul 01, 2002 Dec DISC >A> @ 10MG A 076063 003 Jul 01, 2002 Dec DISC >D> AB 20MG A 076063 004 Jul 01, 2002 Dec DISC >A> @ 20MG A 076063 004 Jul 01, 2002 Dec DISC >D> AB 30MG A 076063 006 Jun 27, 2003 Dec DISC >A> @ 30MG A 076063 006 Jun 27, 2003 Dec DISC >D> AB 40MG A 076063 005 Jul 01, 2002 Dec DISC >A> @ 40MG A 076063 005 Jul 01, 2002 Dec DISC >A> @ INVATECH 2.5MG A 075903 001 Jul 01, 2002 Dec CAHN >A> @ 2.5MG A 075999 001 Jul 01, 2002 Dec CAHN >A> @ 5MG A 075903 002 Jul 01, 2002 Dec CAHN >A> @ 5MG A 075999 002 Jul 01, 2002 Dec CAHN >A> @ 10MG A 075903 003 Jul 01, 2002 Dec CAHN >A> @ 10MG A 075999 003 Jul 01, 2002 Dec CAHN >A> @ 20MG A 075903 004 Jul 01, 2002 Dec CAHN >A> @ 20MG A 075999 004 Jul 01, 2002 Dec CAHN >A> @ 30MG A 075903 005 Jul 01, 2002 Dec CAHN >A> @ 30MG A 075999 005 Jul 01, 2002 Dec CAHN >A> @ 40MG A 075903 006 Jul 01, 2002 Dec CAHN >A> @ 40MG A 075999 006 Jul 01, 2002 Dec CAHN MY LAN@ MYLAN@ 2.5MG A 076071 001 Jul 01, 2002 Aug DISC @ 5MG A 076071 002 Jul 01, 2002 Aug DISC @ 10MG A 076071 003 Jul 01, 2002 Aug DISC @ 20MG A 076071 004 Jul 01, 2002 Aug DISC @ 30MG A 076071 005 Jul 01, 2002 Aug DISC @ 40MG A 076071 006 Jul 01, 2002 Aug DISC >D> SANDOZ@ 2.5MG A 075903 001 Jul 01, 2002 Dec CAHN >D> @ 2.5MG A 075999 001 Jul 01, 2002 Dec CAHN >D> @ 5MG A 075903 002 Jul 01, 2002 Dec CAHN >D> @ 5MG A 075999 002 Jul 01, 2002 Dec CAHN >D> @ 10MG A 075903 003 Jul 01, 2002 Dec CAHN >D> @ 10MG A 075999 003 Jul 01, 2002 Dec CAHN >D> @ 20MG A 075903 004 Jul 01, 2002 Dec CAHN >D> @ 20MG A 075999 004 Jul 01, 2002 Dec CAHN >D> @ 30MG A 075903 005 Jul 01, 2002 Dec CAHN >D> @ 30MG A 075999 005 Jul 01, 2002 Dec CAHN >D> @ 40MG A 075903 006 Jul 01, 2002 Dec CAHN >D> @ 40MG A 075999 006 Jul 01, 2002 Dec CAHN PRINIVIL ME RCK@ MERCK@ 10MG N 019558 002 Dec 29, 1987 Oct DISC @ 20MG N 019558 003 Dec 29, 1987 Oct DISC

LITHIUM CARBONATE CAPSULE;ORAL LITHIUM CARBONATE @ MYLAN 600MG A 078763 001 Apr 15, 2008 Jun DISC TABLET, EXTENDED RELEASE;ORAL LITHIUM CARBONATE @ HERITAGE PHARMA 300MG A 076170 001 Jun 10, 2002 May CAHN @ 450MG A 076366 001 Aug 21, 2003 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -95

LORAZEPAM CONCENTRATE;ORAL LORAZEPAM AA LANNETT CO INC 2MG/ML A 079244 001 Apr 28, 2009 Jul CAHN AA SAPTALIS PHARMS 2MG/ML A 079244 001 Apr 28, 2009 Feb CAHN INJECTABLE;INJECTION ATIVAN AP +! HIKMA 2MG/ML N 018140 001 Mar CAHN AP +! 4MG/ML N 018140 002 Mar CAHN TABLET;ORAL ATIVAN AB + BAUSCH 0.5MG N 017794 001 Feb CAHN AB + 1MG N 017794 002 Feb CAHN AB +! 2MG N 017794 003 Feb CAHN LORAZEPAM >D> AB ANI PHARMS INC 0.5MG A 077396 001 Dec 13, 2006 Dec DISC >A> @ 0.5MG A 077396 001 Dec 13, 2006 Dec DISC >D> AB 1MG A 077396 002 Dec 13, 2006 Dec DISC >A> @ 1MG A 077396 002 Dec 13, 2006 Dec DISC >D> AB 2MG A 077396 003 Dec 13, 2006 Dec DISC >A> @ 2MG A 077396 003 Dec 13, 2006 Dec DISC

LOSARTAN POTASSIUM TABLET;ORAL LOSARTAN POTASSIUM @ HISUN PHARM HANGZHOU 25MG A 204795 001 Apr 04, 2019 Oct DISC AB 25MG A 204795 001 Apr 04, 2019 Mar NEWA @ 50MG A 204795 002 Apr 04, 2019 Oct DISC AB 50MG A 204795 002 Apr 04, 2019 Mar NEWA @ 100MG A 204795 003 Apr 04, 2019 Oct DISC AB 100MG A 204795 003 Apr 04, 2019 Mar NEWA AB MICRO LABS 25MG A 091541 001 Sep 24, 2012 Mar CAHN AB 50MG A 091541 002 Sep 24, 2012 Mar CAHN AB 100MG A 091541 003 Sep 24, 2012 Mar CAHN AB STRIDES PHARMA 25MG A 090382 001 Oct 06, 2010 Apr CAHN AB 50MG A 090382 002 Oct 06, 2010 Apr CAHN AB 100MG A 090382 003 Oct 06, 2010 Apr CAHN @ TEVA 25MG A 076958 001 Apr 06, 2010 Jul DISC @ 50MG A 076958 002 Apr 06, 2010 Jul DISC @ 100MG A 076958 003 Apr 06, 2010 Jul DISC

LOTEPREDNOL ETABONATE GEL;OPHTHALMIC LOTEMAX SM +! BAUSCH AND LOMB INC 0.38% N 208219 001 Feb 22, 2019 Feb NEWA SUSPENSION/DROPS;OPHTHALMIC LOTEMAX AB +! BAUSCH AND LOMB 0.5% N 020583 001 Mar 09, 1998 Apr CFTG LOTEPREDNOL ETABONATE AB HI TECH 0.5% A 207609 001 Apr 17, 2019 Apr NFTG

LOVASTATIN TABLET;ORAL LOVASTATIN AB BEXIMCO PHARMS USA 10MG A 075300 001 Dec 17, 2001 Feb CAHN AB 20MG A 075300 002 Dec 17, 2001 Feb CAHN AB 40MG A 075300 003 Dec 17, 2001 Feb CAHN @ MYLAN 10MG A 075451 001 Dec 17, 2001 Feb DISC @ 20MG A 075451 002 Dec 17, 2001 Feb DISC @ 40MG A 075451 003 Dec 17, 2001 Feb DISC @ SUN PHARM INDUSTRIES 10MG A 077520 001 Apr 14, 2006 Oct DISC @ 20MG A 077520 002 Apr 14, 2006 Oct DISC @ 40MG A 077520 003 Apr 14, 2006 Oct DISC

LOXAPINE POWDER;INHALATION ADASUVE +! ALEXZA PHARMS 10MG N 022549 001 Dec 21, 2012 Aug CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -96

LOXAPINE HYDROCHLORIDE CONCENTRATE;ORAL LOXITANE C @ TEVA BRANDED PHARM EQ 25MG BASE/ML N 017658 001 Feb CAHN

LOXAPINE SUCCINATE CAPSULE;ORAL LOXITANE + @ TEVA BRANDED PHARM EQ 5MG BASE N 017525 001 Feb CAHN + @ EQ 10MG BASE N 017525 002 Feb CAHN + @ EQ 25MG BASE N 017525 003 Feb CAHN + @ EQ 50MG BASE N 017525 004 Feb CAHN TABLET;ORAL LOXITANE + @ TEVA BRANDED PHARM EQ 10MG BASE N 017525 006 Feb CAHN + @ EQ 25MG BASE N 017525 007 Feb CAHN + @ EQ 50MG BASE N 017525 008 Feb CAHN + @ EQ 50MG BASE N 017525 008 Feb CAHN

>A> LUMATEPERONE TOSYLATE >A> CAPSULE;ORAL >A> CAPLYTA >A> +! INTRA-CELLULAR EQ 42MG BASE N 209500 001 Dec 20, 2019 Dec NEWA

LURASIDONE HYDROCHLORIDE TABLET;ORAL LURASIDONE HYDROCHLORIDE @ AMNEAL PHARMS CO 20MG A 208002 001 Jan 03, 2019 Jun DISC @ 40MG A 208002 002 Jan 03, 2019 Jun DISC @ 60MG A 208002 003 Jan 03, 2019 Jun DISC @ 80MG A 208002 004 Jan 03, 2019 Jun DISC @ 120MG A 208002 005 Jan 03, 2019 Jun DISC @ EMCURE PHARMS LTD 20MG A 208058 001 Sep 04, 2019 Sep DISC AB 20MG A 208058 001 Sep 04, 2019 Aug NEWA @ 40MG A 208058 002 Sep 04, 2019 Sep DISC AB 40MG A 208058 002 Sep 04, 2019 Aug NEWA @ 60MG A 208058 003 Sep 04, 2019 Sep DISC AB 60MG A 208058 003 Sep 04, 2019 Aug NEWA @ 80MG A 208058 004 Sep 04, 2019 Sep DISC AB 80MG A 208058 004 Sep 04, 2019 Aug NEWA @ INVAGEN PHARMS 20MG A 208028 001 Jan 03, 2019 Jul DISC @ 40MG A 208028 002 Jan 03, 2019 Jul DISC @ 60MG A 208028 003 Jan 03, 2019 Jul DISC @ 80MG A 208028 004 Jan 03, 2019 Jul DISC @ 120MG A 208028 005 Jan 03, 2019 Jul DISC @ LUPIN LTD 20MG A 208031 001 Jan 03, 2019 Jul DISC @ 40MG A 208031 002 Jan 03, 2019 Jul DISC @ 60MG A 208031 003 Jan 03, 2019 Jul DISC @ 80MG A 208031 004 Jan 03, 2019 Jul DISC @ 120MG A 208031 005 Jan 03, 2019 Jul DISC @ TEVA PHARMS USA 20MG A 208060 001 May 17, 2019 Nov DISC AB 20MG A 208060 001 May 17, 2019 May NEWA @ 40MG A 208060 002 May 17, 2019 Nov DISC AB 40MG A 208060 002 May 17, 2019 May NEWA @ 60MG A 208060 003 May 17, 2019 Nov DISC AB 60MG A 208060 003 May 17, 2019 May NEWA @ 80MG A 208060 004 May 17, 2019 Nov DISC AB 80MG A 208060 004 May 17, 2019 May NEWA @ 120MG A 208060 005 May 17, 2019 Nov DISC AB 120MG A 208060 005 May 17, 2019 May NEWA @ TORRENT 20MG A 208055 001 Jan 03, 2019 Feb DISC @ 40MG A 208055 002 Jan 03, 2019 Feb DISC @ 80MG A 208055 003 Jan 03, 2019 Feb DISC @ 120MG A 208055 004 Jan 03, 2019 Feb DISC @ ZYDUS PHARMS 20MG A 208052 001 Mar 19, 2019 Aug DISC AB 20MG A 208052 001 Mar 19, 2019 Mar NEWA @ 40MG A 208052 002 Mar 19, 2019 Aug DISC AB 40MG A 208052 002 Mar 19, 2019 Mar NEWA @ 60MG A 208052 003 Mar 19, 2019 Aug DISC AB 60MG A 208052 003 Mar 19, 2019 Mar NEWA @ 80MG A 208052 004 Mar 19, 2019 Aug DISC AB 80MG A 208052 004 Mar 19, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -97

TABLET;ORAL LURASIDONE HYDROCHLORIDE @ 120MG A 208052 005 Mar 19, 2019 Aug DISC AB 120MG A 208052 005 Mar 19, 2019 Mar NEWA

MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS MAGNESIUM SULFATE AP +! FRESENIUS KABI USA 10GM/20ML (500MG/ML) N 019316 003 Jan 29, 2016 Jan CTEC AP HOSPIRA INC 10GM/20ML (500MG/ML) A 202411 001 May 14, 2015 Jan CTEC

MALATHION LOTION;TOPICAL MALATHION ! SUVEN LIFE 0.5% A 091559 001 May 23, 2012 Aug CHRS 0.5% A 091559 001 May 23, 2012 Aug CTEC OVIDE + @ TARO PHARM INDS LTD 0.5% N 018613 001 Aug 02, 1982 Aug DISC

MANNITOL INJECTABLE;INJECTION MANNITOL 25% @ LUITPOLD 12.5GM/50ML A 087409 001 Jan 21, 1982 Mar DISC

MECLIZINE HYDROCHLORIDE TABLET;ORAL ANTIVERT AA + CASPER PHARMA LLC 12.5MG N 010721 006 Feb CMFD + @ 12.5MG N 010721 006 Jan CRLD AA + 25MG N 010721 004 Feb CMFD + @ 25MG N 010721 004 Jan CRLD AA + 50MG N 010721 001 Jan 20, 1982 Feb CMFD + @ 50MG N 010721 001 Jan 20, 1982 Jan CRLD MECLIZINE HYDROCHLORIDE AA ! AMNEAL PHARMS 12.5MG A 201451 001 Feb 23, 2011 Jan CHRS AA ! 25MG A 201451 002 Feb 23, 2011 Jan CHRS @ ANI PHARMS INC 12.5MG A 084657 002 Sep CMS1 @ 12.5MG A 088732 001 Dec 11, 1985 May CAHN AA AUREX 12.5MG A 087127 001 Oct CAHN AA 25MG A 087128 001 Oct CAHN AA INDICUS PHARMA 12.5MG A 205136 001 Feb 22, 2019 Feb NEWA AA 25MG A 205136 002 Feb 22, 2019 Feb NEWA 50MG A 205136 003 Feb 22, 2019 Feb NEWA >A> AA INVATECH 25MG A 084092 003 May 22, 1989 Dec CAHN >D> AA SANDOZ 25MG A 084092 003 May 22, 1989 Dec CAHN TABLET, CHEWABLE;ORAL ANTIVERT AA + CASPER PHARMA LLC 25MG N 010721 005 Feb CMFD + @ 25MG N 010721 005 Jan CRLD

MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION MEDROXYPROGESTERONE ACETATE @ CIPLA 150MG/ML A 210335 001 Jan 25, 2019 Jul DISC AB 150MG/ML A 210335 001 Jan 25, 2019 Jan NEWA AB SUN PHARM 150MG/ML A 210760 001 May 01, 2019 Apr NEWA AB 150MG/ML A 210761 001 Apr 24, 2019 Apr NEWA TABLET;ORAL MEDROXYPROGESTERONE ACETATE @ UPSHER SMITH LABS 10MG A 088484 001 Jul 26, 1984 Jul CAHN

MEFENAMIC ACID CAPSULE;ORAL MEFENAMIC ACID @ BRECKENRIDGE 250MG A 090359 001 Feb 05, 2013 Feb DISC

MELOXICAM CAPSULE;ORAL VIVLODEX + EGALET 5MG N 207233 001 Oct 22, 2015 Feb CAHN +! 10MG N 207233 002 Oct 22, 2015 Feb CAHN + ZYLA 5MG N 207233 001 Oct 22, 2015 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -98

CAPSULE;ORAL VIVLODEX +! 10MG N 207233 002 Oct 22, 2015 Jul CAHN SUSPENSION;ORAL MOBIC + @ AVONDALE PHARMS 7.5MG/5ML N 021530 001 Jun 01, 2004 Jun CAHN TABLET;ORAL MELOXICAM @ HERITAGE PHARMA 7.5MG A 077936 001 Jul 19, 2006 Sep DISC AB 7.5MG A 077936 001 Jul 19, 2006 Feb CAHN @ 15MG A 077936 002 Jul 19, 2006 Sep DISC AB 15MG A 077936 002 Jul 19, 2006 Feb CAHN

MELPHALAN HYDROCHLORIDE INJECTABLE;INJECTION ALKERAN AP + APOTEX EQ 50MG BASE/VIAL N 020207 001 Nov 18, 1992 Feb CMFD MELPHALAN HYDROCHLORIDE AP ALVOGEN INC EQ 50MG BASE/VIAL A 204817 001 May 17, 2019 May NEWA AP GLAND PHARMA LTD EQ 50MG BASE/VIAL A 209826 001 May 28, 2019 May NEWA AP NORATECH EQ 50MG BASE/VIAL A 211463 001 Sep 13, 2019 Sep NEWA @ US WORLDMEDS LLC EQ 50MG BASE/VIAL A 207032 001 May 03, 2019 Oct DISC AP EQ 50MG BASE/VIAL A 207032 001 May 03, 2019 Apr NEWA POWDER;INTRAVENOUS EVOMELA +! ACROTECH EQ 50MG BASE/VIAL N 207155 001 Mar 10, 2016 Mar CAHN

MEMANTINE HYDROCHLORIDE SOLUTION;ORAL MEMANTINE HYDROCHLORIDE AA ! LANNETT CO INC 2MG/ML A 204033 001 Oct 13, 2015 Nov CHRS @ TORRENT 2MG/ML A 205446 001 Dec 07, 2015 Nov DISC AA ! 2MG/ML A 205446 001 Dec 07, 2015 Jan CAHN TABLET;ORAL MEMANTINE HYDROCHLORIDE @ APOTEX INC 5MG A 090244 001 Jul 11, 2018 Jan DISC @ 10MG A 090244 002 Jul 11, 2018 Jan DISC AB CADILA 5MG A 090961 001 Jul 10, 2017 Feb CAHN AB 10MG A 090961 002 Jul 10, 2017 Feb CAHN AB CELLTRION 5MG A 090073 001 Sep 04, 2015 Aug CAHN AB 10MG A 090073 002 Sep 04, 2015 Aug CAHN @ MYLAN 5MG A 079225 001 Jan 30, 2015 Oct DISC @ 10MG A 079225 002 Jan 30, 2015 Oct DISC

MEPERIDINE HYDROCHLORIDE TABLET;ORAL DEMEROL + @ US PHARM HOLDINGS 50MG N 005010 001 Aug DISC + @ 100MG N 005010 004 Aug DISC MEPERIDINE HYDROCHLORIDE @ SPECGX LLC 50MG A 040352 001 Jun 13, 2000 Aug DISC @ 100MG A 040352 002 Jun 13, 2000 Aug DISC @ SUN PHARM INDS INC 50MG A 040446 001 Aug 08, 2002 Oct DISC @ 100MG A 040446 002 Aug 08, 2002 Oct DISC

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION MEPERGAN @ HIKMA 25MG/ML;25MG/ML N 011730 001 Jun CAHN

MEQUINOL; TRETINOIN SOLUTION;TOPICAL SOLAGE @ ALMIRALL 2%;0.01% N 020922 001 Dec 10, 1999 Feb CAHN

MEROPENEM INJECTABLE;INJECTION MEROPENEM @ HOSPIRA INC 500MG/VIAL A 090940 001 Jun 22, 2010 Sep DISC @ 1GM/VIAL A 090940 002 Jun 22, 2010 Sep DISC AP HQ SPCLT PHARMA 500MG/VIAL A 210773 001 Aug 16, 2019 Aug NEWA AP 1GM/VIAL A 210773 002 Aug 16, 2019 Aug NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -99

MESALAMINE CAPSULE, DELAYED RELEASE;ORAL DELZICOL AB +! APIL 400MG N 204412 001 Feb 01, 2013 Apr CFTG MESALAMINE AB TEVA PHARMS USA 400MG A 207873 001 May 09, 2019 Apr NFTG CAPSULE, EXTENDED RELEASE;ORAL APRISO AB +! VALEANT PHARMS INTL 375MG N 022301 001 Oct 31, 2008 Nov CFTG MESALAMINE AB MYLAN 375MG A 207271 001 Nov 20, 2019 Nov NFTG SUPPOSITORY;RECTAL MESALAMINE >A> AB AMNEAL PHARMS LLC 1GM A 210509 001 Jan 02, 2020 Dec NEWA AB AMRING PHARMS 1GM A 208362 001 Jun 21, 2019 Jun NEWA AB PHARM SOURCING 1GM A 207448 001 Apr 19, 2019 Apr NEWA AB SANDOZ INC 1GM A 202065 001 Jun 12, 2019 May NEWA TABLET, DELAYED RELEASE;ORAL MESALAMINE >D> @ SUN PHARM 1.2GM A 211858 001 Jan 25, 2019 Dec CMFD >A> AB 1.2GM A 211858 001 Jan 25, 2019 Dec CMFD @ 1.2GM A 211858 001 Jan 25, 2019 Aug DISC AB 1.2GM A 211858 001 Jan 25, 2019 Jan NEWA

MESTRANOL; NORETHINDRONE TABLET;ORAL-28 NORINYL 1+50 28-DAY + @ ACTAVIS LABS UT INC 0.05MG;1MG N 016659 001 Jul DISC

METAPROTERENOL SULFATE TABLET;ORAL METAPROTERENOL SULFATE @ HERITAGE PHARMA 10MG A 072519 001 Mar 30, 1990 May CAHN @ 20MG A 072520 001 Mar 30, 1990 May CAHN @ PAR PHARM 10MG A 072024 001 Jun 28, 1988 Jul DISC @ 20MG A 072025 001 Jun 28, 1988 Jul DISC

METAXALONE TABLET;ORAL METAXALONE AB APPCO 800MG A 208774 001 Sep 24, 2018 Feb CAHN

METFORMIN HYDROCHLORIDE FOR SUSPENSION, EXTENDED RELEASE;ORAL RIOMET ER +! SUN PHARM 500MG/5ML N 212595 001 Aug 29, 2019 Aug NEWA TABLET;ORAL GLUCOPHAGE + @ BRISTOL MYERS SQUIBB 500MG N 020357 001 Mar 03, 1995 Jun DISC + @ 850MG N 020357 002 Mar 03, 1995 Jun DISC + @ 1GM N 020357 005 Nov 05, 1998 Jun DISC + @ EMD SERONO INC 500MG N 020357 001 Mar 03, 1995 Jul CAHN + @ 625MG N 020357 003 Nov 05, 1998 Jul CAHN + @ 750MG N 020357 004 Nov 05, 1998 Jul CAHN + @ 850MG N 020357 002 Mar 03, 1995 Jul CAHN + @ 1GM N 020357 005 Nov 05, 1998 Jul CAHN METFORMIN HYDROCHLORIDE AB ! GRANULES INDIA 1GM A 090564 003 Apr 22, 2010 Jun CHRS AB HERITAGE PHARMA 500MG A 075978 001 Jan 25, 2002 Feb CAHN AB 850MG A 075978 002 Jan 25, 2002 Feb CAHN AB 1GM A 075978 003 Nov 05, 2002 Feb CAHN @ SUN PHARM INDUSTRIES 500MG A 076038 001 Feb 21, 2002 Oct DISC @ 850MG A 076038 002 Feb 21, 2002 Oct DISC @ 1GM A 076038 003 Feb 21, 2002 Oct DISC @ SUNSHINE LAKE 500MG A 208999 001 Oct 12, 2018 Apr DISC @ 850MG A 208999 002 Oct 12, 2018 Apr DISC @ 1GM A 208999 003 Oct 12, 2018 Apr DISC TABLET, EXTENDED RELEASE;ORAL GLUCOPHAGE XR + @ BRISTOL MYERS SQUIBB 500MG N 021202 001 Oct 13, 2000 Jun DISC + @ 750MG N 021202 004 Apr 11, 2003 Jun DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -100

TABLET, EXTENDED RELEASE;ORAL GLUCOPHAGE XR + @ EMD SERONO INC 500MG N 021202 001 Oct 13, 2000 Jul CAHN + @ 750MG N 021202 004 Apr 11, 2003 Jul CAHN METFORMIN HYDROCHLORIDE AB ! AMNEAL PHARMS NY 750MG A 078596 002 Jan 03, 2008 Jun CHRS AB1 CADILA 500MG A 077060 001 Apr 20, 2005 Feb CAHN AB 750MG A 077078 001 Apr 21, 2005 Feb CAHN AB3 GLENMARK PHARMS LTD 500MG A 212969 001 Nov 25, 2019 Nov NEWA AB3 1GM A 212969 002 Nov 25, 2019 Nov NEWA AB1 INVENTIA 500MG A 201991 001 Jan 18, 2012 Aug CAHN AB2 ! LUPIN LTD 1GM A 090692 002 Jun 29, 2011 Apr CHRS AB1 SUN PHARM INDS (IN) 500MG A 077336 001 Feb 09, 2006 Sep CHRS AB1 ! 500MG A 077336 001 Feb 09, 2006 Jun CHRS @ YICHANG HUMANWELL 500MG A 211052 001 Sep 24, 2018 Mar DISC @ 750MG A 211052 002 Sep 24, 2018 Mar DISC

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE @ MYLAN 500MG;EQ 15MG BASE A 090406 001 Feb 25, 2011 Jul DISC @ 850MG;EQ 15MG BASE A 090406 002 Feb 25, 2011 Jul DISC TABLET, EXTENDED RELEASE;ORAL ACTOPLUS MET XR + @ TAKEDA PHARMS USA 1GM;EQ 15MG BASE N 022024 001 May 12, 2009 Mar DISC + @ 1GM;EQ 30MG BASE N 022024 002 May 12, 2009 Mar DISC

METHADONE HYDROCHLORIDE CONCENTRATE;ORAL METHADONE HYDROCHLORIDE AA PHARM ASSOC 10MG/ML A 207368 001 Aug 22, 2019 Aug NEWA SOLUTION;ORAL METHADONE HYDROCHLORIDE AA PHARM ASSOC 5MG/5ML A 207537 001 Oct 02, 2019 Sep NEWA AA 10MG/5ML A 207537 002 Oct 01, 2019 Sep NEWA

METHAZOLAMIDE TABLET;ORAL METHAZOLAMIDE >A> @ INVATECH 25MG A 040102 001 Aug 28, 1996 Dec CAHN >A> @ 50MG A 040102 002 Aug 28, 1996 Dec CAHN @ MICRO LABS 25MG A 207438 001 Oct 05, 2018 Mar DISC @ 50MG A 207438 002 Oct 05, 2018 Mar DISC >D> @ SANDOZ 25MG A 040102 001 Aug 28, 1996 Dec CAHN >D> @ 50MG A 040102 002 Aug 28, 1996 Dec CAHN

METHENAMINE HIPPURATE TABLET;ORAL METHENAMINE HIPPURATE AB MICRO LABS 1GM A 212172 001 Aug 01, 2019 Jul NEWA

METHIMAZOLE TABLET;ORAL METHIMAZOLE @ SUN PHARM INDS INC 5MG A 040870 001 Sep 25, 2007 Oct DISC @ 10MG A 040870 002 Sep 25, 2007 Oct DISC

METHOCARBAMOL SOLUTION;IM-IV METHOCARBAMOL AP SLATE 1GM/10ML (100MG/ML) A 208116 001 Jan 19, 2017 Feb CAHN ROBAXIN AP +! HIKMA 1GM/10ML (100MG/ML) N 011790 001 Feb CAHN TABLET;ORAL METHOCARBAMOL >D> AA ANI PHARMS INC 500MG A 084277 001 Dec DISC >A> @ 500MG A 084277 001 Dec DISC AA 500MG A 084277 001 Sep CAHN >D> AA 750MG A 084276 002 Dec DISC >A> @ 750MG A 084276 002 Dec DISC AA ! GRANULES INDIA LTD 500MG A 209312 001 May 07, 2018 Jul CHRS RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -101

TABLET;ORAL ROBAXIN + @ AUXILIUM PHARMS LLC 500MG N 011011 004 Jul DISC

METHOTREXATE SOLUTION;SUBCUTANEOUS RASUVO +! MEDEXUS 7.5MG/0.15ML (7.5MG/0.15ML) N 205776 001 Jul 10, 2014 Apr CAHN +! 10MG/0.20ML (10MG/0.20ML) N 205776 002 Jul 10, 2014 Apr CAHN +! 12.5MG/0.25ML (12.5MG/0.25ML) N 205776 003 Jul 10, 2014 Apr CAHN +! 15MG/0.30ML (15MG/0.30ML) N 205776 004 Jul 10, 2014 Apr CAHN +! 17.5MG/0.35ML (17.5MG/0.35ML) N 205776 005 Jul 10, 2014 Apr CAHN +! 20MG/0.4ML (20MG/0.4ML) N 205776 006 Jul 10, 2014 Apr CAHN +! 22.5MG/0.45ML (22.5MG/0.45ML) N 205776 007 Jul 10, 2014 Apr CAHN +! 25MG/0.5ML (25MG/0.5ML) N 205776 008 Jul 10, 2014 Apr CAHN + @ 27.5MG/0.55ML (27.5MG/0.55ML) N 205776 009 Jul 10, 2014 Apr CAHN +! 30MG/0.6ML (30MG/0.6ML) N 205776 010 Jul 10, 2014 Apr CAHN REDITREX CUMBERLAND PHARMS 7.5MG/0.3ML (7.5MG/0.3ML) N 210737 001 Nov 27, 2019 Nov NEWA 10MG/0.4ML (10MG/0.4ML) N 210737 002 Nov 27, 2019 Nov NEWA 12.5MG/0.5ML (12.5MG/0.5ML) N 210737 003 Nov 27, 2019 Nov NEWA 15MG/0.6ML (15MG/0.6ML) N 210737 004 Nov 27, 2019 Nov NEWA 17.5MG/0.7ML (17.5MG/0.7ML) N 210737 005 Nov 27, 2019 Nov NEWA 20MG/0.8ML (20MG/0.8ML) N 210737 006 Nov 27, 2019 Nov NEWA 22.5MG/ML (22.5MG/ML) N 210737 007 Nov 27, 2019 Nov NEWA 25MG/1ML (25MG/1ML) N 210737 008 Nov 27, 2019 Nov NEWA

METHOXSALEN CAPSULE;ORAL OXSORALEN-ULTRA AB +! BAUSCH 10MG N 019600 001 Oct 30, 1986 Aug CAHN

METHSCOPOLAMINE BROMIDE TABLET;ORAL METHSCOPOLAMINE BROMIDE BAYSHORE PHARMS LLC 2.5MG A 200602 001 Sep 24, 2012 Oct CTEC ! 5MG A 200602 002 Sep 24, 2012 Oct CHRS 5MG A 200602 002 Sep 24, 2012 Oct CTEC @ BRECKENRIDGE PHARM 2.5MG A 040642 001 Dec 06, 2011 Jun DISC @ 5MG A 040642 002 Dec 06, 2011 Jun DISC @ VINTAGE PHARMS 2.5MG A 040624 001 Dec 28, 2006 Oct DISC @ 5MG A 040624 002 Dec 28, 2006 Oct DISC

>D> METHYCLOTHIAZIDE >D> TABLET;ORAL >D> METHYCLOTHIAZIDE >D> ! MYLAN PHARMS INC 5MG A 087672 001 Aug 17, 1982 Dec DISC >A> @ 5MG A 087672 001 Aug 17, 1982 Dec DISC

METHYLDOPA TABLET;ORAL METHYLDOPA AB HERITAGE PHARMA 250MG A 070098 001 Feb 20, 1986 Feb CAHN AB 500MG A 070343 001 Feb 20, 1986 Feb CAHN

METHYLDOPATE HYDROCHLORIDE INJECTABLE;INJECTION METHYLDOPATE HYDROCHLORIDE @ LUITPOLD 50MG/ML A 071279 001 Oct 02, 1987 Mar DISC

METHYLERGONOVINE MALEATE TABLET;ORAL METHYLERGONOVINE MALEATE AB TEVA PHARMS USA 0.2MG A 211455 001 Mar 20, 2019 Mar NEWA

METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL ADHANSIA XR + PURDUE PHARMA LP 25MG N 212038 001 Feb 27, 2019 Mar CRLD 25MG N 212038 001 Feb 27, 2019 Feb NEWA + 35MG N 212038 002 Feb 27, 2019 Feb NEWA + 45MG N 212038 003 Feb 27, 2019 Feb NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -102

CAPSULE, EXTENDED RELEASE;ORAL ADHANSIA XR + 55MG N 212038 004 Feb 27, 2019 Feb NEWA + 70MG N 212038 005 Feb 27, 2019 Feb NEWA + 85MG N 212038 006 Feb 27, 2019 Feb NEWA METHYLPHENIDATE HYDROCHLORIDE AB1 GRANULES PHARMS 10MG A 211796 001 May 23, 2019 May NEWA AB1 20MG A 211796 002 May 23, 2019 May NEWA AB1 30MG A 211796 003 May 23, 2019 May NEWA AB1 40MG A 211796 004 May 23, 2019 May NEWA AB1 60MG A 211796 005 May 23, 2019 May NEWA AB1 ! MAYNE PHARMA 60MG A 078458 004 Jun 23, 2016 May CTEC FOR SUSPENSION, EXTENDED RELEASE;ORAL METHYLPHENIDATE HYDROCHLORIDE @ ACTAVIS LABS FL INC 5MG/ML A 206049 001 May 17, 2018 Jan DISC QUILLIVANT XR +! NEXTWAVE 5MG/ML N 202100 001 Sep 27, 2012 Feb CAHN +! NEXTWAVE PHARMS 5MG/ML N 202100 001 Sep 27, 2012 Jan CTEC SOLUTION;ORAL METHYLPHENIDATE HYDROCHLORIDE AA NOVELGENIX THERAPS 5MG/5ML A 210139 001 Oct 03, 2018 Sep CAHN AA 10MG/5ML A 210139 002 Oct 03, 2018 Sep CAHN TABLET;ORAL METHYLPHENIDATE HYDROCHLORIDE AB ALKEM LABS LTD 5MG A 211779 001 Oct 04, 2019 Sep NEWA AB 10MG A 211779 002 Oct 04, 2019 Sep NEWA AB 20MG A 211779 003 Oct 04, 2019 Sep NEWA @ AUROLIFE PHARMA LLC 5MG A 209276 001 Oct 25, 2018 Apr DISC @ 10MG A 209276 002 Oct 25, 2018 Apr DISC @ 20MG A 209276 003 Oct 25, 2018 Apr DISC @ CEDIPROF INC 5MG A 208737 001 Feb 01, 2019 Aug DISC AB 5MG A 208737 001 Feb 01, 2019 Jan NEWA @ 10MG A 208737 002 Feb 01, 2019 Aug DISC AB 10MG A 208737 002 Feb 01, 2019 Jan NEWA @ 20MG A 208737 003 Feb 01, 2019 Aug DISC AB 20MG A 208737 003 Feb 01, 2019 Jan NEWA >D> AB CNTY LINE PHARMS 5MG A 206840 001 Sep 15, 2016 Dec DISC >A> @ 5MG A 206840 001 Sep 15, 2016 Dec DISC >D> AB 10MG A 206840 002 Sep 15, 2016 Dec DISC >A> @ 10MG A 206840 002 Sep 15, 2016 Dec DISC >D> AB 20MG A 206840 003 Sep 15, 2016 Dec DISC >A> @ 20MG A 206840 003 Sep 15, 2016 Dec DISC @ LANNETT CO INC 5MG A 086429 001 Jan DISC @ 10MG A 085799 001 Jan DISC @ 20MG A 086428 001 Jan DISC TABLET, EXTENDED RELEASE;ORAL METADATE ER @ LANNETT CO INC 20MG A 089601 001 Jun 01, 1988 Jan DISC METHYLPHENIDATE HYDROCHLORIDE AB ! ABHAI LLC 20MG A 207488 002 Jun 09, 2015 Jan NEWA AB ANDOR PHARMS 18MG A 211918 001 Apr 24, 2019 Apr NEWA AB 27MG A 211918 002 Apr 24, 2019 Apr NEWA AB 36MG A 211918 003 Apr 24, 2019 Apr NEWA AB 54MG A 211918 004 Apr 24, 2019 Apr NEWA AB ASCENT PHARMS INC 18MG A 211009 001 Sep 03, 2019 Aug NEWA AB 27MG A 211009 002 Sep 03, 2019 Aug NEWA AB 36MG A 211009 003 Sep 03, 2019 Aug NEWA AB 54MG A 211009 004 Sep 03, 2019 Aug NEWA @ HERITAGE PHARMA 20MG A 075450 001 Dec 21, 2001 May CAHN @ PAR PHARM 36MG A 204659 001 Jul 15, 2019 Nov DISC AB 36MG A 204659 001 Jul 15, 2019 Jul NEWA @ 54MG A 204659 002 Jul 15, 2019 Nov DISC AB 54MG A 204659 002 Jul 15, 2019 Jul NEWA

METHYLPREDNISOLONE TABLET;ORAL MEDROL AB + PHARMACIA AND UPJOHN 2MG N 011153 002 Mar CFTG METHYLPREDNISOLONE >A> @ INVATECH 4MG A 087341 001 Dec CAHN @ LUPIN LTD 2MG A 209097 001 Feb 22, 2019 Sep DISC AB 2MG A 209097 001 Feb 22, 2019 Mar NFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -103

TABLET;ORAL METHYLPREDNISOLONE AB 2MG A 209097 001 Feb 22, 2019 Feb NEWA @ 4MG A 209097 002 Feb 22, 2019 Sep DISC AB 4MG A 209097 002 Feb 22, 2019 Feb NEWA @ 8MG A 209097 003 Feb 22, 2019 Sep DISC AB 8MG A 209097 003 Feb 22, 2019 Feb NEWA @ 16MG A 209097 004 Feb 22, 2019 Sep DISC AB 16MG A 209097 004 Feb 22, 2019 Feb NEWA @ 32MG A 209097 005 Feb 22, 2019 Sep DISC AB 32MG A 209097 005 Feb 22, 2019 Feb NEWA @ NOVAST LABS 4MG A 210985 001 Jan 09, 2019 Oct DISC AB 4MG A 210985 001 Jan 09, 2019 Sep CAHN >D> @ SANDOZ 4MG A 087341 001 Dec CAHN AB SUNGEN PHARMA 4MG A 212262 001 Jun 27, 2019 Jun NEWA AB TIANJIN TIANYAO 4MG A 204072 001 May 14, 2018 Apr CMFD

METHYLTESTOSTERONE CAPSULE;ORAL VIRILON @ CHARTWELL 10MG A 087750 001 Nov 24, 1982 Jun CAHN

METIPRANOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC METIPRANOLOL @ SANDOZ INC 0.3% A 075720 001 Aug 06, 2001 May DISC OPTIPRANOLOL + @ BAUSCH AND LOMB 0.3% N 019907 001 Dec 29, 1989 Aug DISC +! 0.3% N 019907 001 Dec 29, 1989 May CTEC

METOLAZONE TABLET;ORAL METOLAZONE @ ANI PHARMS INC 5MG A 076833 001 Mar 01, 2004 Sep CAHN @ 10MG A 075543 003 Dec 24, 2003 Sep CAHN

METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL TOPROL-XL AB + TOPROL EQ 25MG TARTRATE N 019962 004 Feb 05, 2001 Mar CAHN AB +! EQ 50MG TARTRATE N 019962 001 Jan 10, 1992 Mar CAHN AB + EQ 100MG TARTRATE N 019962 002 Jan 10, 1992 Mar CAHN AB +! EQ 200MG TARTRATE N 019962 003 Jan 10, 1992 Mar CAHN

METOPROLOL TARTRATE INJECTABLE;INJECTION LOPRESSOR + @ NOVARTIS 1MG/ML N 018704 001 Mar 30, 1984 Jun DISC METOPROLOL TARTRATE AP ! HOSPIRA 1MG/ML A 078085 001 Apr 29, 2008 Jun CHRS @ LUITPOLD 1MG/ML A 090386 001 Sep 30, 2009 Mar DISC @ 1MG/ML A 091307 001 Dec 29, 2010 Feb DISC TABLET;ORAL METOPROLOL TARTRATE AB HERITAGE PHARMA 50MG A 074141 001 Jan 31, 1995 Apr CAHN AB 100MG A 074141 002 Jan 31, 1995 Apr CAHN AB MYLAN 37.5MG A 076704 004 Mar 18, 2015 Oct CTEC AB 75MG A 076704 005 Mar 18, 2015 Oct CTEC AB RUBICON 37.5MG A 200981 004 Aug 21, 2019 Oct NEWA AB 75MG A 200981 005 Aug 21, 2019 Oct NEWA @ SUN PHARM INDUSTRIES 25MG A 073654 002 Jul 15, 2009 Oct DISC @ 50MG A 073654 003 Dec 21, 1993 Oct DISC @ 100MG A 073654 001 Dec 21, 1993 Oct DISC @ WATSON LABS 50MG A 074217 001 May 27, 1994 Oct DISC @ 100MG A 074217 002 May 27, 1994 Oct DISC

METRONIDAZOLE GEL;VAGINAL METROGEL-VAGINAL AB +! BAUSCH 0.75% N 020208 001 Aug 17, 1992 Mar CAHN METRONIDAZOLE AB GAGE DEVELOPMENT 0.75% A 211786 001 Jul 02, 2019 Jun NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -104

GEL;VAGINAL METRONIDAZOLE AB PERRIGO UK FINCO 0.75% A 211786 001 Jul 02, 2019 Jul CAHN INJECTABLE;INJECTION METRONIDAZOLE IN PLASTIC CONTAINER AP INFORLIFE 500MG/100ML A 206191 001 Feb 25, 2019 Feb NEWA TABLET;ORAL METRONIDAZOLE AB CADILA 250MG A 206560 001 Nov 16, 2016 Mar CAHN AB 500MG A 206560 002 Nov 16, 2016 Mar CAHN AB STRIDES PHARMA 250MG A 070040 001 Jan 29, 1985 Apr CAHN AB 500MG A 070039 001 Jan 29, 1985 Apr CAHN

METYRAPONE CAPSULE;ORAL METOPIRONE >A> +! HRA PHARMA 250MG N 012911 002 Aug 09, 1996 Dec CAHN >D> +! LABORATORIE HRA 250MG N 012911 002 Aug 09, 1996 Dec CAHN TABLET;ORAL METOPIRONE >A> @ HRA PHARMA 250MG N 012911 001 Dec CAHN >D> @ LABORATORIE HRA 250MG N 012911 001 Dec CAHN

METYROSINE CAPSULE;ORAL DEMSER +! BAUSCH 250MG N 017871 001 Mar CAHN

MICAFUNGIN SODIUM INJECTABLE;INTRAVENOUS MICAFUNGIN SODIUM AP FRESENIUS KABI USA EQ 50MG BASE/VIAL A 207344 001 May 17, 2019 May NFTG AP EQ 100MG BASE/VIAL A 207344 002 May 17, 2019 May NFTG MYCAMINE AP +! ASTELLAS EQ 50MG BASE/VIAL N 021506 002 Mar 16, 2005 May CFTG AP +! EQ 100MG BASE/VIAL N 021506 003 Jun 27, 2006 May CDFR

MICONAZOLE TABLET;BUCCAL ORAVIG +! FORTOVIA 50MG N 022404 001 Apr 16, 2010 Oct CAHN

MIDAZOLAM SPRAY;NASAL NAYZILAM +! UCB INC 5MG/SPRAY N 211321 001 May 17, 2019 May NEWA

MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION MIDOZALAM HYDROCHLORIDE @ MYLAN ASI EQ 1MG BASE/ML A 090316 001 May 04, 2011 Sep DISC AP EQ 1MG BASE/ML A 090316 001 May 04, 2011 Apr CAHN @ EQ 5MG BASE/ML A 090316 002 May 04, 2011 Sep DISC AP EQ 5MG BASE/ML A 090316 002 May 04, 2011 Apr CAHN

MIDODRINE HYDROCHLORIDE TABLET;ORAL MIDODRINE HYDROCHLORIDE @ CASI PHARMS INC 2.5MG A 076514 001 Sep 11, 2003 May DISC @ 5MG A 076514 002 Sep 11, 2003 May DISC @ 10MG A 076514 003 Jul 02, 2004 May DISC AB MYLAN PHARMS INC 5MG A 076577 002 Sep 10, 2003 May CHRS AB RUBICON 2.5MG A 212543 001 Aug 19, 2019 Aug NEWA AB 5MG A 212543 002 Aug 19, 2019 Aug NEWA AB 10MG A 212543 003 Aug 19, 2019 Aug NEWA ORVATEN AB ! UPSHER SMITH LABS 5MG A 076725 002 Nov 03, 2004 May CHRS RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -105

MIFEPRISTONE TABLET;ORAL MIFEPREX AB +! DANCO LABS LLC 200MG N 020687 001 Sep 28, 2000 Mar CFTG MIFEPRISTONE AB GENBIOPRO 200MG A 091178 001 Apr 11, 2019 Mar NFTG

MILRINONE LACTATE INJECTABLE;INJECTION MILRINONE LACTATE IN DEXTROSE 5% AP WOODWARD EQ 40MG BASE/200ML (EQ 0.2MG A 077151 002 Jul 20, 2005 Oct CAHN BASE/ML) MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER @ WOODWARD EQ 20MG BASE/100ML (EQ 0.2MG A 077151 001 Jul 20, 2005 Oct CAHN BASE/ML)

MINOCYCLINE HYDROCHLORIDE AEROSOL, FOAM;TOPICAL AMZEEQ +! FOAMIX EQ 4% BASE N 212379 001 Oct 18, 2019 Oct NEWA CAPSULE;ORAL MINOCIN AB + BAUSCH EQ 50MG BASE N 050649 001 May 31, 1990 May CAHN + @ EQ 75MG BASE N 050649 003 Feb 12, 2001 May CAHN AB + EQ 100MG BASE N 050649 002 May 31, 1990 May CAHN CAPSULE, EXTENDED RELEASE;ORAL XIMINO SUN PHARM INDS INC EQ 45MG BASE N 201922 001 Jul 11, 2012 Aug CAHN @ EQ 67.5MG BASE N 201922 002 Jul 11, 2012 Aug CAHN EQ 90MG BASE N 201922 003 Jul 11, 2012 Aug CAHN @ EQ 112.5MG BASE N 201922 004 Jul 11, 2012 Aug CAHN EQ 135MG BASE N 201922 005 Jul 11, 2012 Aug CAHN SUSPENSION;ORAL MINOCIN @ BAUSCH EQ 50MG BASE/5ML N 050445 001 May CAHN TABLET;ORAL MINOCYCLINE HYDROCHLORIDE >D> @ SUN PHARM INDUSTRIES EQ 50MG BASE A 090217 001 Jan 29, 2016 Dec CMFD >A> AB EQ 50MG BASE A 090217 001 Jan 29, 2016 Dec CMFD @ EQ 50MG BASE A 090217 001 Jan 29, 2016 Oct DISC >D> @ EQ 75MG BASE A 090217 002 Jan 29, 2016 Dec CMFD >A> AB EQ 75MG BASE A 090217 002 Jan 29, 2016 Dec CMFD @ EQ 75MG BASE A 090217 002 Jan 29, 2016 Oct DISC >D> @ EQ 100MG BASE A 090217 003 Jan 29, 2016 Dec CMFD >A> AB EQ 100MG BASE A 090217 003 Jan 29, 2016 Dec CMFD @ EQ 100MG BASE A 090217 003 Jan 29, 2016 Oct DISC TABLET, EXTENDED RELEASE;ORAL MINOCYCLINE HYDROCHLORIDE >A> AB ALKEM LABS LTD EQ 55MG BASE A 204453 008 Dec 19, 2019 Dec NEWA AB AUROBINDO PHARMA LTD EQ 55MG BASE A 202261 008 Aug 21, 2019 Aug NEWA AB BARR LABS INC EQ 80MG BASE A 065485 007 Apr 26, 2017 Jan CMFD AB EQ 105MG BASE A 065485 008 Apr 26, 2017 Jan CMFD @ MYLAN EQ 55MG BASE A 203443 001 Aug 21, 2019 Aug NEWA @ MYLAN LABS LTD EQ 65MG BASE A 201467 001 Jul 30, 2019 Aug DISC AB EQ 65MG BASE A 201467 001 Jul 30, 2019 Jul NEWA @ EQ 115MG BASE A 201467 002 Jul 30, 2019 Aug DISC AB EQ 115MG BASE A 201467 002 Jul 30, 2019 Jul NEWA AB SUN PHARM INDS LTD EQ 65MG BASE A 091118 003 Dec 03, 2019 Nov NEWA AB EQ 115MG BASE A 091118 007 Dec 03, 2019 Nov NEWA

MIRABEGRON TABLET, EXTENDED RELEASE;ORAL >A> MIRABEGRON >A> AB SAWAI USA 25MG A 209446 001 Dec 27, 2019 Dec NFTG MYRBETRIQ >D> +! APGDI 25MG N 202611 001 Jun 28, 2012 Dec CFTG >A> AB +! 25MG N 202611 001 Jun 28, 2012 Dec CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -106

MIRTAZAPINE TABLET;ORAL MIRTAZAPINE @ WATSON LABS 15MG A 076312 001 Jun 19, 2003 May DISC @ 30MG A 076312 002 Jun 19, 2003 May DISC @ 45MG A 076312 003 Jun 19, 2003 May DISC

MISOPROSTOL TABLET;ORAL MISOPROSTOL >D> AB ANI PHARMS INC 0.1MG A 076095 001 Jul 10, 2002 Dec DISC >A> @ 0.1MG A 076095 001 Jul 10, 2002 Dec DISC >D> AB 0.2MG A 076095 002 Jul 10, 2002 Dec DISC >A> @ 0.2MG A 076095 002 Jul 10, 2002 Dec DISC >D> AB ZYDUS PHARMS 0.1MG A 210201 001 Jul 02, 2019 Dec DISC >A> @ 0.1MG A 210201 001 Jul 02, 2019 Dec DISC AB 0.1MG A 210201 001 Jul 02, 2019 Jun NEWA >D> AB 0.2MG A 210201 002 Jul 02, 2019 Dec DISC >A> @ 0.2MG A 210201 002 Jul 02, 2019 Dec DISC AB 0.2MG A 210201 002 Jul 02, 2019 Jun NEWA

MITOMYCIN INJECTABLE;INJECTION MITOMYCIN AP WEST-WARD PHARMS INT 20MG/VIAL A 064117 002 Apr 19, 1995 Jan CMFD AP 40MG/VIAL A 064117 003 Jun 02, 1999 Jan CMFD

MITOTANE TABLET;ORAL LYSODREN >A> +! HRA PHARMA 500MG N 016885 001 Dec CAHN >D> +! LABORATOIRE HRA 500MG N 016885 001 Dec CAHN

MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION MITOXANTRONE HYDROCHLORIDE @ MYLAN INSTITUTIONAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A 078980 001 Apr 13, 2009 Mar DISC @ EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A 078980 002 Apr 13, 2009 Mar DISC @ MYLAN LABS LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A 201014 001 Dec 11, 2012 Sep DISC NOVANTRONE + @ EMD SERONO EQ 20MG BASE/10ML (EQ 2MG BASE/ML) N 019297 001 Dec 23, 1987 Sep CRLD

MODAFINIL TABLET;ORAL MODAFINIL AB APPCO 100MG A 207196 001 Aug 16, 2017 Nov CAHN AB 200MG A 207196 002 Aug 16, 2017 Nov CAHN AB CADILA 100MG A 209966 001 Sep 14, 2017 Aug CMFD @ 100MG A 209966 001 Sep 14, 2017 May CAHN AB 200MG A 209966 002 Sep 14, 2017 Aug CMFD @ 200MG A 209966 002 Sep 14, 2017 May CAHN @ HIKMA PHARMS 100MG A 090543 001 Sep 26, 2012 Aug DISC @ 200MG A 090543 002 Sep 26, 2012 Aug DISC @ ZYDUS PHARMS 100MG A 209966 001 Sep 14, 2017 Apr DISC @ 200MG A 209966 002 Sep 14, 2017 Apr DISC

MOMETASONE FUROATE AEROSOL, METERED;INHALATION ASMANEX HFA + MERCK SHARP DOHME 0.05MG/INH N 205641 003 Aug 12, 2019 Aug NEWA CREAM;TOPICAL ELOCON + @ MERCK SHARP DOHME 0.1% N 019625 002 Apr 19, 2013 Aug DISC MOMETASONE FUROATE AB ! GLENMARK GENERICS 0.1% A 078541 001 May 28, 2008 Aug CHRS OINTMENT;TOPICAL ELOCON + @ MERCK SHARP DOHME 0.1% N 019543 001 Apr 30, 1987 Jul DISC MOMETASONE FUROATE AB ! GLENMARK GENERICS 0.1% A 078571 001 May 28, 2008 Jul CHRS RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -107

MONTELUKAST SODIUM GRANULE;ORAL MONTELUKAST SODIUM @ MYLAN PHARMS INC EQ 4MG BASE/PACKET A 202776 001 Dec 18, 2012 Feb DISC AB TORRENT EQ 4MG BASE/PACKET A 210431 001 Jul 31, 2018 Mar CAHN TABLET;ORAL MONTELUKAST SODIUM AB L PERRIGO CO EQ 10MG BASE A 206112 001 Apr 26, 2017 May CAHN @ MYLAN PHARMS INC EQ 10MG BASE A 079103 001 Aug 03, 2012 Jul DISC @ VINTAGE PHARMS LLC EQ 10MG BASE A 091576 001 Aug 03, 2012 Feb DISC TABLET, CHEWABLE;ORAL MONTELUKAST SODIUM @ MYLAN PHARMS INC EQ 4MG BASE A 079142 001 Aug 03, 2012 Apr DISC @ EQ 5MG BASE A 079142 002 Aug 03, 2012 Apr DISC @ VINTAGE PHARMS LLC EQ 4MG BASE A 091588 001 Aug 03, 2012 Feb DISC @ EQ 5MG BASE A 091588 002 Aug 03, 2012 Feb DISC

MORPHINE SULFATE CAPSULE, EXTENDED RELEASE;ORAL MORPHINE SULFATE AB IMPAX LABS INC 40MG A 200411 007 Jul 25, 2018 Nov NEWA INJECTABLE;INJECTION ASTRAMORPH PF @ FRESENIUS KABI USA 0.5MG/ML A 071050 001 Oct 07, 1986 Mar DISC MITIGO AP PIRAMAL CRITICAL 10MG/ML A 204393 001 Jul 16, 2018 Aug CAHN AP 25MG/ML A 204393 002 Jul 16, 2018 Aug CAHN MORPHINE SULFATE + @ ICU MEDICAL INC 5MG/ML N 019916 002 Oct 27, 2006 Sep DISC SOLUTION;ORAL MORPHINE SULFATE @ LANNETT CO INC 10MG/5ML A 202309 001 Nov 25, 2015 Feb DISC @ 20MG/5ML A 202310 001 Oct 30, 2015 Jan DISC @ 100MG/5ML N 201517 001 Jun 23, 2011 Jan DISC TABLET;ORAL MORPHINE SULFATE AB UPSHER SMITH LABS 15MG A 210610 001 Jul 22, 2019 Jul NFTG AB 30MG A 210610 002 Jul 22, 2019 Jul NFTG TABLET, EXTENDED RELEASE;ORAL ARYMO ER + EGALET@ 15MG N 208603 001 Jan 09, 2017 Mar CAHN + @ 30MG N 208603 002 Jan 09, 2017 Mar CAHN + @ 60MG N 208603 003 Jan 09, 2017 Mar CAHN + ZYLA@ 15MG N 208603 001 Jan 09, 2017 Jul CAHN + @ 30MG N 208603 002 Jan 09, 2017 Jul CAHN + @ 60MG N 208603 003 Jan 09, 2017 Jul CAHN MORPHINE SULFATE @ MYLAN PHARMS INC 15MG A 200824 001 Oct 18, 2011 Aug DISC @ 30MG A 200824 002 Oct 18, 2011 Aug DISC @ 60MG A 200824 003 Oct 18, 2011 Aug DISC @ 100MG A 200824 004 Oct 18, 2011 Aug DISC @ 200MG A 200824 005 Oct 18, 2011 Feb DISC @ SUN PHARM INDUSTRIES 15MG A 205634 001 Aug 25, 2016 Oct DISC @ 30MG A 205634 002 Aug 25, 2016 Oct DISC @ 60MG A 205634 003 Aug 25, 2016 Oct DISC @ 100MG A 205634 004 Aug 25, 2016 Oct DISC @ 200MG A 205634 005 Aug 25, 2016 Oct DISC

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL EMBEDA + @ ALPHARMA PHARMS 20MG;0.8MG N 022321 001 Aug 13, 2009 Nov DISC + @ 30MG;1.2MG N 022321 002 Aug 13, 2009 Nov DISC + @ 50MG;2MG N 022321 003 Aug 13, 2009 Nov DISC + @ 60MG;2.4MG N 022321 004 Aug 13, 2009 Nov DISC + @ 80MG;3.2MG N 022321 005 Aug 13, 2009 Nov DISC + @ 100MG;4MG N 022321 006 Aug 13, 2009 Nov DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -108

MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC MOXIFLOXACIN HYDROCHLORIDE AT1 ALEMBIC PHARMS LTD EQ 0.5% BASE A 209469 001 Feb 13, 2019 Jan NEWA TABLET;ORAL MOXIFLOXACIN HYDROCHLORIDE @ MYLAN EQ 400MG BASE A 204635 001 Aug 31, 2015 Oct DISC @ SUNSHINE LAKE EQ 400MG BASE A 206295 001 Sep 28, 2018 Mar DISC

MUPIROCIN OINTMENT;TOPICAL MUPIROCIN AB ! PERRIGO ISRAEL 2% A 065123 001 Nov 07, 2003 May CAHN

MYCOPHENOLATE MOFETIL SUSPENSION;ORAL MYCOPHENOLATE MOFETIL AB VISTAPHARM 200MG/ML A 210370 001 Feb 12, 2019 Jan NEWA TABLET;ORAL MYCOPHENOLATE MOFETIL @ OXFORD PHARMS 500MG A 090606 001 Jul 16, 2010 Aug DISC @ TEVA PHARMS 500MG A 065457 001 May 04, 2009 Sep DISC

MYCOPHENOLIC ACID TABLET, DELAYED RELEASE;ORAL MYCOPHENOLIC ACID >A> AB CONCORD BIOTECH LTD 180MG A 211173 001 Dec 13, 2019 Dec NEWA >A> AB 360MG A 211173 002 Dec 13, 2019 Dec NEWA

NABUMETONE TABLET;ORAL NABUMETONE AB NEXGEN PHARMA INC 500MG A 203166 001 Aug 30, 2019 Aug NEWA AB 750MG A 203166 002 Aug 30, 2019 Aug NEWA 1GM A 203166 003 Aug 30, 2019 Aug NEWA AB NOSTRUM LABS INC 500MG A 090427 001 Dec 30, 2011 Oct CAHN AB 750MG A 090427 002 Dec 30, 2011 Oct CAHN AB SCIEGEN PHARMS INC 500MG A 078420 001 Sep 24, 2008 Sep CMFD AB 750MG A 078420 002 Sep 24, 2008 Sep CMFD

NADOLOL TABLET;ORAL NADOLOL AB HERITAGE PHARMA 20MG A 074229 001 Aug 30, 1996 Apr CAHN AB 40MG A 074229 002 Aug 30, 1996 Apr CAHN AB 80MG A 074255 001 Jan 24, 1996 Apr CAHN @ 120MG A 074255 002 Jan 24, 1996 Apr CAHN @ 160MG A 074255 003 Jan 24, 1996 Apr CAHN AB VGYAAN 20MG A 212856 001 Sep 13, 2019 Sep NEWA AB 40MG A 212856 002 Sep 13, 2019 Sep NEWA AB 80MG A 212856 003 Sep 13, 2019 Sep NEWA

NAFCILLIN SODIUM INJECTABLE;INJECTION NAFCILLIN SODIUM AP FRESENIUS EQ 1GM BASE/VIAL A 206682 001 Dec 10, 2019 Nov NEWA AP EQ 2GM BASE/VIAL A 206682 002 Dec 10, 2019 Nov NEWA @ MYLAN LABS LTD EQ 1GM BASE/VIAL A 200002 001 Apr 07, 2014 Sep DISC @ EQ 2GM BASE/VIAL A 200002 002 Apr 07, 2014 Sep DISC

NAFTIFINE HYDROCHLORIDE GEL;TOPICAL NAFTIFINE HYDROCHLORIDE TA RO@ TARO@ 2% A 208201 001 Apr 10, 2019 May DISC AB 2% A 208201 001 Apr 10, 2019 Mar NFTG AB TOLMAR 1% A 206165 001 Mar 20, 2019 Mar NFTG NAFTIN AB +! SEBELA IRELAND LTD 1% N 019356 001 Jun 18, 1990 Mar CFTG AB +! 2% N 204286 001 Jun 27, 2013 Mar CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -109

NALBUPHINE HYDROCHLORIDE INJECTABLE;INJECTION NALBUPHINE HYDROCHLORIDE @ DR REDDYS 10MG/ML A 074471 001 Mar 19, 1998 May CAHN @ 20MG/ML A 074471 002 Mar 19, 1998 May CAHN AP MYLAN LABS LTD 10MG/ML A 206506 001 Feb 06, 2019 Jan NEWA AP 20MG/ML A 206506 002 Feb 06, 2019 Jan NEWA

NALDEMEDINE TOSYLATE TABLET;ORAL SYMPROIC +! BDSI EQ 0.2MG BASE N 208854 001 Mar 23, 2017 Apr CAHN

NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION NALOXONE HYDROCHLORIDE AP AUROBINDO PHARMA LTD 0.4MG/ML A 212455 001 Oct 15, 2019 Sep NEWA AP 0.4MG/ML A 212456 001 Nov 04, 2019 Oct NEWA @ VIRTUS PHARMS 0.4MG/ML A 207846 001 Dec 17, 2018 Oct DISC AP 0.4MG/ML A 207846 001 Dec 17, 2018 Jul CAHN SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS EVZIO (AUTOINJECTOR) +! KALEO INC 2MG/0.4ML (2MG/0.4ML) N 209862 001 Oct 19, 2016 Feb CTNA SPRAY, METERED;NASAL NALOXONE HYDROCHLORIDE @ TEVA PHARMS USA 4MG/SPRAY A 209522 001 Apr 19, 2019 May DISC AB 4MG/SPRAY A 209522 001 Apr 19, 2019 Apr NFTG NARCAN +! ADAPT 4MG/SPRAY N 208411 001 Nov 18, 2015 May CTEC AB +! 4MG/SPRAY N 208411 001 Nov 18, 2015 Apr CFTG

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE TABLET;ORAL NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE AB LUPIN EQ 0.5MG BASE;EQ 50MG BASE A 075735 001 Jul 11, 2001 Feb CAHN

NANDROLONE DECANOATE INJECTABLE;INJECTION NANDROLONE DECANOATE @ LUITPOLD 200MG/ML A 091252 001 Aug 30, 2010 Feb DISC

NAPROXEN SUSPENSION;ORAL NAPROSYN AB + ATNAHS PHARMA US 25MG/ML N 018965 001 Mar 23, 1987 Jun CHRS TABLET;ORAL NAPROXEN AB PERRIGO PHARMS CO 250MG A 077339 001 Apr 27, 2005 Apr CAHN AB 375MG A 077339 002 Apr 27, 2005 Apr CAHN AB 500MG A 077339 003 Apr 27, 2005 Apr CAHN TABLET, DELAYED RELEASE;ORAL NAPROXEN >D> AB INVAGEN PHARMS 375MG A 091432 001 Sep 19, 2011 Dec CAHN >D> AB 500MG A 091432 002 Sep 19, 2011 Dec CAHN >A> AB SUNRISE PHARM INC 375MG A 091432 001 Sep 19, 2011 Dec CAHN >A> AB 500MG A 091432 002 Sep 19, 2011 Dec CAHN

NAPROXEN SODIUM TABLET;ORAL NAPROXEN SODIUM AB SCIEGEN PHARMS INC EQ 250MG BASE A 212199 001 Oct 30, 2019 Oct NEWA AB EQ 500MG BASE A 212199 002 Oct 30, 2019 Oct NEWA

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE TABLET;ORAL TREXIMET + @ CURRAX 60MG;EQ 10MG BASE N 021926 002 May 14, 2015 Apr CAHN AB +! 500MG;EQ 85MG BASE N 021926 001 Apr 15, 2008 Apr CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -110

NARATRIPTAN HYDROCHLORIDE TABLET;ORAL NARATRIPTAN >D> AB ANI PHARMS INC EQ 1MG BASE A 078751 001 Jul 07, 2010 Dec DISC >A> @ EQ 1MG BASE A 078751 001 Jul 07, 2010 Dec DISC AB EQ 1MG BASE A 078751 001 Jul 07, 2010 Sep CAHN >D> AB EQ 2.5MG BASE A 078751 002 Jul 07, 2010 Dec DISC >A> @ EQ 2.5MG BASE A 078751 002 Jul 07, 2010 Dec DISC AB EQ 2.5MG BASE A 078751 002 Jul 07, 2010 Sep CAHN @ CASI PHARMS INC EQ 1MG BASE A 090288 001 Jul 07, 2010 Jun DISC @ EQ 2.5MG BASE A 090288 002 Jul 07, 2010 Jun DISC @ MYLAN PHARMS INC EQ 1MG BASE A 202431 001 May 31, 2012 Oct DISC @ EQ 2.5MG BASE A 202431 002 May 31, 2012 Oct DISC

NATEGLINIDE TABLET;ORAL NATEGLINIDE AB CADILA PHARMS LTD 60MG A 206432 001 Apr 19, 2019 Apr NEWA AB 120MG A 206432 002 Apr 19, 2019 Apr NEWA AB ! ZYDUS PHARMS 120MG A 205248 002 Jul 06, 2016 Jul CHRS STARLIX + @ NOVARTIS 60MG N 021204 001 Dec 22, 2000 Jul DISC + @ 120MG N 021204 002 Dec 22, 2000 Jul DISC

NEBIVOLOL HYDROCHLORIDE; VALSARTAN TABLET;ORAL BYVALSON + @ ALLERGAN EQ 5MG BASE;80MG N 206302 001 Jun 03, 2016 Sep DISC

NEOMYCIN SULFATE TABLET;ORAL NEOMYCIN SULFATE @ LANNETT CO INC 500MG A 204435 001 Jun 10, 2016 Jun DISC

NEOMYCIN SULFATE; POLYMYXIN B SULFATE SOLUTION;IRRIGATION NEOMYCIN AND POLYMYXIN B SULFATE @ WATSON LABS EQ 40MG BASE/ML;200,000 UNITS/ML A 062664 001 Apr 08, 1986 Jul DISC

NEOSTIGMINE METHYLSULFATE SOLUTION;INTRAVENOUS NEOSTIGMINE METHYLSULFATE AP AMRING PHARMS 5MG/10ML (0.5MG/ML) A 210989 001 Aug 22, 2018 Jan CAHN AP 10MG/10ML (1MG/ML) A 210989 002 Aug 22, 2018 Jan CAHN AP BE PHARMS 5MG/10ML (0.5MG/ML) A 212512 001 May 13, 2019 Apr NEWA AP 10MG/10ML (1MG/ML) A 212512 002 May 13, 2019 Apr NEWA AP GLAND PHARMA LTD 5MG/10ML (0.5MG/ML) A 212968 001 Oct 16, 2019 Sep NEWA AP 10MG/10ML (1MG/ML) A 212968 002 Oct 16, 2019 Sep NEWA

NESIRITIDE RECOMBINANT FOR SOLUTION;INTRAVENOUS NATRECOR + @ SCIOS LLC 1.5MG/VIAL N 020920 001 Aug 10, 2001 Aug DISC

NEVIRAPINE TABLET, EXTENDED RELEASE;ORAL NEVIRAPINE >D> AB CIPLA 400MG A 206448 001 Oct 15, 2015 Dec DISC >A> @ 400MG A 206448 001 Oct 15, 2015 Dec DISC @ MYLAN 100MG A 206271 001 Nov 09, 2015 Oct DISC

NIACIN TABLET, EXTENDED RELEASE;ORAL NIACIN AB JUBILANT GENERICS 500MG A 209156 001 May 14, 2018 Sep CMFD @ 500MG A 209156 001 May 14, 2018 Apr DISC AB 750MG A 209156 002 May 14, 2018 Sep CMFD @ 750MG A 209156 002 May 14, 2018 Apr DISC AB 1GM A 209156 003 May 14, 2018 Sep CMFD @ 1GM A 209156 003 May 14, 2018 Apr DISC >D> AB YICHANG HUMANWELL 500MG A 212017 001 Jun 10, 2019 Dec DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -111

TABLET, EXTENDED RELEASE;ORAL NIACIN >A> @ 500MG A 212017 001 Jun 10, 2019 Dec DISC AB 500MG A 212017 001 Jun 10, 2019 May NEWA >D> AB 750MG A 212017 002 Jun 10, 2019 Dec DISC >A> @ 750MG A 212017 002 Jun 10, 2019 Dec DISC AB 750MG A 212017 002 Jun 10, 2019 May NEWA >D> AB 1GM A 212017 003 Jun 10, 2019 Dec DISC >A> @ 1GM A 212017 003 Jun 10, 2019 Dec DISC AB 1GM A 212017 003 Jun 10, 2019 May NEWA

NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL NICARDIPINE HYDROCHLORIDE >D> AB ANI PHARMS INC 20MG A 074439 001 Dec 10, 1996 Dec DISC >A> @ 20MG A 074439 001 Dec 10, 1996 Dec DISC >D> AB 20MG A 074540 001 Oct 28, 1996 Dec DISC >A> @ 20MG A 074540 001 Oct 28, 1996 Dec DISC @ 20MG A 074670 001 Oct 28, 1996 Sep CAHN >D> AB 30MG A 074439 002 Dec 10, 1996 Dec DISC >A> @ 30MG A 074439 002 Dec 10, 1996 Dec DISC >D> AB 30MG A 074540 002 Oct 28, 1996 Dec DISC >A> @ 30MG A 074540 002 Oct 28, 1996 Dec DISC @ 30MG A 074670 002 Oct 28, 1996 Sep CAHN

NIFEDIPINE TABLET, EXTENDED RELEASE;ORAL NIFEDIPINE @ MYLAN 30MG A 090649 001 Jun 21, 2010 Nov DISC @ 60MG A 090649 002 Jun 21, 2010 Nov DISC @ 90MG A 090649 003 Jun 21, 2010 Nov DISC AB2 NOVAST LABS 30MG A 210614 001 Mar 12, 2019 Feb NEWA AB2 60MG A 210614 002 Mar 12, 2019 Feb NEWA AB2 90MG A 210614 003 Mar 12, 2019 Feb NEWA AB2 OSMOTICA PHARM US 90MG A 077127 003 Oct 03, 2007 Apr CMS1 AB2 SPIL 30MG A 210838 001 Apr 16, 2019 Apr NEWA AB2 60MG A 210838 002 Apr 16, 2019 Apr NEWA AB2 90MG A 210838 003 Apr 16, 2019 Apr NEWA

NIMODIPINE CAPSULE;ORAL NIMODIPINE @ SUN PHARM INDS INC 30MG A 077067 001 Apr 17, 2007 Oct DISC

NITISINONE CAPSULE;ORAL NITISINONE AB NOVITIUM PHARMA 2MG A 211041 001 Aug 26, 2019 Aug NFTG AB 5MG A 211041 002 Aug 26, 2019 Aug NFTG AB 10MG A 211041 003 Aug 26, 2019 Aug NFTG ORFADIN AB + SWEDISH ORPHAN 2MG N 021232 001 Jan 18, 2002 Aug CFTG AB + 5MG N 021232 002 Jan 18, 2002 Aug CFTG AB + 10MG N 021232 003 Jan 18, 2002 Aug CFTG

NITRIC OXIDE GAS;INHALATION >A> GENOSYL >A> +! VERO BIOTECH 800PPM N 202860 001 Dec 20, 2019 Dec NEWA

NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL NITROFURANTOIN >A> @ INVATECH 25MG A 074336 001 Jan 25, 1995 Dec CAHN >A> @ 50MG A 074336 002 Jan 25, 1995 Dec CAHN >A> @ 100MG A 074336 003 Jan 25, 1995 Dec CAHN @ MYLAN 50MG A 074967 001 Jul 09, 1997 Jul DISC @ 100MG A 077025 001 Aug 18, 2004 Jul DISC >D> @ SANDOZ 25MG A 074336 001 Jan 25, 1995 Dec CAHN >D> @ 50MG A 074336 002 Jan 25, 1995 Dec CAHN >D> @ 100MG A 074336 003 Jan 25, 1995 Dec CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -112

NITROGLYCERIN AEROSOL, METERED;SUBLINGUAL NITROMIST +! EVUS 0.4MG/SPRAY N 021780 001 Nov 02, 2006 May CAHN FILM, EXTENDED RELEASE;TRANSDERMAL MINITRAN @ MEDICIS 0.4MG/HR A 089773 001 Aug 30, 1996 May DISC @ VALEANT PHARMS 0.1MG/HR A 089771 001 Aug 30, 1996 May DISC @ 0.6MG/HR A 089774 001 Aug 30, 1996 Jun DISC @ VALEANT PHARMS NORTH 0.2MG/HR A 089772 001 Aug 30, 1996 May DISC NITRO-DUR +! USPHARMA 0.1MG/HR N 020145 001 Apr 04, 1995 May CTEC +! 0.2MG/HR N 020145 002 Apr 04, 1995 May CTEC +! 0.4MG/HR N 020145 004 Apr 04, 1995 May CTEC +! 0.6MG/HR N 020145 005 Apr 04, 1995 Jun CTEC NITROGLYCERIN AB2 HERCON PHARM 0.1MG/HR A 089885 002 Oct 30, 2017 Feb NEWA AB2 ! MYLAN TECHNOLOGIES 0.1MG/HR A 074559 004 Feb 06, 1998 Feb CTEC TABLET;SUBLINGUAL NITROGLYCERIN AB ALVOGEN 0.3MG A 211604 001 Apr 30, 2019 Apr NEWA AB 0.4MG A 211604 002 Apr 30, 2019 Apr NEWA AB 0.6MG A 211604 003 Apr 30, 2019 Apr NEWA

NIZATIDINE CAPSULE;ORAL NIZATIDINE >D> AB ANI PHARMS INC 150MG A 075668 001 Sep 12, 2002 Dec DISC >A> @ 150MG A 075668 001 Sep 12, 2002 Dec DISC >D> AB 300MG A 075668 002 Sep 12, 2002 Dec DISC >A> @ 300MG A 075668 002 Sep 12, 2002 Dec DISC

NORETHINDRONE TABLET;ORAL-28 MICRONOR + @ JANSSEN PHARMS 0.35MG N 016954 001 Mar DISC NORETHINDRONE AB2 ! MYLAN LABS LTD 0.35MG A 200980 001 Jun 12, 2013 Mar CHRS

NORETHINDRONE ACETATE TABLET;ORAL NORETHINDRONE ACETATE >A> AB NOVAST LABS 5MG A 206490 001 Nov 05, 2018 Dec CAHN >D> AB RISING 5MG A 206490 001 Nov 05, 2018 Dec CAHN AB 5MG A 206490 001 Nov 05, 2018 May CAHN

NYSTATIN CREAM;TOPICAL NYSTATIN AT TORRENT 100,000 UNITS/GM A 212557 001 Jul 24, 2019 Jul NEWA OINTMENT;TOPICAL NYSTATIN AT CADILA 100,000 UNITS/GM A 207767 001 May 25, 2018 Oct CAHN AT TORRENT 100,000 UNITS/GM A 211838 001 Jan 28, 2019 Jan NEWA POWDER;TOPICAL NYSTATIN AT LUPIN 100,000 UNITS/GM A 065138 001 Jul 23, 2004 Feb CAHN TABLET;ORAL NYSTATIN @ UPSHER SMITH LABS 500,000 UNITS A 062524 001 Nov 26, 1985 Jul CAHN

NYSTATIN; TRIAMCINOLONE ACETONIDE OINTMENT;TOPICAL NYSTATIN AND TRIAMCINOLONE ACETONIDE @ CROWN LABS INC 100,000 UNITS/GM;0.1% A 207731 001 Dec 26, 2017 Sep DISC AT VITRUVIAS THERAP 100000 UNITS/GM;0.1% A 207316 001 Nov 18, 2019 Nov NEWA @ ZYDUS PHARMS 100,000 UNITS/GM;0.1% A 207764 001 Nov 08, 2018 Mar DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -113

OCTREOTIDE ACETATE INJECTABLE;INJECTION OCTREOTIDE ACETATE AP HERITAGE PHARMS INC EQ 0.05MG BASE/ML A 204669 001 Dec 27, 2018 Apr CAHN AP EQ 0.1MG BASE/ML A 204669 002 Dec 27, 2018 Apr CAHN @ EQ 0.2MG BASE/ML A 203765 001 Sep 07, 2018 Mar DISC AP EQ 0.2MG BASE/ML A 203765 001 Sep 07, 2018 Jan CAHN AP EQ 0.5MG BASE/ML A 204669 003 Dec 27, 2018 Apr CAHN @ EQ 1MG BASE/ML A 203765 002 Sep 07, 2018 Mar DISC AP EQ 1MG BASE/ML A 203765 002 Sep 07, 2018 Jan CAHN @ SUN PHARM INDS EQ 0.05MG BASE/ML A 077372 001 Aug 14, 2007 Jul DISC @ EQ 0.1MG BASE/ML A 077372 002 Aug 14, 2007 Jul DISC @ EQ 0.2MG BASE/ML A 077373 001 Aug 14, 2007 Jul DISC @ EQ 0.5MG BASE/ML A 077372 003 Aug 14, 2007 Jul DISC @ EQ 1MG BASE/ML A 077373 002 Aug 14, 2007 Jul DISC

OFLOXACIN SOLUTION/DROPS;OPHTHALMIC OFLOXACIN AT APOTEX INC 0.3% A 076513 001 May 14, 2004 Feb CMFD @ SANDOZ INC 0.3% A 076231 001 May 14, 2004 Mar DISC SOLUTION/DROPS;OTIC OFLOXACIN @ ALVOGEN 0.3% A 090395 001 Aug 11, 2009 Oct DISC @ SANDOZ INC 0.3% A 078222 001 Mar 17, 2008 Mar DISC TABLET;ORAL OFLOXACIN @ LARKEN LABS 400MG A 076093 003 Sep 02, 2003 Sep DISC

OLANZAPINE TABLET;ORAL OLANZAPINE @ SUNSHINE LAKE 2.5MG A 206238 001 Nov 19, 2018 Apr DISC @ 5MG A 206238 002 Nov 19, 2018 Apr DISC @ 7.5MG A 206238 003 Nov 19, 2018 Apr DISC @ 10MG A 206238 004 Nov 19, 2018 Apr DISC @ 15MG A 206238 005 Nov 19, 2018 Apr DISC @ 20MG A 206238 006 Nov 19, 2018 Apr DISC TABLET, ORALLY DISINTEGRATING;ORAL OLANZAPINE @ HEC PHARM 5MG A 208146 001 Jul 02, 2018 Feb DISC @ 10MG A 208146 002 Jul 02, 2018 Feb DISC @ 15MG A 208146 003 Jul 02, 2018 Feb DISC @ 20MG A 208146 004 Jul 02, 2018 Feb DISC

OLIVE OIL; SOYBEAN OIL EMULSION;INTRAVENOUS CLINOLIPID 20% +! BAXTER HLTHCARE CORP 16%(160GM/1000ML);4% N 204508 001 Oct 03, 2013 Aug CMFD (40GM/1000ML) + @ 16%(160GM/1000ML);4% N 204508 001 Oct 03, 2013 Jun CDFR (40GM/1000ML)

OLMESARTAN MEDOXOMIL TABLET;ORAL OLMESARTAN MEDOXOMIL AB MICRO LABS 5MG A 206372 001 Sep 17, 2019 Sep NEWA AB 20MG A 206372 002 Sep 17, 2019 Sep NEWA AB 40MG A 206372 003 Sep 17, 2019 Sep NEWA AB SUNSHINE LAKE 5MG A 211049 001 Feb 22, 2019 Feb NEWA AB 20MG A 211049 002 Feb 22, 2019 Feb NEWA AB 40MG A 211049 003 Feb 22, 2019 Feb NEWA @ TEVA PHARMS USA 5MG A 091079 001 Apr 24, 2017 Nov DISC @ 20MG A 091079 002 Apr 24, 2017 Nov DISC @ 40MG A 091079 003 Apr 24, 2017 Nov DISC AB UMEDICA LABS PVT LTD 5MG A 207135 001 Jul 18, 2019 Jul NEWA AB 20MG A 207135 002 Jul 18, 2019 Jul NEWA AB 40MG A 207135 003 Jul 18, 2019 Jul NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -114

OLOPATADINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC OLOPATADINE HYDROCHLORIDE AT ALEMBIC PHARMS LTD EQ 0.2% BASE A 209420 001 Apr 29, 2019 Apr NEWA AT AUROBINDO PHARMA LTD EQ 0.2% BASE A 209995 001 Apr 04, 2019 Mar NEWA AT FDC LTD EQ 0.1% BASE A 209282 001 Sep 26, 2019 Sep NEWA AT GLAND PHARMA LTD EQ 0.1% BASE A 209619 001 Aug 02, 2019 Jul NEWA AT USV EQ 0.1% BASE A 203152 001 Dec 07, 2015 Jun CAHN

OMBITASVIR; PARITAPREVIR; RITONAVIR TABLET;ORAL TECHNIVIE + @ ABBVIE INC 12.5MG;75MG;50MG N 207931 001 Jul 24, 2015 Apr DISC

OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL OMEGA-3-ACID ETHYL ESTERS AB ASCENT PHARMS INC 1GM CONTAINS AT LEAST 900MG OF THE A 207420 001 Feb 25, 2019 Feb NEWA ETHYL ESTERS OF OMEGA-3 FATTY ACIDS AB BIONPHARMA INC 1GM CONTAINS AT LEAST 900MG OF THE A 206455 001 Aug 07, 2019 Jul NEWA ETHYL ESTERS OF OMEGA-3 FATTY ACIDS @ PAR PHARM INC 1GM CONTAINS AT LEAST 900MG OF THE A 091018 001 Jun 24, 2014 Jun DISC ETHYL ESTERS OF OMEGA-3 FATTY ACIDS >D> AB SOFGEN PHARMS 1GM CONTAINS AT LEAST 900MG OF THE A 211355 001 Jul 10, 2019 Dec DISC ETHYL ESTERS OF OMEGA-3 FATTY ACIDS >A> @ 1GM CONTAINS AT LEAST 900MG OF THE A 211355 001 Jul 10, 2019 Dec DISC ETHYL ESTERS OF OMEGA-3 FATTY ACIDS AB 1GM CONTAINS AT LEAST 900MG OF THE A 211355 001 Jul 10, 2019 Jun NEWA ETHYL ESTERS OF OMEGA-3 FATTY ACIDS >A> AB SUN PHARM 1GM CONTAINS AT LEAST 900MG OF THE A 210834 001 Jan 09, 2020 Dec NEWA ETHYL ESTERS OF OMEGA-3 FATTY ACIDS >D> AB ZYDUS 1GM CONTAINS AT LEAST 900MG OF THE A 210107 001 Jun 14, 2019 Dec DISC ETHYL ESTERS OF OMEGA-3 FATTY ACIDS >A> @ 1GM CONTAINS AT LEAST 900MG OF THE A 210107 001 Jun 14, 2019 Dec DISC ETHYL ESTERS OF OMEGA-3 FATTY ACIDS AB 1GM CONTAINS AT LEAST 900MG OF THE A 210107 001 Jun 14, 2019 Jun NEWA ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL OMEPRAZOLE AB HETERO LABS LTD III 10MG A 204012 001 Sep 26, 2019 Sep NEWA AB 20MG A 204012 002 Sep 26, 2019 Sep NEWA >D> AB LUPIN LTD 40MG A 202384 001 Aug 25, 2015 Dec DISC >A> @ 40MG A 202384 001 Aug 25, 2015 Dec DISC @ MYLAN 10MG A 075876 001 May 29, 2003 Jun DISC @ 40MG A 075876 003 Jan 21, 2009 Sep DISC

OMEPRAZOLE; SODIUM BICARBONATE CAPSULE;ORAL OMEPRAZOLE AND SODIUM BICARBONATE @ PAR PHARM 20MG;1.1GM A 078966 001 May 25, 2010 Nov DISC @ 40MG;1.1GM A 078966 002 May 25, 2010 Nov DISC ZEGERID AB + SALIX 20MG;1.1GM N 021849 001 Feb 27, 2006 Sep CAHN AB +! 40MG;1.1GM N 021849 002 Feb 27, 2006 Sep CAHN FOR SUSPENSION;ORAL ZEGERID AB + SALIX 20MG/PACKET;1.68GM/PACKET N 021636 001 Jun 15, 2004 Apr CAHN AB +! 40MG/PACKET;1.68GM/PACKET N 021636 002 Dec 21, 2004 Apr CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -115

ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION ONDANSETRON HYDROCHLORIDE @ LUITPOLD EQ 2MG BASE/ML A 079039 001 Nov 18, 2008 Feb DISC ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE @ HIKMA FARMACEUTICA EQ 2MG BASE/ML A 076780 001 Dec 26, 2006 Feb DISC @ LUITPOLD EQ 2MG BASE/ML A 079032 001 Nov 18, 2008 Feb DISC @ TEVA EQ 2MG BASE/ML A 076759 001 Nov 22, 2006 Aug DISC TABLET;ORAL ONDANSETRON HYDROCHLORIDE @ MYLAN EQ 24MG BASE A 076930 004 Jun 25, 2007 Feb DISC

ORPHENADRINE CITRATE INJECTABLE;INJECTION NORFLEX + @ TELIGENT 30MG/ML N 013055 001 Jan CRLD TABLET, EXTENDED RELEASE;ORAL ORPHENADRINE CITRATE AB LUPIN 100MG A 040284 001 Jun 19, 1998 Feb CAHN

OSELTAMIVIR PHOSPHATE CAPSULE;ORAL OSELTAMIVIR PHOSPHATE AB ALEMBIC PHARMS LTD EQ 30MG BASE A 211823 001 Jun 24, 2019 Jun NEWA AB EQ 45MG BASE A 211823 002 Jun 24, 2019 Jun NEWA AB EQ 75MG BASE A 211823 003 Jun 24, 2019 Jun NEWA FOR SUSPENSION;ORAL OSELTAMIVIR PHOSPHATE AB TEVA PHARMS USA EQ 6MG BASE/ML A 211125 001 Feb 27, 2019 Feb NEWA

OXACILLIN SODIUM INJECTABLE;INJECTION OXACILLIN SODIUM @ HOSPIRA INC EQ 1GM BASE/VIAL A 203950 001 Dec 11, 2015 Oct DISC @ EQ 2GM BASE/VIAL A 203950 002 Dec 11, 2015 Oct DISC AP PIRAMAL CRITICAL EQ 1GM BASE/VIAL A 206681 001 Sep 11, 2017 Jul CAHN AP EQ 2GM BASE/VIAL A 206681 002 Sep 11, 2017 Jul CAHN AP EQ 10GM BASE/VIAL A 206760 001 Oct 26, 2017 Jul CAHN

OXALIPLATIN INJECTABLE;INTRAVENOUS ELOXATIN + @ SANOFI AVENTIS US 50MG/VIAL N 021492 001 Aug 09, 2002 Feb CDFR AP +! 50MG/10ML (5MG/ML) N 021759 001 Jan 31, 2005 Feb CDFR + @ 100MG/VIAL N 021492 002 Aug 09, 2002 Feb CDFR AP +! 100MG/20ML (5MG/ML) N 021759 002 Jan 31, 2005 Feb CDFR + @ 200MG/40ML (5MG/ML) N 021759 003 Nov 17, 2006 Feb CDFR OXALIPLATIN AP ACCORD HLTHCARE 50MG/10ML (5MG/ML) A 207474 001 Mar 21, 2017 Feb CDFR AP 100MG/20ML (5MG/ML) A 207474 002 Mar 21, 2017 Feb CDFR AP 200MG/40ML (5MG/ML) A 207474 003 Mar 21, 2017 Feb CDFR AP ACTAVIS LLC 50MG/10ML (5MG/ML) A 204880 001 Mar 05, 2018 Feb CDFR AP 100MG/20ML (5MG/ML) A 204880 002 Mar 05, 2018 Feb CDFR AP ! ACTAVIS TOTOWA 50MG/VIAL A 078803 001 Aug 08, 2012 Jul CHRS AP 50MG/VIAL A 078803 001 Aug 08, 2012 Feb CDFR AP ! 100MG/VIAL A 078803 002 Aug 08, 2012 Jul CHRS AP 100MG/VIAL A 078803 002 Aug 08, 2012 Feb CDFR AP CIPLA 50MG/10ML (5MG/ML) A 208523 001 Feb 10, 2017 Feb CDFR AP 100MG/20ML (5MG/ML) A 208523 002 Feb 10, 2017 Feb CDFR AP EUGIA PHARMA 50MG/10ML (5MG/ML) A 205529 001 Sep 06, 2017 Feb CDFR AP 100MG/20ML (5MG/ML) A 205529 002 Sep 06, 2017 Feb CDFR AP FRESENIUS KABI USA 50MG/10ML (5MG/ML) A 078811 001 Jun 10, 2010 Feb CDFR AP 100MG/20ML (5MG/ML) A 078811 002 Jun 10, 2010 Feb CDFR AP 50MG/VIAL A 078819 001 Jun 02, 2010 Feb CDFR AP 50MG/10ML (5MG/ML) A 090030 001 Jan 31, 2017 Feb CDFR AP 100MG/VIAL A 078819 002 Jun 02, 2010 Feb CDFR AP 100MG/20ML (5MG/ML) A 090030 002 Jan 31, 2017 Feb CDFR AP 200MG/40ML (5MG/ML) A 090030 003 Jan 31, 2017 Feb CDFR AP GLAND PHARMA LTD 50MG/10ML (5MG/ML) A 207325 001 Feb 10, 2017 Feb CDFR AP 50MG/VIAL A 207385 001 May 23, 2017 Feb CDFR AP 100MG/20ML (5MG/ML) A 207325 002 Feb 10, 2017 Feb CDFR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -116

INJECTABLE;INTRAVENOUS OXALIPLATIN AP 100MG/VIAL A 207385 002 May 23, 2017 Feb CDFR AP 200MG/40ML (5MG/ML) A 207325 003 Oct 18, 2017 Feb CDFR AP HOSPIRA WORLDWIDE 50MG/10ML (5MG/ML) A 078813 001 Aug 07, 2009 Feb CDFR AP 100MG/20ML (5MG/ML) A 078813 002 Aug 07, 2009 Feb CDFR AP INGENUS PHARMS LLC 50MG/10ML (5MG/ML) A 207562 001 Oct 16, 2018 Feb CDFR AP 100MG/20ML (5MG/ML) A 207562 002 Oct 16, 2018 Feb CDFR AP JIANGSU HENGRUI MED 50MG/10ML (5MG/ML) A 203869 001 Jun 18, 2014 Feb CDFR AP 100MG/20ML (5MG/ML) A 203869 002 Jun 18, 2014 Feb CDFR AP MYLAN LABS LTD 50MG/10ML (5MG/ML) A 091358 001 Aug 07, 2012 Feb CDFR @ 50MG/VIAL A 200979 001 Aug 08, 2012 Oct DISC AP 50MG/VIAL A 200979 001 Aug 08, 2012 Feb CDFR AP 100MG/20ML (5MG/ML) A 091358 002 Aug 07, 2012 Feb CDFR @ 100MG/VIAL A 200979 002 Aug 08, 2012 Oct DISC AP 100MG/VIAL A 200979 002 Aug 08, 2012 Feb CDFR @ 200MG/40ML (5MG/ML) A 091358 003 Nov 14, 2017 Sep DISC AP 200MG/40ML (5MG/ML) A 091358 003 Nov 14, 2017 Feb CDFR AP QILU 50MG/10ML (5MG/ML) A 204368 001 Jun 07, 2016 Feb CDFR AP 50MG/VIAL A 204616 001 May 11, 2016 Feb CDFR AP 100MG/20ML (5MG/ML) A 204368 002 Jun 07, 2016 Feb CDFR AP 100MG/VIAL A 204616 002 May 11, 2016 Feb CDFR AP ! 200MG/40ML (5MG/ML) A 204368 003 Jun 07, 2016 Feb CDFR AP SANDOZ 50MG/10ML (5MG/ML) A 078817 001 Jan 24, 2011 Feb CDFR @ 50MG/VIAL A 090849 001 Apr 28, 2011 Feb CDFR AP 100MG/20ML (5MG/ML) A 078817 002 Jan 24, 2011 Feb CDFR @ 100MG/VIAL A 090849 002 Apr 28, 2011 Feb CDFR @ SANDOZ INC 50MG/10ML (5MG/ML) A 078812 001 Aug 07, 2009 Feb CDFR @ 100MG/20ML (5MG/ML) A 078812 002 Aug 07, 2009 Feb CDFR @ SUN PHARM 50MG/VIAL A 078818 001 Aug 07, 2009 Jul DISC @ 50MG/10ML (5MG/ML) A 202922 001 Apr 08, 2014 Jul DISC @ 100MG/VIAL A 078818 002 Aug 07, 2009 Jul DISC @ 100MG/20ML (5MG/ML) A 202922 002 Apr 08, 2014 Jul DISC @ 200MG/40ML (5MG/ML) A 202922 003 Feb 15, 2019 Jul DISC AP 200MG/40ML (5MG/ML) A 202922 003 Feb 15, 2019 Apr CDFR AP ! SUN PHARMA GLOBAL 50MG/VIAL A 078818 001 Aug 07, 2009 Feb CDFR AP 50MG/10ML (5MG/ML) A 202922 001 Apr 08, 2014 Feb CDFR AP ! 100MG/VIAL A 078818 002 Aug 07, 2009 Feb CDFR AP 100MG/20ML (5MG/ML) A 202922 002 Apr 08, 2014 Feb CDFR AP +! TEVA PHARMS 50MG/10ML (5MG/ML) N 022160 001 Aug 07, 2009 Feb CDFR AP +! 100MG/20ML (5MG/ML) N 022160 002 Aug 07, 2009 Feb CDFR INJECTABLE;IV (INFUSION) OXALIPLATIN AP SUN PHARMA GLOBAL 200MG/40ML (5MG/ML) A 202922 003 Feb 15, 2019 Feb NEWA

OXAPROZIN TABLET;ORAL OXAPROZIN @ BEXIMCO PHARMS USA 600MG A 075842 001 Apr 12, 2001 Mar CAHN @ SUN PHARM INDS INC 600MG A 075844 001 Jan 03, 2002 Oct DISC

OXCARBAZEPINE TABLET;ORAL OXCARBAZEPINE >D> AB ANI PHARMS INC 150MG A 078005 001 Dec 11, 2007 Dec DISC >A> @ 150MG A 078005 001 Dec 11, 2007 Dec DISC >D> AB 300MG A 078005 002 Dec 11, 2007 Dec DISC >A> @ 300MG A 078005 002 Dec 11, 2007 Dec DISC >D> AB 600MG A 078005 003 Dec 11, 2007 Dec DISC >A> @ 600MG A 078005 003 Dec 11, 2007 Dec DISC AB RUBICON 150MG A 077747 001 Apr 09, 2008 Nov CAHN AB 300MG A 077747 002 Apr 09, 2008 Nov CAHN AB 600MG A 077747 003 Apr 09, 2008 Nov CAHN

OXYBUTYNIN CHLORIDE GEL;TRANSDERMAL GELNIQUE +! ALLERGAN 10% (100MG/PACKET) N 022204 001 Jan 27, 2009 Nov CTEC OXYBUTYNIN CHLORIDE @ PAR PHARM INC 10% (100MG/PACKET) A 207329 001 May 31, 2018 Nov DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -117

SYRUP;ORAL OXYBUTYNIN CHLORIDE @ LANNETT CO INC 5MG/5ML A 076682 001 Dec 28, 2004 Sep DISC TABLET;ORAL OXYBUTYNIN CHLORIDE AB ARISE 5MG A 209025 001 Dec 21, 2017 Sep CAHN AB EMCURE PHARMS LTD 5MG A 211682 001 May 10, 2019 Apr NEWA AB NOVAST LABS 5MG A 210611 001 Oct 30, 2019 Oct NEWA TABLET, EXTENDED RELEASE;ORAL OXYBUTYNIN CHLORIDE AB ! ACCORD HLTHCARE 15MG A 207138 003 Feb 29, 2016 Aug CHRS AB AJANTA PHARMA LTD 5MG A 211655 001 Feb 28, 2019 Feb NEWA AB 10MG A 211655 002 Feb 28, 2019 Feb NEWA AB 15MG A 211655 003 Feb 28, 2019 Feb NEWA >A> AB BIONPHARMA INC 5MG A 210717 001 Dec 17, 2019 Dec NEWA >A> AB 10MG A 210717 002 Dec 17, 2019 Dec NEWA >A> AB 15MG A 210717 003 Dec 17, 2019 Dec NEWA >D> AB MYLAN 5MG A 076702 001 Nov 09, 2006 Dec DISC >A> @ 5MG A 076702 001 Nov 09, 2006 Dec DISC

OXYCODONE HYDROCHLORIDE SOLUTION;ORAL OXYCODONE HYDROCHLORIDE AA ALKEM LABS LTD 5MG/5ML A 211748 001 Feb 07, 2019 Feb NEWA AA 100MG/5ML A 211749 001 Feb 04, 2019 Jan NEWA AA EYWA 5MG/5ML A 207511 001 Nov 23, 2016 Sep CAHN AA 100MG/5ML A 209897 001 Sep 06, 2017 Sep CAHN @ LANNETT CO INC 100MG/5ML A 204085 001 Sep 09, 2014 Jan DISC AA PHARM ASSOC 5MG/5ML A 206914 001 Feb 01, 2019 May CPOT AA 5MG/ML A 206914 001 Feb 01, 2019 Jan NEWA TABLET;ORAL OXAYDO ZYLA 5MG N 202080 001 Jun 17, 2011 Jul CAHN 7.5MG N 202080 002 Jun 17, 2011 Jul CAHN OXYCODONE HYDROCHLORIDE AB ! AVANTHI INC 10MG A 091393 002 Aug 31, 2009 Nov CHRS @ VINTAGE PHARMS 5MG A 077712 003 Mar 02, 2009 Apr DISC @ 10MG A 077712 004 Apr 13, 2015 Apr DISC @ 15MG A 077712 001 Jan 31, 2007 Apr DISC @ 20MG A 077712 005 Apr 13, 2015 Apr DISC @ 30MG A 077712 002 Jan 31, 2007 Apr DISC ROXYBOND @ INSPIRION DELIVERY 5MG N 209777 001 Apr 20, 2017 Sep CAHN @ 15MG N 209777 002 Apr 20, 2017 Sep CAHN @ 30MG N 209777 003 Apr 20, 2017 Sep CAHN

OXYMETAZOLINE HYDROCHLORIDE CREAM;TOPICAL RHOFADE +! EPI HLTH 1% N 208552 001 Jan 18, 2017 Oct CAHN

OXYMORPHONE HYDROCHLORIDE TABLET;ORAL >D> OPANA >D> AB + ENDO PHARMS 5MG N 021611 001 Jun 22, 2006 Dec DISC >A> + @ 5MG N 021611 001 Jun 22, 2006 Dec DISC >D> AB +! 10MG N 021611 002 Jun 22, 2006 Dec DISC >A> + @ 10MG N 021611 002 Jun 22, 2006 Dec DISC OXYMORPHONE HYDROCHLORIDE >D> AB AVANTHI INC 10MG A 203601 002 Jan 30, 2013 Dec CHRS >A> AB ! 10MG A 203601 002 Jan 30, 2013 Dec CHRS

OXYTOCIN INJECTABLE;INJECTION OXYTOCIN @ DR REDDYS 10USP UNITS/ML (10USP UNITS/ML) A 077453 001 Jan 24, 2008 May CAHN @ 100USP UNITS/10ML (10USP UNITS/ML) A 077453 002 Jan 24, 2008 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -118

PACLITAXEL INJECTABLE;INJECTION PACLITAXEL @ ACCORD HLTHCARE 6MG/ML A 205720 001 Aug 17, 2018 Mar DISC

PALBOCICLIB TABLET;ORAL IBRANCE + PFIZER INC 75MG N 212436 001 Nov 01, 2019 Nov NEWA + 100MG N 212436 002 Nov 01, 2019 Nov NEWA +! 125MG N 212436 003 Nov 01, 2019 Nov NEWA

PALIPERIDONE TABLET, EXTENDED RELEASE;ORAL PALIPERIDONE AB AMNEAL PHARMS 1.5MG A 204707 001 Sep 23, 2019 Sep NEWA AB 3MG A 204707 002 Sep 23, 2019 Sep NEWA AB 6MG A 204707 003 Sep 23, 2019 Sep NEWA AB 9MG A 204707 004 Sep 23, 2019 Sep NEWA AB INVENTIA 1.5MG A 204452 001 Jun 12, 2019 Aug CAHN AB 3MG A 204452 002 Jun 12, 2019 Aug CAHN AB 6MG A 204452 003 Jun 12, 2019 Aug CAHN AB 9MG A 204452 004 Jun 12, 2019 Aug CAHN AB INVENTIA HLTHCARE 1.5MG A 204452 001 Jun 12, 2019 May NEWA AB 3MG A 204452 002 Jun 12, 2019 May NEWA AB 6MG A 204452 003 Jun 12, 2019 May NEWA AB 9MG A 204452 004 Jun 12, 2019 May NEWA

PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS PALONOSETRON HYDROCHLORIDE @ DR REDDYS LABS LTD EQ 0.075MG BASE/1.5ML (EQ 0.05MG A 201533 001 Apr 21, 2016 Mar DISC BASE/ML) SOLUTION;INTRAVENOUS PALONOSETRON HYDROCHLORIDE HIKMA EQ 0.25MG BASE/2ML (EQ 0.125MG N 207963 001 Aug 22, 2016 Jul CAHN BASE/ML)

PAMIDRONATE DISODIUM INJECTABLE;INJECTION PAMIDRONATE DISODIUM AP DR REDDYS 30MG/10ML (3MG/ML) A 078156 001 Aug 19, 2008 May CAHN AP 60MG/10ML (6MG/ML) A 078156 002 Aug 19, 2008 May CAHN AP 90MG/10ML (9MG/ML) A 078156 003 Aug 19, 2008 May CAHN @ LUITPOLD 30MG/10ML (3MG/ML) A 078942 001 Jul 25, 2008 Mar DISC @ 90MG/10ML (9MG/ML) A 078942 002 Jul 25, 2008 Mar DISC

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE;ORAL ZENPEP >D> + FOREST LABS INC 168,000USP UNITS;40,000USP N 022210 007 Mar 25, 2014 Dec CAHN UNITS;126,000USP UNITS >D> + 14,000USP UNITS;3,000USP N 022210 005 Jun 15, 2011 Dec CAHN UNITS;10,000USP UNITS >D> + 24,000USP UNITS;5,000USP N 022210 001 Aug 27, 2009 Dec CAHN UNITS;17,000USP UNITS >D> + 42,000USP UNITS;10,000USP N 022210 002 Aug 27, 2009 Dec CAHN UNITS;32,000USP UNITS >D> + 63,000USP UNITS;15,000USP N 022210 003 Aug 27, 2009 Dec CAHN UNITS;47,000USP UNITS >D> + 84,000USP UNITS;20,000USP N 022210 004 Aug 27, 2009 Dec CAHN UNITS;63,000USP UNITS >D> +! 105,000USP UNITS;25,000USP N 022210 006 Jul 13, 2011 Dec CAHN UNITS;79,000USP UNITS >A> + ZENPEP 168,000USP UNITS;40,000USP N 022210 007 Mar 25, 2014 Dec CAHN UNITS;126,000USP UNITS >A> + 14,000USP UNITS;3,000USP N 022210 005 Jun 15, 2011 Dec CAHN UNITS;10,000USP UNITS >A> + 24,000USP UNITS;5,000USP N 022210 001 Aug 27, 2009 Dec CAHN UNITS;17,000USP UNITS >A> + 42,000USP UNITS;10,000USP N 022210 002 Aug 27, 2009 Dec CAHN UNITS;32,000USP UNITS >A> + 63,000USP UNITS;15,000USP N 022210 003 Aug 27, 2009 Dec CAHN UNITS;47,000USP UNITS RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -119

CAPSULE, DELAYED RELEASE;ORAL ZENPEP >A> + 84,000USP UNITS;20,000USP N 022210 004 Aug 27, 2009 Dec CAHN UNITS;63,000USP UNITS >A> +! 105,000USP UNITS;25,000USP N 022210 006 Jul 13, 2011 Dec CAHN UNITS;79,000USP UNITS TABLET;ORAL VIOKACE >D> + FOREST LABS INC 39,150USP UNITS;10,440USP N 022542 001 Mar 01, 2012 Dec CAHN UNITS;39,150USP UNITS >D> +! 78,300USP UNITS;20,880USP N 022542 002 Mar 01, 2012 Dec CAHN UNITS;78,300USP UNITS >A> + VIOKACE 39,150USP UNITS;10,440USP N 022542 001 Mar 01, 2012 Dec CAHN UNITS;39,150USP UNITS >A> +! 78,300USP UNITS;20,880USP N 022542 002 Mar 01, 2012 Dec CAHN UNITS;78,300USP UNITS

PANCURONIUM BROMIDE INJECTABLE;INJECTION PANCURONIUM BROMIDE AP ! DR REDDYS 1MG/ML A 072759 001 Jul 31, 1990 May CAHN ! 2MG/ML A 072760 001 Jul 31, 1990 May CAHN

PANOBINOSTAT LACTATE CAPSULE;ORAL FARYDAK + SECURA EQ 10MG BASE N 205353 001 Feb 23, 2015 Jun CAHN + EQ 15MG BASE N 205353 002 Feb 23, 2015 Jun CAHN +! EQ 20MG BASE N 205353 003 Feb 23, 2015 Jun CAHN

PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) PANTOPRAZOLE SODIUM @ MYLAN LABS LTD EQ 40MG BASE/VIAL A 208580 001 May 04, 2018 Oct DISC AP SUN PHARM EQ 40MG BASE/VIAL A 077674 001 Aug 19, 2019 Aug NEWA POWDER;IV (INFUSION) PANTOPRAZOLE SODIUM +! HIKMA EQ 40MG BASE/VIAL N 209463 001 Jun 30, 2017 Sep CRLD ! EQ 40MG BASE/VIAL N 209463 001 Jun 30, 2017 Sep CHRS EQ 40MG BASE/VIAL N 209463 001 Jun 30, 2017 Jul CAHN TABLET, DELAYED RELEASE;ORAL PANTOPRAZOLE SODIUM AB INGENUS PHARMS LLC EQ 40MG BASE A 211368 001 Mar 01, 2019 Feb NEWA AB L PERRIGO CO EQ 20MG BASE A 203024 001 May 07, 2014 May CAHN AB RUBICON EQ 20MG BASE A 090807 001 May 02, 2012 Aug CAHN AB EQ 40MG BASE A 090807 002 May 02, 2012 Aug CAHN

PARICALCITOL CAPSULE;ORAL PARICALCITOL >D> AB LOTUS PHARM CO LTD 1MCG A 206710 001 Feb 24, 2016 Dec DISC >A> @ 1MCG A 206710 001 Feb 24, 2016 Dec DISC >D> AB 2MCG A 206710 002 Feb 24, 2016 Dec DISC >A> @ 2MCG A 206710 002 Feb 24, 2016 Dec DISC >D> AB 4MCG A 206710 003 Feb 24, 2016 Dec DISC >A> @ 4MCG A 206710 003 Feb 24, 2016 Dec DISC

PAROXETINE HYDROCHLORIDE TABLET;ORAL PAROXETINE HYDROCHLORIDE @ SUN PHARM INDS INC EQ 10MG BASE A 078194 001 Jun 29, 2007 Oct DISC @ EQ 20MG BASE A 078194 002 Jun 29, 2007 Oct DISC @ EQ 30MG BASE A 078194 003 Jun 29, 2007 Oct DISC @ EQ 40MG BASE A 078194 004 Jun 29, 2007 Oct DISC

PEGADEMASE BOVINE INJECTABLE;INJECTION ADAGEN + @ LEADIANT BIOSCI INC 250 UNITS/ML N 019818 001 Mar 21, 1990 Oct DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -120

PENICILLAMINE CAPSULE;ORAL CUPRIMINE @ VALEANT PHARMS INTL 125MG N 019853 002 Jan CAHN AB +! 250MG N 019853 001 Apr CFTG +! 250MG N 019853 001 Jan CAHN PENICILLAMINE AB AMERIGEN PHARMS LTD 250MG A 209921 001 May 07, 2019 Apr NFTG >A> AB PAR PHARM INC 250MG A 211231 001 Dec 23, 2019 Dec NEWA AB WATSON LABS INC 250MG A 210976 001 Jun 24, 2019 Jun NEWA TABLET;ORAL DEPEN >D> +! MYLAN SPECIALITY LP 250MG N 019854 001 Dec CFTG >A> AB +! 250MG N 019854 001 Dec CFTG >A> PENICILLAMINE >A> AB PAR PHARM INC 250MG A 211196 001 Dec 23, 2019 Dec NFTG

PENTAMIDINE ISETHIONATE FOR SOLUTION;INHALATION NEBUPENT AN +! FRESENIUS KABI USA 300MG/VIAL N 019887 001 Jun 15, 1989 Apr CFTG PENTAMIDINE ISETHIONATE AN SETON PHARMS 300MG/VIAL A 206667 001 Apr 24, 2019 Apr NFTG

PENTOBARBITAL SODIUM INJECTABLE;INJECTION PENTOBARBITAL SODIUM AP ATHENEX 50MG/ML A 206677 001 Nov 27, 2017 Sep CAHN

PENTOSTATIN INJECTABLE;INJECTION PENTOSTATIN @ MYLAN INSTITUTIONAL 10MG/VIAL A 203554 001 Sep 19, 2014 Mar DISC

PENTOXIFYLLINE TABLET, EXTENDED RELEASE;ORAL PENTOXIFYLLINE @ ANI PHARMS INC 400MG A 074878 001 Jul 09, 1997 May CAHN @ 400MG A 075107 001 Sep 04, 1998 Sep CAHN @ MYLAN 400MG A 074425 001 Jul 08, 1997 Jun DISC

PERINDOPRIL ERBUMINE TABLET;ORAL PERINDOPRIL ERBUMINE >D> AB ANI PHARMS INC 2MG A 078138 001 Nov 10, 2009 Dec DISC >A> @ 2MG A 078138 001 Nov 10, 2009 Dec DISC >D> AB 4MG A 078138 002 Nov 10, 2009 Dec DISC >A> @ 4MG A 078138 002 Nov 10, 2009 Dec DISC >D> AB 8MG A 078138 003 Nov 10, 2009 Dec DISC >A> @ 8MG A 078138 003 Nov 10, 2009 Dec DISC

PERMETHRIN CREAM;TOPICAL PERMETHRIN AB ENCUBE ETHICALS 5% A 211303 001 Apr 03, 2019 Mar NEWA AB PERRIGO ISRAEL 5% A 076369 001 Apr 21, 2003 May CAHN

PEXIDARTINIB HYDROCHLORIDE CAPSULE;ORAL TURALIO +! DAIICHI SANKYO INC EQ 200MG BASE N 211810 001 Aug 02, 2019 Aug NEWA

PHENDIMETRAZINE TARTRATE TABLET;ORAL PHENDIMETRAZINE TARTRATE @ UPSHER SMITH LABS 35MG A 084399 001 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -121

PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE;ORAL DIBENZYLINE >D> AB +! CONCORDIA 10MG N 008708 001 Dec DISC >A> + @ 10MG N 008708 001 Dec DISC PHENOXYBENZAMINE HYDROCHLORIDE >D> AB PAR PHARM INC 10MG A 204522 001 Jan 24, 2017 Dec CHRS >A> AB ! 10MG A 204522 001 Jan 24, 2017 Dec CHRS

PHENTERMINE HYDROCHLORIDE CAPSULE;ORAL PHENTERMINE HYDROCHLORIDE @ LANNETT CO INC 30MG A 091359 001 Jul 16, 2010 Oct DISC TABLET;ORAL PHENTERMINE HYDROCHLORIDE @ NOVAST LABS 37.5MG A 091451 001 Sep 21, 2012 Oct DISC @ SUN PHARM INDS INC 37.5MG A 040790 001 Aug 21, 2007 Oct DISC

PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS BIORPHEN +! ETON PHARMS 0.1MG/ML (0.1MG/ML) N 212909 001 Oct 21, 2019 Oct NEWA PHENYLEPHRINE HYDROCHLORIDE AP2 FRESENIUS KABI USA 10MG/ML (10MG/ML) A 210665 001 Jan 29, 2019 Oct CTEC AP 10MG/ML (10MG/ML) A 210665 001 Jan 29, 2019 Jan NEWA AP1 50MG/5ML (10MG/ML) A 210666 001 Jan 30, 2019 Aug CTEC AP 50MG/5ML (10MG/ML) A 210666 001 Jan 30, 2019 Jan NEWA AP1 100MG/10ML (10MG/ML) A 210666 002 Jan 30, 2019 Aug CTEC AP 100MG/10ML (10MG/ML) A 210666 002 Jan 30, 2019 Jan NEWA AP2 MEITHEAL 10MG/ML (10MG/ML) A 210334 001 Apr 27, 2018 Aug CTEC AP 10MG/ML (10MG/ML) A 210334 001 Apr 27, 2018 Jun CAHN AP1 50MG/5ML (10MG/ML) A 210333 001 Apr 27, 2018 Aug CTEC AP 50MG/5ML (10MG/ML) A 210333 001 Apr 27, 2018 Jun CAHN AP1 100MG/10ML (10MG/ML) A 210333 002 Apr 27, 2018 Aug CTEC AP 100MG/10ML (10MG/ML) A 210333 002 Apr 27, 2018 Jun CAHN AP1 PAR STERILE PRODUCTS 10MG/ML (10MG/ML) A 210025 001 Dec 21, 2018 Aug CTEC AP1 50MG/5ML (10MG/ML) A 210025 002 Dec 21, 2018 Aug CTEC AP1 100MG/10ML (10MG/ML) A 210025 003 Dec 21, 2018 Aug CTEC AP1 SANDOZ INC 10MG/ML (10MG/ML) A 208905 001 Jan 31, 2019 Aug CTEC AP 10MG/ML (10MG/ML) A 208905 001 Jan 31, 2019 Jan NEWA AP1 50MG/5ML (10MG/ML) A 208905 002 Jan 31, 2019 Aug CTEC AP 50MG/5ML (10MG/ML) A 208905 002 Jan 31, 2019 Jan NEWA AP1 100MG/10ML (10MG/ML) A 208905 003 Jan 31, 2019 Aug CTEC AP 100MG/10ML (10MG/ML) A 208905 003 Jan 31, 2019 Jan NEWA AP2 +! WEST WARD PHARM CORP 10MG/ML (10MG/ML) N 203826 001 Dec 20, 2012 Aug CTEC AP2 +! 50MG/5ML (10MG/ML) N 203826 002 Jun 19, 2019 Aug NEWA AP2 +! 100MG/10ML (10MG/ML) N 203826 003 Jun 19, 2019 Aug NEWA VAZCULEP AP1 +! AVADEL LEGACY 10MG/ML (10MG/ML) N 204300 001 Jun 27, 2014 Oct CTEC AP +! 10MG/ML (10MG/ML) N 204300 001 Jun 27, 2014 Aug CHRS AP1 +! 50MG/5ML (10MG/ML) N 204300 002 Jun 27, 2014 Oct CTEC AP +! 50MG/5ML (10MG/ML) N 204300 002 Jun 27, 2014 Aug CHRS AP1 +! 100MG/10ML (10MG/ML) N 204300 003 Jun 27, 2014 Aug CTEC SOLUTION/DROPS;OPHTHALMIC PHENYLEPHRINE HYDROCHLORIDE AT +! AKORN INC 2.5% N 207926 001 Jan 15, 2015 Jan CTEC AT +! 10% N 207926 002 Jan 15, 2015 Jan CTEC AT +! PARAGON BIOTECK 2.5% N 203510 001 Mar 21, 2013 Jan CTEC AT +! 10% N 203510 002 Mar 21, 2013 Jan CTEC

PHENYTOIN SODIUM CAPSULE;ORAL EXTENDED PHENYTOIN SODIUM AB LUPIN LTD 100MG EXTENDED A 211633 001 Sep 30, 2019 Sep NEWA @ SUN PHARM INDS (IN) 100MG EXTENDED A 040621 001 Dec 11, 2006 Jul DISC INJECTABLE;INJECTION PHENYTOIN SODIUM @ LUITPOLD 50MG/ML A 040781 001 Dec 04, 2007 Feb DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -122

PHYTONADIONE INJECTABLE;INJECTION PHYTONADIONE AB DR REDDYS LABS LTD 10MG/ML A 207719 001 May 22, 2019 May NEWA VITAMIN K1 AB ! HOSPIRA 10MG/ML A 087955 001 Jul 25, 1983 May CTEC TABLET;ORAL MEPHYTON AB +! BAUSCH 5MG N 010104 003 Feb CAHN AB +! VALEANT PHARMS INTL 5MG N 010104 003 Jan CAHN PHYTONADIONE AB ZYDUS 5MG A 210189 001 Feb 20, 2019 Feb NEWA

PILOCARPINE HYDROCHLORIDE SOLUTION;OPHTHALMIC PILOCARPINE HYDROCHLORIDE AT SOMERSET THERAPS LLC 1% A 210384 001 Nov 25, 2019 Nov NEWA AT 2% A 210384 002 Nov 25, 2019 Nov NEWA AT 4% A 210384 003 Nov 25, 2019 Nov NEWA TABLET;ORAL PILOCARPINE HYDROCHLORIDE AB AUROBINDO PHARMA LTD 5MG A 212377 001 Aug 13, 2019 Jul NEWA AB 7.5MG A 212377 002 Aug 13, 2019 Jul NEWA SALAGEN AB + CONCORDIA 5MG N 020237 001 Mar 22, 1994 Jul CAHN AB +! 7.5MG N 020237 002 Apr 18, 2003 Jul CAHN

PIMAVANSERIN TARTRATE TABLET;ORAL NUPLAZID + @ ACADIA PHARMS INC EQ 17MG BASE N 207318 001 Apr 29, 2016 Jan DISC

PIMECROLIMUS CREAM;TOPICAL ELIDEL AB +! BAUSCH 1% N 021302 001 Dec 13, 2001 Aug CAHN PIMECROLIMUS AB GLENMARK PHARMS LTD 1% A 211769 001 Aug 29, 2019 Aug NEWA

PIMOZIDE TABLET;ORAL ORAP + TEVA@ 1MG N 017473 003 Aug 27, 1997 Sep DISC + @ 2MG N 017473 001 Jul 31, 1984 Sep DISC PIMOZIDE PAR PHARM 1MG A 204521 001 Sep 28, 2015 Sep CTEC ! 2MG A 204521 002 Sep 28, 2015 Sep CHRS 2MG A 204521 002 Sep 28, 2015 Sep CTEC

PINDOLOL TABLET;ORAL PINDOLOL AB BAYSHORE PHARMS LLC 5MG A 211712 001 Aug 01, 2019 Jul NEWA AB 10MG A 211712 002 Aug 01, 2019 Jul NEWA @ ZYDUS PHARMS 5MG A 209866 001 Aug 18, 2017 Jun DISC @ 10MG A 209866 002 Aug 18, 2017 Jun DISC

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION PIPERACILLIN AND TAZOBACTAM >D> AP ASTRAL EQ 2GM BASE/VIAL;EQ 250MG A 212287 001 Jul 29, 2019 Dec DISC BASE/VIAL >A> @ EQ 2GM BASE/VIAL;EQ 250MG A 212287 001 Jul 29, 2019 Dec DISC BASE/VIAL AP EQ 2GM BASE/VIAL;EQ 250MG A 212287 001 Jul 29, 2019 Jul NEWA BASE/VIAL >D> AP EQ 3GM BASE/VIAL;EQ 375MG A 212287 002 Jul 29, 2019 Dec DISC BASE/VIAL >A> @ EQ 3GM BASE/VIAL;EQ 375MG A 212287 002 Jul 29, 2019 Dec DISC BASE/VIAL AP EQ 3GM BASE/VIAL;EQ 375MG A 212287 002 Jul 29, 2019 Jul NEWA BASE/VIAL RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -123

INJECTABLE;INJECTION PIPERACILLIN AND TAZOBACTAM >D> AP EQ 4GM BASE/VIAL;EQ 500MG A 212287 003 Jul 29, 2019 Dec DISC BASE/VIAL >A> @ EQ 4GM BASE/VIAL;EQ 500MG A 212287 003 Jul 29, 2019 Dec DISC BASE/VIAL AP EQ 4GM BASE/VIAL;EQ 500MG A 212287 003 Jul 29, 2019 Jul NEWA BASE/VIAL @ HOSPIRA INC EQ 2GM BASE/VIAL;EQ 250MG A 065386 001 Sep 15, 2009 Oct DISC BASE/VIAL @ EQ 3GM BASE/VIAL;EQ 375MG A 065386 002 Sep 15, 2009 Oct DISC BASE/VIAL @ EQ 4GM BASE/VIAL;EQ 500MG A 065386 003 Sep 15, 2009 Oct DISC BASE/VIAL @ EQ 36GM BASE/VIAL;EQ 4.5GM A 065446 001 Sep 15, 2009 Oct DISC BASE/VIAL AP QILU EQ 2GM BASE/VIAL;EQ 250MG A 204959 001 Aug 10, 2018 Nov CAHN BASE/VIAL AP EQ 3GM BASE/VIAL;EQ 375MG A 204959 002 Aug 10, 2018 Nov CAHN BASE/VIAL AP EQ 4GM BASE/VIAL;EQ 500MG A 204959 003 Aug 10, 2018 Nov CAHN BASE/VIAL

PIROXICAM CAPSULE;ORAL PIROXICAM >D> AB BRECKENRIDGE 10MG A 206136 001 Jun 20, 2017 Dec CAHN AB 10MG A 206136 001 Jun 20, 2017 Aug CAHN >D> AB 20MG A 206136 002 Jun 20, 2017 Dec CAHN AB 20MG A 206136 002 Jun 20, 2017 Aug CAHN AB CADILA 10MG A 205585 001 Jul 17, 2018 Feb CAHN AB 20MG A 205585 002 Jul 17, 2018 Feb CAHN >D> AB MYLAN IRELAND LTD 10MG A 074116 001 Jun 15, 1993 Dec CAHN >D> AB 20MG A 074118 001 Jun 15, 1993 Dec CAHN >A> AB NOSTRUM LABS INC 10MG A 074116 001 Jun 15, 1993 Dec CAHN >A> AB 20MG A 074118 001 Jun 15, 1993 Dec CAHN >A> AB PII 10MG A 206136 001 Jun 20, 2017 Dec CAHN >A> AB 20MG A 206136 002 Jun 20, 2017 Dec CAHN @ SUN PHARM INDUSTRIES 10MG A 073536 002 Jan 23, 2008 Oct DISC @ 20MG A 073536 001 Mar 12, 1993 Oct DISC

PITAVASTATIN CALCIUM TABLET;ORAL PITAVASTATIN CALCIUM @ MYLAN EQ 1MG BASE A 206070 001 Apr 04, 2019 Apr DISC @ EQ 2MG BASE A 206070 002 Apr 04, 2019 Apr DISC @ EQ 4MG BASE A 206070 003 Apr 04, 2019 Apr DISC AB MYLAN PHARMS INC EQ 1MG BASE A 206070 001 Apr 04, 2019 Mar NEWA AB EQ 2MG BASE A 206070 002 Apr 04, 2019 Mar NEWA AB EQ 4MG BASE A 206070 003 Apr 04, 2019 Mar NEWA

PITAVASTATIN MAGNESIUM TABLET;ORAL ZYPITAMAG + @ MEDICURE EQ 1MG BASE N 208379 001 Jul 14, 2017 Sep DISC + EQ 2MG BASE N 208379 002 Jul 14, 2017 Oct CAHN +! EQ 4MG BASE N 208379 003 Jul 14, 2017 Oct CAHN

PITOLISANT HYDROCHLORIDE TABLET;ORAL WAKIX + BIOPROJET PHARMA EQ 4.45MG BASE N 211150 001 Aug 14, 2019 Aug NEWA +! EQ 17.8MG BASE N 211150 002 Aug 14, 2019 Aug NEWA + HARMONY EQ 4.45MG BASE N 211150 001 Aug 14, 2019 Sep CAHN +! EQ 17.8MG BASE N 211150 002 Aug 14, 2019 Sep CAHN

PLAZOMICIN SULFATE SOLUTION;INTRAVENOUS ZEMDRI +! CIPLA USA EQ 500MG BASE/10ML (EQ 50MG N 210303 001 Jun 25, 2018 Jul CAHN BASE/ML) RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -124

PLECANATIDE TABLET;ORAL TRULANCE +! BAUSCH 3MG N 208745 001 Jan 19, 2017 Mar CAHN +! SALIX 3MG N 208745 001 Jan 19, 2017 Apr CAHN

POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL GLYCOLAX @ LANNETT CO INC 17GM/SCOOPFUL A 076652 001 Jul 02, 2004 May DISC POLYETHYLENE GLYCOL 3350 @ NEXGEN PHARMA INC 17GM/SCOOPFUL A 077706 001 Sep 27, 2006 May DISC @ PADDOCK LLC 17GM/SCOOPFUL A 077893 001 May 26, 2006 May DISC

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS FOR SOLUTION;ORAL GOLYTELY >D> +! BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36G N 019011 002 Jun 02, 1992 Dec DISC M/PACKET;5.53GM/PACKET;21.5GM/PACK ET >A> + @ 227.1GM/PACKET;2.82GM/PACKET;6.36G N 019011 002 Jun 02, 1992 Dec DISC M/PACKET;5.53GM/PACKET;21.5GM/PACK ET

POLYMYXIN B SULFATE INJECTABLE;INJECTION POLYMYXIN B SULFATE AP ! GLAND PHARMA LTD EQ 500,000 UNITS BASE/VIAL A 207322 001 Apr 14, 2016 Oct CHRS @ WEST-WARD PHARMS INT EQ 500,000 UNITS BASE/VIAL A 060716 001 Oct DISC

PORFIMER SODIUM INJECTABLE;INJECTION PHOTOFRIN PINNACLE BIOLGS 75MG/VIAL N 020451 001 Dec 27, 1995 Oct CAHN

POSACONAZOLE TABLET, DELAYED RELEASE;ORAL NOXAFIL AB +! MERCK SHARP DOHME 100MG N 205053 001 Nov 25, 2013 Aug CFTG POSACONAZOLE AB SINOTHERAPEUTICS INC 100MG A 212411 001 Aug 21, 2019 Aug NFTG

POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE;ORAL POTASSIUM CHLORIDE >D> AB ANDA REPOSITORY 8MEQ A 205549 001 Dec 08, 2015 Dec CAHN AB 8MEQ A 205549 001 Dec 08, 2015 Aug CAHN >D> AB 10MEQ A 205549 002 Dec 08, 2015 Dec CAHN AB 10MEQ A 205549 002 Dec 08, 2015 Aug CAHN >A> AB PII 8MEQ A 205549 001 Dec 08, 2015 Dec CAHN >A> AB 10MEQ A 205549 002 Dec 08, 2015 Dec CAHN AB PRINSTON INC 8MEQ A 209026 001 Jun 11, 2019 May NEWA AB 10MEQ A 209026 002 Jun 11, 2019 May NEWA AB ZYDUS PHARMS 8MEQ A 208445 001 Mar 11, 2019 Feb NEWA AB 10MEQ A 208445 002 Mar 11, 2019 Feb NEWA FOR SOLUTION;ORAL POTASSIUM CHLORIDE AA AMNEAL PHARMS LLC 20MEQ A 210902 001 May 23, 2019 May NEWA AA BELCHER PHARMS LLC 20MEQ A 212183 001 May 06, 2019 Apr NEWA SOLUTION;ORAL POTASSIUM CHLORIDE AA PHARM ASSOC 20MEQ/15ML A 210766 001 Mar 29, 2019 Mar NEWA AA 40MEQ/15ML A 210766 002 Mar 29, 2019 Mar NEWA TABLET, EXTENDED RELEASE;ORAL K-TAB AB3 +! ABBVIE 20MEQ N 018279 003 Nov 25, 2013 Sep CTEC KLOR-CON M15 AB1 UPSHER SMITH LABS 15MEQ A 074726 003 Jun 06, 2003 Mar CTEC POTASSIUM CHLORIDE AB1 ADARE PHARMS INC 10MEQ A 076368 002 Jun 05, 2019 Jun NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -125

TABLET, EXTENDED RELEASE;ORAL POTASSIUM CHLORIDE >D> @ ANDA REPOSITORY 8MEQ A 206881 001 Jan 22, 2019 Dec CAHN @ 8MEQ A 206881 001 Jan 22, 2019 Aug CAHN >D> @ 10MEQ A 206881 002 Jan 22, 2019 Dec CAHN @ 10MEQ A 206881 002 Jan 22, 2019 Aug CAHN >D> @ BRECKENRIDGE 10MEQ A 206630 001 Mar 29, 2019 Dec CAHN @ 10MEQ A 206630 001 Mar 29, 2019 Nov DISC AB1 10MEQ A 206630 001 Mar 29, 2019 Aug CAHN >D> AB3 10MEQ A 210097 001 Jun 17, 2019 Dec DISC >A> @ 10MEQ A 210097 001 Jun 17, 2019 Dec DISC AB3 10MEQ A 210097 001 Jun 17, 2019 Aug CAHN >D> @ 15MEQ A 206630 002 Mar 29, 2019 Dec CAHN @ 15MEQ A 206630 002 Mar 29, 2019 Nov DISC AB1 15MEQ A 206630 002 Mar 29, 2019 Aug CAHN >D> @ 20MEQ A 206630 003 Mar 29, 2019 Dec CAHN @ 20MEQ A 206630 003 Mar 29, 2019 Nov DISC AB1 20MEQ A 206630 003 Mar 29, 2019 Aug CAHN >D> AB3 20MEQ A 210098 001 Apr 26, 2019 Dec DISC >A> @ 20MEQ A 210098 001 Apr 26, 2019 Dec DISC AB3 20MEQ A 210098 001 Apr 26, 2019 Sep CTEC AB2 20MEQ A 210098 001 Apr 26, 2019 Aug CAHN >A> @ PII 8MEQ A 206881 001 Jan 22, 2019 Dec CAHN @ 8MEQ A 206881 001 Jan 22, 2019 Jul DISC AB2 8MEQ A 206881 001 Jan 22, 2019 Jan NEWA >A> @ 10MEQ A 206630 001 Mar 29, 2019 Dec CAHN AB1 10MEQ A 206630 001 Mar 29, 2019 Mar NEWA >A> @ 10MEQ A 206881 002 Jan 22, 2019 Dec CAHN @ 10MEQ A 206881 002 Jan 22, 2019 Jul DISC AB2 10MEQ A 206881 002 Jan 22, 2019 Jan NEWA >A> @ 10MEQ A 210097 001 Jun 17, 2019 Dec CAHN AB3 10MEQ A 210097 001 Jun 17, 2019 Jun NEWA >A> @ 15MEQ A 206630 002 Mar 29, 2019 Dec CAHN AB1 15MEQ A 206630 002 Mar 29, 2019 Mar NEWA >A> @ 20MEQ A 206630 003 Mar 29, 2019 Dec CAHN AB1 20MEQ A 206630 003 Mar 29, 2019 Mar NEWA >A> @ 20MEQ A 210098 001 Apr 26, 2019 Dec CAHN AB2 20MEQ A 210098 001 Apr 26, 2019 Apr NEWA AB1 PRINSTON INC 10MEQ A 209922 001 Apr 30, 2019 Apr NEWA AB1 15MEQ A 209922 002 Apr 30, 2019 Apr NEWA AB1 20MEQ A 209922 003 Apr 30, 2019 Apr NEWA AB3 VITRUVIAS THERAP 20MEQ A 209688 002 Jan 12, 2018 Sep CTEC AB3 YICHANG HUMANWELL 10MEQ A 212561 001 Sep 30, 2019 Sep NEWA AB3 20MEQ A 212561 002 Sep 30, 2019 Sep NEWA

POTASSIUM CITRATE TABLET, EXTENDED RELEASE;ORAL POTASSIUM CITRATE >A> AB ANI PHARMS INC 10MEQ A 212779 001 Jan 14, 2020 Dec NEWA >A> AB 15MEQ A 212779 002 Jan 14, 2020 Dec NEWA

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC SOLUTION;INTRAVENOUS POTASSIUM PHOSPHATES +! CMP DEV LLC 4.5GM/15ML (300MG/ML);2.65GM/15ML N 212121 001 Sep 19, 2019 Nov CPOT (175MG/ML) +! 4500MG/15ML (300MG/ML);2650MG/15ML N 212121 001 Sep 19, 2019 Sep NEWA (175MG/ML) +! FRESENIUS KABI USA 1.18GM/5ML (236MG/ML);1.12GM/5ML N 212832 001 Nov 26, 2019 Nov NEWA (224MG/ML) +! 3.54GM/15ML (236MG/ML);3.36GM/15ML N 212832 002 Nov 26, 2019 Nov NEWA (224MG/ML) +! 11.8GM/50ML (236MG/ML);11.2GM/50ML N 212832 003 Nov 26, 2019 Nov NEWA (224MG/ML)

PRALATREXATE SOLUTION;INTRAVENOUS FOLOTYN + ACROTECH 20MG/ML (20MG/ML) N 022468 001 Sep 24, 2009 Mar CAHN +! 40MG/2ML (20MG/ML) N 022468 002 Sep 24, 2009 Mar CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -126

PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL PRAMIPEXOLE DIHYDROCHLORIDE AB HERITAGE PHARMA 0.125MG A 077724 001 Feb 19, 2008 May CAHN >D> AB 0.125MG A 090241 001 Oct 08, 2010 Dec DISC >A> @ 0.125MG A 090241 001 Oct 08, 2010 Dec DISC AB 0.125MG A 090241 001 Oct 08, 2010 Sep CAHN @ 0.125MG A 091254 001 Nov 30, 2010 May CAHN AB 0.25MG A 077724 002 Feb 19, 2008 May CAHN >D> AB 0.25MG A 090241 002 Oct 08, 2010 Dec DISC >A> @ 0.25MG A 090241 002 Oct 08, 2010 Dec DISC AB 0.25MG A 090241 002 Oct 08, 2010 Sep CAHN @ 0.25MG A 091254 002 Nov 30, 2010 May CAHN AB 0.5MG A 077724 003 Feb 19, 2008 May CAHN >D> AB 0.5MG A 090241 003 Oct 08, 2010 Dec DISC >A> @ 0.5MG A 090241 003 Oct 08, 2010 Dec DISC AB 0.5MG A 090241 003 Oct 08, 2010 Sep CAHN @ 0.5MG A 091254 003 Nov 30, 2010 May CAHN >D> AB 0.75MG A 090241 004 Oct 08, 2010 Dec DISC >A> @ 0.75MG A 090241 004 Oct 08, 2010 Dec DISC AB 0.75MG A 090241 004 Oct 08, 2010 Sep CAHN @ 0.75MG A 091254 004 Nov 30, 2010 May CAHN AB 1MG A 077724 004 Feb 19, 2008 May CAHN >D> AB 1MG A 090241 005 Oct 08, 2010 Dec DISC >A> @ 1MG A 090241 005 Oct 08, 2010 Dec DISC AB 1MG A 090241 005 Oct 08, 2010 Sep CAHN @ 1MG A 091254 005 Nov 30, 2010 May CAHN AB 1.5MG A 077724 005 Feb 19, 2008 May CAHN >D> AB 1.5MG A 090241 006 Oct 08, 2010 Dec DISC >A> @ 1.5MG A 090241 006 Oct 08, 2010 Dec DISC AB 1.5MG A 090241 006 Oct 08, 2010 Sep CAHN @ 1.5MG A 091254 006 Nov 30, 2010 May CAHN @ SUN PHARM INDS INC 0.125MG A 091683 001 Mar 27, 2013 Oct DISC @ 0.25MG A 091683 002 Mar 27, 2013 Oct DISC @ 0.5MG A 091683 003 Mar 27, 2013 Oct DISC @ 0.75MG A 091683 004 Mar 27, 2013 Oct DISC @ 1MG A 091683 005 Mar 27, 2013 Oct DISC @ 1.5MG A 091683 006 Mar 27, 2013 Oct DISC

PRAVASTATIN SODIUM TABLET;ORAL PRAVASTATIN SODIUM AB APNAR PHARMA LP 10MG A 076397 003 Oct 23, 2006 Jun CAHN >A> AB 10MG A 077491 002 Oct 23, 2006 Dec CMS1 AB 20MG A 076397 002 Oct 23, 2006 Jun CAHN >A> AB 20MG A 077491 003 Oct 23, 2006 Dec CMS1 AB 40MG A 076397 001 Oct 23, 2006 Jun CAHN >A> AB 40MG A 077491 004 Oct 23, 2006 Dec CMS1 AB 80MG A 077491 001 Feb 11, 2008 Jun CAHN

PREDNISOLONE ACETATE SUSPENSION/DROPS;OPHTHALMIC ECONOPRED @ EYEVANCE 0.125% N 017468 001 May CAHN

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE ! BAUSCH AND LOMB EQ 0.23% PHOSPHATE;10% A 074449 001 Dec 29, 1995 May CTEC @ SANDOZ INC EQ 0.23% PHOSPHATE;10% A 073630 001 May 27, 1993 May DISC

PREDNISONE TABLET;ORAL PREDNISONE AB GENEYORK PHARMS 1MG A 211496 001 Dec 28, 2018 Jul CMFD @ 1MG A 211496 001 Dec 28, 2018 May DISC AB 2.5MG A 211495 001 Dec 07, 2018 Jul CMFD @ 2.5MG A 211495 001 Dec 07, 2018 May DISC AB 5MG A 211495 002 Dec 07, 2018 Jul CMFD @ 5MG A 211495 002 Dec 07, 2018 May DISC AB 10MG A 210525 001 Dec 04, 2018 Jul CMFD @ 10MG A 210525 001 Dec 04, 2018 May DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -127

TABLET;ORAL PREDNISONE AB 20MG A 210525 002 Dec 04, 2018 Jul CMFD @ 20MG A 210525 002 Dec 04, 2018 May DISC AB 50MG A 210525 003 Dec 04, 2018 Jul CMFD @ 50MG A 210525 003 Dec 04, 2018 May DISC AB NOVITIUM PHARMA 2.5MG A 211575 001 Nov 15, 2019 Nov NEWA AB 5MG A 211575 002 Nov 15, 2019 Nov NEWA AB 10MG A 211575 003 Nov 15, 2019 Nov NEWA AB 20MG A 211575 004 Nov 15, 2019 Nov NEWA AB 50MG A 211575 005 Nov 15, 2019 Nov NEWA AB SUN PHARM INDUSTRIES 5MG A 089247 002 Dec 04, 1985 Jan CMS1 AB 10MG A 089247 003 Dec 04, 1985 Jan CMS1

PREGABALIN CAPSULE;ORAL LYRICA AB + PF PRISM CV 25MG N 021446 001 Dec 30, 2004 Jul CFTG AB + 50MG N 021446 002 Dec 30, 2004 Jul CFTG AB + 75MG N 021446 003 Dec 30, 2004 Jul CFTG AB + 100MG N 021446 004 Dec 30, 2004 Jul CFTG AB + 150MG N 021446 005 Dec 30, 2004 Jul CFTG AB + 200MG N 021446 006 Dec 30, 2004 Jul CFTG AB + 225MG N 021446 007 Dec 30, 2004 Jul CFTG AB +! 300MG N 021446 008 Dec 30, 2004 Jul CFTG PREGABALIN AB ALEMBIC PHARMS LTD 25MG A 203459 001 Jul 19, 2019 Jul NFTG AB 50MG A 203459 002 Jul 19, 2019 Jul NFTG AB 75MG A 203459 003 Jul 19, 2019 Jul NFTG AB 100MG A 203459 004 Jul 19, 2019 Jul NFTG AB 150MG A 203459 005 Jul 19, 2019 Jul NFTG AB 200MG A 203459 006 Jul 19, 2019 Jul NFTG AB 225MG A 203459 007 Jul 19, 2019 Jul NFTG AB 300MG A 203459 008 Jul 19, 2019 Jul NFTG AB ALKEM LABS LTD 25MG A 211177 001 Sep 30, 2019 Sep NEWA AB 50MG A 211177 002 Sep 30, 2019 Sep NEWA AB 75MG A 207799 001 Jul 19, 2019 Jul NFTG AB 100MG A 207799 002 Jul 19, 2019 Jul NFTG AB 150MG A 207799 003 Jul 19, 2019 Jul NFTG AB 200MG A 207799 004 Jul 19, 2019 Jul NFTG AB 225MG A 207799 005 Jul 19, 2019 Jul NFTG AB 300MG A 207799 006 Jul 19, 2019 Jul NFTG AB AMNEAL PHARMS CO 25MG A 209743 001 Jul 19, 2019 Jul NFTG AB 50MG A 209743 002 Jul 19, 2019 Jul NFTG AB 75MG A 209743 003 Jul 19, 2019 Jul NFTG AB 100MG A 209743 004 Jul 19, 2019 Jul NFTG AB 150MG A 209743 005 Jul 19, 2019 Jul NFTG AB 200MG A 209743 006 Jul 19, 2019 Jul NFTG AB 225MG A 209743 007 Jul 19, 2019 Jul NFTG AB 300MG A 209743 008 Jul 19, 2019 Jul NFTG >A> AB CIPLA 25MG A 212280 001 Jan 10, 2020 Dec NEWA >A> AB 50MG A 212280 002 Jan 10, 2020 Dec NEWA >A> AB 75MG A 212280 003 Jan 10, 2020 Dec NEWA >A> AB 100MG A 212280 004 Jan 10, 2020 Dec NEWA >A> AB 150MG A 212280 005 Jan 10, 2020 Dec NEWA >A> AB 200MG A 212280 006 Jan 10, 2020 Dec NEWA >A> AB 225MG A 212280 007 Jan 10, 2020 Dec NEWA >A> AB 300MG A 212280 008 Jan 10, 2020 Dec NEWA >A> AB CSPC OUYI 50MG A 210585 001 Dec 26, 2019 Dec NEWA >A> AB 75MG A 210585 002 Dec 26, 2019 Dec NEWA >A> AB 100MG A 210585 003 Dec 26, 2019 Dec NEWA >A> AB 150MG A 210585 004 Dec 26, 2019 Dec NEWA >A> AB 200MG A 210585 005 Dec 26, 2019 Dec NEWA >A> AB 300MG A 210585 006 Dec 26, 2019 Dec NEWA AB DR REDDYS 25MG A 209664 001 Jul 19, 2019 Jul NFTG AB 50MG A 209664 002 Jul 19, 2019 Jul NFTG AB 75MG A 209664 003 Jul 19, 2019 Jul NFTG AB 100MG A 209664 004 Jul 19, 2019 Jul NFTG AB 150MG A 209664 005 Jul 19, 2019 Jul NFTG AB 200MG A 209664 006 Jul 19, 2019 Jul NFTG AB 225MG A 209664 007 Jul 19, 2019 Jul NFTG AB 300MG A 209664 008 Jul 19, 2019 Jul NFTG AB HETERO LABS LTD III 25MG A 206912 001 Oct 08, 2019 Sep NEWA AB 50MG A 206912 002 Oct 08, 2019 Sep NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -128

CAPSULE;ORAL PREGABALIN AB 75MG A 206912 003 Oct 08, 2019 Sep NEWA AB 100MG A 206912 004 Oct 08, 2019 Sep NEWA AB 150MG A 206912 005 Oct 08, 2019 Sep NEWA AB 200MG A 206912 006 Oct 08, 2019 Sep NEWA AB 225MG A 206912 007 Oct 08, 2019 Sep NEWA AB 300MG A 206912 008 Oct 08, 2019 Sep NEWA AB INVAGEN PHARMS 25MG A 211384 001 Jul 19, 2019 Jul NFTG AB 50MG A 211384 002 Jul 19, 2019 Jul NFTG AB 75MG A 211384 003 Jul 19, 2019 Jul NFTG AB 100MG A 211384 004 Jul 19, 2019 Jul NFTG AB 150MG A 211384 005 Jul 19, 2019 Jul NFTG AB 200MG A 211384 006 Jul 19, 2019 Jul NFTG AB 225MG A 211384 007 Jul 19, 2019 Jul NFTG AB 300MG A 211384 008 Jul 19, 2019 Jul NFTG AB MSN 25MG A 209357 001 Jul 19, 2019 Jul NFTG AB 50MG A 209357 002 Jul 19, 2019 Jul NFTG AB 75MG A 209357 003 Jul 19, 2019 Jul NFTG AB 100MG A 209357 004 Jul 19, 2019 Jul NFTG AB 150MG A 209357 005 Jul 19, 2019 Jul NFTG AB 200MG A 209357 006 Jul 19, 2019 Jul NFTG AB 225MG A 209357 007 Jul 19, 2019 Jul NFTG AB 300MG A 209357 008 Jul 19, 2019 Jul NFTG AB MYLAN 25MG A 091228 001 Sep 20, 2019 Sep NEWA AB 50MG A 091228 002 Sep 20, 2019 Sep NEWA AB 75MG A 091228 003 Sep 20, 2019 Sep NEWA AB 100MG A 091228 004 Sep 20, 2019 Sep NEWA AB 150MG A 091228 005 Sep 20, 2019 Sep NEWA AB 200MG A 091228 006 Sep 20, 2019 Sep NEWA AB 225MG A 091228 007 Sep 20, 2019 Sep NEWA AB 300MG A 091228 008 Sep 20, 2019 Sep NEWA AB RISING 25MG A 210432 001 Jul 19, 2019 Jul NFTG AB 50MG A 210432 002 Jul 19, 2019 Jul NFTG AB 75MG A 210432 003 Jul 19, 2019 Jul NFTG AB 100MG A 210432 004 Jul 19, 2019 Jul NFTG AB 150MG A 210432 005 Jul 19, 2019 Jul NFTG AB 200MG A 210432 006 Jul 19, 2019 Jul NFTG AB 225MG A 210432 007 Jul 19, 2019 Jul NFTG AB 300MG A 210432 008 Jul 19, 2019 Jul NFTG AB SCIEGEN PHARMS INC 25MG A 208677 001 Jul 19, 2019 Jul NFTG AB 50MG A 208677 002 Jul 19, 2019 Jul NFTG AB 75MG A 208677 003 Jul 19, 2019 Jul NFTG AB 100MG A 208677 004 Jul 19, 2019 Jul NFTG AB 150MG A 208677 005 Jul 19, 2019 Jul NFTG AB 200MG A 208677 006 Jul 19, 2019 Jul NFTG AB 225MG A 208677 007 Jul 19, 2019 Jul NFTG AB 300MG A 208677 008 Jul 19, 2019 Jul NFTG AB SHUANGCHENG 75MG A 210891 001 Sep 30, 2019 Sep NEWA AB 300MG A 210891 002 Sep 30, 2019 Sep NEWA AB SUN PHARM 25MG A 091157 001 Nov 29, 2019 Nov NEWA AB 50MG A 091157 002 Nov 29, 2019 Nov NEWA AB 75MG A 091157 003 Nov 29, 2019 Nov NEWA AB 100MG A 091157 004 Nov 29, 2019 Nov NEWA AB 150MG A 091157 005 Nov 29, 2019 Nov NEWA AB 200MG A 091157 006 Nov 29, 2019 Nov NEWA AB 225MG A 091157 007 Nov 29, 2019 Nov NEWA AB 300MG A 091157 008 Nov 29, 2019 Nov NEWA AB TEVA PHARMS 25MG A 091219 001 Jul 19, 2019 Jul NFTG AB 50MG A 091219 002 Jul 19, 2019 Jul NFTG AB 75MG A 091224 001 Jul 19, 2019 Jul NFTG AB 100MG A 091224 002 Jul 19, 2019 Jul NFTG AB 150MG A 091224 003 Jul 19, 2019 Jul NFTG AB 200MG A 091224 004 Jul 19, 2019 Jul NFTG AB 225MG A 091224 005 Jul 19, 2019 Jul NFTG AB 300MG A 091224 006 Jul 19, 2019 Jul NFTG SOLUTION;ORAL LYRICA AA +! PF PRISM CV 20MG/ML N 022488 001 Jan 04, 2010 Jul CFTG PREGABALIN AA ALKEM LABS LTD 20MG/ML A 207623 001 Jul 19, 2019 Jul NFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -129

PRETOMANID TABLET;ORAL PRETOMANID +! MYLAN IRELAND LTD 200MG N 212862 001 Aug 14, 2019 Oct CAHN +! TB ALLIANCE 200MG N 212862 001 Aug 14, 2019 Aug NEWA

PROBENECID TABLET;ORAL PROBENECID AB MYLAN 500MG A 084211 002 Sep CHRS ! WATSON LABS TEVA 500MG A 084442 004 Mar 29, 1983 Sep CHRS

PROCHLORPERAZINE EDISYLATE INJECTABLE;INJECTION PROCHLORPERAZINE EDISYLATE AP NEXUS PHARMS EQ 5MG BASE/ML A 204860 001 Feb 15, 2019 Feb NEWA

PROCHLORPERAZINE MALEATE TABLET;ORAL PROCHLORPERAZINE MALEATE @ TEVA PHARMS EQ 5MG BASE A 040120 001 Jul 11, 1996 Jul DISC @ EQ 10MG BASE A 040120 002 Jul 11, 1996 Jul DISC

PROGESTERONE CAPSULE;ORAL PROGESTERONE AB XIROMED 100MG A 205229 001 Oct 20, 2017 Nov CAHN AB 200MG A 205229 002 Oct 20, 2017 Nov CAHN INJECTABLE;INJECTION PROGESTERONE @ LUITPOLD 50MG/ML A 090845 001 Jun 22, 2009 Mar DISC

PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL PROMETHAZINE HYDROCHLORIDE AB PERRIGO ISRAEL 12.5MG A 040500 001 Jun 30, 2003 May CAHN AB 25MG A 040500 002 Jun 30, 2003 May CAHN TABLET;ORAL PROMETHAZINE HYDROCHLORIDE @ IMPAX LABS 12.5MG A 040791 002 Feb 12, 2008 Mar DISC @ 25MG A 040791 003 Feb 12, 2008 Mar DISC >A> @ INVATECH 12.5MG A 084233 001 Dec CAHN >A> @ 25MG A 085146 001 Dec CAHN >A> @ 50MG A 085146 002 Dec CAHN >D> @ SANDOZ 12.5MG A 084233 001 Dec CAHN >D> @ 25MG A 085146 001 Dec CAHN >D> @ 50MG A 085146 002 Dec CAHN

PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL INNOPRAN XL BX + ANI PHARMS INC 80MG N 021438 001 Mar 12, 2003 Jul CRLD BX +! 120MG N 021438 002 Mar 12, 2003 Jul CHRS BX + 120MG N 021438 002 Mar 12, 2003 Jul CRLD PROPRANOLOL HYDROCHLORIDE AB ADARE PHARMS INC 60MG A 078703 001 Jul 15, 2011 Sep CAHN AB 80MG A 078703 002 Jul 15, 2011 Sep CAHN AB 120MG A 078703 003 Jul 15, 2011 Sep CAHN AB 160MG A 078703 004 Jul 15, 2011 Sep CAHN >A> AB AMTA 60MG A 212026 001 Jan 06, 2020 Dec NEWA >A> AB 80MG A 212026 002 Jan 06, 2020 Dec NEWA >A> AB 120MG A 212026 003 Jan 06, 2020 Dec NEWA >A> AB 160MG A 212026 004 Jan 06, 2020 Dec NEWA TABLET;ORAL PROPRANOLOL HYDROCHLORIDE @ ANI PHARMS INC 60MG A 071791 001 Jul 15, 1987 Sep CAHN AB INNOGENIX 10MG A 070322 002 Oct 22, 1985 Oct CMFD @ 10MG A 070322 002 Oct 22, 1985 May CMS1 AB 20MG A 070322 003 Oct 22, 1985 Oct CMFD @ 20MG A 070322 003 Oct 22, 1985 May CMS1 AB 40MG A 070322 004 Oct 22, 1985 Oct CMFD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -130

TABLET;ORAL PROPRANOLOL HYDROCHLORIDE @ 40MG A 070322 004 Oct 22, 1985 May CMS1 AB 60MG A 070322 005 Sep 24, 1986 Oct CMFD @ 60MG A 070322 005 Sep 24, 1986 May CMS1 AB 80MG A 070322 001 Aug 04, 1986 Oct CMFD @ 80MG A 070322 001 Aug 04, 1986 Mar CAHN

PROPYLTHIOURACIL TABLET;ORAL PROPYLTHIOURACIL @ QUAGEN 50MG A 080154 001 Nov CAHN

PROTRIPTYLINE HYDROCHLORIDE TABLET;ORAL VIVACTIL AB HERITAGE PHARMA 5MG A 073644 001 Aug 24, 1995 May CAHN AB ! 10MG A 073645 001 Aug 24, 1995 May CAHN

PYRIDOSTIGMINE BROMIDE INJECTABLE;INJECTION MESTINON AP +! BAUSCH 5MG/ML N 009830 001 Feb CAHN SYRUP;ORAL MESTINON AA +! BAUSCH 60MG/5ML N 015193 001 Feb CFTG +! 60MG/5ML N 015193 001 Feb CAHN PYRIDOSTIGMINE BROMIDE >A> AA AMNEAL PHARMS LLC 60MG/5ML A 212702 001 Jan 10, 2020 Dec NEWA >A> AA INVATECH 60MG/5ML A 208797 001 Jan 09, 2020 Dec NEWA AA NOVITIUM PHARMA 60MG/5ML A 211694 001 Mar 08, 2019 Feb NFTG TABLET;ORAL MESTINON AB +! BAUSCH 60MG N 009829 002 Feb CAHN PYRIDOSTIGMINE BROMIDE APNAR PHARMA LP 30MG A 211181 002 May 14, 2019 May NEWA ELYSIUM 30MG A 211181 002 May 14, 2019 Sep CAHN AB 60MG A 211181 001 Jul 20, 2018 Sep CAHN TABLET, EXTENDED RELEASE;ORAL MESTINON AB +! BAUSCH 180MG N 011665 001 Feb CAHN

PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION PYRIDOXINE HYDROCHLORIDE @ DR REDDYS 100MG/ML A 080572 001 May CAHN

QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE;ORAL QUETIAPINE FUMARATE @ AMNEAL PHARMS EQ 400MG BASE A 211405 001 Oct 26, 2018 Apr DISC

QUINAPRIL HYDROCHLORIDE TABLET;ORAL QUINAPRIL HYDROCHLORIDE >D> AB ANI PHARMS INC EQ 5MG BASE A 075504 001 Aug 24, 2007 Dec DISC >A> @ EQ 5MG BASE A 075504 001 Aug 24, 2007 Dec DISC >D> AB EQ 10MG BASE A 075504 002 Aug 24, 2007 Dec DISC >A> @ EQ 10MG BASE A 075504 002 Aug 24, 2007 Dec DISC >D> AB EQ 20MG BASE A 075504 003 Aug 24, 2007 Dec DISC >A> @ EQ 20MG BASE A 075504 003 Aug 24, 2007 Dec DISC >D> AB EQ 40MG BASE A 075504 004 Aug 24, 2007 Dec DISC >A> @ EQ 40MG BASE A 075504 004 Aug 24, 2007 Dec DISC

QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE;ORAL QUINAGLUTE + @ BAYER HLTHCARE 324MG N 016647 001 Sep CRLD QUINIDINE GLUCONATE ! SUN PHARM INDUSTRIES 324MG A 089338 001 Feb 11, 1987 Sep CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -131

QUINIDINE SULFATE TABLET;ORAL QUINIDINE SULFATE @ SUN PHARM INDUSTRIES 200MG A 081030 001 Apr 14, 1989 Oct DISC @ 300MG A 081031 001 Apr 14, 1989 Oct DISC

QUININE SULFATE CAPSULE;ORAL QUININE SULFATE @ MYLAN PHARMS INC 324MG A 202581 001 Dec 14, 2012 Mar DISC

RABEPRAZOLE SODIUM CAPSULE, DELAYED RELEASE;ORAL ACIPHEX SPRINKLE + AYTU 5MG N 204736 001 Mar 26, 2013 Nov CAHN +! 10MG N 204736 002 Mar 26, 2013 Nov CAHN TABLET, DELAYED RELEASE;ORAL RABEPRAZOLE SODIUM @ MYLAN 20MG A 076885 001 Nov 08, 2013 Jul DISC AB RUBICON 20MG A 204237 001 Nov 18, 2015 Feb CAHN

RAMELTEON TABLET;ORAL RAMELTEON AB ZYDUS PHARMS 8MG A 211567 001 Jul 22, 2019 Jul NEWA

RANITIDINE CAPSULE;ORAL >D> RANITIDINE >D> AB NOVITIUM PHARMA EQ 150MG BASE A 210681 001 Nov 23, 2018 Dec CAIN >D> AB EQ 300MG BASE A 210681 002 Nov 23, 2018 Dec CAIN

>A> RANITIDINE HYDROCHLORIDE >A> CAPSULE;ORAL >A> RANITIDINE >A> AB NOVITIUM PHARMA EQ 150MG BASE A 210681 001 Nov 23, 2018 Dec CAIN >A> AB EQ 300MG BASE A 210681 002 Nov 23, 2018 Dec CAIN RANITIDINE HYDROCHLORIDE AB APPCO EQ 150MG BASE A 211893 001 Apr 05, 2019 Mar NEWA AB EQ 300MG BASE A 211893 002 Apr 05, 2019 Mar NEWA >A> AB NOVITIUM PHARMA EQ 150MG BASE A 210681 001 Nov 23, 2018 Dec CTNA >A> AB EQ 300MG BASE A 210681 002 Nov 23, 2018 Dec CTNA SYRUP;ORAL RANITIDINE HYDROCHLORIDE @ ACTAVIS MID ATLANTIC EQ 15MG BASE/ML A 076124 001 Feb 21, 2007 Nov DISC @ TORRENT EQ 15MG BASE/ML A 090102 001 May 26, 2009 Jul DISC AA EQ 15MG BASE/ML A 090102 001 May 26, 2009 Jan CAHN TABLET;ORAL RANITIDINE HYDROCHLORIDE @ ANI PHARMS INC EQ 150MG BASE A 074488 001 Jul 31, 1997 Oct DISC @ EQ 300MG BASE A 074488 002 Jul 31, 1997 Oct DISC AB HERITAGE PHARMA EQ 150MG BASE A 075165 001 Sep 30, 1998 Feb CAHN AB EQ 300MG BASE A 075165 002 Sep 30, 1998 Feb CAHN AB VKT PHARMA PVT LTD EQ 150MG BASE A 211289 001 Jan 31, 2019 Jan NEWA AB EQ 300MG BASE A 211289 002 Jan 31, 2019 Jan NEWA

RANOLAZINE TABLET, EXTENDED RELEASE;ORAL RANEXA AB + GILEAD 500MG N 021526 002 Jan 27, 2006 Feb CTEC AB +! 1GM N 021526 001 Feb 12, 2007 Feb CTEC RANOLAZINE AB ACTAVIS ELIZABETH 500MG A 208862 001 May 28, 2019 May NEWA AB 1GM A 208862 002 May 28, 2019 May NEWA AB AJANTA PHARMA LTD 500MG A 210054 001 May 28, 2019 May NEWA AB 1GM A 210054 002 May 28, 2019 May NEWA AB AMERIGEN PHARMS LTD 500MG A 210482 001 Oct 29, 2019 Oct NEWA AB 1GM A 210482 002 Oct 29, 2019 Oct NEWA AB CADILA 500MG A 210188 001 Aug 19, 2019 Aug NEWA AB 1GM A 210188 002 Aug 19, 2019 Aug NEWA AB CIPLA 500MG A 211291 001 May 28, 2019 May NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -132

TABLET, EXTENDED RELEASE;ORAL RANOLAZINE AB 1GM A 211291 002 May 28, 2019 May NEWA AB GLENMARK PHARMS LTD 500MG A 211082 001 Jul 05, 2019 Jun NEWA AB 1GM A 211082 002 Jul 05, 2019 Jun NEWA AB LUPIN LTD 500MG A 201046 001 Jul 29, 2013 Feb CMFD AB 1GM A 201046 002 Jul 29, 2013 Feb CMFD AB SCIEGEN PHARMS INC 500MG A 211829 001 Jun 04, 2019 May NEWA AB 1GM A 211829 002 Jun 04, 2019 May NEWA AB SUN PHARM 500MG A 211707 001 May 28, 2019 May NEWA AB 1GM A 211707 002 May 28, 2019 May NEWA

RASAGILINE TABLET;ORAL >D> RASAGILINE >D> AB INDOCO REMEDIES EQ 0.5MG BASE A 206153 001 Oct 04, 2019 Dec CAIN AB EQ 0.5MG BASE A 206153 001 Oct 04, 2019 Sep NEWA >D> AB EQ 1MG BASE A 206153 002 Oct 04, 2019 Dec CAIN AB EQ 1MG BASE A 206153 002 Oct 04, 2019 Sep NEWA

>A> RASAGILINE MESYLATE >A> TABLET;ORAL >A> RASAGILINE >A> AB INDOCO REMEDIES EQ 0.5MG BASE A 206153 001 Oct 04, 2019 Dec CAIN >A> AB EQ 1MG BASE A 206153 002 Oct 04, 2019 Dec CAIN >A> RASAGILINE MESYLATE >A> AB INDOCO REMEDIES EQ 0.5MG BASE A 206153 001 Oct 04, 2019 Dec CTNA >A> AB EQ 1MG BASE A 206153 002 Oct 04, 2019 Dec CTNA AB MICRO LABS EQ 0.5MG BASE A 207004 001 Mar 29, 2019 Mar NEWA AB EQ 1MG BASE A 207004 002 Mar 29, 2019 Mar NEWA

REPAGLINIDE TABLET;ORAL PRANDIN + @ GEMINI LABS LLC 0.5MG N 020741 001 Dec 22, 1997 Mar DISC + @ 1MG N 020741 002 Dec 22, 1997 Mar DISC + @ 2MG N 020741 003 Dec 22, 1997 Mar DISC REPAGLINIDE AB ! AUROBINDO PHARMA LTD 2MG A 203820 003 Jan 22, 2014 Mar CHRS @ MYLAN 0.5MG A 090252 001 Aug 23, 2013 Feb DISC @ 1MG A 090252 002 Jan 22, 2014 Jul DISC @ 2MG A 090252 003 Jan 22, 2014 Jul DISC

RETAPAMULIN OINTMENT;TOPICAL ALTABAX +! ALMIRALL 1% N 022055 001 Apr 12, 2007 Mar CAHN

RIBAVIRIN CAPSULE;ORAL RIBAVIRIN @ CASI PHARMS INC 200MG A 076192 001 Apr 06, 2004 Jun DISC SOLUTION;ORAL REBETOL + @ SCHERING 40MG/ML N 021546 001 Jul 29, 2003 Jun DISC TABLET;ORAL RIBAVIRIN AB BEXIMCO PHARMS USA 200MG A 202546 001 Aug 12, 2014 Feb CAHN AB 400MG A 202546 002 Aug 12, 2014 Feb CAHN AB 500MG A 202546 003 Aug 12, 2014 Feb CAHN AB 600MG A 202546 004 Aug 12, 2014 Feb CAHN @ HERITAGE PHARMA 200MG A 077053 001 Dec 05, 2005 Oct DISC AB 200MG A 077053 001 Dec 05, 2005 May CAHN

RIFAMYCIN SODIUM TABLET, DELAYED RELEASE;ORAL AEMCOLO >D> +! COSMO TECHNOLOGIES EQ 194MG BASE N 210910 001 Nov 16, 2018 Dec CAHN +! EQ 194MG BASE N 210910 001 Nov 16, 2018 Oct CPOT +! 194MG N 210910 001 Nov 16, 2018 Oct CAIN >A> +! REDHILL EQ 194MG BASE N 210910 001 Nov 16, 2018 Dec CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -133

RILUZOLE FILM;ORAL EXSERVAN +! AQUESTIVE THERAP 50MG N 212640 001 Nov 22, 2019 Nov NEWA TABLET;ORAL RILUZOLE @ DAITO PHARMS CO LTD 50MG A 204430 001 Oct 16, 2018 Mar DISC AB STANDARD CHEM PHARM 50MG A 206045 001 Dec 09, 2019 Nov NEWA

RIMANTADINE HYDROCHLORIDE TABLET;ORAL RIMANTADINE HYDROCHLORIDE @ HERITAGE PHARMA 100MG A 076375 001 Jan 14, 2003 May CAHN

RIMEXOLONE SUSPENSION/DROPS;OPHTHALMIC VEXOL @ EYEVANCE 1% N 020474 001 Dec 30, 1994 May CAHN

RISEDRONATE SODIUM TABLET;ORAL RISEDRONATE SODIUM @ HANGZHOU BINJIANG 35MG A 207516 001 Feb 15, 2019 Aug DISC AB 35MG A 207516 001 Feb 15, 2019 Feb NEWA @ MYLAN 5MG A 200477 001 Nov 30, 2015 May DISC @ 30MG A 200477 002 Nov 30, 2015 May DISC @ 35MG A 200477 003 Nov 30, 2015 May DISC @ 75MG A 200477 004 Jun 10, 2014 May DISC @ 150MG A 200477 005 Jun 10, 2014 May DISC AB ORCHID HLTHCARE 30MG A 205280 001 May 13, 2019 Apr NEWA AB 35MG A 205280 002 May 13, 2019 Apr NEWA TABLET, DELAYED RELEASE;ORAL RISEDRONATE SODIUM AB SUN PHARM 35MG A 203925 001 Jul 09, 2019 Jun NEWA @ ZYDUS PHARMS 35MG A 203822 001 Sep 11, 2018 Feb DISC

RISPERIDONE SOLUTION;ORAL RISPERIDONE >D> AA ANI PHARMS INC 1MG/ML A 076440 001 Jan 30, 2009 Dec DISC >A> @ 1MG/ML A 076440 001 Jan 30, 2009 Dec DISC AA PHARM ASSOC 1MG/ML A 077719 001 Jul 29, 2009 Oct CAHN @ TORRENT 1MG/ML A 078909 001 Jul 29, 2009 Oct DISC AA 1MG/ML A 078909 001 Jul 29, 2009 Jan CAHN TABLET;ORAL RISPERIDONE AB CELLTRION 0.25MG A 078871 001 Oct 09, 2008 Aug CAHN AB 0.5MG A 078871 002 Oct 09, 2008 Aug CAHN AB 1MG A 078871 003 Oct 09, 2008 Aug CAHN AB 2MG A 078871 004 Oct 09, 2008 Aug CAHN AB 3MG A 078871 005 Oct 09, 2008 Aug CAHN AB 4MG A 078871 006 Oct 09, 2008 Aug CAHN @ HERITAGE PHARMA 0.25MG A 076228 001 Jun 30, 2008 Aug DISC AB 0.25MG A 076228 001 Jun 30, 2008 May CAHN >D> AB 0.25MG A 077769 001 Oct 16, 2008 Dec DISC >A> @ 0.25MG A 077769 001 Oct 16, 2008 Dec DISC AB 0.25MG A 077769 001 Oct 16, 2008 May CAHN @ 0.5MG A 076228 002 Jun 30, 2008 Aug DISC AB 0.5MG A 076228 002 Jun 30, 2008 May CAHN >D> AB 0.5MG A 077769 002 Oct 16, 2008 Dec DISC >A> @ 0.5MG A 077769 002 Oct 16, 2008 Dec DISC AB 0.5MG A 077769 002 Oct 16, 2008 May CAHN @ 1MG A 076228 003 Jun 30, 2008 Aug DISC AB 1MG A 076228 003 Jun 30, 2008 May CAHN >D> AB 1MG A 077769 003 Oct 16, 2008 Dec DISC >A> @ 1MG A 077769 003 Oct 16, 2008 Dec DISC AB 1MG A 077769 003 Oct 16, 2008 May CAHN @ 2MG A 076228 004 Jun 30, 2008 Aug DISC AB 2MG A 076228 004 Jun 30, 2008 May CAHN >D> AB 2MG A 077769 004 Oct 16, 2008 Dec DISC >A> @ 2MG A 077769 004 Oct 16, 2008 Dec DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -134

TABLET;ORAL RISPERIDONE AB 2MG A 077769 004 Oct 16, 2008 May CAHN @ 3MG A 076228 005 Jun 30, 2008 Aug DISC AB 3MG A 076228 005 Jun 30, 2008 May CAHN >D> AB 3MG A 077769 005 Oct 16, 2008 Dec DISC >A> @ 3MG A 077769 005 Oct 16, 2008 Dec DISC AB 3MG A 077769 005 Oct 16, 2008 May CAHN @ 4MG A 076228 006 Jun 30, 2008 Aug DISC AB 4MG A 076228 006 Jun 30, 2008 May CAHN >D> AB 4MG A 077769 006 Oct 16, 2008 Dec DISC >A> @ 4MG A 077769 006 Oct 16, 2008 Dec DISC AB 4MG A 077769 006 Oct 16, 2008 May CAHN AB RISING 0.25MG A 078269 001 Oct 08, 2008 Sep CAHN AB 0.5MG A 078269 002 Oct 08, 2008 Sep CAHN AB 1MG A 078269 003 Oct 08, 2008 Sep CAHN AB 2MG A 078269 004 Oct 08, 2008 Sep CAHN AB 3MG A 078269 005 Oct 08, 2008 Sep CAHN AB 4MG A 078269 006 Oct 08, 2008 Sep CAHN @ SUN PHARM INDS INC 0.25MG A 078036 001 Mar 10, 2014 Oct DISC @ 0.5MG A 078036 002 Mar 10, 2014 Oct DISC @ 1MG A 078036 003 Mar 10, 2014 Oct DISC @ 2MG A 078036 004 Mar 10, 2014 Oct DISC @ 3MG A 078036 005 Mar 10, 2014 Oct DISC @ 4MG A 078036 006 Mar 10, 2014 Oct DISC TABLET, ORALLY DISINTEGRATING;ORAL RISPERIDONE AB HERITAGE PHARMA 0.5MG A 076908 001 Mar 12, 2012 May CAHN AB 1MG A 076908 002 Mar 12, 2012 May CAHN AB 2MG A 076908 003 Mar 12, 2012 May CAHN

RIVASTIGMINE FILM, EXTENDED RELEASE;TRANSDERMAL RIVASTIGMINE AB BRECKENRIDGE 4.6MG/24HR A 209063 001 Nov 26, 2019 Nov NEWA AB 9.5MG/24HR A 209063 002 Nov 26, 2019 Nov NEWA AB 13.3MG/24HR A 209063 003 Nov 26, 2019 Nov NEWA AB ZYDUS NOVELTECH INC 4.6MG/24HR A 206318 001 Mar 04, 2019 Feb NEWA AB 9.5MG/24HR A 206318 002 Mar 04, 2019 Feb NEWA AB 13.3MG/24HR A 206318 003 Mar 04, 2019 Feb NEWA

RIVASTIGMINE TARTRATE CAPSULE;ORAL EXELON + @ NOVARTIS EQ 1.5MG BASE N 020823 003 Apr 21, 2000 Aug DISC + @ EQ 3MG BASE N 020823 004 Apr 21, 2000 Aug DISC + @ EQ 4.5MG BASE N 020823 005 Apr 21, 2000 Aug DISC + @ EQ 6MG BASE N 020823 006 Apr 21, 2000 Aug DISC RIVASTIGMINE TARTRATE AB ! DR REDDYS LABS INC EQ 1.5MG BASE A 077130 001 Oct 31, 2007 Aug CHRS AB ! EQ 6MG BASE A 077130 004 Oct 31, 2007 Aug CHRS

ROCURONIUM BROMIDE INJECTABLE;INJECTION ROCURONIUM BROMIDE AP CAMARGO PHARM 50MG/5ML (10MG/ML) A 210437 001 Aug 13, 2019 Jul NEWA AP 100MG/10ML (10MG/ML) A 210437 002 Aug 13, 2019 Jul NEWA AP SANOVEL ILAC 50MG/5ML (10MG/ML) A 210437 001 Aug 13, 2019 Aug CAHN AP 100MG/10ML (10MG/ML) A 210437 002 Aug 13, 2019 Aug CAHN

ROFLUMILAST TABLET;ORAL ROFLUMILAST AB MICRO LABS 500MCG A 208180 001 Mar 22, 2019 Mar NEWA

ROPINIROLE HYDROCHLORIDE TABLET;ORAL ROPINIROLE HYDROCHLORIDE AB CADILA EQ 0.25MG BASE A 090411 001 Jun 01, 2009 Feb CAHN AB EQ 0.5MG BASE A 090411 002 Jun 01, 2009 Feb CAHN AB EQ 1MG BASE A 090411 003 Jun 01, 2009 Feb CAHN AB EQ 2MG BASE A 090411 004 Jun 01, 2009 Feb CAHN AB EQ 3MG BASE A 090411 005 Jun 01, 2009 Feb CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -135

TABLET;ORAL ROPINIROLE HYDROCHLORIDE AB EQ 4MG BASE A 090411 006 Jun 01, 2009 Feb CAHN AB EQ 5MG BASE A 090411 007 Jun 01, 2009 Feb CAHN AB CELLTRION EQ 0.25MG BASE A 079050 001 May 29, 2008 Jul CAHN AB EQ 0.5MG BASE A 079050 002 May 29, 2008 Jul CAHN AB EQ 1MG BASE A 079050 003 May 29, 2008 Jul CAHN AB EQ 2MG BASE A 079050 004 May 29, 2008 Jul CAHN AB EQ 3MG BASE A 079050 005 May 29, 2008 Jul CAHN AB EQ 4MG BASE A 079050 006 May 29, 2008 Jul CAHN AB EQ 5MG BASE A 079050 007 May 29, 2008 Jul CAHN AB LAX EQ 0.25MG BASE A 079165 001 Feb 07, 2012 Mar CAHN AB EQ 0.5MG BASE A 079165 002 Feb 07, 2012 Mar CAHN AB EQ 1MG BASE A 079165 003 Feb 07, 2012 Mar CAHN AB EQ 2MG BASE A 079165 004 Feb 07, 2012 Mar CAHN AB EQ 3MG BASE A 079165 005 Feb 07, 2012 Mar CAHN AB EQ 4MG BASE A 079165 006 Feb 07, 2012 Mar CAHN AB EQ 5MG BASE A 079165 007 Feb 07, 2012 Mar CAHN AB MLV EQ 0.25MG BASE A 079165 001 Feb 07, 2012 Sep CAHN AB EQ 0.5MG BASE A 079165 002 Feb 07, 2012 Sep CAHN AB EQ 1MG BASE A 079165 003 Feb 07, 2012 Sep CAHN AB EQ 2MG BASE A 079165 004 Feb 07, 2012 Sep CAHN AB EQ 3MG BASE A 079165 005 Feb 07, 2012 Sep CAHN AB EQ 4MG BASE A 079165 006 Feb 07, 2012 Sep CAHN AB EQ 5MG BASE A 079165 007 Feb 07, 2012 Sep CAHN TABLET, EXTENDED RELEASE;ORAL REQUIP XL + @ GLAXOSMITHKLINE LLC EQ 4MG BASE N 022008 003 Jun 13, 2008 Nov DISC ROPINIROLE HYDROCHLORIDE AB CELLTRION EQ 2MG BASE A 091395 001 Aug 27, 2012 Aug CAHN AB EQ 4MG BASE A 091395 002 Aug 27, 2012 Aug CAHN AB EQ 6MG BASE A 091395 003 Aug 27, 2012 Aug CAHN AB EQ 8MG BASE A 091395 004 Aug 27, 2012 Aug CAHN AB EQ 12MG BASE A 091395 005 Aug 27, 2012 Aug CAHN

ROSIGLITAZONE MALEATE TABLET;ORAL ROSIGLITAZONE MALEATE @ ANI PHARMS INC EQ 2MG BASE A 076747 001 Jan 25, 2013 Sep CAHN @ EQ 4MG BASE A 076747 002 Jan 25, 2013 Sep CAHN @ EQ 8MG BASE A 076747 003 Jan 25, 2013 Sep CAHN

ROSUVASTATIN CALCIUM TABLET;ORAL ROSUVASTATIN CALCIUM @ AMNEAL PHARMS CO 5MG A 208850 001 Oct 16, 2018 Apr DISC @ 10MG A 208850 002 Oct 16, 2018 Apr DISC @ 20MG A 208850 003 Oct 16, 2018 Apr DISC @ 40MG A 208850 004 Oct 16, 2018 Apr DISC @ MYLAN 5MG A 079161 001 Jul 19, 2016 Jul DISC @ 10MG A 079161 002 Jul 19, 2016 Jul DISC @ 20MG A 079161 003 Jul 19, 2016 Jul DISC @ 40MG A 079161 004 Jul 19, 2016 Jul DISC @ SCIEGEN PHARMS INC 5MG A 206381 001 Apr 24, 2019 Nov DISC AB 5MG A 206381 001 Apr 24, 2019 Apr NEWA @ 10MG A 206381 002 Apr 24, 2019 Nov DISC AB 10MG A 206381 002 Apr 24, 2019 Apr NEWA @ 20MG A 206381 003 Apr 24, 2019 Nov DISC AB 20MG A 206381 003 Apr 24, 2019 Apr NEWA @ 40MG A 206381 004 Apr 24, 2019 Nov DISC AB 40MG A 206381 004 Apr 24, 2019 Apr NEWA AB SHANDONG 5MG A 207375 001 May 07, 2019 Apr NEWA AB 10MG A 207375 002 May 07, 2019 Apr NEWA AB 20MG A 207375 003 May 07, 2019 Apr NEWA AB 40MG A 207375 004 May 07, 2019 Apr NEWA @ TEVA PHARMS USA 5MG A 079166 001 Jul 19, 2016 Jul DISC @ 10MG A 079166 002 Jul 19, 2016 Jul DISC @ 20MG A 079166 003 Jul 19, 2016 Jul DISC @ 40MG A 079166 004 Jul 19, 2016 Jul DISC @ UMEDICA LABS PVT LTD 5MG A 207626 001 Apr 09, 2019 Oct DISC AB 5MG A 207626 001 Apr 09, 2019 Mar NEWA @ 10MG A 207626 002 Apr 09, 2019 Oct DISC AB 10MG A 207626 002 Apr 09, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -136

TABLET;ORAL ROSUVASTATIN CALCIUM @ 20MG A 207626 003 Apr 09, 2019 Oct DISC AB 20MG A 207626 003 Apr 09, 2019 Mar NEWA @ 40MG A 207626 004 Apr 09, 2019 Oct DISC AB 40MG A 207626 004 Apr 09, 2019 Mar NEWA AB ZHEJIANG YONGTAI 5MG A 212059 001 Nov 04, 2019 Oct NEWA AB 10MG A 212059 002 Nov 04, 2019 Oct NEWA AB 20MG A 212059 003 Nov 04, 2019 Oct NEWA AB 40MG A 212059 004 Nov 04, 2019 Oct NEWA @ ZYDUS PHARMS 5MG A 206513 001 Mar 01, 2019 Aug DISC AB 5MG A 206513 001 Mar 01, 2019 Feb NEWA @ 10MG A 206513 002 Mar 01, 2019 Aug DISC AB 10MG A 206513 002 Mar 01, 2019 Feb NEWA @ 20MG A 206513 003 Mar 01, 2019 Aug DISC AB 20MG A 206513 003 Mar 01, 2019 Feb NEWA @ 40MG A 206513 004 Mar 01, 2019 Aug DISC AB 40MG A 206513 004 Mar 01, 2019 Feb NEWA

RUFINAMIDE SUSPENSION;ORAL BANZEL AB +! EISAI INC 40MG/ML N 201367 001 Mar 03, 2011 Apr CFTG RUFINAMIDE AB BIONPHARMA INC 40MG/ML A 211388 001 Apr 23, 2019 Apr NFTG AB HIKMA 40MG/ML A 207363 001 Apr 23, 2019 Apr NFTG TABLET;ORAL RUFINAMIDE MY LAN@ MYLAN@ 200MG A 205095 001 May 16, 2016 Feb DISC @ 400MG A 205095 002 May 16, 2016 Feb DISC

SAPROPTERIN DIHYDROCHLORIDE POWDER;ORAL KUVAN AB +! BIOMARIN PHARM 100MG/PACKET N 205065 001 Dec 19, 2013 Aug CFTG + 500MG/PACKET N 205065 002 Oct 27, 2015 Sep CTEC AB + 500MG/PACKET N 205065 002 Oct 27, 2015 Aug CFTG SAPROPTERIN DIHYDROCHLORIDE AB PAR PHARM INC 100MG/PACKET A 207207 001 Aug 20, 2019 Aug NFTG @ 500MG/PACKET A 210027 001 Aug 20, 2019 Sep DISC AB 500MG/PACKET A 210027 001 Aug 20, 2019 Aug NFTG TABLET;ORAL KUVAN +! BIOMARIN PHARM 100MG N 022181 001 Dec 13, 2007 May CTEC AB +! 100MG N 022181 001 Dec 13, 2007 Apr CFTG SAPROPTERIN DIHYDROCHLORIDE @ PAR PHARM INC 100MG A 207200 001 May 10, 2019 May DISC AB 100MG A 207200 001 May 10, 2019 Apr NFTG

SCOPOLAMINE FILM, EXTENDED RELEASE;TRANSDERMAL SCOPOLAMINE AB MYLAN TECHNOLOGIES 1MG/72HR A 203753 001 Jun 19, 2019 Jun NEWA

SELEGILINE HYDROCHLORIDE TABLET;ORAL SELEGILINE HYDROCHLORIDE >A> @ ALLIED 5MG A 074672 001 Apr 01, 1997 Dec CAHN AB BOSCOGEN 5MG A 074912 001 Apr 30, 1998 Jun CAHN AB KENTON 5MG A 074912 001 Apr 30, 1998 Mar CAHN @ MYLAN 5MG A 074866 001 Nov 26, 1997 Aug DISC >D> @ SIEGFRIED 5MG A 074672 001 Apr 01, 1997 Dec CAHN TABLET, ORALLY DISINTEGRATING;ORAL ZELAPAR +! BAUSCH 1.25MG N 021479 001 Jun 14, 2006 Mar CAHN

SELENIOUS ACID SOLUTION;INTRAVENOUS SELENIOUS ACID +! AM REGENT EQ 600MCG BASE/10ML (EQ 60MCG N 209379 001 Apr 30, 2019 Apr NEWA BASE/ML) RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -137

SELINEXOR TABLET;ORAL XPOVIO +! KARYOPHARM THERAPS 20MG N 212306 001 Jul 03, 2019 Jul NEWA

SEMAGLUTIDE TABLET;ORAL RYBELSUS + NOVO 3MG N 213051 001 Sep 20, 2019 Sep NEWA + 7MG N 213051 002 Sep 20, 2019 Sep NEWA +! 14MG N 213051 003 Sep 20, 2019 Sep NEWA

SERTACONAZOLE NITRATE CREAM;TOPICAL ERTACZO +! BAUSCH 2% N 021385 001 Dec 10, 2003 Jun CAHN

SERTRALINE HYDROCHLORIDE TABLET;ORAL SERTRALINE HYDROCHLORIDE @ CADILA EQ 25MG BASE A 077106 001 Feb 06, 2007 Jun DISC AB EQ 25MG BASE A 077106 001 Feb 06, 2007 Feb CAHN @ EQ 50MG BASE A 077106 002 Feb 06, 2007 Jun DISC AB EQ 50MG BASE A 077106 002 Feb 06, 2007 Feb CAHN @ EQ 100MG BASE A 077106 003 Feb 06, 2007 Jun DISC AB EQ 100MG BASE A 077106 003 Feb 06, 2007 Feb CAHN @ HERITAGE PHARMA EQ 25MG BASE A 076465 001 Aug 11, 2006 Oct DISC AB EQ 25MG BASE A 076465 001 Aug 11, 2006 May CAHN @ EQ 25MG BASE A 077299 001 Feb 06, 2007 May CAHN @ EQ 25MG BASE A 077345 001 Feb 06, 2007 May CAHN @ EQ 50MG BASE A 076465 002 Aug 11, 2006 Oct DISC AB EQ 50MG BASE A 076465 002 Aug 11, 2006 May CAHN @ EQ 50MG BASE A 077299 002 Feb 06, 2007 May CAHN @ EQ 50MG BASE A 077345 002 Feb 06, 2007 May CAHN @ EQ 100MG BASE A 076465 003 Aug 11, 2006 Oct DISC AB EQ 100MG BASE A 076465 003 Aug 11, 2006 May CAHN @ EQ 100MG BASE A 077299 003 Feb 06, 2007 May CAHN @ EQ 100MG BASE A 077345 003 Feb 06, 2007 May CAHN @ MYLAN PHARMS INC EQ 25MG BASE A 078626 001 Jan 31, 2008 May DISC @ EQ 50MG BASE A 078626 002 Jan 31, 2008 May DISC

SEVELAMER HYDROCHLORIDE TABLET;ORAL RENAGEL AB + GENZYME 400MG N 021179 001 Jul 12, 2000 Feb CFTG AB +! 800MG N 021179 002 Jul 12, 2000 Feb CFTG SEVELAMER HYDROCHLORIDE AB GLENMARK PHARMS LTD 400MG A 204724 001 Feb 08, 2019 Feb NFTG AB 800MG A 204724 002 Feb 08, 2019 Feb NFTG

SILDENAFIL CITRATE FOR SUSPENSION;ORAL REVATIO AB +! PFIZER EQ 10MG BASE/ML N 203109 001 Aug 30, 2012 May CFTG SILDENAFIL CITRATE AB AJANTA PHARMA LTD EQ 10MG BASE/ML A 212883 001 Nov 27, 2019 Nov NEWA AB ALKEM LABS LTD EQ 10MG BASE/ML A 212440 001 Nov 27, 2019 Nov NEWA AB AMNEAL PHARMS EQ 10MG BASE/ML A 211092 001 Nov 27, 2019 Nov NEWA AB NOVITIUM PHARMA EQ 10MG BASE/ML A 212260 001 May 31, 2019 May NFTG TABLET;ORAL SILDENAFIL CITRATE AB LUPIN LTD EQ 25MG BASE A 212051 001 Mar 22, 2019 Mar NEWA AB EQ 50MG BASE A 212051 002 Mar 22, 2019 Mar NEWA AB EQ 100MG BASE A 212051 003 Mar 22, 2019 Mar NEWA AB MYLAN EQ 25MG BASE A 201171 001 Mar 25, 2019 Mar NEWA AB EQ 50MG BASE A 201171 002 Mar 25, 2019 Mar NEWA AB EQ 100MG BASE A 201171 003 Mar 25, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -138

SILODOSIN CAPSULE;ORAL SILODOSIN AB ALEMBIC PHARMS LTD 4MG A 211731 001 Nov 22, 2019 Nov NEWA AB 8MG A 211731 002 Nov 22, 2019 Nov NEWA

SIMVASTATIN TABLET;ORAL SIMVASTATIN AB MICRO LABS 5MG A 090383 001 Sep 16, 2011 Mar CAHN AB 10MG A 090383 002 Sep 16, 2011 Mar CAHN AB 20MG A 090383 003 Sep 16, 2011 Mar CAHN AB 40MG A 090383 004 Sep 16, 2011 Mar CAHN AB 80MG A 090383 005 Sep 16, 2011 Mar CAHN

SIPONIMOD TABLET;ORAL MAYZENT + NOVARTIS PHARMS CORP 0.25MG N 209884 001 Mar 26, 2019 Mar NEWA +! 2MG N 209884 002 Mar 26, 2019 Mar NEWA

SIPONIMOD FUMARIC ACID TABLET;ORAL MAYZENT + NOVARTIS EQ 0.25MG BASE N 209884 001 Mar 26, 2019 Apr CAIN +! EQ 2MG BASE N 209884 002 Mar 26, 2019 Apr CAIN

SIROLIMUS SOLUTION;ORAL RAPAMUNE AA +! PF PRISM CV 1MG/ML N 021083 001 Sep 15, 1999 Jan CFTG SIROLIMUS AA AMNEAL PHARMS LLC 1MG/ML A 211212 001 Oct 18, 2019 Oct NEWA AA APOTEX 1MG/ML A 211406 001 Oct 22, 2019 Oct NEWA AA NOVITIUM PHARMA 1MG/ML A 211040 001 Jan 28, 2019 Jan NFTG

SODIUM BICARBONATE INJECTABLE;INJECTION SODIUM BICARBONATE AP EXELA PHARMA SCS LLC 0.5MEQ/ML A 211091 001 Jun 20, 2019 Oct CTEC 0.5MEQ/ML A 211091 001 Jun 20, 2019 Jun NEWA AP 0.9MEQ/ML A 211091 002 Jun 20, 2019 Jun NEWA AP 1MEQ/ML A 211091 003 Jun 20, 2019 Jun NEWA AP HOSPIRA INC 0.5MEQ/ML A 202981 001 Mar 04, 2016 Oct CMFD

SODIUM CHLORIDE INJECTABLE;INJECTION SODIUM CHLORIDE 0.9% >A> + B BRAUN 9MG/10ML N 019635 005 Aug 11, 2016 Dec CPOT >D> + 900MG/10ML N 019635 005 Aug 11, 2016 Dec CPOT SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER AP JUBILANT CADISTA 9MG/ML A 203352 001 May 18, 2016 Sep CAHN + @ LIEBEL-FLARSHEIM 405MG/50ML (9MG/ML) N 021569 001 Jul 27, 2006 Aug DISC SODIUM CHLORIDE 3% IN PLASTIC CONTAINER AP FRESENIUS KABI USA 3GM/100ML A 209476 001 Mar 13, 2019 Feb NEWA

SODIUM CHROMATE CR-51 INJECTABLE;INJECTION SODIUM CHROMATE CR 51 @ CURIUM 100uCi/ML N 016708 001 Jan CAHN

SODIUM FLUORIDE F-18 INJECTABLE;INTRAVENOUS SODIUM FLUORIDE F-18 AP DECATUR 10-200mCi/ML A 204464 001 Oct 21, 2014 Apr CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -139

SODIUM IODIDE I-131 CAPSULE;ORAL SODIUM IODIDE I 131 CU RIU M@ CURIUM@ 0.8-100mCi N 016515 002 Jan CAHN + @ 0.8-100mCi N 016517 001 Jan CAHN @ 15-100uCi N 016517 002 Jan CAHN SOLUTION;ORAL SODIUM IODIDE I 131 + CURIUM@ 3.5-150mCi/VIAL N 016515 001 Jan CAHN

SODIUM NITROPRUSSIDE INJECTABLE;INJECTION SODIUM NITROPRUSSIDE AP CAPLIN 25MG/ML A 211016 001 Nov 29, 2019 Nov NEWA AP DR REDDYS LABS LTD 25MG/ML A 210114 001 Apr 10, 2019 Mar NEWA AP SAGENT PHARMS INC 25MG/ML A 207426 001 Dec 08, 2016 Sep CAHN @ SUN PHARM 25MG/ML A 210467 001 Nov 26, 2018 Jul DISC @ VIRTUS PHARM 25MG/ML A 209834 001 Jun 26, 2018 Oct DISC AP 25MG/ML A 209834 001 Jun 26, 2018 Jul CAHN SOLUTION;INTRAVENOUS NIPRIDE RTU IN SODIUM CHLORIDE 0.9% + @ EXELA PHARMA SCS LLC 10MG/50ML (0.2MG/ML) N 209387 002 Dec 07, 2017 Jul DISC

SODIUM PHENYLBUTYRATE POWDER;ORAL BUPHENYL AB +! HORIZON THERAP 3GM/TEASPOONFUL N 020573 001 Apr 30, 1996 Feb CAHN TABLET;ORAL BUPHENYL AB +! HORIZON THERAP 500MG N 020572 001 May 13, 1996 Feb CAHN

SODIUM POLYSTYRENE SULFONATE POWDER;ORAL, RECTAL SODIUM POLYSTYRENE SULFONATE AA NOVELGENIX THERAPS 454GM/BOT A 206815 001 Feb 18, 2016 Sep CAHN

SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION SODIUM TETRADECYL SULFATE AP CUSTOPHARM INC 60MG/2ML (30MG/ML) A 209937 001 Dec 09, 2019 Nov NEWA SOTRADECOL AP ! MYLAN INSTITUTIONAL 60MG/2ML (30MG/ML) A 040541 002 Nov 12, 2004 Nov CTEC

SOFOSBUVIR PELLETS;ORAL SOVALDI + GILEAD SCIENCES INC 150MG/PACKET N 212480 001 Aug 28, 2019 Aug NEWA +! 200MG/PACKET N 212480 002 Aug 28, 2019 Aug NEWA TABLET;ORAL SOVALDI + GILEAD SCIENCES INC 200MG N 204671 002 Aug 28, 2019 Aug NEWA

SOLIFENACIN SUCCINATE TABLET;ORAL SOLIFENACIN SUCCINATE AB AJANTA PHARMA LTD 5MG A 205483 001 May 20, 2019 May NEWA AB 10MG A 205483 002 May 20, 2019 May NEWA AB ALEMBIC PHARMS LTD 5MG A 205575 001 May 20, 2019 May NEWA AB 10MG A 205575 002 May 20, 2019 May NEWA AB ALKEM LABS LTD 5MG A 210224 001 May 20, 2019 May NEWA AB 10MG A 210224 002 May 20, 2019 May NEWA AB AMNEAL PHARMS CO 5MG A 209719 001 May 20, 2019 May NEWA AB 10MG A 209719 002 May 20, 2019 May NEWA AB BRECKENRIDGE 5MG A 209818 001 May 20, 2019 May NEWA AB 10MG A 209818 002 May 20, 2019 May NEWA AB CELLTRION 5MG A 210582 001 May 20, 2019 May NEWA AB 10MG A 210582 002 May 20, 2019 May NEWA AB CIPLA 5MG A 209839 001 May 20, 2019 May NEWA AB 10MG A 209839 002 May 20, 2019 May NEWA AB CSPC OUYI 5MG A 211423 001 Dec 11, 2019 Nov NEWA AB 10MG A 211423 002 Dec 11, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -140

TABLET;ORAL SOLIFENACIN SUCCINATE AB GLENMARK PHARMS INC 5MG A 209239 001 May 20, 2019 May NEWA AB 10MG A 209239 002 May 20, 2019 May NEWA AB JIANGXI BOYA SEEHOT 5MG A 210281 001 May 20, 2019 May NEWA AB 10MG A 210281 002 May 20, 2019 May NEWA AB MSN 5MG A 210688 001 May 20, 2019 May NEWA AB 10MG A 210688 002 May 20, 2019 May NEWA AB QILU 5MG A 209333 001 May 20, 2019 May NEWA AB 10MG A 209333 002 May 20, 2019 May NEWA AB SCIEGEN PHARMS INC 5MG A 211657 001 May 20, 2019 May NEWA AB 10MG A 211657 002 May 20, 2019 May NEWA AB STRIDES PHARMA 5MG A 212214 001 Sep 26, 2019 Sep NEWA AB 10MG A 212214 002 Sep 26, 2019 Sep NEWA AB UNICHEM LABS LTD 5MG A 211701 001 Aug 27, 2019 Aug NEWA AB 10MG A 211701 002 Aug 27, 2019 Aug NEWA AB WATSON LABS INC 5MG A 202551 001 May 20, 2019 May NEWA AB 10MG A 202551 002 May 20, 2019 May NEWA

SOLRIAMFETOL TABLET;ORAL SUNOSI + JAZZ 75MG N 211230 001 Jun 17, 2019 Jun NEWA + 150MG N 211230 002 Jun 17, 2019 Jun NEWA

SOMATROPIN INJECTABLE;INJECTION GENOTROPIN >A> BX +! PHARMACIA 5.8MG/VIAL N 020280 006 Aug 24, 1995 Dec CAHN >A> +! 13.8MG/VIAL N 020280 007 Oct 23, 1996 Dec CAHN >D> BX +! PHARMACIA AND UPJOHN 5.8MG/VIAL N 020280 006 Aug 24, 1995 Dec CAHN BX +! 5.8MG/VIAL N 020280 006 Aug 24, 1995 Aug CAIN >D> +! 13.8MG/VIAL N 020280 007 Oct 23, 1996 Dec CAHN +! 13.8MG/VIAL N 020280 007 Oct 23, 1996 Aug CAIN GENOTROPIN PRESERVATIVE FREE >A> + PHARMACIA 0.2MG/VIAL N 020280 001 Jan 27, 1998 Dec CAHN >A> + 0.4MG/VIAL N 020280 002 Jan 27, 1998 Dec CAHN >A> + 0.6MG/VIAL N 020280 003 Jan 27, 1998 Dec CAHN >A> + 0.8MG/VIAL N 020280 005 Jan 27, 1998 Dec CAHN >A> + 1MG/VIAL N 020280 008 Jan 27, 1998 Dec CAHN >A> + 1.2MG/VIAL N 020280 009 Jan 27, 1998 Dec CAHN >A> + 1.4MG/VIAL N 020280 010 Jan 27, 1998 Dec CAHN >A> + @ 1.5MG/VIAL N 020280 004 Aug 24, 1995 Dec CAHN >A> + 1.6MG/VIAL N 020280 011 Jan 27, 1998 Dec CAHN >A> + 1.8MG/VIAL N 020280 012 Jan 27, 1998 Dec CAHN >A> +! 2MG/VIAL N 020280 013 Jan 27, 1998 Dec CAHN >D> + PHARMACIA AND UPJOHN 0.2MG/VIAL N 020280 001 Jan 27, 1998 Dec CAHN + 0.2MG/VIAL N 020280 001 Jan 27, 1998 Aug CAIN >D> + 0.4MG/VIAL N 020280 002 Jan 27, 1998 Dec CAHN + 0.4MG/VIAL N 020280 002 Jan 27, 1998 Aug CAIN >D> + 0.6MG/VIAL N 020280 003 Jan 27, 1998 Dec CAHN + 0.6MG/VIAL N 020280 003 Jan 27, 1998 Aug CAIN >D> + 0.8MG/VIAL N 020280 005 Jan 27, 1998 Dec CAHN + 0.8MG/VIAL N 020280 005 Jan 27, 1998 Aug CAIN >D> + 1MG/VIAL N 020280 008 Jan 27, 1998 Dec CAHN + 1MG/VIAL N 020280 008 Jan 27, 1998 Aug CAIN >D> + 1.2MG/VIAL N 020280 009 Jan 27, 1998 Dec CAHN + 1.2MG/VIAL N 020280 009 Jan 27, 1998 Aug CAIN >D> + 1.4MG/VIAL N 020280 010 Jan 27, 1998 Dec CAHN + 1.4MG/VIAL N 020280 010 Jan 27, 1998 Aug CAIN >D> + @ 1.5MG/VIAL N 020280 004 Aug 24, 1995 Dec CAHN + @ 1.5MG/VIAL N 020280 004 Aug 24, 1995 Aug CAIN >D> + 1.6MG/VIAL N 020280 011 Jan 27, 1998 Dec CAHN + 1.6MG/VIAL N 020280 011 Jan 27, 1998 Aug CAIN >D> + 1.8MG/VIAL N 020280 012 Jan 27, 1998 Dec CAHN + 1.8MG/VIAL N 020280 012 Jan 27, 1998 Aug CAIN >D> +! 2MG/VIAL N 020280 013 Jan 27, 1998 Dec CAHN +! 2MG/VIAL N 020280 013 Jan 27, 1998 Aug CAIN NORDITROPIN @ NOVO NORDISK INC 5MG/1.5ML N 021148 001 Jun 20, 2000 Aug CAIN @ 10MG/1.5ML N 021148 002 Jun 20, 2000 Aug CAIN @ 15MG/1.5ML N 021148 003 Jun 20, 2000 Aug CAIN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -141

INJECTABLE;INJECTION NORDITROPIN FLEXPRO BX NOVO NORDISK INC 5MG/1.5ML N 021148 008 Mar 01, 2010 Aug CAIN BX 10MG/1.5ML N 021148 009 Mar 01, 2010 Aug CAIN 15MG/1.5ML N 021148 010 Mar 01, 2010 Aug CAIN 30MG/3ML N 021148 011 Jan 23, 2015 Aug CAIN NORDITROPIN NORDIFLEX @ NOVO NORDISK INC 5MG/1.5ML N 021148 004 Oct 01, 2004 Aug CAIN @ 10MG/1.5ML N 021148 005 Oct 01, 2004 Aug CAIN @ 15MG/1.5ML N 021148 006 Oct 01, 2004 Aug CAIN @ 30MG/3ML N 021148 007 Mar 10, 2009 Aug CAIN NUTROPIN @ GENENTECH 5MG/VIAL N 020168 001 Nov 17, 1993 Aug CAIN @ 10MG/VIAL N 020168 002 Nov 17, 1993 Aug CAIN NUTROPIN AQ @ GENENTECH 10MG/2ML (5MG/ML) N 020522 001 Dec 29, 1995 Aug CAIN NUTROPIN AQ NUSPIN +! GENENTECH 5MG/2ML (2.5MG/ML) N 020522 003 Jan 03, 2008 Aug CAIN +! 10MG/2ML (5MG/ML) N 020522 005 Jan 03, 2008 Aug CAIN +! 20MG/2ML (10MG/ML) N 020522 004 Jan 03, 2008 Aug CAIN NUTROPIN AQ PEN + @ GENENTECH 10MG/2ML (5MG/ML) N 020522 002 Apr 22, 2002 Aug CAIN + @ 20MG/2ML (10MG/ML) N 020522 006 Jan 03, 2008 Aug CAIN OMNITROPE BX SANDOZ 1.5MG/VIAL N 021426 002 May 30, 2006 Aug CAIN BX 5MG/1.5ML N 021426 003 Jan 16, 2008 Aug CAIN BX 5.8MG/VIAL N 021426 001 May 30, 2006 Aug CAIN BX 10MG/1.5ML N 021426 004 Aug 25, 2008 Aug CAIN SAIZEN @ EMD SERONO 4MG/VIAL N 019764 005 Jan 16, 2007 Aug CAIN BX + 5MG/VIAL N 019764 002 Oct 08, 1996 Aug CAIN @ 6MG/VIAL N 019764 001 Oct 08, 1996 Aug CAIN +! 8.8MG/VIAL N 019764 003 Aug 29, 2000 Aug CAIN SEROSTIM EMD SERONO 4MG/VIAL N 020604 003 Jul 25, 1997 Aug CAIN BX 5MG/VIAL N 020604 002 Aug 23, 1996 Aug CAIN BX 6MG/VIAL N 020604 001 Aug 23, 1996 Aug CAIN @ 8.8MG/VIAL N 020604 004 Sep 06, 2001 Aug CAIN INJECTABLE;SUBCUTANEOUS SEROSTIM LQ @ EMD SERONO 6MG/0.5ML (6MG/0.5ML) N 020604 005 Feb 11, 2005 Aug CAIN

SOTALOL HYDROCHLORIDE TABLET;ORAL BETAPACE AB + COVIS PHARMA BV 80MG N 019865 001 Oct 30, 1992 May CTEC AB + 120MG N 019865 005 Apr 20, 1994 May CTEC AB +! 160MG N 019865 002 Oct 30, 1992 May CTEC AB + 240MG N 019865 003 Oct 30, 1992 May CTEC BETAPACE AF AB + COVIS PHARMA BV 80MG N 021151 001 Feb 22, 2000 May CTEC AB + 120MG N 021151 002 Feb 22, 2000 May CTEC AB +! 160MG N 021151 003 Feb 22, 2000 May CTEC SORINE AB UPSHER SMITH LABS 80MG A 075500 001 Apr 27, 2001 May CTEC AB 120MG A 075500 004 Apr 27, 2001 May CTEC AB 160MG A 075500 002 Apr 27, 2001 May CTEC AB 240MG A 075500 003 Apr 27, 2001 May CTEC SOTALOL HYDROCHLORIDE AB APOTEX 80MG A 076140 001 Sep 26, 2002 May CTEC AB 80MG A 076214 001 Aug 27, 2003 May CTEC AB 120MG A 076140 002 Sep 26, 2002 May CTEC AB 120MG A 076214 002 Aug 27, 2003 May CTEC AB 160MG A 076140 003 Sep 26, 2002 May CTEC AB 160MG A 076214 003 Aug 27, 2003 May CTEC AB 240MG A 076140 004 Sep 26, 2002 May CTEC AB BEXIMCO PHARMS USA 80MG A 207428 001 Oct 21, 2016 May CTEC AB 80MG A 207429 001 Nov 02, 2018 May CTEC AB 120MG A 207428 002 Oct 21, 2016 May CTEC AB 120MG A 207429 002 Nov 02, 2018 May CTEC AB 160MG A 207428 003 Oct 21, 2016 May CTEC AB 160MG A 207429 003 Nov 02, 2018 May CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -142

TABLET;ORAL SOTALOL HYDROCHLORIDE AB EPIC PHARMA INC 80MG A 077070 001 Nov 04, 2005 May CTEC AB 120MG A 077070 002 Nov 04, 2005 May CTEC AB 160MG A 077070 003 Nov 04, 2005 May CTEC AB MYLAN 80MG A 077616 001 Feb 07, 2007 May CTEC AB 120MG A 077616 002 Feb 07, 2007 May CTEC AB 160MG A 077616 003 Feb 07, 2007 May CTEC AB OXFORD PHARMS 80MG A 075563 001 Nov 07, 2003 May CTEC AB 120MG A 075563 002 Nov 07, 2003 May CTEC AB 160MG A 075563 003 Nov 07, 2003 May CTEC AB 240MG A 075563 004 Nov 07, 2003 May CTEC AB TEVA 80MG A 075429 001 May 01, 2000 May CTEC AB 120MG A 075429 002 May 01, 2000 May CTEC AB 160MG A 075429 003 May 01, 2000 May CTEC AB 240MG A 075429 004 May 01, 2000 May CTEC

SPIRONOLACTONE TABLET;ORAL SPIRONOLACTONE @ ACTAVIS ELIZABETH 25MG A 040353 003 Mar 15, 2006 Jun DISC @ 50MG A 040353 001 Jul 29, 1999 Jun DISC @ 100MG A 040353 002 Jul 29, 1999 Jun DISC @ CASI PHARMS INC 25MG A 086809 001 Jun DISC

STAVUDINE CAPSULE;ORAL STAVUDINE @ HETERO LABS LTD III 15MG A 078957 001 Dec 29, 2008 Nov DISC @ 20MG A 078957 002 Dec 29, 2008 Nov DISC @ 30MG A 078957 003 Dec 29, 2008 Nov DISC @ 40MG A 078957 004 Dec 29, 2008 Nov DISC @ MYLAN 15MG A 079069 001 Dec 29, 2008 Oct DISC @ 20MG A 079069 002 Dec 29, 2008 Oct DISC @ 30MG A 079069 003 Dec 29, 2008 Oct DISC @ 40MG A 079069 004 Dec 29, 2008 Oct DISC FOR SOLUTION;ORAL ZERIT + @ BRISTOL-MYERS SQUIBB 1MG/ML N 020413 001 Sep 06, 1996 Mar DISC

STERILE WATER FOR INJECTION LIQUID;N/A STERILE WATER FOR INJECTION + @ HOSPIRA 100% (1ML) N 018801 001 Oct 27, 1982 Nov DISC AP +! 100% (1ML) N 018801 001 Oct 27, 1982 Nov CPOT AP +! 100% (10ML) N 018801 002 Oct 27, 1982 Nov NEWA +! 100% (20ML) N 018801 003 Oct 27, 1982 Nov NEWA +! 100% (50ML) N 018801 004 Oct 27, 1982 Nov NEWA +! 100% (100ML) N 018801 005 Oct 27, 1982 Nov NEWA MEDEFIL INC 100% (1ML) A 211188 001 Dec 02, 2019 Nov NEWA ! 100% (2.5ML) A 211188 002 Dec 02, 2019 Nov NEWA ! 100% (3ML) A 211188 003 Dec 02, 2019 Nov NEWA ! 100% (5ML) A 211188 004 Dec 02, 2019 Nov NEWA AP 100% (10ML) A 211188 005 Dec 02, 2019 Nov NEWA AP WEST-WARD PHARMS INT 100% (10ML) A 206369 001 Sep 02, 2015 Nov CPOT @ 100% (20ML) A 206369 002 Sep 02, 2015 Nov DISC 100% (20ML) A 206369 002 Sep 02, 2015 Nov NEWA

STERILE WATER FOR IRRIGATION LIQUID;IRRIGATION STERILE WATER AT + BAXTER HLTHCARE 100% N 017428 001 Oct CRLD

STRONTIUM CHLORIDE SR-89 INJECTABLE;INJECTION METASTRON AP +! Q BIOMED 1mCi/ML N 020134 001 Jun 18, 1993 Jan CAHN STRONTIUM CHLORIDE SR-89 AP Q BIOMED 1mCi/ML A 075941 001 Jan 06, 2003 Oct CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -143

SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION SUCCINYLCHOLINE CHLORIDE AP AMRING PHARMS 20MG/ML A 210231 001 Jun 04, 2018 Jan CAHN AP BRECKENRIDGE 20MG/ML A 212638 001 Oct 09, 2019 Nov CAHN AP DR REDDYS 20MG/ML A 210698 001 Aug 02, 2019 Jul NEWA AP GPP 20MG/ML A 212638 001 Oct 09, 2019 Sep NEWA >A> AP SOMERSET THERAPS LLC 20MG/ML A 211589 001 Jan 15, 2020 Dec NEWA

SUCRALFATE SUSPENSION;ORAL CARAFATE AB +! ALLERGAN 1GM/10ML N 019183 001 Dec 16, 1993 Nov CFTG SUCRALFATE AB AMNEAL PHARMS LLC 1GM/10ML A 209356 001 Dec 02, 2019 Nov NFTG TABLET;ORAL SUCRALFATE >D> @ MYLAN IRELAND LTD 1GM A 074415 001 Jun 08, 1998 Dec CAHN >A> @ NOSTRUM LABS INC 1GM A 074415 001 Jun 08, 1998 Dec CAHN

SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE;INJECTION SULFAMETHOXAZOLE AND TRIMETHOPRIM AP ANDA REPOSITORY 80MG/ML;16MG/ML A 212231 001 Jun 26, 2019 Sep CAHN AP ! MYLAN LABS LTD 80MG/ML;16MG/ML A 206607 001 Aug 30, 2017 Aug CHRS AP SOMERSET 80MG/ML;16MG/ML A 212231 001 Jun 26, 2019 Oct CAHN AP SOMERSET THERAPS LLC 80MG/ML;16MG/ML A 212231 001 Jun 26, 2019 Jun NEWA @ TEVA PHARMS USA 80MG/ML;16MG/ML A 073303 001 Oct 31, 1991 Aug DISC SUSPENSION;ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM AB ANI PHARMS INC 200MG/5ML;40MG/5ML A 077612 001 Nov 13, 2006 Oct CMFD TABLET;ORAL SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH @ HERITAGE PHARMA 800MG;160MG A 070037 001 Jun 02, 1987 Nov DISC AB 800MG;160MG A 070037 001 Jun 02, 1987 May CAHN SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH @ HERITAGE PHARMA 400MG;80MG A 070030 001 Jun 02, 1987 Nov DISC AB 400MG;80MG A 070030 001 Jun 02, 1987 May CAHN

SUMATRIPTAN SPRAY;NASAL TOSYMRA +! DR REDDYS LABS LTD 10MG/SPRAY N 210884 001 Jan 25, 2019 Jan NEWA +! UPSHER SMITH LABS 10MG/SPRAY N 210884 001 Jan 25, 2019 Sep CAHN +! 10MG/SPRAY N 210884 001 Jan 25, 2019 Jul CAHN

SUMATRIPTAN SUCCINATE INJECTABLE;SUBCUTANEOUS SUMATRIPTAN SUCCINATE @ MYLAN LABS LTD EQ 6MG BASE/0.5ML (EQ 12MG A 203322 001 Apr 14, 2014 Sep DISC BASE/ML) @ PAR STERILE PRODUCTS EQ 6MG BASE/0.5ML (EQ 12MG A 077871 001 Jul 09, 2009 Apr DISC BASE/ML) >D> AP TEVA PHARMS USA EQ 6MG BASE/0.5ML (EQ 12MG A 077907 001 Feb 06, 2009 Dec DISC BASE/ML) >A> @ EQ 6MG BASE/0.5ML (EQ 12MG A 077907 001 Feb 06, 2009 Dec DISC BASE/ML) ZY DUS@ ZYDUS@ EQ 6MG BASE/0.5ML (EQ 12MG A 090310 001 Aug 11, 2010 Apr CAHN BASE/ML) POWDER;NASAL ONZETRA XSAIL +! AVANIR PHARMS EQ 11MG BASE N 206099 001 Jan 27, 2016 Sep CDFR +! CURRAX EQ 11MG BASE N 206099 001 Jan 27, 2016 Sep CAHN SOLUTION;SUBCUTANEOUS ZEMBRACE SYMTOUCH + UPSHER SMITH LABS EQ 3MG BASE/0.5ML (EQ 3MG N 208223 001 Jan 28, 2016 Jul CAHN BASE/0.5ML) RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -144

TACROLIMUS OINTMENT;TOPICAL TACROLIMUS AB ACCORD HLTHCARE 0.03% A 211688 001 Jan 31, 2019 Jan NEWA AB 0.1% A 211688 002 Jan 31, 2019 Jan NEWA

TADALAFIL TABLET;ORAL ALYQ AB2 TEVA PHARMS USA 20MG A 209942 001 Feb 05, 2019 Jan NEWA TADALAFIL AB ACCORD HLTHCARE 2.5MG A 209167 001 Mar 26, 2019 Mar NEWA AB 5MG A 209167 002 Mar 26, 2019 Mar NEWA AB1 20MG A 209167 004 Mar 26, 2019 Mar NEWA AB AJANTA PHARMA LTD 2.5MG A 209654 001 Mar 26, 2019 Mar NEWA AB 5MG A 209654 002 Mar 26, 2019 Mar NEWA AB 10MG A 209654 003 Mar 26, 2019 Mar NEWA AB1 20MG A 209654 004 Mar 26, 2019 Mar NEWA AB2 20MG A 210392 001 Feb 05, 2019 Jan NEWA AB ALEMBIC PHARMS LTD 2.5MG A 204809 001 Mar 26, 2019 Mar NEWA AB 5MG A 204809 002 Mar 26, 2019 Mar NEWA AB 10MG A 204809 003 Mar 26, 2019 Mar NEWA AB1 20MG A 204809 004 Mar 26, 2019 Mar NEWA AB AMNEAL PHARMS CO 2.5MG A 209744 001 Mar 26, 2019 Mar NEWA AB 5MG A 209744 002 Mar 26, 2019 Mar NEWA AB 10MG A 209744 003 Mar 26, 2019 Mar NEWA AB1 20MG A 209744 004 Mar 26, 2019 Mar NEWA AB AUROBINDO PHARMA LTD 2.5MG A 206285 001 Mar 26, 2019 Mar NEWA AB 5MG A 206285 002 Mar 26, 2019 Mar NEWA AB 10MG A 206285 003 Mar 26, 2019 Mar NEWA AB1 20MG A 206285 004 Mar 26, 2019 Mar NEWA AB2 20MG A 206286 001 Feb 05, 2019 Jan NEWA AB CIPLA 2.5MG A 209539 001 Mar 26, 2019 Mar NEWA AB 5MG A 209539 002 Mar 26, 2019 Mar NEWA AB 10MG A 209539 003 Mar 26, 2019 Mar NEWA AB1 20MG A 209539 004 Mar 26, 2019 Mar NEWA AB2 20MG A 210255 001 Feb 05, 2019 Jan NEWA AB DR REDDYS LABS LTD 2.5MG A 210069 001 Mar 26, 2019 Mar NEWA AB 5MG A 210069 002 Mar 26, 2019 Mar NEWA AB 10MG A 210069 003 Mar 26, 2019 Mar NEWA AB1 20MG A 210069 004 Mar 26, 2019 Mar NEWA AB2 20MG A 210145 001 Feb 05, 2019 Jan NEWA AB HETERO LABS LTD III 2.5MG A 209908 001 Mar 26, 2019 Mar NEWA AB 5MG A 209908 002 Mar 26, 2019 Mar NEWA AB 10MG A 209908 003 Mar 26, 2019 Mar NEWA AB2 20MG A 209907 001 Feb 05, 2019 Jan NEWA AB1 20MG A 209908 004 Mar 26, 2019 Mar NEWA AB LUPIN LTD 2.5MG A 210567 001 Mar 26, 2019 Mar NEWA AB 5MG A 210567 002 Mar 26, 2019 Mar NEWA AB 10MG A 210567 003 Mar 26, 2019 Mar NEWA AB1 20MG A 210567 004 Mar 26, 2019 Mar NEWA AB2 20MG A 210572 001 Feb 05, 2019 Jan NEWA AB MACLEODS PHARMS LTD 2.5MG A 207244 001 Oct 07, 2019 Sep NEWA AB 5MG A 207244 002 Oct 07, 2019 Sep NEWA AB 10MG A 207244 003 Oct 07, 2019 Sep NEWA AB1 20MG A 207244 004 Oct 07, 2019 Sep NEWA AB2 20MG A 207290 001 Oct 16, 2019 Sep NEWA AB MYLAN 2.5MG A 206956 001 Apr 29, 2019 Apr NEWA AB 5MG A 206957 001 Apr 29, 2019 Apr NEWA AB 10MG A 206956 002 Apr 29, 2019 Apr NEWA AB1 20MG A 206956 003 Apr 29, 2019 Apr NEWA AB QILU 2.5MG A 210420 001 Mar 26, 2019 Mar NEWA AB 5MG A 210420 002 Mar 26, 2019 Mar NEWA AB 10MG A 210420 003 Mar 26, 2019 Mar NEWA AB1 20MG A 210420 004 Mar 26, 2019 Mar NEWA AB SUN PHARM 2.5MG A 208934 001 Mar 26, 2019 Mar NEWA AB 5MG A 208934 002 Mar 26, 2019 Mar NEWA AB 10MG A 208934 003 Mar 26, 2019 Mar NEWA AB1 20MG A 208934 004 Mar 26, 2019 Mar NEWA AB SUNSHINE LAKE 2.5MG A 211335 001 Mar 26, 2019 Mar NEWA AB 5MG A 211335 002 Mar 26, 2019 Mar NEWA AB 10MG A 211335 003 Mar 26, 2019 Mar NEWA AB1 20MG A 211335 004 Mar 26, 2019 Mar NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -145

TABLET;ORAL TADALAFIL AB TORRENT 2.5MG A 211839 001 Mar 26, 2019 Mar NEWA AB 5MG A 211839 002 Mar 26, 2019 Mar NEWA AB 10MG A 211839 003 Mar 26, 2019 Mar NEWA AB1 20MG A 211839 004 Mar 26, 2019 Mar NEWA AB2 20MG A 212062 001 Mar 26, 2019 Mar NEWA AB UNICHEM LABS LTD 2.5MG A 209250 001 Mar 26, 2019 Mar NEWA AB 5MG A 209250 002 Mar 26, 2019 Mar NEWA AB 10MG A 209250 003 Mar 26, 2019 Mar NEWA AB1 20MG A 209250 004 Mar 26, 2019 Mar NEWA @ WATSON LABS INC 2.5MG A 205885 001 Mar 29, 2019 Sep DISC AB 2.5MG A 205885 001 Mar 29, 2019 Mar NEWA @ 5MG A 205885 002 Mar 29, 2019 Sep DISC AB 5MG A 205885 002 Mar 29, 2019 Mar NEWA @ 10MG A 205885 003 Mar 29, 2019 Sep DISC AB 10MG A 205885 003 Mar 29, 2019 Mar NEWA @ 20MG A 205885 004 Mar 29, 2019 Sep DISC AB1 20MG A 205885 004 Mar 29, 2019 Mar NEWA AB ZYDUS PHARMS 2.5MG A 206693 001 Mar 26, 2019 Mar NEWA AB 5MG A 206693 002 Mar 26, 2019 Mar NEWA AB 10MG A 206693 003 Mar 26, 2019 Mar NEWA AB1 20MG A 206693 004 Mar 26, 2019 Mar NEWA

TAFAMIDIS CAPSULE;ORAL VYNDAMAX +! FOLDRX PHARMS 61MG N 212161 001 May 03, 2019 May NEWA

TAFAMIDIS MEGLUMINE CAPSULE;ORAL VYNDAQEL +! FOLDRX PHARMS 20MG N 211996 001 May 03, 2019 May NEWA

TAFLUPROST SOLUTION/DROPS;OPHTHALMIC TAFLUPROST AT MICRO LABS 0.0015% A 209051 001 Aug 19, 2019 Aug NFTG ZIOPTAN AT +! OAK PHARMS INC 0.0015% N 202514 001 Feb 10, 2012 Aug CFTG

TAMOXIFEN CITRATE SOLUTION;ORAL SOLTAMOX FORTOVIA EQ 20MG BASE/10ML N 021807 001 Oct 29, 2005 Aug CAHN

TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL TAMSULOSIN HYDROCHLORIDE AB ANBISON LAB 0.4MG A 211885 001 Oct 17, 2019 Oct NEWA @ MYLAN 0.4MG A 090408 001 Apr 27, 2010 Nov DISC

TAZAROTENE CREAM;TOPICAL TAZAROTENE @ FOUGERA PHARMS INC 0.1% A 211175 001 Jan 28, 2019 Aug DISC AB 0.1% A 211175 001 Jan 28, 2019 May CPOT AB 1% A 211175 001 Jan 28, 2019 Jan NEWA >A> LOTION;TOPICAL >A> ARAZLO >A> +! BAUSCH 0.045% N 211882 001 Dec 18, 2019 Dec NEWA

TECHNETIUM TC-99M DISOFENIN KIT INJECTABLE;INJECTION HEPATOLITE @ PHARMALUCENCE N/A N 018467 001 Mar 16, 1982 Aug DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -146

TECHNETIUM TC-99M MERTIATIDE KIT INJECTABLE;INJECTION TECHNESCAN MAG3 AP +! CURIUM N/A N 019882 001 Jun 15, 1990 Jul CFTG +! N/A N 019882 001 Jun 15, 1990 Jan CAHN TECHNETIUM TC99M MERTIATIDE KIT AP PHARMALUCENCE N/A A 208994 001 Jul 12, 2019 Jul NFTG

TECHNETIUM TC-99M OXIDRONATE KIT INJECTABLE;INJECTION TECHNESCAN +! CURIUM N/A N 018321 001 Jan CAHN

TECHNETIUM TC-99M PENTETATE KIT INJECTABLE;INJECTION DRAXIMAGE DTPA +! JUBILANT DRAXIMAGE N/A N 018511 001 Dec 29, 1989 Sep CTNA

TECHNETIUM TC-99M PYROPHOSPHATE KIT INJECTABLE;INJECTION TECHNESCAN PYP KIT AP CURIUM N/A N 017538 001 Jan CAHN

TECHNETIUM TC-99M RED BLOOD CELL KIT INJECTABLE;INJECTION ULTRATAG +! CURIUM N/A N 019981 001 Jun 10, 1991 Jan CAHN

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR SOLUTION;INTRAVENOUS ULTRA-TECHNEKOW FM +! CURIUM 1-19 CI/GENERATOR N 017243 003 Feb 18, 2014 Jan CAHN @ 0.25-3 CI/GENERATOR N 017243 002 Jan CAHN SOLUTION;INTRAVENOUS, ORAL TECHNETIUM TC 99M GENERATOR + @ GE HEALTHCARE 68-2703mCi/GENERATOR N 017693 002 Dec 13, 2013 Feb DISC

TEGASEROD MALEATE TABLET;ORAL ZELNORM + @ ALFASIGMA EQ 2MG BASE N 021200 001 Jul 24, 2002 Aug CAHN +! EQ 6MG BASE N 021200 002 Jul 24, 2002 Sep CMFD + @ EQ 6MG BASE N 021200 002 Jul 24, 2002 Aug CAHN + @ US WORLDMEDS LLC EQ 2MG BASE N 021200 001 Jul 24, 2002 Jul CRLD + @ EQ 6MG BASE N 021200 002 Jul 24, 2002 Jul CRLD

TELMISARTAN TABLET;ORAL TELMISARTAN @ CIPLA 20MG A 078710 001 Jan 08, 2014 Jun DISC AB 20MG A 078710 001 Jan 08, 2014 Feb CAHN @ 40MG A 078710 002 Jan 08, 2014 Feb CAHN @ 80MG A 078710 003 Jan 08, 2014 Feb CAHN @ HISUN PHARM HANGZHOU 20MG A 207843 001 Feb 19, 2019 Aug DISC AB 20MG A 207843 001 Feb 19, 2019 Feb NEWA @ 40MG A 207843 002 Feb 19, 2019 Aug DISC AB 40MG A 207843 002 Feb 19, 2019 Feb NEWA @ 80MG A 207843 003 Feb 19, 2019 Aug DISC AB 80MG A 207843 003 Feb 19, 2019 Feb NEWA AB INVENTIA 20MG A 205150 001 Oct 30, 2015 Aug CAHN AB 40MG A 205150 002 Oct 30, 2015 Aug CAHN AB 80MG A 205150 003 Oct 30, 2015 Aug CAHN @ MICRO LABS 20MG A 207016 001 Oct 03, 2017 Mar DISC @ 40MG A 207016 002 Oct 03, 2017 Mar DISC @ 80MG A 207016 003 Oct 03, 2017 Mar DISC @ WATSON LABS 80MG A 078710 003 Jan 08, 2014 Feb DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -147

TEMOZOLOMIDE CAPSULE;ORAL TEMOZOLOMIDE @ APOTEX INC 5MG A 204159 001 Jul 05, 2018 Jan DISC @ 20MG A 204159 002 Jul 05, 2018 Jan DISC @ 100MG A 204159 003 Jul 05, 2018 Jan DISC @ 140MG A 204159 004 Jul 05, 2018 Jan DISC @ 180MG A 204159 005 Jul 05, 2018 Jan DISC @ 250MG A 204159 006 Jul 05, 2018 Jan DISC @ LANNETT CO INC 5MG A 203898 001 Feb 10, 2016 Oct DISC @ 20MG A 203898 002 Feb 10, 2016 Oct DISC @ 100MG A 203898 003 Feb 10, 2016 Oct DISC @ 140MG A 203898 004 Feb 10, 2016 Oct DISC @ 180MG A 203898 005 Feb 10, 2016 Oct DISC @ 250MG A 203898 006 Feb 10, 2016 Oct DISC

TEMSIROLIMUS SOLUTION;INTRAVENOUS TEMSIROLIMUS AP GLAND PHARMA LTD 25MG/ML (25MG/ML) A 207383 001 Aug 16, 2019 Aug NEWA

TENAPANOR HYDROCHLORIDE TABLET;ORAL IBSRELA +! ARDELYX INC EQ 50MG BASE N 211801 001 Sep 12, 2019 Sep NEWA

TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL TENOFOVIR DISOPROXIL FUMARATE @ APOTEX 300MG A 206481 001 Jul 26, 2018 Jan DISC @ CHARTWELL 300MG A 206481 001 Jul 26, 2018 Nov CAHN

TERAZOSIN HYDROCHLORIDE CAPSULE;ORAL TERAZOSIN HYDROCHLORIDE AB APNAR PHARMA LP EQ 1MG BASE A 074823 001 Mar 30, 1998 Jun CAHN AB ! EQ 2MG BASE A 074823 002 Mar 30, 1998 Jun CAHN AB EQ 5MG BASE A 074823 003 Mar 30, 1998 Jun CAHN AB EQ 10MG BASE A 074823 004 Mar 30, 1998 Jun CAHN @ BEXIMCO PHARMS USA EQ 1MG BASE A 075667 001 Jul 28, 2000 Feb CAHN @ EQ 2MG BASE A 075667 002 Jul 28, 2000 Feb CAHN @ EQ 5MG BASE A 075667 003 Jul 28, 2000 Feb CAHN @ EQ 10MG BASE A 075667 004 Jul 28, 2000 Feb CAHN AB HERITAGE PHARMA EQ 1MG BASE A 075614 002 Jan 30, 2001 Mar CAHN AB EQ 2MG BASE A 075614 001 Jan 30, 2001 Mar CAHN AB EQ 5MG BASE A 075614 003 Jan 30, 2001 Mar CAHN AB EQ 10MG BASE A 075614 004 Jan 30, 2001 Mar CAHN AB HIKMA EQ 1MG BASE A 075498 001 Apr 12, 2001 Jun CAHN AB EQ 2MG BASE A 075498 002 Apr 12, 2001 Jun CAHN AB EQ 5MG BASE A 075498 003 Apr 12, 2001 Jun CAHN AB EQ 10MG BASE A 075498 004 Apr 12, 2001 Jun CAHN

TERBINAFINE HYDROCHLORIDE TABLET;ORAL TERBINAFINE HYDROCHLORIDE @ CHARTWELL EQ 250MG BASE A 078199 001 Jul 02, 2007 Nov CAHN AB HERITAGE PHARMA EQ 250MG BASE A 076377 001 Jul 02, 2007 May CAHN

TERBUTALINE SULFATE INJECTABLE;INJECTION TERBUTALINE SULFATE @ DR REDDYS 1MG/ML A 076853 001 Jul 20, 2004 May CAHN

TERCONAZOLE CREAM;VAGINAL TERCONAZOLE BX +! FOUGERA PHARMS INC 0.8% N 021735 001 Oct 01, 2004 May CAHN SUPPOSITORY;VAGINAL TERCONAZOLE AB ! PERRIGO ISRAEL 80MG A 077149 001 Mar 17, 2006 May CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -148

TERIFLUNOMIDE TABLET;ORAL TERIFLUNOMIDE AB ALEMBIC PHARMS LTD 7MG A 209572 001 Apr 19, 2019 Apr NEWA AB 14MG A 209572 002 Apr 19, 2019 Apr NEWA @ AMNEAL PHARMS CO 7MG A 209613 001 Sep 28, 2018 Feb DISC @ 14MG A 209613 002 Sep 28, 2018 Feb DISC @ APOTEX 7MG A 209601 001 Nov 02, 2018 Jan DISC @ 14MG A 209601 002 Nov 02, 2018 Jan DISC @ AUROBINDO PHARMA LTD 7MG A 209638 001 Oct 26, 2018 Feb DISC @ 14MG A 209638 002 Oct 26, 2018 Feb DISC @ MSN 7MG A 209623 001 Apr 24, 2019 Oct DISC @ 14MG A 209623 002 Apr 24, 2019 Oct DISC AB MSN LABS PVT LTD 7MG A 209623 001 Apr 24, 2019 Apr NEWA AB 14MG A 209623 002 Apr 24, 2019 Apr NEWA @ TEVA PHARMS USA 7MG A 209700 001 Sep 04, 2018 Mar DISC @ 14MG A 209700 002 Sep 04, 2018 Mar DISC @ WATSON LABS TEVA 7MG A 209549 001 Jul 27, 2018 Feb DISC @ 14MG A 209549 002 Jul 27, 2018 Feb DISC @ ZYDUS PHARMS 7MG A 209668 001 Nov 30, 2018 May DISC @ 14MG A 209668 002 Nov 30, 2018 May DISC

TERIPARATIDE RECOMBINANT HUMAN SOLUTION;SUBCUTANEOUS BONSITY ALVOGEN 0.62MG/2.48ML (0.25MG/ML) N 211939 001 Oct 04, 2019 Nov CAHN PFENEX INC 0.62MG/2.48ML (0.25MG/ML) N 211939 001 Oct 04, 2019 Oct NEWA

TESTOSTERONE GEL;TRANSDERMAL TESTOSTERONE @ PAR PHARM 25MG/2.5GM PACKET A 076744 001 May 23, 2007 Mar DISC GEL, METERED;NASAL NATESTO >A> ACERUS 5.5MG/0.122GM ACTUATION N 205488 001 May 28, 2014 Dec CAHN >D> AYTU 5.5MG/0.122GM ACTUATION N 205488 001 May 28, 2014 Dec CAHN GEL, METERED;TRANSDERMAL TESTOSTERONE AB ACTAVIS LABS UT INC 1.62% (20.25MG/1.25GM ACTUATION) A 204570 001 Apr 10, 2019 Mar NEWA AB AMNEAL PHARMS LLC 1.62% (20.25MG/1.25GM ACTUATION) A 207373 001 Apr 10, 2019 Mar NEWA AB DR REDDYS 1.62% (20.25MG/1.25GM ACTUATION) A 208620 001 Apr 10, 2019 Mar NEWA AB LUPIN ATLANTIS 1.62% (20.25MG/1.25GM ACTUATION) A 208560 001 Apr 10, 2019 Mar NEWA AB TWI PHARMS 1.62% (20.25MG/1.25GM ACTUATION) A 209390 001 Sep 23, 2019 Sep NEWA TABLET, EXTENDED RELEASE;BUCCAL STRIANT + @ AUXILIUM PHARMS LLC 30MG N 021543 001 Jun 19, 2003 Jul DISC

TESTOSTERONE CYPIONATE INJECTABLE;INJECTION TESTOSTERONE CYPIONATE @ MYLAN INSTITUTIONAL 200MG/ML A 040652 001 Dec 11, 2006 Mar DISC AO WILSHIRE PHARMS INC 200MG/ML A 206368 001 Apr 24, 2019 Apr NEWA

TESTOSTERONE UNDECANOATE CAPSULE;ORAL JATENZO + CLARUS 158MG N 206089 001 Mar 27, 2019 Mar NEWA + 198MG N 206089 002 Mar 27, 2019 Mar NEWA +! 237MG N 206089 003 Mar 27, 2019 Mar NEWA

TETRABENAZINE TABLET;ORAL TETRABENAZINE >D> @ LUPIN LTD 12.5MG A 210544 001 Apr 20, 2018 Dec CMFD >A> AB 12.5MG A 210544 001 Apr 20, 2018 Dec CMFD @ 12.5MG A 210544 001 Apr 20, 2018 Feb DISC >D> @ 25MG A 210544 002 Apr 20, 2018 Dec CMFD >A> AB 25MG A 210544 002 Apr 20, 2018 Dec CMFD @ 25MG A 210544 002 Apr 20, 2018 Feb DISC AB MYLAN 12.5MG A 207682 001 Jan 31, 2017 Jul CAHN AB 25MG A 207682 002 Jan 31, 2017 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -149

TETRACAINE HYDROCHLORIDE SOLUTION;OPHTHALMIC TETRACAINE HYDROCHLORIDE BAUSCH 0.5% N 210821 001 Mar 12, 2019 Apr CAHN VALEANT PHARMS 0.5% N 210821 001 Mar 12, 2019 Mar NEWA

TETRACYCLINE HYDROCHLORIDE CAPSULE;ORAL ACHROMYCIN V AB + AVET 250MG N 050278 003 Oct CAHN AB +! 500MG N 050278 001 Oct CAHN

THALLOUS CHLORIDE TL-201 INJECTABLE;INJECTION THALLOUS CHLORIDE TL 201 AP +! CURIUM 1mCi/ML N 018150 001 Jan CAHN

THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL THEOPHYLLINE AB ! HERITAGE PHARMA 100MG A 089807 001 Apr 30, 1990 Feb CAHN AB ! 200MG A 089808 001 Apr 30, 1990 Feb CAHN AB 300MG A 089763 001 Apr 30, 1990 Feb CAHN @ 450MG A 081236 001 Nov 09, 1992 Feb CAHN >D> AB MYLAN IRELAND LTD 400MG A 040560 003 Apr 21, 2006 Dec CAHN >D> AB ! 600MG A 040560 002 Apr 21, 2006 Dec CAHN >A> AB NOSTRUM LABS INC 400MG A 040560 003 Apr 21, 2006 Dec CAHN >A> AB ! 600MG A 040560 002 Apr 21, 2006 Dec CAHN >A> AB RHODES PHARMS 400MG A 040086 002 Sep 01, 1982 Dec CMS1

THIORIDAZINE HYDROCHLORIDE TABLET;ORAL THIORIDAZINE HYDROCHLORIDE MYLAN 10MG A 088004 002 Mar 15, 1983 Oct CTEC 25MG A 088004 003 Mar 15, 1983 Oct CTEC 50MG A 088004 004 Mar 15, 1983 Oct CTEC ! 100MG A 088004 001 Nov 18, 1983 Oct CTEC @ SUN PHARM INDUSTRIES 10MG A 089953 004 Aug 01, 1986 Oct DISC @ 25MG A 089953 003 Aug 01, 1986 Oct DISC @ 50MG A 089953 002 Aug 01, 1986 Oct DISC @ 100MG A 089953 001 Oct 07, 1988 Oct DISC

THIOTEPA INJECTABLE;INJECTION THIOTEPA >A> AP STI PHARMA LLC 15MG/VIAL A 208242 001 Jan 10, 2020 Dec NEWA

THIOTHIXENE CAPSULE;ORAL THIOTHIXENE AB MYLAN 1MG A 071093 002 Jun 23, 1987 Mar CTEC AB 2MG A 071093 003 Jun 23, 1987 Mar CTEC AB 5MG A 071093 004 Jun 23, 1987 Jul CHRS AB ! 5MG A 071093 004 Jun 23, 1987 Mar CTEC AB 10MG A 071093 001 Jun 23, 1987 Mar CTEC AB NOVITIUM PHARMA 1MG A 211642 001 Apr 05, 2019 Mar NEWA AB 2MG A 211642 002 Apr 05, 2019 Mar NEWA AB ! 5MG A 211642 003 Apr 05, 2019 Jul CHRS AB 5MG A 211642 003 Apr 05, 2019 Mar NEWA AB 10MG A 211642 004 Apr 05, 2019 Mar NEWA

THIOTHIXENE HYDROCHLORIDE CONCENTRATE;ORAL THIOTHIXENE HYDROCHLORIDE INTENSOL @ HIKMA EQ 5MG BASE/ML A 073494 001 Jun 30, 1992 Sep CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -150

TICAGRELOR TABLET;ORAL BRILINTA + ASTRAZENECA PHARMS 60MG N 022433 002 Sep 03, 2015 Jun CTEC TICAGRELOR @ AMNEAL PHARMS CO 90MG A 208531 001 Jan 23, 2019 Jun DISC AB 90MG A 208531 001 Jan 23, 2019 Jan NEWA AB HISUN PHARM HANGZHOU 90MG A 208575 001 Jan 23, 2019 Jan NEWA @ WATSON LABS INC 60MG A 208390 001 Sep 04, 2018 Feb DISC @ 90MG A 208390 002 Sep 04, 2018 Feb DISC

TICLOPIDINE HYDROCHLORIDE TABLET;ORAL TICLOPIDINE HYDROCHLORIDE @ SUN PHARM INDS INC 250MG A 075526 001 Sep 26, 2002 Oct DISC

TIGECYCLINE POWDER;INTRAVENOUS TIGECYCLINE AP AMNEAL PHARMS LLC 50MG/VIAL N 211158 001 Aug 02, 2018 Jul CMFD @ 50MG/VIAL N 211158 001 Aug 02, 2018 Feb DISC AP AUROBINDO PHARMA LTD 50MG/VIAL A 206335 001 Jun 11, 2019 May NEWA AP XELLIA PHARMS APS 50MG/VIAL A 205722 001 Oct 18, 2019 Oct NEWA

TIMOLOL MALEATE SOLUTION, GEL FORMING/DROPS;OPHTHALMIC TIMOLOL MALEATE >D> AB SANDOZ INC EQ 0.25% BASE N 020963 001 Oct 21, 1998 Dec CRLD >A> AB +! EQ 0.25% BASE N 020963 001 Oct 21, 1998 Dec CHRS >A> AB + EQ 0.25% BASE N 020963 001 Oct 21, 1998 Dec CRLD >D> AB EQ 0.5% BASE N 020963 002 Oct 21, 1998 Dec CRLD >A> AB +! EQ 0.5% BASE N 020963 002 Oct 21, 1998 Dec CHRS >A> AB + EQ 0.5% BASE N 020963 002 Oct 21, 1998 Dec CRLD SOLUTION/DROPS;OPHTHALMIC TIMOPTIC AT + VALEANT PHARMS INTL EQ 0.25% BASE N 018086 001 Jan CAHN AT1 + EQ 0.5% BASE N 018086 002 Jan CAHN TIMOPTIC IN OCUDOSE +! VALEANT PHARMS INTL EQ 0.25% BASE N 019463 001 Nov 05, 1986 Jan CAHN +! EQ 0.5% BASE N 019463 002 Nov 05, 1986 Jan CAHN TABLET;ORAL BLOCADREN + MERCK@ 5MG N 018017 001 Apr CRLD + @ 10MG N 018017 002 Apr CRLD + @ 20MG N 018017 004 Apr CRLD TIMOLOL MALEATE @ ANI PHARMS INC 5MG A 072917 001 Jul 31, 1991 Sep CAHN @ 10MG A 072918 001 Jul 31, 1991 Sep CAHN @ 20MG A 072919 001 Jul 31, 1991 Sep CAHN AB ELYSIUM 5MG A 207556 001 May 02, 2019 Sep CAHN AB 10MG A 207556 002 May 02, 2019 Sep CAHN AB 20MG A 207556 003 May 02, 2019 Sep CAHN AB INVATECH PHARMA 5MG A 207556 001 May 02, 2019 Apr NEWA AB 10MG A 207556 002 May 02, 2019 Apr NEWA AB 20MG A 207556 003 May 02, 2019 Apr NEWA AB MYLAN 5MG A 072668 002 Jun 08, 1990 Apr CTEC AB 10MG A 072668 003 Jun 08, 1990 Apr CTEC AB ! 20MG A 072668 001 Jun 08, 1990 Apr CTEC

TIOPRONIN TABLET, DELAYED RELEASE;ORAL THIOLA EC + MISSION PHARMACAL CO 100MG N 211843 001 Jun 28, 2019 Jun NEWA +! 300MG N 211843 002 Jun 28, 2019 Jun NEWA

TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL TIZANIDINE HYDROCHLORIDE >A> AB ALEMBIC PHARMS LTD EQ 2MG BASE A 213223 001 Jan 13, 2020 Dec NEWA >A> AB EQ 4MG BASE A 213223 002 Jan 13, 2020 Dec NEWA >A> AB EQ 6MG BASE A 213223 003 Jan 13, 2020 Dec NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -151

CAPSULE;ORAL TIZANIDINE HYDROCHLORIDE AB ALKEM LABS LTD EQ 2MG BASE A 212196 001 Mar 27, 2019 Mar NEWA AB EQ 4MG BASE A 212196 002 Mar 27, 2019 Mar NEWA AB EQ 6MG BASE A 212196 003 Mar 27, 2019 Mar NEWA AB CADILA PHARMS LTD EQ 2MG BASE A 210021 001 Mar 26, 2019 Mar NEWA AB EQ 4MG BASE A 210021 002 Mar 26, 2019 Mar NEWA AB EQ 6MG BASE A 210021 003 Mar 26, 2019 Mar NEWA AB NOVAST LABS EQ 2MG BASE A 210267 001 Mar 12, 2019 Sep CAHN AB EQ 4MG BASE A 210267 002 Mar 12, 2019 Sep CAHN AB EQ 6MG BASE A 210267 003 Mar 12, 2019 Sep CAHN AB RICONPHARMA LLC EQ 2MG BASE A 210267 001 Mar 12, 2019 Feb NEWA AB EQ 4MG BASE A 210267 002 Mar 12, 2019 Feb NEWA AB EQ 6MG BASE A 210267 003 Mar 12, 2019 Feb NEWA TABLET;ORAL TIZANIDINE HYDROCHLORIDE AB ALKEM LABS LTD EQ 2MG BASE A 211798 001 Jan 25, 2019 Jan NEWA AB EQ 4MG BASE A 211798 002 Jan 25, 2019 Jan NEWA @ ANI PHARMS INC EQ 2MG BASE A 076283 001 Jul 12, 2002 May CAHN >D> AB EQ 2MG BASE A 076284 001 Jul 03, 2002 Dec DISC >A> @ EQ 2MG BASE A 076284 001 Jul 03, 2002 Dec DISC AB EQ 2MG BASE A 076284 001 Jul 03, 2002 Sep CAHN @ EQ 2MG BASE A 076371 001 Apr 09, 2003 May CAHN @ EQ 4MG BASE A 076283 002 Jul 12, 2002 May CAHN >D> AB EQ 4MG BASE A 076284 002 Jul 03, 2002 Dec DISC >A> @ EQ 4MG BASE A 076284 002 Jul 03, 2002 Dec DISC AB EQ 4MG BASE A 076284 002 Jul 03, 2002 Sep CAHN @ EQ 4MG BASE A 076371 002 Apr 09, 2003 May CAHN @ PAR PHARM INC EQ 2MG BASE A 207170 001 Jan 26, 2017 Mar DISC @ EQ 4MG BASE A 207170 002 Jan 26, 2017 Mar DISC

TOBRAMYCIN SOLUTION;INHALATION BETHKIS +! CHIESI USA INC 300MG/4ML N 201820 001 Oct 12, 2012 Jul CTEC AN +! 300MG/4ML N 201820 001 Oct 12, 2012 Jun CFTG TOBRAMYCIN AN DR REDDYS LABS SA 300MG/5ML A 207080 001 Jul 09, 2018 Mar CMFD @ 300MG/5ML A 207080 001 Jul 09, 2018 Jan DISC >A> AN SUN PHARM 300MG/5ML A 207136 001 Dec 26, 2019 Dec NEWA @ TEVA PHARMS USA 300MG/4ML A 210915 001 Jun 26, 2019 Jul DISC AN 300MG/4ML A 210915 001 Jun 26, 2019 Jun NFTG SOLUTION/DROPS;OPHTHALMIC TOBRAMYCIN AT ALEMBIC PHARMS LTD 0.3% A 211847 001 Apr 19, 2019 Apr NEWA

TOFACITINIB CITRATE TABLET;ORAL XELJANZ + PF PRISM CV EQ 5MG BASE N 203214 001 Nov 06, 2012 May CHRS TABLET, EXTENDED RELEASE;ORAL XELJANZ XR >A> + PFIZER INC EQ 22MG BASE N 208246 002 Dec 12, 2019 Dec NEWA

TOLAZAMIDE TABLET;ORAL TOLAZAMIDE @ COSETTE 100MG N 018894 001 Nov 02, 1984 Jun CAHN @ 250MG N 018894 002 Nov 02, 1984 Jun CAHN @ 500MG N 018894 003 Nov 02, 1984 Jun CAHN

TOLCAPONE TABLET;ORAL TASMAR AB +! BAUSCH 100MG N 020697 001 Jan 29, 1998 Mar CAHN @ 200MG N 020697 002 Jan 29, 1998 Mar CAHN TOLCAPONE AB KINEDEXE UK 100MG A 210095 001 Aug 01, 2019 Jul NEWA AB MAYNE PHARMA 100MG A 210095 001 Aug 01, 2019 Sep CAHN AB NOVAST LABS 100MG A 208937 001 Aug 07, 2018 Sep CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -152

TOLMETIN SODIUM CAPSULE;ORAL TOLECTIN DS + @ ORTHO MCNEIL JANSSEN EQ 400MG BASE N 018084 001 Nov CRLD TOLMETIN SODIUM @ ANI PHARMS INC EQ 400MG BASE A 073308 001 Jan 24, 1992 May CAHN @ EQ 400MG BASE A 073519 001 May 29, 1992 Sep CAHN TABLET;ORAL TOLECTIN + @ ORTHO MCNEIL JANSSEN EQ 200MG BASE N 017628 001 Nov CRLD TOLECTIN 600 + @ ORTHO MCNEIL JANSSEN EQ 600MG BASE N 017628 002 Mar 08, 1989 Nov CRLD TOLMETIN SODIUM @ ANI PHARMS INC EQ 600MG BASE A 073527 001 Jun 30, 1992 May CAHN

TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE;ORAL TOLTERODINE TARTRATE AB INVENTIA HLTHCARE 2MG A 204562 001 Aug 19, 2019 Aug NEWA AB 4MG A 204562 002 Aug 19, 2019 Aug NEWA TABLET;ORAL TOLTERODINE TARTRATE >A> AB INVATECH 1MG A 210775 001 Dec 30, 2019 Dec NEWA >A> AB 2MG A 210775 002 Dec 30, 2019 Dec NEWA

TOLVAPTAN TABLET;ORAL JYNARQUE +! OTSUKA PHARM CO LTD 45MG N 204441 003 Apr 23, 2018 Jun CHRS + 90MG N 204441 005 Apr 23, 2018 Jun CHRS

TOPIRAMATE CAPSULE, EXTENDED RELEASE;ORAL QUDEXY XR BC + UPSHER SMITH LABS 25MG N 205122 001 Mar 11, 2014 Feb CTEC BC + 50MG N 205122 002 Mar 11, 2014 Feb CTEC BC + 100MG N 205122 003 Mar 11, 2014 Feb CTEC BC +! 200MG N 205122 005 Mar 11, 2014 Feb CTEC TROKENDI XR BC +! SUPERNUS PHARMS 200MG N 201635 004 Aug 16, 2013 Apr CTEC TABLET;ORAL TOPIRAMATE >D> AB LUPIN 25MG A 078410 001 Sep 11, 2013 Dec DISC >A> @ 25MG A 078410 001 Sep 11, 2013 Dec DISC >D> AB 50MG A 078410 002 Sep 11, 2013 Dec DISC >A> @ 50MG A 078410 002 Sep 11, 2013 Dec DISC >D> AB 100MG A 078410 003 Sep 11, 2013 Dec DISC >A> @ 100MG A 078410 003 Sep 11, 2013 Dec DISC >D> AB 200MG A 078410 004 Sep 11, 2013 Dec DISC >A> @ 200MG A 078410 004 Sep 11, 2013 Dec DISC

TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION TOPOTECAN HYDROCHLORIDE @ FRESENIUS KABI USA EQ 4MG BASE/VIAL A 091376 001 Nov 29, 2010 Oct CAHN AP MEITHEAL EQ 4MG BASE/VIAL A 201166 001 Aug 08, 2012 Nov CAHN @ MYLAN LABS LTD EQ 4MG BASE/VIAL A 091542 001 Aug 28, 2012 Oct DISC

TRAMADOL HYDROCHLORIDE TABLET;ORAL TRAMADOL HYDROCHLORIDE >D> AB POLYGEN PHARMS 50MG A 206706 001 Jul 02, 2019 Dec DISC >A> @ 50MG A 206706 001 Jul 02, 2019 Dec DISC AB 50MG A 206706 001 Jul 02, 2019 Jun NEWA AB RUBICON 50MG A 208708 001 Jun 28, 2019 Jun NEWA AB 100MG A 208708 002 Jun 28, 2019 Jun NEWA @ SPECGX LLC 50MG A 075983 001 Jun 25, 2002 Nov DISC @ SUN PHARM INDUSTRIES 50MG A 076100 001 Jun 20, 2002 Oct DISC AB UNICHEM LABS LTD 50MG A 211825 001 Aug 09, 2019 Jul NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -153

TABLET, EXTENDED RELEASE;ORAL TRAMADOL HYDROCHLORIDE @ PAR PHARM INC 100MG A 078783 001 Nov 13, 2009 Nov DISC @ 200MG A 078783 002 Nov 13, 2009 Nov DISC @ 300MG A 078783 003 Sep 20, 2011 Nov DISC

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL TARKA + @ ABBVIE 1MG;240MG N 020591 003 Oct 22, 1996 Aug DISC TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS 1MG;240MG A 079135 004 Aug 30, 2010 Aug CTEC

TRANEXAMIC ACID INJECTABLE;INJECTION TRANEXAMIC ACID AP APOLLO 100MG/ML A 212676 001 Jul 17, 2019 Jul NEWA >A> AP APOTEX 100MG/ML A 209860 001 Jan 14, 2020 Dec NEWA AP CAPLIN 100MG/ML A 212360 001 Jul 17, 2019 Jul NEWA +! EXELA PHARMA SCS LLC 10MG/ML N 212020 001 Apr 15, 2019 Apr NEWA AP MICRO LABS 100MG/ML A 206713 001 Jun 27, 2017 Mar CAHN >D> AP VIRTUS PHARMS 100MG/ML A 202755 001 Feb 25, 2016 Dec DISC >A> @ 100MG/ML A 202755 001 Feb 25, 2016 Dec DISC SOLUTION;INTRAVENOUS TRANEXAMIC ACID +! EXELA PHARMA SCS LLC 1GM/100ML (10MG/ML) N 212020 001 Apr 15, 2019 May CPOT

TRAVOPROST SOLUTION/DROPS;OPHTHALMIC TRAVOPROST >A> AT1 ALEMBIC PHARMS LTD 0.004% A 210458 001 Dec 20, 2019 Dec NEWA >D> ! PAR PHARM 0.004% A 091340 001 Mar 01, 2013 Dec CTEC >A> AT1 ! 0.004% A 091340 001 Mar 01, 2013 Dec CTEC

TREPROSTINIL INJECTABLE;IV (INFUSION), SUBCUTANEOUS TREPROSTINIL AP PAR STERILE PRODUCTS 1MG/ML A 209382 001 Sep 24, 2019 Sep NEWA AP 2.5MG/ML A 209382 002 Sep 24, 2019 Sep NEWA AP 5MG/ML A 209382 003 Sep 24, 2019 Sep NEWA AP 10MG/ML A 209382 004 Sep 24, 2019 Sep NEWA AP TEVA PHARMS USA 1MG/ML A 206648 001 Sep 26, 2019 Sep NEWA AP 2.5MG/ML A 206648 002 Sep 26, 2019 Sep NEWA AP 5MG/ML A 206648 003 Sep 26, 2019 Sep NEWA AP 10MG/ML A 206648 004 Sep 26, 2019 Sep NEWA

TREPROSTINIL DIOLAMINE TABLET, EXTENDED RELEASE;ORAL ORENITRAM +! UNITED THERAP EQ 1MG BASE N 203496 003 Dec 20, 2013 Feb CHRS + EQ 2.5MG BASE N 203496 004 Dec 20, 2013 Feb CHRS

TRETINOIN CREAM;TOPICAL TRETINOIN AB1 TARO PHARMS 0.05% A 211644 001 Jan 25, 2019 Jan NEWA AB 0.1% A 211645 001 Jan 22, 2019 Jan NEWA

TRIAMCINOLONE ACETONIDE CREAM;TOPICAL TRIAMCINOLONE ACETONIDE AT MLV 0.025% A 040671 001 Jun 09, 2006 Sep CAHN AT 0.1% A 040671 002 Jun 09, 2006 Sep CAHN AT SAPTALIS PHARMS 0.025% A 040671 001 Jun 09, 2006 May CAHN AT 0.1% A 040671 002 Jun 09, 2006 May CAHN AT STRIDES PHARMA 0.025% A 210346 001 Feb 11, 2019 Jan NEWA AT 0.1% A 210346 002 Feb 11, 2019 Jan NEWA AT 0.5% A 210346 003 Feb 11, 2019 Jan NEWA INJECTABLE;INJECTION KENALOG-80 +! APOTHECON 80MG/ML N 014901 002 Apr 12, 2019 Apr NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -154

INJECTABLE;INJECTION TRIAMCINOLONE ACETONIDE AB TEVA PHARMS USA 40MG/ML A 209852 001 Oct 05, 2018 Jul CMFD @ 40MG/ML A 209852 001 Oct 05, 2018 Mar DISC LOTION;TOPICAL TRIAMCINOLONE ACETONIDE AT ALLIED 0.1% A 040672 002 Dec 13, 2006 Sep CAHN AT SAPTALIS PHARMS 0.1% A 040672 002 Dec 13, 2006 May CAHN OINTMENT;TOPICAL >D> KENALOG >D> + MYLAN@ 0.025% N 011600 003 Dec CTNA >D> + @ 0.1% N 011600 001 Dec CTNA TRIAMCINOLONE ACETONIDE AT ENCUBE 0.05% A 212384 001 Nov 29, 2019 Nov NEWA >A> + @ MYLAN 0.025% N 011600 003 Dec CTNA >A> + @ 0.1% N 011600 001 Dec CTNA TRIAMCINOLONE ACETONIDE IN ABSORBASE AT ! CMP PHARMA INC 0.05% A 089595 001 Mar 23, 1995 Nov CTEC

TRIAMTERENE CAPSULE;ORAL DYRENIUM AB + CONCORDIA 50MG N 013174 001 Aug CFTG AB +! 100MG N 013174 002 Aug CFTG TRIAMTERENE AB AGNITIO 50MG A 211581 001 Aug 19, 2019 Aug NFTG AB 100MG A 211581 002 Aug 19, 2019 Aug NFTG

TRICLABENDAZOLE TABLET;ORAL EGATEN +! NOVARTIS 250MG N 208711 001 Feb 13, 2019 Feb NEWA

TRIENTINE HYDROCHLORIDE CAPSULE;ORAL CLOVIQUE AB KADMON PHARMS LLC 250MG A 209731 001 Oct 21, 2019 Nov CTNA AB 250MG A 209731 001 Oct 21, 2019 Oct NEWA SYPRINE AB +! BAUSCH 250MG N 019194 001 Nov 08, 1985 Sep CAHN TRIENTINE HYDROCHLORIDE AB AMNEAL PHARMS LLC 250MG A 210619 001 Feb 08, 2019 Feb NEWA AB DR REDDYS LABS LTD 250MG A 211076 001 Jul 03, 2019 Jun NEWA AB KADMON PHARMS LLC 250MG A 209415 001 Sep 16, 2019 Sep NEWA AB MSN 250MG A 211134 001 May 22, 2019 May NEWA AB PAR PHARM INC 250MG A 210096 001 Sep 25, 2019 Sep NEWA AB ZYDUS PHARMS 250MG A 211554 001 Apr 26, 2019 Apr NEWA

TRIFAROTENE CREAM;TOPICAL AKLIEF +! GALDERMA R AND D 0.005% N 211527 001 Oct 04, 2019 Oct NEWA

TRIFLUOPERAZINE HYDROCHLORIDE TABLET;ORAL TRIFLUOPERAZINE HYDROCHLORIDE >A> @ INVATECH EQ 1MG BASE A 040153 001 Oct 25, 1996 Dec CAHN >A> @ EQ 2MG BASE A 040153 002 Oct 25, 1996 Dec CAHN >A> @ EQ 5MG BASE A 040153 003 Oct 25, 1996 Dec CAHN >A> @ EQ 10MG BASE A 040153 004 Oct 25, 1996 Dec CAHN >D> @ SANDOZ EQ 1MG BASE A 040153 001 Oct 25, 1996 Dec CAHN >D> @ EQ 2MG BASE A 040153 002 Oct 25, 1996 Dec CAHN >D> @ EQ 5MG BASE A 040153 003 Oct 25, 1996 Dec CAHN >D> @ EQ 10MG BASE A 040153 004 Oct 25, 1996 Dec CAHN

TRIMETHADIONE TABLET;ORAL TRIDIONE + @ ABBVIE 150MG N 005856 009 Jul DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -155

TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE;ORAL TRIMETHOBENZAMIDE HYDROCHLORIDE AB LUPIN 300MG A 076546 001 Aug 20, 2003 Feb CAHN INJECTABLE;INJECTION TIGAN +! PAR STERILE PRODUCTS 100MG/ML N 017530 001 May CTEC

TRIMIPRAMINE MALEATE CAPSULE;ORAL SURMONTIL + @ ODYSSEY PHARMS EQ 25MG BASE N 016792 001 Jul DISC + @ EQ 50MG BASE N 016792 002 Jul DISC + @ EQ 100MG BASE N 016792 003 Sep 15, 1982 Jul DISC TRIMIPRAMINE MALEATE AB ! CROSSMEDIKA SA EQ 50MG BASE A 208127 002 Apr 15, 2016 Jul CHRS

TROPICAMIDE SOLUTION/DROPS;OPHTHALMIC TROPICAMIDE >A> AT SOMERSET THERAPS LLC 1% A 207524 001 Dec 12, 2019 Dec NEWA

>A> UBROGEPANT >A> TABLET;ORAL >A> UBRELVY >A> + ALLERGAN 50MG N 211765 001 Dec 23, 2019 Dec NEWA >A> +! 100MG N 211765 002 Dec 23, 2019 Dec NEWA

UPADACITINIB TABLET, EXTENDED RELEASE;ORAL RINVOQ +! ABBVIE INC 15MG N 211675 001 Aug 16, 2019 Nov CPOT +! EQ 15MG BASE N 211675 001 Aug 16, 2019 Aug NEWA

URSODIOL CAPSULE;ORAL URSODIOL AB AMNEAL PHARMS CO 300MG A 211301 001 Oct 16, 2018 Jun CMFD @ 300MG A 211301 001 Oct 16, 2018 Apr DISC AB EYWA PHARMA 300MG A 212452 001 Oct 30, 2019 Oct NEWA

VALACYCLOVIR HYDROCHLORIDE TABLET;ORAL VALACYCLOVIR HYDROCHLORIDE @ WATSON LABS INC EQ 500MG BASE A 090370 001 Mar 16, 2011 Apr DISC @ EQ 1GM BASE A 090370 002 Mar 16, 2011 Apr DISC

VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL VALGANCICLOVIR HYDROCHLORIDE >A> AB AJANTA PHARMA LTD 50MG/ML A 212890 001 Jan 13, 2020 Dec NEWA TABLET;ORAL VALGANCICLOVIR HYDROCHLORIDE >A> AB AJANTA PHARMA LTD EQ 450MG BASE A 212234 001 Dec 26, 2019 Dec NEWA

VALPROATE SODIUM INJECTABLE;INJECTION DEPACON + ABBVIE@ EQ 100MG BASE/ML N 020593 001 Dec 30, 1996 Apr DISC VALPROATE SODIUM AP ! HIKMA FARMACEUTICA EQ 100MG BASE/ML A 078523 001 Feb 17, 2010 Apr CHRS

VALPROIC ACID CAPSULE;ORAL DEPAKENE + ABBVIE@ 250MG N 018081 001 Oct DISC VALPROIC ACID AB ! BIONPHARMA INC 250MG A 073484 001 Jun 29, 1993 Oct CHRS AB NOVELGENIX THERAPS 250MG A 207611 001 Aug 05, 2019 Jul NEWA @ UPSHER SMITH LABS 250MG A 070631 001 Jun 11, 1987 Jul CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -156

SYRUP;ORAL DEPAKENE + @ ABBVIE 250MG/5ML N 018082 001 Aug DISC VALPROIC ACID >D> AA ANI PHARMS INC 250MG/5ML A 073178 001 Aug 25, 1992 Dec DISC >A> @ 250MG/5ML A 073178 001 Aug 25, 1992 Dec DISC @ APOTEX 250MG/5ML A 077105 001 Jul 29, 2005 Oct CAHN @ PD PARTNERS 250MG/5ML A 077105 001 Jul 29, 2005 May CAHN AA ! PHARM ASSOC 250MG/5ML A 075379 001 Dec 15, 2000 Aug CHRS

VALRUBICIN SOLUTION;INTRAVESICAL VALRUBICIN AO CUSTOPHARM INC 40MG/ML A 206430 001 Apr 19, 2019 Apr NFTG VALSTAR PRESERVATIVE FREE AO +! ENDO PHARM 40MG/ML N 020892 001 Sep 25, 1998 Apr CFTG

VALSARTAN TABLET;ORAL VALSARTAN AB ALKEM LABS LTD 40MG A 205536 001 Mar 12, 2019 Feb NEWA AB 80MG A 205536 002 Mar 12, 2019 Feb NEWA AB 160MG A 205536 003 Mar 12, 2019 Feb NEWA AB 320MG A 205536 004 Mar 12, 2019 Feb NEWA @ TORRENT 40MG A 202728 001 Jan 05, 2015 Nov DISC @ 80MG A 202728 002 Jan 05, 2015 Nov DISC @ 160MG A 202728 003 Jan 05, 2015 Nov DISC @ 320MG A 202728 004 Jan 05, 2015 Nov DISC

VANCOMYCIN HYDROCHLORIDE CAPSULE;ORAL VANCOMYCIN HYDROCHLORIDE AB ORIENT PHARMA CO LTD EQ 125MG BASE A 210729 001 Apr 29, 2019 Apr NEWA AB EQ 250MG BASE A 210729 002 Apr 29, 2019 Apr NEWA FOR SOLUTION;ORAL VANCOCIN HYDROCHLORIDE ANI PHARMS INC EQ 250MG BASE/5ML A 061667 002 Jul 13, 1983 Jul CMFD INJECTABLE;INJECTION VANCOMYCIN HYDROCHLORIDE @ EMCURE PHARMS LTD EQ 500MG BASE/VIAL A 202275 001 Oct 31, 2013 Nov DISC @ EQ 1GM BASE/VIAL A 202275 002 Oct 31, 2013 Nov DISC @ EQ 10GM BASE/VIAL A 202464 001 Oct 09, 2013 Nov DISC @ EQ 5GM BASE/VIAL A 202274 001 Oct 31, 2013 Nov DISC >D> AP HAINAN POLY PHARM EQ 500MG BASE/VIAL A 212332 001 Jun 12, 2019 Dec DISC >A> @ EQ 500MG BASE/VIAL A 212332 001 Jun 12, 2019 Dec DISC AP EQ 500MG BASE/VIAL A 212332 001 Jun 12, 2019 May NEWA >D> AP EQ 1GM BASE/VIAL A 212332 002 Jun 12, 2019 Dec DISC >A> @ EQ 1GM BASE/VIAL A 212332 002 Jun 12, 2019 Dec DISC AP EQ 1GM BASE/VIAL A 212332 002 Jun 12, 2019 May NEWA SOLUTION;INTRAVENOUS VANCOMYCIN HYDROCHLORIDE +! XELLIA PHARMS APS EQ 500MG BASE/100ML N 211962 001 Feb 15, 2019 Feb NEWA +! EQ 1GM BASE/200ML N 211962 002 Feb 15, 2019 Feb NEWA +! EQ 1.5GM BASE/300ML N 211962 003 Feb 15, 2019 Feb NEWA +! EQ 2GM BASE/400ML N 211962 004 Feb 15, 2019 Feb NEWA

VARDENAFIL HYDROCHLORIDE TABLET;ORAL VARDENAFIL HYDROCHLORIDE @ AMNEAL PHARMS CO 5MG A 210738 001 Oct 31, 2018 Apr DISC @ 10MG A 210738 002 Oct 31, 2018 Apr DISC @ 20MG A 210738 003 Oct 31, 2018 Apr DISC AB MACLEODS PHARMS LTD 2.5MG A 204632 001 Oct 22, 2019 Oct NEWA AB 5MG A 204632 002 Oct 22, 2019 Oct NEWA AB 10MG A 204632 003 Oct 22, 2019 Oct NEWA AB 20MG A 204632 004 Oct 22, 2019 Oct NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -157

VASOPRESSIN SOLUTION;INTRAVENOUS VASOSTRICT +! PAR STERILE PRODUCTS 20UNITS/ML (20UNITS/ML) N 204485 001 Apr 17, 2014 Mar CDFR +! 200UNITS/10ML (20UNITS/ML) N 204485 002 Dec 17, 2016 Mar CDFR

VECURONIUM BROMIDE INJECTABLE;INJECTION VECURONIUM BROMIDE AP HIKMA 10MG/VIAL A 203725 001 Jul 30, 2019 Jul NEWA AP 20MG/VIAL A 203725 002 Jul 30, 2019 Jul NEWA

VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL VENLAFAXINE HYDROCHLORIDE AB ANNORA PHARMA EQ 37.5MG BASE A 212277 001 Jul 08, 2019 Jun NEWA AB EQ 75MG BASE A 212277 002 Jul 08, 2019 Jun NEWA AB EQ 150MG BASE A 212277 003 Jul 08, 2019 Jun NEWA TABLET;ORAL VENLAFAXINE HYDROCHLORIDE @ PRINSTON INC EQ 25MG BASE A 090027 001 Aug 04, 2010 Oct DISC @ EQ 37.5MG BASE A 090027 002 Aug 04, 2010 Oct DISC @ EQ 50MG BASE A 090027 003 Aug 04, 2010 Oct DISC @ EQ 75MG BASE A 090027 004 Aug 04, 2010 Oct DISC @ EQ 100MG BASE A 090027 005 Aug 04, 2010 Oct DISC TABLET, EXTENDED RELEASE;ORAL VENLAFAXINE HYDROCHLORIDE AB CADILA PHARMS LTD EQ 75MG BASE A 211323 001 Aug 29, 2019 Aug NEWA AB EQ 150MG BASE A 211323 002 Aug 29, 2019 Aug NEWA AB EQ 225MG BASE A 211323 003 Aug 29, 2019 Aug NEWA AB DEXCEL PHARMA EQ 150MG BASE A 209193 001 Oct 31, 2019 Oct NEWA AB EQ 225MG BASE A 209193 002 Oct 31, 2019 Oct NEWA

VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL VERAPAMIL HYDROCHLORIDE MY LAN@ MYLAN@ 100MG A 078306 001 Aug 09, 2007 Nov DISC @ 200MG A 078306 002 Aug 09, 2007 Nov DISC @ 300MG A 078306 003 Aug 09, 2007 May DISC VERELAN PM + RECRO GAINESVILLE 100MG N 020943 001 Nov 25, 1998 Nov CTEC + 200MG N 020943 002 Nov 25, 1998 Nov CTEC +! 300MG N 020943 003 Nov 25, 1998 May CTEC SOLUTION;INTRAVENOUS VERAPAMIL HYDROCHLORIDE AP ANDA REPOSITORY 5MG/2ML (2.5MG/ML) A 211035 001 Jun 18, 2018 Sep CAHN AP 10MG/4ML (2.5MG/ML) A 211035 002 Jun 18, 2018 Sep CAHN AP SOMERSET 5MG/2ML (2.5MG/ML) A 211035 001 Jun 18, 2018 Oct CAHN AP 10MG/4ML (2.5MG/ML) A 211035 002 Jun 18, 2018 Oct CAHN TABLET;ORAL CALAN + @ GD SEARLE LLC 80MG N 018817 001 Sep 10, 1984 May DISC + @ 120MG N 018817 002 Sep 10, 1984 Nov DISC AB + 120MG N 018817 002 Sep 10, 1984 May CHRS VERAPAMIL HYDROCHLORIDE AB ! HERITAGE PHARMS INC 120MG A 071881 001 Apr 05, 1988 May CHRS

VIGABATRIN FOR SOLUTION;ORAL VIGABATRIN AA INVAGEN PHARMS 500MG/PACKET A 211592 001 Dec 03, 2019 Nov NEWA VIGADRONE AA AUCTA 500MG/PACKET A 210196 001 Jun 21, 2018 Jun CAHN AA SHANGHAI 500MG/PACKET A 210196 001 Jun 21, 2018 Mar CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -158

VILAZODONE HYDROCHLORIDE TABLET;ORAL VIIBRYD AB +! ALLERGAN 10MG N 022567 001 Jan 21, 2011 Sep CFTG AB + 20MG N 022567 002 Jan 21, 2011 Sep CFTG AB + 40MG N 022567 003 Jan 21, 2011 Sep CFTG VILAZODONE HYDROCHLORIDE >A> AB ALEMBIC PHARMS LTD 10MG A 208202 001 Jan 10, 2020 Dec NEWA >A> AB 20MG A 208202 002 Jan 10, 2020 Dec NEWA >A> AB 40MG A 208202 003 Jan 10, 2020 Dec NEWA AB TEVA PHARMS USA 10MG A 208212 001 Sep 30, 2019 Sep NFTG AB 20MG A 208212 002 Sep 30, 2019 Sep NFTG AB 40MG A 208212 003 Sep 30, 2019 Sep NFTG

VINCRISTINE SULFATE INJECTABLE;INJECTION VINCRISTINE SULFATE PFS ! HOSPIRA 1MG/ML A 071484 001 Apr 19, 1988 Oct CTEC @ TEVA PHARMS USA 1MG/ML A 075493 001 Sep 01, 1999 Oct DISC INJECTABLE, LIPOSOMAL;INTRAVENOUS MARQIBO KIT +! ACROTECH 5MG/5ML (1MG/ML) N 202497 001 Aug 09, 2012 Mar CAHN

VINORELBINE TARTRATE INJECTABLE;INJECTION NAVELBINE + @ PIERRE FABRE EQ 10MG BASE/ML N 020388 001 Dec 23, 1994 Jun DISC VINORELBINE TARTRATE AP INGENUS PHARMS LLC EQ 10MG BASE/ML A 208997 001 Aug 05, 2019 Jul NEWA @ NOVAST LABS EQ 10MG BASE/ML A 208997 001 Aug 05, 2019 Oct DISC AP EQ 10MG BASE/ML A 208997 001 Aug 05, 2019 Sep CAHN

VORAPAXAR SULFATE TABLET;ORAL ZONTIVITY +! TOPROL EQ 2.08MG BASE N 204886 001 May 08, 2014 May CAHN

VORICONAZOLE INJECTABLE;INTRAVENOUS VFEND AP +! PF PRISM CV 200MG/VIAL N 021267 001 May 24, 2002 May CDFR VORICONAZOLE AP ALVOGEN 200MG/VIAL A 206398 001 Mar 23, 2016 Sep CAHN AP ALVOGEN INC 200MG/VIAL A 206398 001 Mar 23, 2016 May CDFR AP HAINAN POLY PHARM 200MG/VIAL A 211661 001 Nov 30, 2018 May CDFR AP SANDOZ INC 200MG/VIAL A 090862 001 May 30, 2012 May CDFR AP ZYDUS PHARMS 200MG/VIAL A 208983 001 Jul 16, 2018 May CDFR POWDER;INTRAVENOUS VORICONAZOLE AP XELLIA PHARMS APS 200MG/VIAL N 208562 001 Mar 09, 2017 May CDFR POWDER;IV (INFUSION) VORICONAZOLE AP XELLIA PHARMS APS 200MG/VIAL N 208562 001 Mar 09, 2017 Feb CTEC TABLET;ORAL VORICONAZOLE AB APPCO 50MG A 206762 001 May 24, 2016 Feb CAHN AB 200MG A 206762 002 May 24, 2016 Feb CAHN AB CADILA 50MG A 206747 001 May 24, 2016 Apr CAHN AB 200MG A 206747 002 May 24, 2016 Apr CAHN @ TEVA PHARMS 50MG A 091658 001 Apr 06, 2012 Nov DISC @ 200MG A 091658 002 Apr 06, 2012 Nov DISC

VOXELOTOR TABLET;ORAL OXBRYTA +! GLOBAL BLOOD THERAPS 500MG N 213137 001 Nov 25, 2019 Nov NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -159

WARFARIN SODIUM TABLET;ORAL JANTOVEN AB UPSHER SMITH LABS 1MG A 040416 001 Oct 02, 2003 Jul CAHN AB 2MG A 040416 002 Oct 02, 2003 Jul CAHN AB 2.5MG A 040416 003 Oct 02, 2003 Jul CAHN AB 3MG A 040416 004 Oct 02, 2003 Jul CAHN AB 4MG A 040416 005 Oct 02, 2003 Jul CAHN AB 5MG A 040416 006 Oct 02, 2003 Jul CAHN AB 6MG A 040416 007 Oct 02, 2003 Jul CAHN AB 7.5MG A 040416 008 Oct 02, 2003 Jul CAHN AB 10MG A 040416 009 Oct 02, 2003 Jul CAHN

XENON XE-133 GAS;INHALATION XENON XE 133 CURIUM 10mCi/VIAL N 018327 001 Mar 09, 1982 May CAHN 20mCi/VIAL N 018327 002 Mar 09, 1982 May CAHN

ZANUBRUTINIB CAPSULE;ORAL BRUKINSA +! BEIGENE 80MG N 213217 001 Nov 14, 2019 Nov NEWA

ZIDOVUDINE INJECTABLE;INJECTION ZIDOVUDINE @ LUITPOLD 10MG/ML A 091457 001 May 06, 2010 Feb DISC

ZILEUTON TABLET, EXTENDED RELEASE;ORAL ZILEUTON AB LUPIN LTD 600MG A 211972 001 Nov 05, 2019 Oct NEWA >A> AB PAR PHARM INC 600MG A 212670 001 Dec 16, 2019 Dec NEWA

ZINC SULFATE SOLUTION;INTRAVENOUS ZINC SULFATE +! AM REGENT EQ 25MG BASE/5ML (EQ 5MG BASE/ML) N 209377 002 Jul 18, 2019 Oct CMS1 +! EQ 25MG BASE/5ML (EQ 5 BASE/ML) N 209377 002 Jul 18, 2019 Jul NEWA +! EQ 30MG BASE/10ML (EQ 3MG BASE/ML) N 209377 001 Jul 18, 2019 Jul NEWA

ZIPRASIDONE HYDROCHLORIDE CAPSULE;ORAL ZIPRASIDONE HYDROCHLORIDE @ CADILA EQ 20MG BASE A 208988 001 Aug 22, 2017 Jun DISC AB EQ 20MG BASE A 208988 001 Aug 22, 2017 Feb CAHN @ EQ 40MG BASE A 208988 002 Aug 22, 2017 Jun DISC AB EQ 40MG BASE A 208988 002 Aug 22, 2017 Feb CAHN @ EQ 60MG BASE A 208988 003 Aug 22, 2017 Jun DISC AB EQ 60MG BASE A 208988 003 Aug 22, 2017 Feb CAHN @ EQ 80MG BASE A 208988 004 Aug 22, 2017 Jun DISC AB EQ 80MG BASE A 208988 004 Aug 22, 2017 Feb CAHN

ZIPRASIDONE MESYLATE INJECTABLE;INTRAMUSCULAR GEODON >D> +! PFIZER EQ 20MG BASE/ML N 020919 001 Jun 21, 2002 Dec CFTG >A> AP +! EQ 20MG BASE/ML N 020919 001 Jun 21, 2002 Dec CFTG >A> ZIPRASIDONE MESYLATE >A> AP GLAND PHARMA LTD EQ 20MG BASE/ML A 211908 001 Dec 26, 2019 Dec NFTG

ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS RECLAST AP +! NOVARTIS EQ 5MG BASE/100ML N 021817 001 Apr 16, 2007 Mar CDFR ZOLEDRONIC AP GLAND PHARMA LTD EQ 4MG BASE/100ML A 205749 001 Jun 29, 2018 Mar CDFR ZOLEDRONIC ACID AP ACCORD HLTHCARE EQ 4MG BASE/5ML A 205279 001 Nov 28, 2016 Mar CDFR @ ACTAVIS INC EQ 4MG BASE/5ML A 202472 001 Mar 04, 2013 Jul DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -160

INJECTABLE;INTRAVENOUS ZOLEDRONIC ACID AP EQ 4MG BASE/5ML A 202472 001 Mar 04, 2013 Mar CDFR AP AKORN EQ 5MG BASE/100ML A 200918 001 Aug 21, 2014 Mar CDFR AP AKORN INC EQ 4MG BASE/5ML A 202548 001 May 22, 2014 Mar CDFR AP APOTEX EQ 5MG BASE/100ML A 204367 001 Dec 24, 2015 Mar CDFR AP AUROBINDO PHARMA LTD EQ 4MG BASE/5ML A 207751 001 Sep 26, 2016 Mar CDFR AP EQ 5MG BASE/100ML A 209125 001 Dec 08, 2017 Mar CDFR AP BPI LABS LLC EQ 4MG BASE/5ML A 207341 001 Dec 29, 2017 Mar CDFR AP BRECKENRIDGE EQ 4MG BASE/5ML A 091170 001 Mar 04, 2013 Mar CDFR AP EQ 4MG BASE/5ML A 202571 001 May 07, 2013 Mar CDFR AP EQ 5MG BASE/100ML A 202163 001 Aug 05, 2013 Mar CDFR AP CIPLA EQ 4MG BASE/100ML A 210174 001 Oct 27, 2017 Mar CDFR AP DR REDDYS LABS LTD EQ 4MG BASE/5ML A 091186 001 Mar 04, 2013 May CDFR @ EQ 4MG BASE/100ML A 204344 001 Nov 19, 2018 Oct DISC AP EQ 4MG BASE/100ML A 204344 001 Nov 19, 2018 Mar CDFR AP EQ 5MG BASE/100ML A 091363 001 Mar 29, 2013 Mar CDFR AP EMCURE PHARMS LTD EQ 4MG BASE/5ML A 201783 001 Mar 12, 2013 Mar CDFR AP EQ 5MG BASE/100ML A 201801 001 Mar 29, 2013 Mar CDFR AP FRESENIUS KABI USA EQ 4MG BASE/5ML A 091516 001 Apr 23, 2015 Mar CDFR AP GLAND PHARMA LTD EQ 4MG BASE/5ML A 202930 001 Aug 05, 2013 Mar CDFR AP EQ 5MG BASE/100ML A 204217 001 Aug 18, 2016 Mar CDFR AP EQ 5MG BASE/100ML A 209578 001 Aug 08, 2019 Jul NEWA AP HIKMA FARMACEUTICA EQ 4MG BASE/5ML A 202182 001 Jun 03, 2013 Mar CDFR AP HOSPIRA INC EQ 4MG BASE/5ML A 090621 001 Mar 19, 2015 Mar CDFR AP EQ 5MG BASE/100ML A 202837 001 Apr 05, 2013 Mar CDFR AP INFORLIFE EQ 4MG BASE/100ML N 203231 001 Aug 02, 2013 Mar CDFR AP EQ 5MG BASE/100ML A 202828 001 Sep 23, 2013 Mar CDFR AP MYLAN LABS LTD EQ 4MG BASE/5ML A 202650 001 Mar 04, 2013 Mar CDFR AP EQ 5MG BASE/100ML A 203841 001 Feb 14, 2017 Mar CDFR AP EQ 5MG BASE/100ML A 205254 001 Oct 27, 2017 Mar CDFR AP SAGENT PHARMS INC EQ 4MG BASE/5ML A 091493 001 Nov 24, 2014 Mar CDFR @ SHILPA MEDICARE LTD EQ 4MG BASE/5ML A 208513 001 May 15, 2019 Oct DISC AP EQ 4MG BASE/5ML A 208513 001 May 15, 2019 Apr NEWA @ SUN PHARMA GLOBAL EQ 4MG BASE/VIAL A 090018 001 Mar 04, 2013 Mar CDFR @ EQ 4MG BASE/5ML A 202746 001 Mar 04, 2013 Mar CDFR AP USV EQ 4MG BASE/5ML A 202923 001 Sep 04, 2014 Jun CAHN AP USV NORTH AMERICA EQ 4MG BASE/5ML A 202923 001 Sep 04, 2014 Mar CDFR ZOMETA + @ NOVARTIS EQ 4MG BASE/VIAL N 021223 001 Aug 20, 2001 Mar CDFR AP +! EQ 4MG BASE/5ML N 021223 002 Mar 07, 2003 Mar CDFR AP +! EQ 4MG BASE/100ML N 021223 003 Jun 17, 2011 Mar CDFR INJECTABLE;IV (INFUSION) ZOLEDRONIC ACID AP DR REDDYS LABS LTD EQ 4MG BASE/5ML A 091186 001 Mar 04, 2013 Mar CDFR SOLUTION;INTRAVENOUS ZOLEDRONIC ACID HOSPIRA INC EQ 4MG BASE/100ML (EQ 0.04MG N 204016 001 Dec 28, 2015 Mar CDFR BASE/ML)

ZOLMITRIPTAN TABLET;ORAL ZOLMITRIPTAN >D> AB ANI PHARMS INC 2.5MG A 090861 001 Mar 04, 2014 Dec DISC >A> @ 2.5MG A 090861 001 Mar 04, 2014 Dec DISC >D> AB 5MG A 090861 002 Mar 04, 2014 Dec DISC >A> @ 5MG A 090861 002 Mar 04, 2014 Dec DISC @ MACLEODS PHARMS LTD 2.5MG A 203772 001 Sep 30, 2015 Oct DISC @ 5MG A 203772 002 Sep 30, 2015 Oct DISC AB ORCHID HLTHCARE 2.5MG A 203726 001 Oct 21, 2019 Oct NEWA AB 5MG A 203726 002 Oct 21, 2019 Oct NEWA TABLET, ORALLY DISINTEGRATING;ORAL ZOLMITRIPTAN @ MACLEODS PHARMS LTD 2.5MG A 204336 001 Oct 22, 2015 Oct DISC @ 5MG A 204336 002 Oct 22, 2015 Oct DISC AB MYLAN 2.5MG A 202855 001 Sep 20, 2019 Sep NEWA AB 5MG A 202855 002 Sep 20, 2019 Sep NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 1 -161

ZOLPIDEM TARTRATE SPRAY, METERED;ORAL ZOLPIMIST +! AYTU 5MG/SPRAY N 022196 001 Dec 19, 2008 Feb CAHN TABLET;ORAL ZOLPIDEM TARTRATE MY LAN@ MYLAN@ 5MG A 076578 001 Apr 23, 2007 Nov DISC @ 10MG A 076578 002 Apr 23, 2007 Nov DISC @ STRIDES PHARMA 5MG A 076062 001 Apr 23, 2007 Apr CAHN @ 10MG A 076062 002 Apr 23, 2007 Apr CAHN @ SUN PHARM INDS INC 5MG A 077359 001 Apr 23, 2007 Oct DISC @ 10MG A 077359 002 Apr 23, 2007 Oct DISC TABLET;SUBLINGUAL ZOLPIDEM TARTRATE AB ! NOVEL LABS INC 3.5MG A 204299 002 Jun 03, 2015 Mar CHRS

ZONISAMIDE CAPSULE;ORAL ZONISAMIDE AB BIONPHARMA INC 25MG A 077813 001 Aug 16, 2006 Apr CAHN AB 50MG A 077813 002 Aug 16, 2006 Apr CAHN AB 100MG A 077813 003 Aug 16, 2006 Apr CAHN AB CELLTRION 25MG A 077636 003 Jul 27, 2006 Aug CAHN AB 50MG A 077636 002 Jul 27, 2006 Aug CAHN AB 100MG A 077636 001 Dec 22, 2005 Aug CAHN @ MYLAN 25MG A 077637 001 Dec 22, 2005 Nov DISC @ 50MG A 077637 002 Dec 22, 2005 Nov DISC @ 100MG A 077637 003 Dec 22, 2005 Nov DISC OTC DRUG PRODUCT LIST - 39TH EDITION OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 2 -1

ACETAMINOPHEN SUPPOSITORY;RECTAL ACEPHEN ACP NIMBLE 120MG N 018060 001 Feb CAHN @ 325MG N 018060 003 Dec 18, 1986 Feb CAHN @ 650MG N 018060 002 Feb CAHN TABLET, EXTENDED RELEASE;ORAL ACETAMINOPHEN GRANULES INDIA LTD 650MG A 211544 001 Apr 16, 2019 Apr NEWA HERITAGE PHARMA 650MG A 207035 001 May 31, 2018 Sep CMFD @ 650MG A 207035 001 May 31, 2018 Mar DISC

ADAPALENE GEL;TOPICAL ADAPALENE GLENMARK GENERICS 0.1% A 091314 002 Jul 09, 2019 Jul NEWA

CETIRIZINE HYDROCHLORIDE SYRUP;ORAL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ATHEM 5MG/5ML A 091327 001 Oct 17, 2011 Sep CAHN HETERO LABS LTD III 5MG/5ML A 210622 001 Mar 13, 2019 Feb NEWA @ TORRENT 5MG/5ML A 090474 002 Mar 30, 2009 Nov DISC 5MG/5ML A 090474 002 Mar 30, 2009 Jan CAHN CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF ATHEM 5MG/5ML A 091327 002 Oct 17, 2011 Sep CAHN @ TORRENT 5MG/5ML A 090474 001 Mar 30, 2009 Nov DISC 5MG/5ML A 090474 001 Mar 30, 2009 Jan CAHN TABLET;ORAL CETIRIZINE HYDROCHLORIDE ALLERGY @ HERITAGE PHARMA 5MG A 078615 003 Dec 28, 2007 May CAHN @ 10MG A 078615 004 Dec 28, 2007 May CAHN @ SUN PHARM INDS INC 5MG A 077499 001 Dec 27, 2007 Oct DISC @ 10MG A 077499 002 Dec 27, 2007 Oct DISC CETIRIZINE HYDROCHLORIDE HIVES @ SUN PHARM INDS INC 5MG A 077499 003 Dec 27, 2007 Oct DISC @ 10MG A 077499 004 Dec 27, 2007 Oct DISC

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE @ PERRIGO R AND D 5MG;120MG A 210719 001 Nov 16, 2018 May DISC

CHLORHEXIDINE GLUCONATE SOLUTION;TOPICAL CHLORHEXIDINE GLUCONATE BAJAJ 0.75% N 020111 001 Sep 11, 1997 Apr CTNA 0.75% N 020111 001 Sep 11, 1997 Jan CMFD

CHLORPHENIRAMINE MALEATE TABLET, EXTENDED RELEASE;ORAL CHLORPHENIRAMINE MALEATE ! AVANTHI INC 12MG A 040829 001 May 13, 2009 Jan CHRS

CLOTRIMAZOLE CREAM;VAGINAL CLOTRIMAZOLE ! P AND L 1% A 074165 001 Jul 16, 1993 Aug CAHN

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN CAPSULE;ORAL IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE AUROBINDO PHARMA LTD 25MG;EQ 200MG FREE ACID AND A 210676 001 Feb 14, 2019 Jan NEWA POTASSIUM SALT OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 2 -2

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM TABLET;ORAL NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE @ ACTAVIS ELIZABETH 25MG;220MG A 207597 001 Jan 25, 2019 Jul DISC 25MG;220MG A 207597 001 Jan 25, 2019 Jan NEWA APOTEX 25MG;220MG A 211830 001 Aug 22, 2019 Aug NEWA @ P AND L 25MG;220MG A 207597 001 Jan 25, 2019 Aug CAHN PERRIGO R AND D 25MG;220MG A 208499 001 May 10, 2019 Apr NEWA

DOCOSANOL CREAM;TOPICAL DOCOSANOL P AND L 10% A 208754 001 Nov 19, 2018 Aug CAHN

ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE;ORAL ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY EQ 20MG BASE A 209716 001 Jun 05, 2019 May NEWA MYLAN EQ 20MG BASE A 212376 001 Oct 16, 2019 Sep NEWA TABLET, DELAYED RELEASE;ORAL ESOMEPRAZOLE MAGNESIUM @ ACTAVIS ELIZABETH EQ 20MG BASE A 209202 001 Mar 05, 2019 Apr DISC EQ 20MG BASE A 209202 001 Mar 05, 2019 Feb NEWA @ P AND L EQ 20MG BASE A 209202 001 Mar 05, 2019 Aug CAHN

FAMOTIDINE TABLET;ORAL FAMOTIDINE P AND L 10MG A 075512 001 Jul 26, 2001 Aug CAHN

FEXOFENADINE HYDROCHLORIDE SUSPENSION;ORAL CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY P AND L 30MG/5ML A 203330 001 Nov 18, 2014 Aug CAHN CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES ! P AND L 30MG/5ML A 203330 002 Nov 18, 2014 Aug CAHN TABLET;ORAL CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY @ MYLAN 30MG A 077081 004 Jul 21, 2011 Jul DISC CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES @ MYLAN 30MG A 077081 005 Jul 21, 2011 Jul DISC FEXOFENADINE HYDROCHLORIDE ALLERGY GRANULES INDIA LTD 60MG A 211075 001 Oct 18, 2019 Oct NEWA 180MG A 211075 002 Oct 18, 2019 Oct NEWA

FLUTICASONE PROPIONATE SPRAY, METERED;NASAL FLUTICASONE PROPIONATE HI TECH 0.05MG/SPRAY A 208024 001 Apr 17, 2019 Apr NEWA

GUAIFENESIN TABLET, EXTENDED RELEASE;ORAL GUAIFENESIN AUROBINDO PHARMA LTD 600MG A 210453 001 Oct 21, 2019 Oct NEWA 1.2GM A 210453 002 Oct 21, 2019 Oct NEWA @ OHM LABS INC 600MG A 209254 001 Jul 16, 2018 Mar DISC @ 1.2GM A 209254 002 Jul 16, 2018 Mar DISC

IBUPROFEN CAPSULE;ORAL IBUPROFEN >D> STRIDES PHARMA EQ 200MG FREE ACID AND POTASSIUM A 204469 001 Mar 28, 2018 Dec DISC SALT >A> @ EQ 200MG FREE ACID AND POTASSIUM A 204469 001 Mar 28, 2018 Dec DISC SALT SUSPENSION;ORAL CHILDREN'S ELIXSURE @ MOBERG PHARMA NORTH 100MG/5ML N 021604 001 Jan 07, 2004 Sep DISC IBUPROFEN @ GUARDIAN DRUG 100MG/5ML A 210149 001 Aug 17, 2018 Feb DISC P AND L 100MG/5ML A 074916 001 Apr 30, 1999 Aug CAHN OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2 -3 2019

TABLET;ORAL IBUPROFEN ! PERRIGO R AND D 200MG A 077349 001 Jun 21, 2005 Jun CHRS >A> ULTRATAB LABS INC 200MG A 209076 001 Jan 06, 2020 Dec NEWA IBUPROHM @ OHM LABS 200MG A 071214 001 Dec 01, 1986 Oct DISC MOTRIN IB + J AND J CONSUMER INC 200MG N 019012 003 Dec 17, 1990 May CHRS

ISOPROPYL ALCOHOL SOLUTION;TOPICAL ZURAGARD

+ @ ZUREX PHARMA 70% (10.5ML) N 210872 001 Apr 26, 2019 Sep DISC +! 70% (10.5ML) N 210872 001 Apr 26, 2019 May CMS2

KETOCONAZOLE SHAMPOO;TOPICAL NIZORAL A-D +! KRAMER 1% N 020310 001 Oct 10, 1997 Jan CAHN

KETOTIFEN FUMARATE SOLUTION/DROPS;OPHTHALMIC KETOTIFEN FUMARATE APOTEX INC EQ 0.025% BASE A 077354 001 May 09, 2006 Oct CMFD ZADITOR ! ALCON PHARMS LTD EQ 0.025% BASE A 077200 001 Sep 02, 2008 Feb CTNA

LANSOPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL PREVACID 24 HR >D> +! GLAXOSMITHKLINE CONS 15MG N 022327 001 May 18, 2009 Dec CAHN >A> +! PERRIGO PHARMA INTL 15MG N 022327 001 May 18, 2009 Dec CAHN

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET;ORAL LEVOCETIRIZINE DIHYDROCHLORIDE

@ PERRIGO R AND D 5MG A 211983 001 Mar 28, 2019 Nov DISC 5MG A 211983 001 Mar 28, 2019 Jul CMS1 5MG A 211983 001 Mar 26, 2019 Mar NEWA

LEVONORGESTREL TABLET;ORAL LEVONORGESTREL @ ACCORD HLTHCARE 1.5MG A 207660 001 May 02, 2019 Nov DISC 1.5MG A 207660 001 May 02, 2019 Apr NEWA >D> ALVOGEN 1.5MG A 202246 001 Jun 05, 2015 Dec DISC >A> @ 1.5MG A 202246 001 Jun 05, 2015 Dec DISC 1.5MG A 202246 001 Jun 05, 2015 Jul CAHN @ FDN CONSUMER 1.5MG A 200670 001 Jul 12, 2012 Jun DISC ! L PERRIGO CO 0.75MG A 090740 001 Dec 30, 2010 May CAHN >D> LOTUS PHARM CO LTD 0.75MG A 202684 001 Sep 02, 2016 Dec DISC >A> @ 0.75MG A 202684 001 Sep 02, 2016 Dec DISC NAARI PTE LTD 1.5MG A 202380 001 May 29, 2015 Sep CAHN

LORATADINE CAPSULE;ORAL LORATADINE @ BIONPHARMA INC 10MG A 202538 001 Dec 21, 2018 Mar DISC >A> STRIDES PHARMA 10MG A 211926 001 Jan 15, 2020 Dec NEWA

TABLET;ORAL

LORATADINE >A> GRANULES INDIA LTD 10MG A 210722 001 Dec 23, 2019 Dec NEWA GUARDIAN DRUG 10MG A 207569 001 Mar 12, 2019 Mar CAHN NEWGEN PHARMS LLC 10MG A 207569 001 Mar 12, 2019 Feb NEWA TABLET, CHEWABLE;ORAL LORATADINE PERRIGO PHARMA INTL 5MG A 210033 001 Jun 12, 2019 May NEWA SUN PHARM 5MG A 210088 001 Apr 16, 2018 Mar CAHN

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 2 -4

LORATADINE; PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE;ORAL LORATADINE AND PSEUDOEPHEDRINE SULFATE @ HERITAGE PHARMA 5MG;120MG A 076208 001 Jan 28, 2004 May CAHN P AND L 10MG;240MG A 075706 001 Feb 21, 2003 Aug CAHN

MICONAZOLE NITRATE CREAM;VAGINAL MICONAZOLE 7 P AND L 2% A 074164 001 Mar 29, 1996 Aug CAHN CREAM, SUPPOSITORY;TOPICAL, VAGINAL M-ZOLE 3 COMBINATION PACK P AND L 2%,200MG A 074926 001 Apr 16, 1999 Aug CAHN SUPPOSITORY;VAGINAL MICONAZOLE NITRATE P AND L 100MG A 073507 001 Nov 19, 1993 Aug CAHN

MINOXIDIL AEROSOL, FOAM;TOPICAL MINOXIDIL (FOR MEN) P AND L 5% A 208092 001 Feb 17, 2017 Aug CAHN MINOXIDIL (FOR WOMEN) P AND L 5% A 208092 002 Jul 27, 2017 Aug CAHN TARO 5% A 209074 002 Apr 22, 2019 Apr NEWA SOLUTION;TOPICAL MINOXIDIL (FOR MEN) P AND L 2% A 074588 001 Apr 05, 1996 Aug CAHN MINOXIDIL EXTRA STRENGTH (FOR MEN) P AND L 5% A 075518 001 Nov 17, 2000 Aug CAHN

NAPROXEN SODIUM CAPSULE;ORAL NAPROXEN SODIUM CATALENT EQ 200MG BASE A 202807 001 Jan 04, 2019 Nov CMFD @ EQ 200MG BASE A 202807 001 Jan 04, 2019 Jul DISC TABLET;ORAL ALEVE +! BAYER 220MG N 020204 002 Jan 11, 1994 Sep CPOT NAPROXEN SODIUM AMNEAL PHARMS NY 220MG A 079096 001 Dec 16, 2008 Sep CPOT AUROBINDO PHARMA LTD 220MG A 205497 001 Mar 18, 2016 Sep CPOT CONTRACT PHARMACAL 220MG A 074635 001 Jan 13, 1997 Sep CPOT @ 220MG A 074789 001 Feb 27, 1997 Sep CPOT DR REDDYS LABS INC 220MG A 075168 001 Jul 28, 1998 Sep CPOT GRANULES INDIA 220MG A 091353 001 Sep 20, 2011 Sep CPOT LNK INTL INC 220MG A 204872 001 Jan 23, 2017 Sep CPOT MARKSANS PHARMA 220MG A 090545 001 Mar 16, 2011 Sep CPOT NOVELGENIX THERAPS 220MG A 207612 001 Nov 16, 2018 Sep CPOT PERRIGO 220MG A 074661 001 Jan 13, 1997 Sep CPOT @ PLD ACQUISITIONS LLC 220MG A 074646 001 Jan 13, 1997 Sep CPOT SUN PHARM INDS LTD 220MG A 091183 001 May 20, 2011 Sep CPOT YICHANG HUMANWELL EQ 200MG BASE A 212033 001 Aug 30, 2019 Aug NEWA 220MG A 212033 001 Aug 30, 2019 Sep CPOT

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL ALEVE-D SINUS & COLD +! BAYER EQ 200MG BASE;120MG N 021076 001 Nov 29, 1999 Mar CPOT +! 220MG;120MG N 021076 001 Nov 29, 1999 Sep CPOT NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS INC 220MG;120MG A 077381 001 Sep 27, 2006 Sep CPOT PERRIGO 220MG;120MG A 076518 001 Mar 17, 2004 Sep CPOT

NICOTINE POLACRILEX GUM, CHEWING;BUCCAL NICOTINE POLACRILEX P AND L EQ 2MG BASE A 074507 001 Mar 15, 1999 Aug CAHN EQ 2MG BASE A 076569 001 Jul 29, 2004 Aug CAHN EQ 2MG BASE A 078699 001 Dec 29, 2008 Aug CAHN EQ 2MG BASE A 079044 001 Jul 08, 2009 Aug CAHN EQ 2MG BASE A 079216 001 Jul 08, 2009 Aug CAHN OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 2 -5

GUM, CHEWING;BUCCAL NICOTINE POLACRILEX EQ 2MG BASE A 204794 001 May 10, 2016 Aug CAHN EQ 4MG BASE A 074707 001 Mar 19, 1999 Aug CAHN EQ 4MG BASE A 076568 002 Jul 29, 2004 Aug CAHN EQ 4MG BASE A 078697 001 Dec 29, 2008 Aug CAHN EQ 4MG BASE A 079038 001 Jul 08, 2009 Aug CAHN EQ 4MG BASE A 079219 001 Jul 08, 2009 Aug CAHN EQ 4MG BASE A 204833 001 Feb 26, 2016 Aug CAHN TROCHE/LOZENGE;ORAL NICOTINE POLACRILEX >A> DR REDDYS LABS SA EQ 2MG BASE A 212796 001 Jan 08, 2020 Dec NEWA >A> EQ 4MG BASE A 212796 002 Jan 08, 2020 Dec NEWA P AND L EQ 2MG BASE A 208875 001 Oct 31, 2019 Oct NEWA EQ 2MG BASE A 209206 001 Jun 26, 2018 Nov CMFD @ EQ 2MG BASE A 209206 001 Jun 26, 2018 Aug CAHN EQ 2MG BASE A 209519 001 Jul 02, 2018 Nov CMFD @ EQ 2MG BASE A 209519 001 Jul 02, 2018 Aug CAHN EQ 2MG BASE A 209520 001 Oct 31, 2019 Oct NEWA EQ 2MG BASE A 210711 001 Oct 31, 2019 Oct NEWA EQ 2MG BASE A 210712 001 Sep 06, 2019 Aug NEWA EQ 2MG BASE A 212056 001 Jul 26, 2019 Jul CAHN EQ 4MG BASE A 208875 002 Oct 31, 2019 Oct NEWA EQ 4MG BASE A 209206 002 Jun 26, 2018 Nov CMFD @ EQ 4MG BASE A 209206 002 Jun 26, 2018 Aug CAHN EQ 4MG BASE A 209519 002 Jul 02, 2018 Nov CMFD @ EQ 4MG BASE A 209519 002 Jul 02, 2018 Aug CAHN EQ 4MG BASE A 209520 002 Oct 31, 2019 Oct NEWA EQ 4MG BASE A 210711 002 Oct 31, 2019 Oct NEWA EQ 4MG BASE A 210712 002 Sep 06, 2019 Aug NEWA EQ 4MG BASE A 212056 002 Jul 26, 2019 Jul CAHN PLD ACQUISITIONS EQ 2MG BASE A 207868 001 Feb 07, 2019 Feb NEWA EQ 4MG BASE A 207868 002 Feb 07, 2019 Feb NEWA TEVA PHARMS USA INC EQ 2MG BASE A 212056 001 Jul 26, 2019 Jul NEWA EQ 4MG BASE A 212056 002 Jul 26, 2019 Jul NEWA @ WATSON LABS INC EQ 2MG BASE A 209206 001 Jun 26, 2018 Feb DISC @ EQ 4MG BASE A 209206 002 Jun 26, 2018 Feb DISC @ WATSON LABS TEVA EQ 2MG BASE A 209519 001 Jul 02, 2018 Feb DISC @ EQ 4MG BASE A 209519 002 Jul 02, 2018 Feb DISC

OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL OMEPRAZOLE @ APOTEX 20MG A 210070 001 Feb 11, 2019 Aug DISC APOTEX INC 20MG A 210070 001 Feb 11, 2019 Apr CTEC

POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL GLYCOLAX @ LANNETT CO INC 17GM/PACKET A 090600 001 Oct 06, 2009 Jun DISC @ 17GM/SCOOPFUL A 090600 002 Oct 06, 2009 Jun DISC POLYETHYLENE GLYCOL 3350 NOVELGENIX THERAPS 17GM/SCOOPFUL A 202071 001 Dec 28, 2012 Sep CAHN

RANITIDINE HYDROCHLORIDE TABLET;ORAL RANITIDINE HYDROCHLORIDE @ ANI PHARMS INC EQ 75MG BASE A 075296 001 Jan 14, 2000 Oct DISC @ MYLAN EQ 75MG BASE A 075497 001 Jan 14, 2000 Oct DISC STRIDES PHARMA EQ 75MG BASE A 209160 001 Mar 05, 2018 Apr CAHN EQ 150MG BASE A 209161 001 Feb 22, 2018 Apr CAHN UNIQUE PHARM LABS EQ 75MG BASE A 210250 001 Aug 30, 2019 Aug NEWA EQ 150MG BASE A 210228 001 Aug 30, 2019 Aug NEWA

SODIUM FLUORIDE; TRICLOSAN PASTE;DENTAL COLGATE TOTAL + @ COLGATE PALMOLIVE 0.24%;0.3% N 020231 001 Jul 11, 1997 Mar DISC

3-1

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

CUMULATIVE SUPPLEMENT NUMBER 12 DECEMBER 2019

NO DECEMBER 2019 APPROVALS

4-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of Orphan Designations and Approvals is available at: https://www.fda.gov/industry/developing-products-rare-diseases conditions/designating-orphan-product-drugs-and-biological-products.

5-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO DECEMBER 2019 ADDITIONS PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 39TH EDITION A - 1 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ABIRATERONE ACETATE - ABIRATERONE ACETATE A 208327 001 PC Apr 29, 2019

ABIRATERONE ACETATE - ZYTIGA N 202379 002 8822438 Aug 24, 2027 U-1579 Y 8822438 Aug 24, 2027 U-1580 Y 8822438 Aug 24, 2027 U-2235 Y

ABIRATERONE ACETATE - YONSA N 210308 001 10292990 May 20, 2034 U-2535

ACALABRUTINIB - CALQUENCE N 210259 001 >A> 10167291 Jul 01, 2036 DP U-2145 I-817 Nov 21, 2022 >A> 10167291 Jul 01, 2036 DP U-2666 >A> ODE-274 Nov 21, 2026 >A> 10167291 Jul 01, 2036 DP U-2667 >A> 10167291 Jul 01, 2036 DP U-2668 >A> 10167291 Jul 01, 2036 DP U-2669 >A> 10167291 Jul 01, 2036 DP U-2670 >A> 10167291 Jul 01, 2036 DP U-2671 >A> 10239883 Jul 11, 2032 U-2666 >A> 10239883 Jul 11, 2032 U-2668 >A> 10272083 Jan 21, 2035 U-2519 >A> 10272083 Jan 21, 2035 U-2682 >A> 10272083 Jan 21, 2035 U-2683 >A> 10272083 Jan 21, 2035 U-2684 >A> 10272083 Jan 21, 2035 U-2685 >A> 10272083 Jan 21, 2035 U-2686 >A> 10272083 Jan 21, 2035 U-2687 >A> 9796721 Jul 01, 2036 DS DP U-2145 >A> 9796721 Jul 01, 2036 DS DP U-2666 >A> 9796721 Jul 01, 2036 DS DP U-2667 >A> 9796721 Jul 01, 2036 DS DP U-2668 >A> 9796721 Jul 01, 2036 DS DP U-2669 >A> 9796721 Jul 01, 2036 DS DP U-2670 >A> 9796721 Jul 01, 2036 DS DP U-2671

ACETAMINOPHEN - OFIRMEV N 022450 001 10383834 Nov 13, 2028 U-2262 10383834 Nov 13, 2028 U-2621

ACETAMINOPHEN - ACETAMINOPHEN N 204767 001 8741959 Apr 19, 2030 DP

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE - APADAZ N 208653 002 8461137 Feb 22, 2031 DS DP 8748413 Jul 10, 2030 DS DP 8828978 Jul 01, 2030 DP 9132125 Jul 01, 2030 DS DP U-2249 9549923 Jul 01, 2030 DS DP

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE - APADAZ N 208653 003 8461137 Feb 22, 2031 DS DP 8748413 Jul 10, 2030 DS DP 8828978 Jul 01, 2030 DP 9132125 Jul 01, 2030 DS DP U-2249 9549923 Jul 01, 2030 DS DP

ACLIDINIUM BROMIDE - TUDORZA PRESSAIR N 202450 001 10034867 Jul 07, 2020 DP U-2513 10034867 Jul 07, 2020 DP U-2514 10085974 Mar 13, 2029 DP U-2513 7078412 Jul 07, 2020 DS DP U-2513 9056100 Jul 07, 2020 DP U-2513 A - 2 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ACLIDINIUM BROMIDE - TUDORZA PRESSAIR N 202450 001 9333195 Jul 07, 2020 DP U-2513 RE46417 Feb 10, 2025 DS DP U-2513

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE - DUAKLIR PRESSAIR N 210595 001 10034867 Jul 07, 2020 DP U-2513 NC Mar 29, 2022 10034867 Jul 07, 2020 DP U-2514 10085974 Mar 13, 2029 DP U-2513 6681768 Aug 07, 2022 DP 7078412 Jul 07, 2020 DS DP U-2513 7750023 Jul 07, 2020 DP U-2513 8051851 Apr 22, 2027 DP 8129405 Jul 07, 2020 DP U-2513 9056100 Jul 07, 2020 DP U-2513 9333195 Jul 07, 2020 DP U-2513 RE46417 Feb 10, 2025 DS DP U-2513

ACYCLOVIR - AVACLYR N 202408 001 ODE-235 Mar 29, 2026

AFAMELANOTIDE - SCENESSE N 210797 001 10076555 Feb 11, 2025 U-2638 NCE Oct 08, 2024 8334265 Mar 11, 2029 U-2638 ODE-270 Oct 08, 2026

AFATINIB DIMALEATE - GILOTRIF N 201292 001 ODE-230 Jan 12, 2025

AFATINIB DIMALEATE - GILOTRIF N 201292 002 ODE-230 Jan 12, 2025

AFATINIB DIMALEATE - GILOTRIF N 201292 003 ODE-230 Jan 12, 2025

AIR POLYMER-TYPE A - EXEM FOAM KIT N 212279 001 >A> 9034300 Oct 15, 2030 DP U-2663 NCE Nov 07, 2024 >A> 9259494 May 04, 2035 DP U-2663 >A> 9849199 Feb 11, 2036 DP

ALBUTEROL SULFATE - PROAIR RESPICLICK N 205636 001 10124131 May 18, 2031 DP

ALBUTEROL SULFATE - PROAIR DIGIHALER N 205636 002 10022510 May 18, 2031 DP 10124131 May 18, 2031 DP 6701917 Jun 23, 2021 DP 6718972 Jun 23, 2021 DP 6748947 Jun 23, 2021 DP 6871646 Jun 23, 2021 DP 7540282 May 06, 2023 DP 8006690 Jun 23, 2021 DP 8651103 Mar 26, 2028 DP 8978966 Jan 13, 2032 DP 9216260 Jun 28, 2031 DP 9463288 May 19, 2025 DP 9731087 May 18, 2031 DP 9782550 Aug 28, 2035 DP 9782551 Aug 28, 2035 DP

ALLOPURINOL; LESINURAD - DUZALLO N 209203 001 10183012 Nov 26, 2028 U-2104 A - 3 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ALLOPURINOL; LESINURAD - DUZALLO N 209203 002 10183012 Nov 26, 2028 U-2104

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N 022426 006 6329404 Jun 19, 2021 DP U-1334

ALPELISIB - PIQRAY N 212526 001 8227462 Sep 28, 2030 DS DP U-2539 NCE May 24, 2024 8476268 Sep 10, 2029 DS DP

ALPELISIB - PIQRAY N 212526 002 8227462 Sep 28, 2030 DS DP U-2539 NCE May 24, 2024 8476268 Sep 10, 2029 DS DP

ALPELISIB - PIQRAY N 212526 003 8227462 Sep 28, 2030 DS DP U-2539 NCE May 24, 2024 8476268 Sep 10, 2029 DS DP

AMANTADINE HYDROCHLORIDE - OSMOLEX ER N 209410 001 10213393 Feb 15, 2038 U-20 10213394 Feb 15, 2038 U-2497 >A> 10500170 Feb 15, 2038 U-20 >A> 10500171 Feb 15, 2038 U-2497 >A> 10500172 Feb 15, 2038 U-2497 >A> 10512617 Feb 15, 2038 U-2497

AMANTADINE HYDROCHLORIDE - OSMOLEX ER N 209410 002 10213393 Feb 15, 2038 U-20 10213394 Feb 15, 2038 U-2497 >A> 10500170 Feb 15, 2038 U-20 >A> 10500171 Feb 15, 2038 U-2497 >A> 10500172 Feb 15, 2038 U-2497 >A> 10512617 Feb 15, 2038 U-2497

AMANTADINE HYDROCHLORIDE - OSMOLEX ER N 209410 003 10213393 Feb 15, 2038 U-20 10213394 Feb 15, 2038 U-2497 >A> 10500170 Feb 15, 2038 U-20 >A> 10500171 Feb 15, 2038 U-2497 >A> 10500172 Feb 15, 2038 U-2497 >A> 10512617 Feb 15, 2038 U-2497

AMIFAMPRIDINE - RUZURGI N 209321 001 ODE-244 May 06, 2026

AMIKACIN SULFATE - ARIKAYCE KIT N 207356 001 10251900 May 15, 2035 U-2414 ODE-214 Sep 28, 2025 GAIN Sep 28, 2030

AMINOCAPROIC ACID - AMINOCAPROIC ACID A 212492 001 CGT May 30, 2020

AMINOCAPROIC ACID - AMINOCAPROIC ACID A 212780 001 CGT Feb 26, 2020

AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN N 020965 001 10357567 Jan 12, 2038 U-804

AMLODIPINE BESYLATE; CELECOXIB - CONSENSI N 210045 001 10350171 Jun 14, 2038 DP 9662315 May 22, 2029 DP U-2410 A - 4 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

AMLODIPINE BESYLATE; CELECOXIB - CONSENSI N 210045 002 10350171 Jun 14, 2038 DP 9662315 May 22, 2029 DP U-2410

AMLODIPINE BESYLATE; CELECOXIB - CONSENSI N 210045 003 10350171 Jun 14, 2038 DP 9662315 May 22, 2029 DP U-2410

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN - TALICIA N 213004 001 10238606 Feb 12, 2034 DP 9050263 Feb 12, 2034 DP U-2660 9498445 Feb 12, 2034 DP U-2660 9603806 Feb 12, 2034 DP U-2660

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - MYDAYIS N 022063 001 >A> M-248 Sep 13, 2022 >A> PED Mar 13, 2023

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - MYDAYIS N 022063 002 >A> M-248 Sep 13, 2022 >A> PED Mar 13, 2023

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - MYDAYIS N 022063 003 >A> M-248 Sep 13, 2022 >A> PED Mar 13, 2023

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - MYDAYIS N 022063 004 >A> M-248 Sep 13, 2022 >A> PED Mar 13, 2023

AMPHETAMINE SULFATE - EVEKEO ODT N 209905 001 10130580 Apr 19, 2024 DP 10441554 Mar 10, 2037 DP

AMPHETAMINE SULFATE - EVEKEO ODT N 209905 002 10130580 Apr 19, 2024 DP 10441554 Mar 10, 2037 DP

AMPHETAMINE SULFATE - EVEKEO ODT N 209905 003 10130580 Apr 19, 2024 DP 10441554 Mar 10, 2037 DP

AMPHETAMINE SULFATE - EVEKEO ODT N 209905 004 10130580 Apr 19, 2024 DP 10441554 Mar 10, 2037 DP

ANGIOTENSIN II ACETATE - GIAPREZA N 209360 001 10335451 Dec 16, 2029 U-2581 >A> 10493124 Dec 18, 2034 U-2679 >A> 10500247 Dec 16, 2029 U-2680 >A> 10500247 Dec 16, 2029 U-2681 9572856 Nov 20, 2030 U-2221

ANGIOTENSIN II ACETATE - GIAPREZA N 209360 002 10335451 Dec 16, 2029 U-2581 >A> 10493124 Dec 18, 2034 U-2679 >A> 10500247 Dec 16, 2029 U-2680 >A> 10500247 Dec 16, 2029 U-2681 9572856 Nov 20, 2030 U-2221 A - 5 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

APALUTAMIDE - ERLEADA N 210951 001 8445507 Sep 15, 2030 DS DP U-2237 I-808 Sep 17, 2022 8445507 Sep 15, 2030 DS DP U-2624 8802689 Mar 27, 2027 U-2237 8802689 Mar 27, 2027 U-2624 9481663 Jun 04, 2033 DS DP U-2237 9481663 Jun 04, 2033 DS DP U-2624

APREMILAST - OTEZLA N 205437 001 10092541 May 29, 2034 U-2403 I-803 Jul 19, 2022 10092541 May 29, 2034 U-2659 ODE-248 Jul 19, 2026 6962940 Mar 19, 2023 U-1504 6962940 Mar 19, 2023 U-2656 6962940 Mar 19, 2023 U-2657 6962940 Mar 19, 2023 U-2658 7659302 Mar 19, 2023 U-1505 7659302 Mar 19, 2023 U-1595 7659302 Mar 19, 2023 U-2657 7659302 Mar 19, 2023 U-2658 8455536 Mar 19, 2023 U-1505 8455536 Mar 19, 2023 U-1595 8455536 Mar 19, 2023 U-2657 8455536 Mar 19, 2023 U-2658 9018243 Mar 19, 2023 U-1505 9018243 Mar 19, 2023 U-1595 9018243 Mar 19, 2023 U-2656 9018243 Mar 19, 2023 U-2657 9018243 Mar 19, 2023 U-2658 9724330 Mar 19, 2023 U-1561 9724330 Mar 19, 2023 U-1595 9724330 Mar 19, 2023 U-2656 9724330 Mar 19, 2023 U-2657 9724330 Mar 19, 2023 U-2658

APREMILAST - OTEZLA N 205437 002 10092541 May 29, 2034 U-2403 I-803 Jul 19, 2022 10092541 May 29, 2034 U-2659 ODE-248 Jul 19, 2026 6962940 Mar 19, 2023 U-1504 6962940 Mar 19, 2023 U-2656 6962940 Mar 19, 2023 U-2657 6962940 Mar 19, 2023 U-2658 7659302 Mar 19, 2023 U-1505 7659302 Mar 19, 2023 U-1595 7659302 Mar 19, 2023 U-2657 7659302 Mar 19, 2023 U-2658 8455536 Mar 19, 2023 U-1505 8455536 Mar 19, 2023 U-1595 8455536 Mar 19, 2023 U-2657 8455536 Mar 19, 2023 U-2658 9018243 Mar 19, 2023 U-1505 9018243 Mar 19, 2023 U-1595 9018243 Mar 19, 2023 U-2656 9018243 Mar 19, 2023 U-2657 9018243 Mar 19, 2023 U-2658 9724330 Mar 19, 2023 U-1561 9724330 Mar 19, 2023 U-1595 9724330 Mar 19, 2023 U-2656 9724330 Mar 19, 2023 U-2657 9724330 Mar 19, 2023 U-2658

APREMILAST - OTEZLA N 205437 003 10092541 May 29, 2034 U-2403 I-803 Jul 19, 2022 10092541 May 29, 2034 U-2659 ODE-248 Jul 19, 2026 6962940 Mar 19, 2023 U-1504 6962940 Mar 19, 2023 U-2656 6962940 Mar 19, 2023 U-2657 A - 6 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

APREMILAST - OTEZLA N 205437 003 6962940 Mar 19, 2023 U-2658 7659302 Mar 19, 2023 U-1505 7659302 Mar 19, 2023 U-1595 7659302 Mar 19, 2023 U-2657 7659302 Mar 19, 2023 U-2658 8455536 Mar 19, 2023 U-1505 8455536 Mar 19, 2023 U-1595 8455536 Mar 19, 2023 U-2657 8455536 Mar 19, 2023 U-2658 9018243 Mar 19, 2023 U-1505 9018243 Mar 19, 2023 U-1595 9018243 Mar 19, 2023 U-2656 9018243 Mar 19, 2023 U-2657 9018243 Mar 19, 2023 U-2658 9724330 Mar 19, 2023 U-1561 9724330 Mar 19, 2023 U-1595 9724330 Mar 19, 2023 U-2656 9724330 Mar 19, 2023 U-2657 9724330 Mar 19, 2023 U-2658

APREPITANT - CINVANTI N 209296 001 >A> 10500208 Sep 18, 2035 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 001 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 002 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 003 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 004 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 005 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE - ABILIFY MYCITE KIT N 207202 006 10441194 May 12, 2029 DP 8114021 Jun 21, 2030 DP

ARIPIPRAZOLE LAUROXIL - ARISTADA N 207533 001 10226458 Mar 19, 2032 U-543 10238651 Mar 19, 2035 U-2402

ARIPIPRAZOLE LAUROXIL - ARISTADA N 207533 002 10226458 Mar 19, 2032 U-543 10238651 Mar 19, 2035 U-2402

ARIPIPRAZOLE LAUROXIL - ARISTADA N 207533 003 10226458 Mar 19, 2032 U-543 10238651 Mar 19, 2035 U-2402

ARIPIPRAZOLE LAUROXIL - ARISTADA N 207533 004 10226458 Mar 19, 2032 U-543 10238651 Mar 19, 2035 U-2402 A - 7 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ARIPIPRAZOLE LAUROXIL - ARISTADA N 207533 004 10226458 Mar 19, 2032 U-543 10238651 Mar 19, 2035 U-2402

ASENAPINE - SECUADO N 212268 001 10022445 Jul 25, 2033 DP NP Oct 11, 2022 9687474 Jul 25, 2033 DP

ASENAPINE - SECUADO N 212268 002 10022445 Jul 25, 2033 DP NP Oct 11, 2022 9687474 Jul 25, 2033 DP

ASENAPINE - SECUADO N 212268 003 10022445 Jul 25, 2033 DP NP Oct 11, 2022 9687474 Jul 25, 2033 DP

AVATROMBOPAG MALEATE - DOPTELET N 210238 001 8338429 Jun 30, 2023 U-2577 I-802 Jun 26, 2022 8765764 Jan 15, 2023 U-2314 ODE-246 Jun 26, 2026 8765764 Jan 15, 2023 U-2578

AVIBACTAM SODIUM; CEFTAZIDIME - AVYCAZ N 206494 001 7112592 Feb 24, 2022 DS DP U-2244 7112592 Feb 24, 2022 DS DP U-2508 7112592 Feb 24, 2022 DS DP U-282 8178554 Jul 24, 2021 DS DP U-2245 8178554 Jul 24, 2021 DS DP U-2509 8178554 Jul 24, 2021 DS DP U-282

AZELAIC ACID - FINACEA N 207071 001 10322085 Oct 24, 2023 DP

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR N 202331 001 9387249 Jul 01, 2031 U-3

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR N 202331 002 9387249 Jul 01, 2031 U-3

BALOXAVIR MARBOXIL - XOFLUZA N 210854 001 10392406 Apr 27, 2036 DS I-811 Oct 16, 2022 NCE Oct 24, 2023

BALOXAVIR MARBOXIL - XOFLUZA N 210854 002 10392406 Apr 27, 2036 DS I-811 Oct 16, 2022 NCE Oct 24, 2023

BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED - DUAVEE N 022247 001 6479535 May 06, 2024 DP U-594 6479535 May 06, 2024 DP U-904

BECLOMETHASONE DIPROPIONATE - QNASL N 202813 001 10188811 Oct 21, 2031 DP

BECLOMETHASONE DIPROPIONATE - QNASL N 202813 002 10188811 Oct 21, 2031 DP

BEDAQUILINE FUMARATE - SIRTURO N 204384 001 NPP Aug 09, 2022 ODE-251 Aug 09, 2026 A - 8 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE A 205128 001 PC Aug 18, 2019

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA N 050819 001 10220049 Jun 03, 2029 DP U-916

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ONEXTON N 050819 002 10220049 Jun 03, 2029 DP U-916

BETAMETHASONE DIPROPIONATE - SERNIVO N 208079 001 10179137 Aug 31, 2030 DP U-1858

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - TACLONEX N 022185 001 6753013 Jan 27, 2020 DP U-1761 NPP Jul 25, 2022 6753013 Jan 27, 2020 DP U-193 PED Jan 25, 2023 6753013 Jan 27, 2020 DP U-88 6787529 Jan 27, 2020 DP U-1761 6787529 Jan 27, 2020 DP U-193 6787529 Jan 27, 2020 DP U-88

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - ENSTILAR N 207589 001 10130640 Jun 10, 2031 DP NPP Jul 30, 2022 10130640*PED Dec 10, 2031 PED Jan 30, 2023 6753013 Jan 27, 2020 DP U-1761 6753013 Jan 27, 2020 DP U-2627 9119781 Jun 10, 2031 DP U-1761 9119781 Jun 10, 2031 DP U-2627 9119781*PED Dec 10, 2031 9566286 Jun 10, 2031 DP

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - BIKTARVY N 210251 001 10385067 Jun 19, 2035 U-257 NPP Jun 18, 2022 ODE-256 Jun 18, 2026

BOSUTINIB MONOHYDRATE - BOSULIF N 203341 003 7417148 Dec 11, 2025 U-1283

BREMELANOTIDE ACETATE - VYLEESI (AUTOINJECTOR) N 210557 001 10286034 Nov 05, 2033 U-2568 NCE Jun 21, 2024 6579968 Jun 28, 2020 DS DP 6794489 Jun 28, 2020 DS DP 9352013 Nov 05, 2033 U-2568 9700592 Nov 05, 2033 U-2568

BREXANOLONE - ZULRESSO N 211371 001 10117951 Mar 13, 2029 DP NCE Jun 17, 2024 10251894 Nov 27, 2033 U-2552 10322139 Jan 23, 2033 DP 7635773 Mar 13, 2029 DP 8410077 Mar 13, 2029 DP 9200088 Mar 13, 2029 DP 9750822 Mar 13, 2029 DP

BREXPIPRAZOLE - REXULTI N 205422 001 10307419 Oct 12, 2032 DP 7888362 Apr 12, 2026 DS

BREXPIPRAZOLE - REXULTI N 205422 002 10307419 Oct 12, 2032 DP 7888362 Apr 12, 2026 DS A - 9 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

BREXPIPRAZOLE - REXULTI N 205422 003 10307419 Oct 12, 2032 DP 7888362 Apr 12, 2026 DS

BREXPIPRAZOLE - REXULTI N 205422 004 10307419 Oct 12, 2032 DP 7888362 Apr 12, 2026 DS

BREXPIPRAZOLE - REXULTI N 205422 005 10307419 Oct 12, 2032 DP 7888362 Apr 12, 2026 DS

BREXPIPRAZOLE - REXULTI N 205422 006 7888362 Apr 12, 2026 DS

BRIGATINIB - ALUNBRIG N 208772 001 10385078 Nov 10, 2035 DS DP U-1927 9012462 Jul 31, 2030 DS

BRIGATINIB - ALUNBRIG N 208772 002 10385078 Nov 10, 2035 DS DP U-1927 9012462 Jul 31, 2030 DS

BRIGATINIB - ALUNBRIG N 208772 003 10385078 Nov 10, 2035 DS DP U-1927 9012462 Jul 31, 2030 DS

BRIMONIDINE TARTRATE - ALPHAGAN P N 021770 001 10307368 Jul 10, 2021 DP

BRIMONIDINE TARTRATE - MIRVASO N 204708 001 10201517 Jun 13, 2031 DP

BUDESONIDE - UCERIS N 203634 001 10307375 Sep 07, 2031 DP

BUDESONIDE - ORTIKOS N 211929 001 10172802 Sep 09, 2036 U-2554 9707182 Sep 09, 2036 DP U-2554

BUDESONIDE - ORTIKOS N 211929 002 10172802 Sep 09, 2036 U-2554 9707182 Sep 09, 2036 DP U-2554

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT N 021929 001 10166247 Jan 29, 2023 DP U-2001 10166247 Jan 29, 2023 DP U-2002 10166247 Jan 29, 2023 DP U-2122 10166247*PED Jul 29, 2023

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT N 021929 002 10166247 Jan 29, 2023 DP U-2001 10166247 Jan 29, 2023 DP U-2002 10166247 Jan 29, 2023 DP U-2122 10166247*PED Jul 29, 2023

BUPRENORPHINE - BUTRANS N 021306 001 >A> M-250 Oct 13, 2020 A - 10 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

BUPRENORPHINE - BUTRANS N 021306 002 >A> M-250 Oct 13, 2020

BUPRENORPHINE - BUTRANS N 021306 003 >A> M-250 Oct 13, 2020

BUPRENORPHINE - BUTRANS N 021306 004 >A> M-250 Oct 13, 2020

BUPRENORPHINE - BUTRANS N 021306 005 >A> M-250 Oct 13, 2020

BUPRENORPHINE - SUBLOCADE N 209819 001 10198218 Jun 06, 2031 U-2489

BUPRENORPHINE - SUBLOCADE N 209819 002 10198218 Jun 06, 2031 U-2489

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N 022410 001 10285910 Oct 11, 2022 DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N 022410 002 10285910 Oct 11, 2022 DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N 022410 003 10285910 Oct 11, 2022 DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N 022410 004 10285910 Oct 11, 2022 DP

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE - CONTRAVE N 200063 001 10231964 Jul 02, 2034 U-1583 10307376 Nov 08, 2027 U-1585

CABAZITAXEL - JEVTANA KIT N 201023 001 8927592 Oct 27, 2030 U-1630 8927592*PED Apr 27, 2031

CABOZANTINIB S-MALATE - CABOMETYX N 208692 001 10034873 Jul 18, 2031 U-2488 I-792 Jan 14, 2022 8497284 Sep 24, 2024 U-1220 ODE-227 Jan 14, 2026 8497284 Sep 24, 2024 U-1480 8497284 Sep 24, 2024 U-2488

CABOZANTINIB S-MALATE - CABOMETYX N 208692 002 10034873 Jul 18, 2031 U-2488 I-792 Jan 14, 2022 8497284 Sep 24, 2024 U-1220 ODE-227 Jan 14, 2026 8497284 Sep 24, 2024 U-1480 8497284 Sep 24, 2024 U-2488

CABOZANTINIB S-MALATE - CABOMETYX N 208692 003 10034873 Jul 18, 2031 U-2488 I-792 Jan 14, 2022 8497284 Sep 24, 2024 U-1220 ODE-227 Jan 14, 2026 8497284 Sep 24, 2024 U-1480 8497284 Sep 24, 2024 U-2488

CALCIFEDIOL - RAYALDEE N 208010 001 10213442 Feb 02, 2027 DP 10300078 Mar 14, 2034 DP 10357502 Mar 14, 2034 DP A - 11 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

CALCIPOTRIENE - SORILUX N 022563 001 8263580 May 07, 2028 DP U-1280 8263580 May 07, 2028 DP U-2662 8629128 May 26, 2026 DP U-1280 8629128 May 26, 2026 DP U-1767 8629128 May 26, 2026 DP U-2662

CALCIUM GLUCONATE - CALCIUM GLUCONATE IN SODIUM CHLORIDE N 210906 001 10130646 Jul 25, 2037 DP 10342813 Jul 25, 2037 DP

CALCIUM GLUCONATE - CALCIUM GLUCONATE IN SODIUM CHLORIDE N 210906 002 10130646 Jul 25, 2037 DP 10342813 Jul 25, 2037 DP

CANAGLIFLOZIN - INVOKANA N 204042 001 7943582 Feb 26, 2029 DS DP U-2441 I-809 Sep 27, 2022 7943582 Feb 26, 2029 DS DP U-2632 7943582 Feb 26, 2029 DS DP U-493 8222219 Apr 11, 2025 U-2441 8222219 Apr 11, 2025 U-2632 8222219 Apr 11, 2025 U-493 8513202 Dec 03, 2027 DS DP U-2441 8513202 Dec 03, 2027 DS DP U-2632 8513202 Dec 03, 2027 DS DP U-493

CANAGLIFLOZIN - INVOKANA N 204042 002 7943582 Feb 26, 2029 DS DP U-2441 I-809 Sep 27, 2022 7943582 Feb 26, 2029 DS DP U-2632 7943582 Feb 26, 2029 DS DP U-493 8222219 Apr 11, 2025 U-2441 8222219 Apr 11, 2025 U-2632 8222219 Apr 11, 2025 U-493 8513202 Dec 03, 2027 DS DP U-2441 8513202 Dec 03, 2027 DS DP U-2632 8513202 Dec 03, 2027 DS DP U-493

CANNABIDIOL - EPIDIOLEX N 210365 001 10195159 May 07, 2022 DS

CAPSAICIN - QUTENZA N 022395 001 >A> 10034841 Sep 06, 2025 DP >A> 10463598 Sep 05, 2023 DP >A> 8263059 Sep 05, 2023 U-2705 >A> 8821920 Mar 26, 2030 DP >A> 8889113 Sep 05, 2023 U-2705 >A> 9226903 Dec 15, 2028 DP

CARBOPROST TROMETHAMINE - CARBOPROST TROMETHAMINE A 211941 001 CGT Dec 29, 2019

CARIPRAZINE HYDROCHLORIDE - VRAYLAR N 204370 001 >A> 7737142 Sep 17, 2029 DS DP U-1750 I-798 May 24, 2022 >A> 7737142 Sep 17, 2029 DS DP U-2543 >A> 7737142 Sep 17, 2029 DS DP U-2544 >A> 7737142 Sep 17, 2029 DS DP U-2545 RE47350 Jul 16, 2029 U-1750 RE47350 Jul 16, 2029 U-2543 RE47350 Jul 16, 2029 U-2544 RE47350 Jul 16, 2029 U-2545

CARIPRAZINE HYDROCHLORIDE - VRAYLAR N 204370 002 >A> 7737142 Sep 17, 2029 DS DP U-1750 I-798 May 24, 2022 >A> 7737142 Sep 17, 2029 DS DP U-2543 A - 12 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

CARIPRAZINE HYDROCHLORIDE - VRAYLAR N 204370 002 >A> 7737142 Sep 17, 2029 DS DP U-2544 >A> 7737142 Sep 17, 2029 DS DP U-2545

CARIPRAZINE HYDROCHLORIDE - VRAYLAR N 204370 003 >A> 7737142 Sep 17, 2029 DS DP U-1750 I-798 May 24, 2022 >A> 7737142 Sep 17, 2029 DS DP U-2543 >A> 7737142 Sep 17, 2029 DS DP U-2544

CARIPRAZINE HYDROCHLORIDE - VRAYLAR N 204370 004 >A> 7737142 Sep 17, 2029 DS DP U-1750 I-798 May 24, 2022 >A> 7737142 Sep 17, 2029 DS DP U-2543 >A> 7737142 Sep 17, 2029 DS DP U-2544

CEFIDEROCOL SULFATE TOSYLATE - FETROJA N 209445 001 10004750 Sep 03, 2035 DS DP NCE Nov 14, 2024 9238657 Nov 19, 2031 DS DP U-282 GAIN Nov 14, 2029 9949982 Sep 03, 2035 DP

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - ZERBAXA N 206829 001 10028963 Sep 07, 2032 U-2565 10028963 Sep 07, 2032 U-2566 10376496 Sep 09, 2034 U-2610 10376496 Sep 09, 2034 U-2611 10420841 Mar 14, 2034 U-1672 10420841 Mar 14, 2034 U-2631 >A> 7129232 May 15, 2028 DS DP U-1676 >A> 7129232 May 15, 2028 DS DP U-36 9724353 Sep 07, 2032 U-2565 9724353 Sep 07, 2032 U-2566

CERITINIB - ZYKADIA N 211225 001 7153964 Feb 26, 2021 DS DP NCE Apr 29, 2019 7893074 Apr 25, 2026 DS DP 7964592 Jan 13, 2027 DS DP 8039479 Jun 29, 2030 DS DP 8188276 Jan 31, 2023 DS DP 8377921 Nov 20, 2027 U-1179 8399450 Nov 20, 2027 DS DP 8703787 Feb 02, 2032 U-1179 8835430 Jan 31, 2023 DS DP 9018204 Jan 31, 2023 DS DP 9309229 Jan 18, 2032 DS DP 9416112 Jan 31, 2023 DS DP

CETIRIZINE HYDROCHLORIDE - QUZYTTIR N 211415 001 8263581 Feb 28, 2030 U-2635 NP Oct 04, 2022 8314083 Feb 28, 2030 U-2634 8513259 Feb 11, 2030 U-2636 9119771 Feb 11, 2030 U-2635 9180090 Feb 11, 2030 U-2635

CHLOROPROCAINE HYDROCHLORIDE - CLOROTEKAL N 208791 001 8969412 Sep 05, 2026 DP U-2609 9504666 Dec 11, 2033 DP

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S ADVIL ALLERGY SINUS N 021587 001 10238640 May 25, 2024 DP

CHLORZOXAZONE - CHLORZOXAZONE A 212253 001 CGT May 25, 2020 A - 13 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

CHLORZOXAZONE - CHLORZOXAZONE A 212253 002 CGT May 25, 2020

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM - RECARBRIO N 212819 001 8487093 Nov 19, 2029 DS DP U-2586 8487093 Nov 19, 2029 DS DP U-2587

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - CLENPIQ N 209589 001 9827231 Jun 26, 2034 DP U-2162

CLADRIBINE - MAVENCLAD N 022561 001 7713947 Oct 16, 2026 U-2520 NP Mar 29, 2022 7888328 Apr 11, 2024 DP U-2521 8377903 May 31, 2026 U-2522 8785415 Apr 11, 2024 DP U-2523

CLOZAPINE - VERSACLOZ N 203479 001 8057811 May 01, 2028 DP

COBICISTAT - TYBOST N 203094 001 NPP Aug 22, 2022 ODE-260 Aug 22, 2026

COBIMETINIB FUMARATE - COTELLIC N 206192 001 >A> 10478400 Jun 29, 2036 DS DP U-1776

COCAINE HYDROCHLORIDE - GOPRELTO N 209963 001 10231961 Feb 07, 2037 DP 10413505 Feb 07, 2037 U-2479 10420760 Feb 07, 2037 U-2478

COLCHICINE - GLOPERBA N 210942 001 10226423 Dec 20, 2037 DP 9907751 Nov 22, 2036 DP

COLESEVELAM HYDROCHLORIDE - WELCHOL N 210895 001 7229613 Apr 17, 2022 U-2516

COPANLISIB DIHYDROCHLORIDE - ALIQOPA N 209936 001 10383876 Mar 29, 2032 DS DP

CROFELEMER - MYTESI N 202292 001 7341744 Jun 02, 2022 DP U-1319 9585868 Oct 31, 2031 U-1319

CYCLOSPORINE - CEQUA N 210913 001 10441630 Aug 23, 2033 DP

CYSTEAMINE BITARTRATE - PROCYSBI N 203389 001 10328037 Aug 16, 2036 U-1399

CYSTEAMINE BITARTRATE - PROCYSBI N 203389 002 10328037 Aug 16, 2036 U-1399

CYSTEINE HYDROCHLORIDE - ELCYS N 210660 001 10478453 Jan 15, 2039 DP

CYTARABINE; DAUNORUBICIN - VYXEOS N 209401 001 10166184 Oct 15, 2032 DP U-2341 A - 14 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DABRAFENIB MESYLATE - TAFINLAR N 202806 001 M-246 Oct 06, 2022

DABRAFENIB MESYLATE - TAFINLAR N 202806 002 M-246 Oct 06, 2022

DALFAMPRIDINE - DALFAMPRIDINE A 206863 001 PC Mar 09, 2019

DALFAMPRIDINE - AMPYRA N 022250 001 8007826 May 26, 2027 U-1030 Y 8354437 Dec 22, 2026 U-1030 Y 8440703 Apr 08, 2025 U-1030 Y

DALTEPARIN SODIUM - FRAGMIN N 020287 001 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 002 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 003 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 004 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 005 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 006 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 007 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 008 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 009 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 010 NPP May 16, 2022

DALTEPARIN SODIUM - FRAGMIN N 020287 011 NPP May 16, 2022

DAPAGLIFLOZIN - FARXIGA N 202293 001 M-238 Feb 22, 2022

DAPAGLIFLOZIN - FARXIGA N 202293 002 M-238 Feb 22, 2022

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - QTERNMET XR N 210874 001 6414126 Oct 04, 2020 DS DP U-493 NP May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-493 7919598 Dec 16, 2029 DS 8501698 Jun 20, 2027 DP U-493 8628799 Jul 13, 2025 DP 8716251 Mar 21, 2028 DP A - 15 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - QTERNMET XR N 210874 001 9198925 Oct 04, 2020 U-493 9616028 Nov 12, 2030 DP RE44186 Jul 31, 2023 DS DP U-493

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - QTERNMET XR N 210874 002 6414126 Oct 04, 2020 DS DP U-493 NP May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-493 7919598 Dec 16, 2029 DS 8501698 Jun 20, 2027 DP U-493 8628799 Jul 13, 2025 DP 8716251 Mar 21, 2028 DP 9198925 Oct 04, 2020 U-493 9616028 Nov 12, 2030 DP RE44186 Jul 31, 2023 DS DP U-493

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - QTERNMET XR N 210874 003 6414126 Oct 04, 2020 DS DP U-493 NP May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-493 7919598 Dec 16, 2029 DS 8501698 Jun 20, 2027 DP U-493 8628799 Jul 13, 2025 DP 8716251 Mar 21, 2028 DP 9198925 Oct 04, 2020 U-493 9616028 Nov 12, 2030 DP RE44186 Jul 31, 2023 DS DP U-493

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - QTERNMET XR N 210874 004 6414126 Oct 04, 2020 DS DP U-493 NP May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-493 7919598 Dec 16, 2029 DS 8501698 Jun 20, 2027 DP U-493 8628799 Jul 13, 2025 DP 8716251 Mar 21, 2028 DP 9198925 Oct 04, 2020 U-493 9616028 Nov 12, 2030 DP RE44186 Jul 31, 2023 DS DP U-493

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - QTERN N 209091 001 6414126 Oct 04, 2020 DS DP U-493 I-804 May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-1976 6936590 Oct 04, 2020 U-1977 6936590 Oct 04, 2020 U-493 8361972 Mar 21, 2028 U-1976 8361972 Mar 21, 2028 U-1977 8361972 Mar 21, 2028 U-493 8501698 Jun 20, 2027 DP U-1976 8501698 Jun 20, 2027 DP U-1977 8501698 Jun 20, 2027 DP U-493 9198925 Oct 04, 2020 U-1976 9198925 Oct 04, 2020 U-1977 9198925 Oct 04, 2020 U-493 RE44186 Jul 31, 2023 DS DP U-493

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - QTERN N 209091 002 6414126 Oct 04, 2020 DS DP U-493 NS May 02, 2022 6515117 Oct 04, 2020 DS DP U-493 6936590 Oct 04, 2020 U-493 7919598 Dec 16, 2029 DS 8221786 Mar 21, 2028 DP 8361972 Mar 21, 2028 U-493 8501698 Jun 20, 2027 DP U-493 A - 16 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - QTERN N 209091 002 8628799 Jul 13, 2025 DP 8716251 Mar 21, 2028 DP 9198925 Oct 04, 2020 U-493 RE44186 Jul 31, 2023 DS DP U-493

DAPSONE - ACZONE N 207154 001 NPP Sep 10, 2022

DAPTOMYCIN - DAPTOMYCIN A 212667 001 CGT Jan 12, 2020

DAROLUTAMIDE - NUBEQA N 212099 001 10010530 Jan 28, 2036 DS NCE Jul 30, 2024 10383853 Jan 28, 2036 DS 8975254 Oct 27, 2030 DS DP U-2605 9657003 Oct 27, 2030 DS DP U-2605

DARUNAVIR - PREZISTA N 021976 002 9889115 Jun 23, 2019 U-1305 9889115*PED Dec 23, 2019

DARUNAVIR - PREZISTA N 021976 004 9889115 Jun 23, 2019 U-1305 9889115*PED Dec 23, 2019

DARUNAVIR - PREZISTA N 021976 005 9889115 Jun 23, 2019 U-1305 9889115*PED Dec 23, 2019

DARUNAVIR - PREZISTA N 021976 006 9889115 Jun 23, 2019 U-1305 9889115*PED Dec 23, 2019

DARUNAVIR - PREZISTA N 202895 001 9889115 Jun 23, 2019 U-1305 9889115*PED Dec 23, 2019

DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR - VIEKIRA PAK (COPACKAGED) N 206619 001 10201542 Oct 18, 2033 DP U-1753

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR - VIEKIRA XR N 208624 001 10201541 May 17, 2032 DP 10201584 May 17, 2032 U-1889

DASATINIB - SPRYCEL N 021986 001 ODE-225 Dec 21, 2025 PED Jun 21, 2026

DASATINIB - SPRYCEL N 021986 002 ODE-225 Dec 21, 2025 PED Jun 21, 2026

DASATINIB - SPRYCEL N 021986 003 ODE-225 Dec 21, 2025 PED Jun 21, 2026

DASATINIB - SPRYCEL N 021986 004 ODE-225 Dec 21, 2025 PED Jun 21, 2026 A - 17 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DASATINIB - SPRYCEL N 021986 005 ODE-225 Dec 21, 2025 PED Jun 21, 2026

DASATINIB - SPRYCEL N 021986 006 ODE-225 Dec 21, 2025 PED Jun 21, 2026

DEFERASIROX - DEFERASIROX A 203560 001 PC Apr 05, 2019

DEFERASIROX - DEFERASIROX A 203560 002 PC Apr 05, 2019

DEFERASIROX - DEFERASIROX A 203560 003 PC Apr 05, 2019

DEFERASIROX - DEFERASIROX A 208697 002 >A> PC Jun 14, 2020

DEFERASIROX - EXJADE N 021882 001 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - EXJADE N 021882 002 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - EXJADE N 021882 003 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU N 206910 001 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU N 206910 002 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU N 206910 003 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU SPRINKLE N 207968 001 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU SPRINKLE N 207968 002 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERASIROX - JADENU SPRINKLE N 207968 003 M-239 Dec 12, 2021 M-241 Jul 24, 2022

DEFERIPRONE - FERRIPROX N 208030 002 7049328 Jun 28, 2021 U-735 8703156 Oct 29, 2029 DP U-735 A - 18 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DEFLAZACORT - EMFLAZA N 208684 001 ODE-252 Jun 07, 2026

DEFLAZACORT - EMFLAZA N 208684 002 ODE-252 Jun 07, 2026

DEFLAZACORT - EMFLAZA N 208684 003 ODE-252 Jun 07, 2026

DEFLAZACORT - EMFLAZA N 208684 004 ODE-252 Jun 07, 2026

DEFLAZACORT - EMFLAZA N 208685 001 ODE-252 Jun 07, 2026

DELAFLOXACIN MEGLUMINE - BAXDELA N 208610 001 I-815 Oct 24, 2022

DELAFLOXACIN MEGLUMINE - BAXDELA N 208611 001 I-815 Oct 24, 2022

DESMOPRESSIN ACETATE - NOCDURNA N 022517 001 10307459 May 07, 2023 DP

DESMOPRESSIN ACETATE - NOCDURNA N 022517 002 10307459 May 07, 2023 DP

DESONIDE - VERDESO N 021978 001 8460641 Aug 13, 2027 DP U-1412

DEXAMETHASONE - DEXTENZA N 208742 001 8409606 May 14, 2030 DP I-800 Jun 20, 2022 8563027 Feb 12, 2030 U-2487 NP Nov 30, 2021 9254267 Sep 11, 2024 DP

DEXAMETHASONE - DEXYCU KIT N 208912 001 10159683 May 23, 2034 DP

DEXAMETHASONE - HEMADY N 211379 001 ODE-271 Oct 03, 2026

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE HYDROCHLORIDE A 208129 001 PC Nov 30, 2019

DIAZOXIDE - DIAZOXIDE A 211050 001 >A> CGT Jun 17, 2020

DIGOXIN - DIGOXIN A 213000 001 CGT Apr 01, 2020

DIROXIMEL FUMARATE - VUMERITY N 211855 001 10080733 Sep 20, 2033 DS DP U-1384 8669281 Sep 20, 2033 DS DP 9090558 Sep 20, 2033 U-1384

DOCETAXEL - DOCETAXEL N 205934 001 9763880 Sep 30, 2033 U-2558 9763880 Sep 30, 2033 U-2559 9763880 Sep 30, 2033 U-2560 9763880 Sep 30, 2033 U-2561 9763880 Sep 30, 2033 U-2562 A - 19 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DOCETAXEL - DOCETAXEL N 205934 001 9763880 Sep 30, 2033 U-2563 9763880 Sep 30, 2033 U-2564

DOCETAXEL - DOCETAXEL N 205934 002 9763880 Sep 30, 2033 U-2558 9763880 Sep 30, 2033 U-2559 9763880 Sep 30, 2033 U-2560 9763880 Sep 30, 2033 U-2561 9763880 Sep 30, 2033 U-2562 9763880 Sep 30, 2033 U-2563 9763880 Sep 30, 2033 U-2564

DOCETAXEL - DOCETAXEL N 205934 003 9763880 Sep 30, 2033 U-2558 9763880 Sep 30, 2033 U-2559 9763880 Sep 30, 2033 U-2560 9763880 Sep 30, 2033 U-2561 9763880 Sep 30, 2033 U-2562 9763880 Sep 30, 2033 U-2563 9763880 Sep 30, 2033 U-2564

DOLUTEGRAVIR SODIUM; LAMIVUDINE - DOVATO N 211994 001 8129385 Oct 05, 2027 DS DP NC Apr 08, 2022 9242986 Dec 08, 2029 DS DP

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE - JULUCA N 210192 001 10426780 Jan 24, 2031 DS DP U-257

DORAVIRINE - PIFELTRO N 210806 001 8486975 Oct 07, 2031 DS DP U-2394 8486975 Oct 07, 2031 DS DP U-2630

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - DELSTRIGO N 210807 001 8486975 Oct 07, 2031 DS DP U-2395 I-806 Sep 19, 2022 8486975 Oct 07, 2031 DS DP U-2629

DOXEPIN HYDROCHLORIDE - SILENOR N 022036 001 10238620 May 18, 2027 U-620

DOXEPIN HYDROCHLORIDE - SILENOR N 022036 002 10238620 May 18, 2027 U-620

DOXYCYCLINE - ORACEA N 050805 001 10058564 Apr 05, 2022 U-1063

DRONABINOL - SYNDROS N 205525 001 10265293 Aug 06, 2028 DS DP

DROSPIRENONE - SLYND N 211367 001 10179140 Jun 28, 2031 U-2553 NP May 23, 2022 9603860 Jun 28, 2031 U-2553

DULOXETINE HYDROCHLORIDE - DRIZALMA SPRINKLE N 212516 001 10413525 Apr 13, 2037 DP 9839626 Apr 13, 2037 DP

DULOXETINE HYDROCHLORIDE - DRIZALMA SPRINKLE N 212516 002 10413525 Apr 13, 2037 DP 9839626 Apr 13, 2037 DP A - 20 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

DULOXETINE HYDROCHLORIDE - DRIZALMA SPRINKLE N 212516 003 10413525 Apr 13, 2037 DP 9839626 Apr 13, 2037 DP

DULOXETINE HYDROCHLORIDE - DRIZALMA SPRINKLE N 212516 004 10413525 Apr 13, 2037 DP 9839626 Apr 13, 2037 DP

EDARAVONE - RADICAVA N 209176 002 NCE May 05, 2022

EDOXABAN TOSYLATE - SAVAYSA N 206316 001 M-243 Aug 09, 2022

EDOXABAN TOSYLATE - SAVAYSA N 206316 002 M-243 Aug 09, 2022

EDOXABAN TOSYLATE - SAVAYSA N 206316 003 M-243 Aug 09, 2022

EFINACONAZOLE - JUBLIA N 203567 001 >A> 10512640 Jan 03, 2028 U-1969

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TRIKAFTA (COPACKAGED) N 212273 001 10022352 Apr 09, 2027 DP U-2651 NCE Feb 12, 2023 10081621 Mar 25, 2031 DP U-2652 NCE Oct 21, 2024 10239867 Apr 09, 2027 DS DP U-2653 >A> ODE-275 Oct 21, 2026 7495103 May 20, 2027 DS DP 7645789 May 01, 2027 DS DP 7776905 Jun 03, 2027 DS DP 8324242 Aug 05, 2027 U-2645 8354427 Jul 06, 2026 U-2646 8410274 Dec 28, 2026 DP 8415387 Nov 12, 2027 U-2645 8598181 May 01, 2027 U-2645 8623905 May 01, 2027 DS DP 8629162 Jun 24, 2025 U-2648 8754224 Dec 28, 2026 DS DP 9012496 Jul 15, 2033 U-2649 9670163 Dec 28, 2026 DP U-2650 9931334 Dec 28, 2026 DP U-2650 9974781 Apr 09, 2027 DP U-2645

ELTROMBOPAG OLAMINE - PROMACTA N 022291 001 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-2451 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-2451 7332481*PED Nov 24, 2021 7452874 May 24, 2021 DS DP 7452874*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-2451 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-2451 7547719 Jul 13, 2025 DS DP U-2452 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-2451 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 A - 21 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ELTROMBOPAG OLAMINE - PROMACTA N 022291 001 7795293 May 21, 2023 U-2451 7795293*PED Nov 21, 2023 8052993 Aug 01, 2027 DP U-1306 8052993 Aug 01, 2027 DP U-1575 8052993 Aug 01, 2027 DP U-2451 8052993 Aug 01, 2027 DP U-930 8052993*PED Feb 01, 2028 8828430 Aug 01, 2027 DP U-1306 8828430 Aug 01, 2027 DP U-2451 8828430*PED Feb 01, 2028

ELTROMBOPAG OLAMINE - PROMACTA N 022291 002 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-2451 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-2451 7332481*PED Nov 24, 2021 7452874 May 24, 2021 DS DP 7452874*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-2451 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-2451 7547719 Jul 13, 2025 DS DP U-2452 7547719 Jul 13, 2025 DS DP U-930 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-2451 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 7795293 May 21, 2023 U-2451 7795293 May 21, 2023 U-930 7795293*PED Nov 21, 2023 8052994 Aug 01, 2027 DP U-1306 8052994 Aug 01, 2027 DP U-2451 8052994 Aug 01, 2027 DP U-930 8052994*PED Feb 01, 2028 8828430 Aug 01, 2027 DP U-1306 8828430 Aug 01, 2027 DP U-2451 8828430*PED Feb 01, 2028

ELTROMBOPAG OLAMINE - PROMACTA N 022291 003 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-2451 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-2451 7332481*PED Nov 24, 2021 7452874 May 24, 2021 DS DP 7452874*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-2451 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-2451 7547719 Jul 13, 2025 DS DP U-2452 7547719 Jul 13, 2025 DS DP U-930 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-2451 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 A - 22 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ELTROMBOPAG OLAMINE - PROMACTA N 022291 003 7795293 May 21, 2023 U-2451 7795293 May 21, 2023 U-930 7795293*PED Nov 21, 2023 8062665 Aug 01, 2027 DP U-1306 8062665 Aug 01, 2027 DP U-2451 8062665 Aug 01, 2027 DP U-930 8062665*PED Feb 01, 2028 8828430 Aug 01, 2027 DP U-1306 8828430 Aug 01, 2027 DP U-2451 8828430*PED Feb 01, 2028

ELTROMBOPAG OLAMINE - PROMACTA N 022291 004 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-2451 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-2451 7332481*PED Nov 24, 2021 7452874 May 24, 2021 DS DP 7452874*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-2451 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-2451 7547719 Jul 13, 2025 DS DP U-2452 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-2451 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 7795293 May 21, 2023 U-2451 7795293*PED Nov 21, 2023 8071129 Aug 01, 2027 DP U-1306 8071129 Aug 01, 2027 DP U-2451 8071129 Aug 01, 2027 DP U-930 8071129*PED Feb 01, 2028 8828430 Aug 01, 2027 DP U-1306 8828430 Aug 01, 2027 DP U-2451 8828430*PED Feb 01, 2028

ELTROMBOPAG OLAMINE - PROMACTA KIT N 207027 001 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-1736 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-1736 7332481*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-1736 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-1736 7547719 Jul 13, 2025 DS DP U-2452 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-1736 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 7795293 May 21, 2023 U-1736 7795293*PED Nov 24, 2023 A - 23 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ELTROMBOPAG OLAMINE - PROMACTA KIT N 207027 002 7160870 Nov 20, 2022 DS DP U-1306 7160870 Nov 20, 2022 DS DP U-1736 7160870*PED May 20, 2023 7332481 May 24, 2021 U-1306 7332481 May 24, 2021 U-1736 7332481*PED Nov 24, 2021 7452874 May 24, 2021 DS DP 7452874*PED Nov 24, 2021 7473686 May 24, 2021 DS DP U-1306 7473686 May 24, 2021 DS DP U-1736 7473686*PED Nov 24, 2021 7547719 Jul 13, 2025 DS DP U-1306 7547719 Jul 13, 2025 DS DP U-1575 7547719 Jul 13, 2025 DS DP U-1736 7547719 Jul 13, 2025 DS DP U-2452 7547719*PED Jan 13, 2026 7790704 May 24, 2021 U-1306 7790704 May 24, 2021 U-1736 7790704*PED Nov 24, 2021 7795293 May 21, 2023 U-1306 7795293 May 21, 2023 U-1736 7795293*PED Nov 21, 2023

ELUXADOLINE - VIBERZI N 206940 001 10188632 Mar 14, 2033 DP 10213415 Mar 14, 2025 DS U-2152

ELUXADOLINE - VIBERZI N 206940 002 10188632 Mar 14, 2033 DP 10213415 Mar 14, 2025 DS U-2152

EMPAGLIFLOZIN - JARDIANCE N 204629 001 10258637 Apr 03, 2034 U-2290 10406172 Jun 15, 2030 U-1652

EMPAGLIFLOZIN - JARDIANCE N 204629 002 10258637 Apr 03, 2034 U-2290 10406172 Jun 15, 2030 U-1652

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI N 206073 001 10258637 Apr 03, 2034 U-2290 10406172 Jun 15, 2030 U-1652

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI N 206073 002 10258637 Apr 03, 2034 U-2290 10406172 Jun 15, 2030 U-1652

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY N 206111 001 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY N 206111 002 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY N 206111 003 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY N 206111 004 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR N 208658 001 10258637 Apr 03, 2034 U-2290 A - 24 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR N 208658 002 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR N 208658 003 10258637 Apr 03, 2034 U-2290

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR N 208658 004 10258637 Apr 03, 2034 U-2290

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - DESCOVY N 208215 001 6642245 Nov 04, 2020 U-1663 I-812 Oct 03, 2022 6642245*PED May 04, 2021 7803788 Feb 02, 2022 U-1663 8754065 Aug 15, 2032 DS DP U-1259 8754065 Aug 15, 2032 DS DP U-1663 8754065 Aug 15, 2032 DS DP U-257 9296769 Aug 15, 2032 DS DP U-1259 9296769 Aug 15, 2032 DS DP U-1663 9296769 Aug 15, 2032 DS DP U-257

ENASIDENIB MESYLATE - IDHIFA N 209606 001 10294215 Jan 07, 2033 DP U-2087

ENASIDENIB MESYLATE - IDHIFA N 209606 002 10294215 Jan 07, 2033 DP U-2087

ENTRECTINIB - ROZLYTREK N 212725 001 10231965 Feb 17, 2035 U-2617 NCE Aug 15, 2024 10231965 Feb 17, 2035 U-2618 ODE-265 Aug 15, 2026 10398693 Jul 18, 2038 DP 8299057 Mar 01, 2029 DS DP 8673893 Jul 08, 2028 U-2617 8673893 Jul 08, 2028 U-2618 9029356 Jul 08, 2028 DS DP 9085558 Jul 08, 2028 DP 9085565 May 22, 2033 DS DP 9255087 Jul 08, 2028 U-2617 9255087 Jul 08, 2028 U-2618 9616059 Jul 08, 2028 U-2618 9649306 May 22, 2033 U-2617 9649306 May 22, 2033 U-2618

ENTRECTINIB - ROZLYTREK N 212725 002 10231965 Feb 17, 2035 U-2617 NCE Aug 15, 2024 10231965 Feb 17, 2035 U-2618 ODE-265 Aug 15, 2026 10398693 Jul 18, 2038 DP 8299057 Mar 01, 2029 DS DP 8673893 Jul 08, 2028 U-2617 8673893 Jul 08, 2028 U-2618 9029356 Jul 08, 2028 DS DP 9085558 Jul 08, 2028 DP 9085565 May 22, 2033 DS DP 9255087 Jul 08, 2028 U-2617 9255087 Jul 08, 2028 U-2618 9616059 Jul 08, 2028 U-2618 9649306 May 22, 2033 U-2617 9649306 May 22, 2033 U-2618

ENZALUTAMIDE - XTANDI N 203415 001 >A> I-808 Dec 16, 2022

EPINEPHRINE - ADRENACLICK N 020800 003 10166344 Jan 21, 2025 DP A - 25 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

EPINEPHRINE - ADRENACLICK N 020800 004 10166344 Jan 21, 2025 DP

EPINEPHRINE - AUVI-Q N 201739 001 10314977 Nov 23, 2024 DP 10335549 Apr 30, 2025 DP

EPINEPHRINE - AUVI-Q N 201739 002 10314977 Nov 23, 2024 DP 10335549 Apr 30, 2025 DP

EPINEPHRINE - AUVI-Q N 201739 003 10314977 Nov 23, 2024 DP 10335549 Apr 30, 2025 DP

ERAVACYCLINE DIHYDROCHLORIDE - XERAVA N 211109 001 8796245 Aug 07, 2029 U-2380 8906887 Dec 28, 2030 DP

ERDAFITINIB - BALVERSA N 212018 001 8895601 May 22, 2031 DS DP NCE Apr 12, 2024 9464071 Apr 28, 2031 U-2518 9902714 Mar 26, 2035 DP

ERDAFITINIB - BALVERSA N 212018 002 8895601 May 22, 2031 DS DP NCE Apr 12, 2024 9464071 Apr 28, 2031 U-2518 9902714 Mar 26, 2035 DP

ERDAFITINIB - BALVERSA N 212018 003 8895601 May 22, 2031 DS DP NCE Apr 12, 2024 9464071 Apr 28, 2031 U-2518 9902714 Mar 26, 2035 DP

ERLOTINIB HYDROCHLORIDE - ERLOTINIB HYDROCHLORIDE A 091002 001 PC Nov 05, 2019

ERLOTINIB HYDROCHLORIDE - ERLOTINIB HYDROCHLORIDE A 091002 002 PC Nov 05, 2019

ERLOTINIB HYDROCHLORIDE - ERLOTINIB HYDROCHLORIDE A 091002 003 PC Nov 05, 2019

ERYTHROMYCIN ETHYLSUCCINATE - ERYTHROMYCIN ETHYLSUCCINATE A 211991 001 CGT May 09, 2020

ERYTHROMYCIN ETHYLSUCCINATE - ERYTHROMYCIN ETHYLSUCCINATE A 211991 002 CGT May 09, 2020

ESKETAMINE HYDROCHLORIDE - SPRAVATO N 211243 001 8785500 Jul 09, 2031 U-2502 NCE* Mar 05, 2024 9592207 Mar 20, 2027 U-2502

ESTRADIOL - IMVEXXY N 208564 001 10258630 Dec 20, 2033 U-2316 10258630 Dec 20, 2033 U-2317 10398708 Dec 20, 2033 U-2317 10398708 Dec 20, 2033 U-2614 10471072 Jun 18, 2033 U-2316 10471072 Jun 18, 2033 U-2317 A - 26 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ESTRADIOL - IMVEXXY N 208564 002 10258630 Dec 20, 2033 U-2316 10258630 Dec 20, 2033 U-2317 10398708 Dec 20, 2033 U-2317 10398708 Dec 20, 2033 U-2614 10471072 Jun 18, 2033 U-2316 10471072 Jun 18, 2033 U-2317

ESTRADIOL; PROGESTERONE - BIJUVA N 210132 001 10206932 Nov 21, 2032 U-2439

ETELCALCETIDE - PARSABIV N 208325 001 10344765 Jun 27, 2034 DP

ETELCALCETIDE - PARSABIV N 208325 002 10344765 Jun 27, 2034 DP

ETELCALCETIDE - PARSABIV N 208325 003 10344765 Jun 27, 2034 DP

ETEPLIRSEN - EXONDYS 51 N 206488 001 10337003 Mar 14, 2034 U-1918 10364431 Mar 14, 2034 U-1918 10364431 Mar 14, 2034 U-1919 >A> RE47751 Jun 28, 2025 U-1918 >A> RE47751 Jun 28, 2025 U-2664 >A> RE47751 Jun 28, 2025 U-2673 >A> RE47751 Jun 28, 2025 U-2674 >A> RE47769 Jun 28, 2025 DP

ETEPLIRSEN - EXONDYS 51 N 206488 002 10337003 Mar 14, 2034 U-1918 10364431 Mar 14, 2034 U-1918 10364431 Mar 14, 2034 U-1919 >A> RE47751 Jun 28, 2025 U-1918 >A> RE47751 Jun 28, 2025 U-2664 >A> RE47751 Jun 28, 2025 U-2673 >A> RE47751 Jun 28, 2025 U-2674 >A> RE47769 Jun 28, 2025 DP

EXENATIDE - BYDUREON BCISE N 209210 001 6414126 Oct 04, 2020 U-2588 6515117 Oct 04, 2020 U-2588 6872700 Jan 14, 2020 U-2589 6872700 Jan 14, 2020 U-2590 6872700 Jan 14, 2020 U-2591 6936590 Oct 04, 2020 U-2588 7456254 Jun 30, 2025 DP U-2588 7456254 Jun 30, 2025 DP U-2589 7456254 Jun 30, 2025 DP U-2590 7456254 Jun 30, 2025 DP U-2592 7612176 Apr 13, 2025 DP U-2589 7612176 Apr 13, 2025 DP U-2590 7612176 Apr 13, 2025 DP U-2592 8329648 Aug 18, 2026 U-2588 8329648 Aug 18, 2026 U-2589 8329648 Aug 18, 2026 U-2590 8329648 Aug 18, 2026 U-2593 8329648 Aug 18, 2026 U-2594 8329648 Aug 18, 2026 U-2595 8329648 Aug 18, 2026 U-2596 8361972 Mar 21, 2028 U-2588 8431685 Apr 13, 2025 DP U-2589 8431685 Apr 13, 2025 DP U-2590 8431685 Apr 13, 2025 DP U-2597 A - 27 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

EXENATIDE - BYDUREON BCISE N 209210 001 8431685 Apr 13, 2025 DP U-2598 8461105 Apr 13, 2025 DP U-2589 8461105 Apr 13, 2025 DP U-2590 8461105 Apr 13, 2025 DP U-2597 8461105 Apr 13, 2025 DP U-2598 8501698 Jun 20, 2027 U-2588 8895033 Oct 04, 2030 DP U-2589 8895033 Oct 04, 2030 DP U-2590 8895033 Oct 04, 2030 DP U-2597 8895033 Oct 04, 2030 DP U-2600 8895033 Oct 04, 2030 DP U-2601 8895033 Oct 04, 2030 DP U-2602 8906851 Aug 18, 2026 U-2589 8906851 Aug 18, 2026 U-2590 8906851 Aug 18, 2026 U-2593 8906851 Aug 18, 2026 U-2597 9198925 Oct 04, 2020 U-2588 9238076 Apr 15, 2024 DP U-2589 9238076 Apr 15, 2024 DP U-2590 9238076 Apr 15, 2024 DP U-2597 9238076 Apr 15, 2024 DP U-2599 9884092 Aug 18, 2026 U-2589 9884092 Aug 18, 2026 U-2590 9884092 Aug 18, 2026 U-2593 9884092 Aug 18, 2026 U-2594 9884092 Aug 18, 2026 U-2595 9884092 Aug 18, 2026 U-2596 9884092 Aug 18, 2026 U-2597

FEBUXOSTAT - FEBUXOSTAT A 205385 001 PC Dec 28, 2019

FEBUXOSTAT - FEBUXOSTAT A 205385 002 PC Dec 28, 2019

FEDRATINIB HYDROCHLORIDE - INREBIC N 212327 001 >A> 10391094 Jun 04, 2032 DP U-2607 NCE Aug 16, 2024 7528143 Dec 16, 2026 DS ODE-259 Aug 16, 2026 7825246 Dec 16, 2026 DS 8138199 Jun 30, 2028 U-2607

FERRIC CARBOXYMALTOSE - INJECTAFER N 203565 001 7754702 Feb 15, 2028 DP U-1432 7754702 Feb 15, 2028 DP U-2555 7754702 Feb 15, 2028 DP U-2556 7754702 Feb 15, 2028 DP U-2557

FERRIC CITRATE - AURYXIA N 205874 001 10300039 Jul 21, 2030 U-2549 I-790 Nov 06, 2020 5753706 Feb 03, 2020 DP U-1577

FERRIC MALTOL - ACCRUFER N 212320 001 10179120 Jan 06, 2035 U-2603 NCE Jul 25, 2024 9248148 Mar 29, 2031 U-2603 9802973 Oct 23, 2035 DS DP U-2603

FERRIC PYROPHOSPHATE CITRATE - TRIFERIC N 208551 001 7816404 Apr 17, 2029 U-1656 7857977 Sep 08, 2027 U-1656

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY N 201373 001 8933097 Aug 02, 2030 DP A - 28 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES N 201373 002 8933097 Aug 02, 2030 DP

FIDAXOMICIN - DIFICID N 201699 001 >A> 8586551 Jul 15, 2023 DS DP >A> 8586551*PED Jan 15, 2024 >A> 8859510 Jul 31, 2027 U-319 >A> 8859510*PED Jan 31, 2028

FINGOLIMOD HYDROCHLORIDE - GILENYA N 022527 001 9187405 Jun 25, 2027 U-2613 9187405*PED Dec 25, 2027

FISH OIL TRIGLYCERIDES - OMEGAVEN N 210589 001 10350186 Nov 05, 2024 U-2585 9566260 Jul 11, 2025 DP U-2366 9629821 Jul 11, 2025 DP U-2367

FISH OIL TRIGLYCERIDES - OMEGAVEN N 210589 002 10350186 Nov 05, 2024 U-2585 9566260 Jul 11, 2025 DP U-2366 9629821 Jul 11, 2025 DP U-2367

FLUORODOPA F-18 - FLUORODOPA F18 N 200655 001 NCE Oct 10, 2024 W Oct 10, 2024

FLUTICASONE PROPIONATE - ARMONAIR RESPICLICK N 208798 001 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE - ARMONAIR RESPICLICK N 208798 002 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE - ARMONAIR RESPICLICK N 208798 003 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE - XHANCE N 209022 001 10179216 Jul 08, 2033 DP U-2133 10252010 Feb 07, 2031 DP 10300229 Jul 07, 2035 DP U-2133 >A> 10478574 Nov 04, 2033 U-2133

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO RESPICLICK N 208799 001 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO RESPICLICK N 208799 002 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO RESPICLICK N 208799 003 10195375 Feb 14, 2031 DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO DIGIHALER N 208799 004 10022510 May 18, 2031 DP 10124131 May 18, 2031 DP 10195375 Feb 14, 2031 DP 6701917 Jun 23, 2021 DP 6718972 Jun 23, 2021 DP 6748947 Jun 23, 2021 DP 6871646 Jun 23, 2021 DP 7540282 May 06, 2023 DP 8006690 Jun 23, 2021 DP 8651103 Mar 26, 2028 DP A - 29 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO DIGIHALER N 208799 004 8714149 Feb 25, 2032 DP 8978966 Jan 13, 2032 DP 9066957 Oct 06, 2034 DP U-645 9216260 Jun 28, 2031 DP 9415008 Oct 06, 2034 DP U-645 9463288 May 19, 2025 DP 9616024 Sep 01, 2024 DP 9731087 May 18, 2031 DP 9782550 Aug 28, 2035 DP 9782551 Aug 28, 2035 DP 9987229 Sep 01, 2024 DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO DIGIHALER N 208799 005 10022510 May 18, 2031 DP 10124131 May 18, 2031 DP 10195375 Feb 14, 2031 DP 6701917 Jun 23, 2021 DP 6718972 Jun 23, 2021 DP 6748947 Jun 23, 2021 DP 6871646 Jun 23, 2021 DP 7540282 May 06, 2023 DP 8006690 Jun 23, 2021 DP 8651103 Mar 26, 2028 DP 8714149 Feb 25, 2032 DP 8978966 Jan 13, 2032 DP 9066957 Oct 06, 2034 DP U-645 9216260 Jun 28, 2031 DP 9463288 May 19, 2025 DP 9616024 Sep 01, 2024 DP 9731087 May 18, 2031 DP 9782550 Aug 28, 2035 DP 9782551 Aug 28, 2035 DP 9987229 Sep 01, 2024 DP

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - AIRDUO DIGIHALER N 208799 006 10022510 May 18, 2031 DP 10124131 May 18, 2031 DP 10195375 Feb 14, 2031 DP 6701917 Jun 23, 2021 DP 6718972 Jun 23, 2021 DP 6748947 Jun 23, 2021 DP 6871646 Jun 23, 2021 DP 7540282 May 06, 2023 DP 8006690 Jun 23, 2021 DP 8651103 Mar 26, 2028 DP 8714149 Feb 25, 2032 DP 8978966 Jan 13, 2032 DP 9066957 Oct 06, 2034 DP U-645 9216260 Jun 28, 2031 DP 9463288 May 19, 2025 DP 9616024 Sep 01, 2024 DP 9731087 May 18, 2031 DP 9782550 Aug 28, 2035 DP 9782551 Aug 28, 2035 DP 9987229 Sep 01, 2024 DP

FORMOTEROL FUMARATE; GLYCOPYRROLATE - BEVESPI AEROSPHERE N 208294 001 8324266 May 28, 2030 U-2546 8703806 May 28, 2030 U-2546 8808713 May 28, 2030 DP U-2546 8815258 Mar 17, 2031 U-2546 9415009 May 28, 2030 U-2546 9463161 May 28, 2030 DP U-2546 A - 30 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA N 022518 001 7067502 May 21, 2020 DP U-1068 M-214 Dec 20, 2020 7067502*PED Nov 21, 2020 PED Jun 20, 2021 7566705 May 21, 2020 DP U-1068 7566705*PED Nov 21, 2020

FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA N 022518 002 7067502 May 21, 2020 DP U-1068 M-214 Dec 20, 2020 7067502*PED Nov 21, 2020 PED Jun 20, 2021 7566705 May 21, 2020 DP U-1068 7566705*PED Nov 21, 2020

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE - AKYNZEO N 210493 001 10208073 May 23, 2032 U-2301

FULVESTRANT - FASLODEX N 021344 001 6774122 Jan 09, 2021 U-1826 6774122 Jan 09, 2021 U-2108 6774122 Jan 09, 2021 U-2163 6774122 Jan 09, 2021 U-2504 6774122 Jan 09, 2021 U-596 6774122*PED Jul 09, 2021 7456160 Jan 09, 2021 U-1826 7456160 Jan 09, 2021 U-2108 7456160 Jan 09, 2021 U-2163 7456160 Jan 09, 2021 U-2504 7456160 Jan 09, 2021 U-596 7456160*PED Jul 09, 2021 8329680 Jan 09, 2021 U-1826 8329680 Jan 09, 2021 U-2108 8329680 Jan 09, 2021 U-2163 8329680 Jan 09, 2021 U-2504 8329680 Jan 09, 2021 U-596 8329680*PED Jul 09, 2021 8466139 Jan 09, 2021 U-1826 8466139 Jan 09, 2021 U-2108 8466139 Jan 09, 2021 U-2163 8466139 Jan 09, 2021 U-2504 8466139 Jan 09, 2021 U-596 8466139*PED Jul 09, 2021

FULVESTRANT - FULVESTRANT N 210326 001 10188663 Feb 14, 2034 DP U-2540 9271990 May 17, 2034 DP U-2540 9833459 Feb 14, 2034 DP U-2540

GABAPENTIN ENACARBIL - HORIZANT N 022399 001 6818787 Apr 06, 2025 DS DP

GABAPENTIN ENACARBIL - HORIZANT N 022399 002 6818787 Apr 06, 2025 DS DP

GADOBUTROL - GADAVIST N 201277 001 I-801 Jul 12, 2022

GADOBUTROL - GADAVIST N 201277 002 I-801 Jul 12, 2022

GADOBUTROL - GADAVIST N 201277 003 I-801 Jul 12, 2022 A - 31 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

GADOBUTROL - GADAVIST N 201277 004 I-801 Jul 12, 2022

GADOBUTROL - GADAVIST N 201277 005 I-801 Jul 12, 2022

GADOBUTROL - GADAVIST N 201277 006 I-801 Jul 12, 2022

GALLIUM DOTATOC GA-68 - GALLIUM DOTATOC GA 68 N 210828 001 NCE Aug 21, 2024 W Aug 21, 2024

GILTERITINIB FUMARATE - XOSPATA N 211349 001 NCE Nov 28, 2023

GIVOSIRAN SODIUM - GIVLAARI N 212194 001 >A> 10119143 Oct 03, 2034 DS DP U-2672 NCE Nov 20, 2024 >A> 10125364 Mar 15, 2033 DS DP U-2672 >A> ODE-273 Nov 20, 2026 >A> 10131907 Aug 24, 2028 DS DP U-2672 >A> 10273477 Mar 08, 2024 DS >A> 8106022 Dec 12, 2029 DS DP U-2672 >A> 8546143 Jan 09, 2022 DS U-2672 >A> 8828956 Dec 04, 2028 DS DP U-2672 >A> 9133461 May 14, 2033 DS DP U-2672 >A> 9150605 Aug 28, 2025 DS DP >A> 9631193 Mar 15, 2033 U-2672 >A> 9708610 Jan 01, 2024 DS DP U-2672 >A> 9708615 Mar 08, 2024 DS

GLASDEGIB MALEATE - DAURISMO N 210656 001 10414748 Apr 13, 2036 DS DP

GLASDEGIB MALEATE - DAURISMO N 210656 002 10414748 Apr 13, 2036 DS DP

GLECAPREVIR; PIBRENTASVIR - MAVYRET N 209394 001 10028937 Jun 10, 2030 U-2141 D-175 Sep 26, 2022 10028937 Jun 10, 2030 U-2532 NPP Apr 30, 2022 10039754 Jun 10, 2030 U-2141 ODE-232 Apr 30, 2026 10039754 Jun 10, 2030 U-2532 ODE-233 Apr 30, 2026 10286029 Mar 14, 2034 U-2532 8648037 Jan 19, 2032 DS DP U-2141 8648037 Jan 19, 2032 DS DP U-2532 9586978 Jun 10, 2030 U-2141 9586978 Jun 10, 2030 U-2532

GLUCAGON - BAQSIMI N 210134 001 10213487 Feb 16, 2036 DP U-2604 NP Jul 24, 2022 6938798 Jan 03, 2022 DP

GLUCAGON - GVOKE PFS N 212097 001 NP Sep 10, 2022

GLUCAGON - GVOKE PFS N 212097 002 NP Sep 10, 2022

GLUCAGON - GVOKE HYPOPEN N 212097 003 NP Sep 10, 2022 A - 32 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

GLUCAGON - GVOKE HYPOPEN N 212097 004 NP Sep 10, 2022

GLYCEROL PHENYLBUTYRATE - RAVICTI N 203284 001 10183002 Sep 22, 2030 U-1816 10183003 Sep 22, 2030 U-1816 10183004 Sep 22, 2030 U-1816 10183005 Sep 22, 2030 U-1816 10183006 Sep 22, 2030 U-1816

GLYCOPYRROLATE - LONHALA MAGNAIR KIT N 208437 001 10376661 Sep 14, 2035 DP

GOLODIRSEN - VYONDYS 53 N 211970 001 >A> 10227590 Jun 28, 2025 DS DP >A> NCE Dec 12, 2024 >A> 10266827 Jun 28, 2025 U-2675 >A> 10421966 Jun 28, 2025 DS DP >A> 9024007 Jun 28, 2025 DS DP >A> 9416361 May 04, 2021 DS >A> 9994851 Jun 28, 2025 DS DP >A> RE47691 Jun 28, 2025 DP

GRANISETRON - SUSTOL N 022445 001 10357570 Sep 28, 2024 U-2253

HALOBETASOL PROPIONATE - BRYHALI N 209355 001 10478502 Nov 02, 2031 DP U-2625 6517847 Aug 03, 2020 DP 8809307 Nov 02, 2031 DP

HALOBETASOL PROPIONATE; TAZAROTENE - DUOBRII N 209354 001 10251895 Jun 06, 2036 DP NP Apr 25, 2022 10426787 Jun 06, 2036 U-2625 10478502 Nov 02, 2031 DP U-2625 6517847 Aug 03, 2020 DP 8809307 Nov 02, 2031 DP

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 001 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 002 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 003 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 004 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 005 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810

HYDROCODONE BITARTRATE - ZOHYDRO ER N 202880 006 10322120 Jul 25, 2033 DP 10456393 Jul 25, 2033 U-1810 A - 33 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 001 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 002 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 003 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 004 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 005 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 006 10369109 Jun 16, 2023 DP

HYDROCODONE BITARTRATE - HYSINGLA ER N 206627 007 10369109 Jun 16, 2023 DP

HYDROCORTISONE VALERATE - HYDROCORTISONE VALERATE A 211750 001 CGT Jul 16, 2019

HYDROXYPROGESTERONE CAPROATE - MAKENA (AUTOINJECTOR) N 021945 004 10471075 May 02, 2036 U-2236

IBRUTINIB - IMBRUVICA N 205552 001 10294231 Jun 03, 2033 DP >A> D-176 Aug 24, 2021 10294232 Jun 03, 2033 DP M-236 Jan 25, 2022 10463668 Oct 24, 2034 U-2654 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 10478439 Jun 03, 2031 U-2665

IBRUTINIB - IMBRUVICA N 205552 002 10294231 Jun 03, 2033 DP >A> D-176 Aug 24, 2021 10294232 Jun 03, 2033 DP M-236 Jan 25, 2022 10463668 Oct 24, 2034 U-2654 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 10478439 Jun 03, 2031 U-2665

IBRUTINIB - IMBRUVICA N 210563 001 10213386 Mar 03, 2036 DP >A> D-176 Aug 24, 2021 10463668 Oct 24, 2034 U-2654 M-236 Jan 25, 2022 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 A - 34 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

IBRUTINIB - IMBRUVICA N 210563 001 10478439 Jun 03, 2031 U-2665

IBRUTINIB - IMBRUVICA N 210563 002 10213386 Mar 03, 2036 DP >A> D-176 Aug 24, 2021 10463668 Oct 24, 2034 U-2654 M-236 Jan 25, 2022 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 10478439 Jun 03, 2031 U-2665

IBRUTINIB - IMBRUVICA N 210563 003 10213386 Mar 03, 2036 DP >A> D-176 Aug 24, 2021 10463668 Oct 24, 2034 U-2654 M-236 Jan 25, 2022 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 10478439 Jun 03, 2031 U-2665

IBRUTINIB - IMBRUVICA N 210563 004 10213386 Mar 03, 2036 DP >A> D-176 Aug 24, 2021 10463668 Oct 24, 2034 U-2654 M-236 Jan 25, 2022 10478439 Jun 03, 2031 U-1456 10478439 Jun 03, 2031 U-1650 10478439 Jun 03, 2031 U-1684 10478439 Jun 03, 2031 U-1946 10478439 Jun 03, 2031 U-1947 10478439 Jun 03, 2031 U-2241 10478439 Jun 03, 2031 U-2242 10478439 Jun 03, 2031 U-2665

IBUPROFEN - CHILDREN'S ADVIL-FLAVORED N 020589 002 10238640 May 25, 2024 DP

IBUPROFEN - CALDOLOR N 022348 002 8871810 Sep 30, 2029 U-981

IBUPROFEN - CALDOLOR N 022348 003 8735452 Sep 30, 2029 U-981 8871810 Sep 30, 2029 U-981 9012508 Sep 14, 2030 U-981 9072661 Mar 16, 2032 U-2264 9072710 Mar 16, 2032 U-2266

ICOSAPENT ETHYL - VASCEPA N 202057 001 >A> 10010517 Apr 29, 2030 U-2690 >A> I-819 Dec 13, 2022 >A> 10265287 Apr 29, 2030 U-2700 >A> 10278935 Jun 28, 2033 U-2701 >A> 10278936 Jun 28, 2033 U-2702 >A> 10278937 Jun 28, 2033 U-2703 >A> 10383840 Jun 28, 2033 U-2704 >A> 8410086 Jun 15, 2030 U-2688 >A> 8454994 Apr 29, 2030 U-2689 >A> 8455472 Jun 15, 2030 U-2690 >A> 8617593 Apr 29, 2030 U-1478 >A> 8617593 Apr 29, 2030 U-2691 >A> 8618166 Apr 29, 2030 U-2689 A - 35 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ICOSAPENT ETHYL - VASCEPA N 202057 001 >A> 8623406 Apr 29, 2030 U-1478 >A> 8623406 Apr 29, 2030 U-2692 >A> 8642077 Apr 29, 2030 U-2693 >A> 8669245 Jun 15, 2030 U-2694 >A> 8680144 Feb 09, 2030 U-2695 >A> 8691871 Apr 29, 2030 U-2689 >A> 8703185 Apr 29, 2030 U-2691 >A> 8709475 Apr 29, 2030 U-2689 >A> 8710041 Jun 15, 2030 U-2690 >A> 9198892 Sep 25, 2027 U-2706 >A> 9603826 Jun 28, 2033 U-2696 >A> 9610272 Jun 28, 2033 U-2697 >A> 9623001 Jun 28, 2033 U-2698 >A> 9693984 Jun 28, 2033 U-2697 >A> 9693985 Jun 28, 2033 U-2696 >A> 9693986 Jun 28, 2033 U-2698 >A> 9700537 May 31, 2027 U-2707 >A> 9918954 Jun 28, 2033 U-2699

ICOSAPENT ETHYL - VASCEPA N 202057 002 >A> 10010517 Apr 29, 2030 U-2690 >A> I-819 Dec 13, 2022 >A> 10265287 Apr 29, 2030 U-2700 >A> 10278935 Jun 28, 2033 U-2701 >A> 10278936 Jun 28, 2033 U-2702 >A> 10278937 Jun 28, 2033 U-2703 >A> 10383840 Jun 28, 2033 U-2704 >A> 8410086 Jun 15, 2030 U-2688 >A> 8454994 Apr 29, 2030 U-2689 >A> 8617593 Apr 29, 2030 U-1287 >A> 8617593 Apr 29, 2030 U-2691 >A> 8623406 Apr 29, 2030 U-1287 >A> 8623406 Apr 29, 2030 U-2692 >A> 8642077 Apr 29, 2030 U-2693 >A> 8669245 Jun 15, 2030 U-2694 >A> 8680144 Feb 09, 2030 U-2695 >A> 8691871 Apr 29, 2030 U-2689 >A> 8703185 Apr 29, 2030 U-2691 >A> 8709475 Apr 29, 2030 U-2689 >A> 8710041 Jun 15, 2030 U-2690 >A> 9198892 Sep 25, 2027 U-2706 >A> 9603826 Jun 28, 2033 U-2696 >A> 9610272 Jun 28, 2033 U-2697 >A> 9623001 Jun 28, 2033 U-2698 >A> 9693984 Jun 28, 2033 U-2697 >A> 9693985 Jun 28, 2033 U-2696 >A> 9693986 Jun 28, 2033 U-2698 >A> 9700537 May 31, 2027 U-2707 >A> 9918954 Jun 28, 2033 U-2699

IMIQUIMOD - ZYCLARA N 022483 001 10238644 Dec 11, 2029 U-68 10238645 Aug 18, 2029 U-1455 10238645 Aug 18, 2029 U-172

INSULIN ASPART - FIASP N 208751 001 M-247 Oct 21, 2022 >A> NPP Dec 19, 2022

INSULIN ASPART - FIASP FLEXTOUCH N 208751 002 10220155 Jul 17, 2026 DP >A> NPP Dec 19, 2022 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP RE46363 Aug 03, 2026 DP A - 36 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

INSULIN ASPART - FIASP PENFILL N 208751 003 >A> NPP Dec 19, 2022

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 FLEXPEN N 021172 004 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN ASPART RECOMBINANT - NOVOLOG PENFILL N 020986 002 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXPEN N 020986 003 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN ASPART RECOMBINANT - NOVOLOG FLEXTOUCH N 020986 005 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN ASPART; INSULIN DEGLUDEC - RYZODEG 70/30 N 203313 001 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN DEGLUDEC - TRESIBA N 203314 001 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN DEGLUDEC - TRESIBA N 203314 002 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN DEGLUDEC - TRESIBA N 203314 003 10376652 Jan 20, 2026 DP 7615532 Jun 28, 2029 DS DP

INSULIN DEGLUDEC; LIRAGLUTIDE - XULTOPHY 100/3.6 N 208583 001 10220155 Jul 17, 2026 DP M-242 Aug 08, 2022 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 6268343 Aug 22, 2022 DS DP 6268343*PED Feb 22, 2023 6899699 Jan 02, 2022 DP 7615532 Jun 28, 2029 DS DP 7762994 May 23, 2024 DP A - 37 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

INSULIN DEGLUDEC; LIRAGLUTIDE - XULTOPHY 100/3.6 N 208583 001 7762994*PED Nov 23, 2024 8579869 Jun 30, 2023 DP 8579869*PED Dec 30, 2023 8672898 Jan 02, 2022 DP 8684969 Oct 20, 2025 DP 8846618 Jun 27, 2022 DS DP 8846618*PED Dec 27, 2022 8920383 Jul 17, 2026 DP 8937042 May 05, 2029 DP 9108002 Jan 20, 2026 DP 9132239 Feb 01, 2032 DP 9457154 Sep 27, 2027 DP 9486588 Jan 02, 2022 DP 9616180 Jan 20, 2026 DP 9687611 Feb 27, 2027 DP 9775953 Jul 17, 2026 DP 9861757 Jan 20, 2026 DP RE46363 Aug 03, 2026 DP

INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXTOUCH N 021536 005 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

INSULIN GLARGINE RECOMBINANT - TOUJEO SOLOSTAR N 206538 001 >A> 10369291 Sep 16, 2035 DP >A> NPP Nov 26, 2022

INSULIN GLARGINE RECOMBINANT - TOUJEO MAX SOLOSTAR N 206538 002 >A> 10369291 Sep 16, 2035 DP >A> NPP Nov 26, 2022

INSULIN GLARGINE; LIXISENATIDE - SOLIQUA 100/33 N 208673 001 10029011 Nov 11, 2030 DP 9011391 Mar 26, 2024 U-1923 9011391 Mar 26, 2024 U-2496

INSULIN RECOMBINANT HUMAN - AFREZZA N 022472 001 10201672 Aug 02, 2030 DP 10342938 Jun 12, 2029 DP >A> 10500159 Nov 02, 2030 DP

INSULIN RECOMBINANT HUMAN - AFREZZA N 022472 002 10201672 Aug 02, 2030 DP 10342938 Jun 12, 2029 DP >A> 10500159 Nov 02, 2030 DP

INSULIN RECOMBINANT HUMAN - AFREZZA N 022472 003 10201672 Aug 02, 2030 DP 10342938 Jun 12, 2029 DP >A> 10500159 Nov 02, 2030 DP

IRINOTECAN HYDROCHLORIDE - ONIVYDE N 207793 001 10456360 Oct 15, 2036 DP

ISOPROPYL ALCOHOL - ZURAGARD N 210872 001 NP Apr 26, 2022

ISOTRETINOIN - ABSORICA LD N 211913 001 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP A - 38 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ISOTRETINOIN - ABSORICA LD N 211913 002 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP

ISOTRETINOIN - ABSORICA LD N 211913 003 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP

ISOTRETINOIN - ABSORICA LD N 211913 004 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP

ISOTRETINOIN - ABSORICA LD N 211913 005 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP

ISOTRETINOIN - ABSORICA LD N 211913 006 9700535 Aug 04, 2035 DP 9750711 May 29, 2035 DP

ISTRADEFYLLINE - NOURIANZ N 022075 001 7541363 Nov 13, 2024 DS DP NCE Aug 27, 2024 7727993 Jan 28, 2023 U-2623 7727994 Jan 18, 2023 U-2623 8318201 Sep 05, 2027 DP

ISTRADEFYLLINE - NOURIANZ N 022075 002 7541363 Nov 13, 2024 DS DP NCE Aug 27, 2024 7727993 Jan 28, 2023 U-2623 7727994 Jan 18, 2023 U-2623 8318201 Sep 05, 2027 DP

ITRACONAZOLE - TOLSURA N 208901 001 10463740 Jun 21, 2033 DP U-2453

IVABRADINE - CORLANOR N 209964 001 7361649 Feb 22, 2026 DS DP U-1694 NCE Apr 15, 2020 7361650 Feb 22, 2026 DS DP U-1694 NP Apr 22, 2022 7867996 Feb 22, 2026 DS DP U-1694 ODE-234 Apr 22, 2026 7879842 Feb 22, 2026 DS DP U-1694 PED Oct 15, 2020 PED Oct 22, 2022 PED Oct 22, 2026

IVABRADINE HYDROCHLORIDE - CORLANOR N 206143 001 7361649 Feb 22, 2026 DS DP U-1694 NCE Apr 15, 2020 7361649*PED Aug 22, 2026 PED Oct 15, 2020 7361650 Feb 22, 2026 DS DP U-1694 7361650*PED Aug 22, 2026 7867996 Feb 22, 2026 DS DP U-1694 7867996*PED Aug 22, 2026 7879842 Feb 22, 2026 DS DP U-1694 7879842*PED Aug 22, 2026

IVABRADINE HYDROCHLORIDE - CORLANOR N 206143 002 7361649 Feb 22, 2026 DS DP U-1694 NCE Apr 15, 2020 7361649*PED Aug 22, 2026 PED Oct 15, 2020 7361650 Feb 22, 2026 DS DP U-1694 7361650*PED Aug 22, 2026 7867996 Feb 22, 2026 DS DP U-1694 7867996*PED Aug 22, 2026 7879842 Feb 22, 2026 DS DP U-1694 7879842*PED Aug 22, 2026 A - 39 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

IVACAFTOR - KALYDECO N 203188 002 NPP Jul 31, 2020 ODE-186 Feb 21, 2021 ODE-187 Dec 29, 2021 ODE-189 Jul 31, 2024 ODE-190 May 17, 2024 ODE-199 Aug 15, 2025

IVACAFTOR - KALYDECO N 207925 001 10272046 Feb 27, 2033 DP U-2531 NPP Apr 29, 2022 8324242 Aug 05, 2027 U-1311 ODE-236 Apr 29, 2026 8324242 Aug 05, 2027 U-1906 8324242 Aug 05, 2027 U-2527 8354427 Jul 06, 2026 U-1311 8354427 Jul 06, 2026 U-1905 8354427 Jul 06, 2026 U-2528 8629162 Jun 24, 2025 U-2234 8629162 Jun 24, 2025 U-2529 9670163 Dec 28, 2026 DP U-1311 9670163 Dec 28, 2026 DP U-2530

IVACAFTOR - KALYDECO N 207925 002 10272046 Feb 27, 2033 DP U-2531 NPP Apr 29, 2022 8324242 Aug 05, 2027 U-1311 ODE-236 Apr 29, 2026 8324242 Aug 05, 2027 U-1906 8324242 Aug 05, 2027 U-2527 8354427 Jul 06, 2026 U-1311 8354427 Jul 06, 2026 U-1905 8354427 Jul 06, 2026 U-2528 8629162 Jun 24, 2025 U-2234 8629162 Jun 24, 2025 U-2529 9670163 Dec 28, 2026 DP U-1311 9670163 Dec 28, 2026 DP U-2530

IVACAFTOR - KALYDECO N 207925 003 10272046 Feb 27, 2033 DP U-2531 NPP Jul 31, 2020 7495103 May 20, 2027 DS DP NPP Apr 29, 2022 8324242 Aug 05, 2027 U-1311 ODE-188 Mar 17, 2022 8324242 Aug 05, 2027 U-1906 ODE-189 Jul 31, 2024 8324242 Aug 05, 2027 U-2527 ODE-190 May 17, 2024 8354427 Jul 06, 2026 U-1311 ODE-199 Aug 15, 2025 8354427 Jul 06, 2026 U-1905 ODE-236 Apr 29, 2026 8354427 Jul 06, 2026 U-2528 8410274 Dec 28, 2026 DP 8629162 Jun 24, 2025 U-2234 8629162 Jun 24, 2025 U-2529 8754224 Dec 28, 2026 DS DP 8883206 Feb 27, 2033 DP 9670163 Dec 28, 2026 DP U-1311 9670163 Dec 28, 2026 DP U-2530

IVACAFTOR; IVACAFTOR, TEZACAFTOR - SYMDEKO (COPACKAGED) N 210491 001 10022352 Apr 09, 2027 DP U-2343 NPP Jun 21, 2022 10022352 Apr 09, 2027 DP U-2573 ODE-247 Jun 21, 2026 10058546 Jul 15, 2033 U-2399 10058546 Jul 15, 2033 U-2572 10081621 Mar 25, 2031 DP U-2420 10081621 Mar 25, 2031 DP U-2571 10206877 Apr 14, 2035 DP U-2498 10206877 Apr 14, 2035 DP U-2570 10239867 Apr 09, 2027 DS DP U-2512 10239867 Apr 09, 2027 DS DP U-2569 9931334 Dec 28, 2026 DP U-2275 9931334 Dec 28, 2026 DP U-2575 9974781 Apr 09, 2027 DP U-2318 9974781 Apr 09, 2027 DP U-2574 A - 40 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

IVACAFTOR; IVACAFTOR, TEZACAFTOR - SYMDEKO (COPACKAGED) N 210491 002 10022352 Apr 09, 2027 DP U-2343 NCE Feb 12, 2023 10022352 Apr 09, 2027 DP U-2573 NPP Jun 21, 2022 10058546 Jul 15, 2033 U-2399 ODE-173 Feb 12, 2025 10058546 Jul 15, 2033 U-2572 ODE-247 Jun 21, 2026 10081621 Mar 25, 2031 DP U-2420 10081621 Mar 25, 2031 DP U-2571 10206877 Apr 14, 2035 DP U-2498 10206877 Apr 14, 2035 DP U-2570 10239867 Apr 09, 2027 DS DP U-2512 10239867 Apr 09, 2027 DS DP U-2569 7495103 May 20, 2027 DS DP 7645789 May 01, 2027 DS DP 7776905 Jun 03, 2027 DS DP 8324242 Aug 05, 2027 U-2246 8410274 Dec 28, 2026 DP 8415387 Nov 12, 2027 U-2246 8598181 May 01, 2027 U-2246 8623905 May 01, 2027 DS DP 8629162 Jun 24, 2025 U-2247 8754224 Dec 28, 2026 DS DP 9012496 Jul 15, 2033 U-2248 9670163 Dec 28, 2026 DP U-2246 9931334 Dec 28, 2026 DP U-2275 9931334 Dec 28, 2026 DP U-2575 9974781 Apr 09, 2027 DP U-2318 9974781 Apr 09, 2027 DP U-2574

IVERMECTIN - IVERMECTIN A 210019 001 PC Apr 11, 2020

IVERMECTIN - SOOLANTRA N 206255 001 10206939 Mar 13, 2034 U-1631

IVOSIDENIB - TIBSOVO N 211192 001 10449184 Mar 13, 2035 DP I-816 May 02, 2022 9474779 Aug 19, 2033 DS DP U-2350 ODE-242 May 02, 2026 9474779 Aug 19, 2033 DS DP U-2533 9474779 Aug 19, 2033 DS DP U-2534 9850277 Jan 18, 2033 DS DP U-2350 9850277 Jan 18, 2033 DS DP U-2533 9850277 Jan 18, 2033 DS DP U-2534 9968595 Mar 13, 2035 DP U-2351 9968595 Mar 13, 2035 DP U-2533 9968595 Mar 13, 2035 DP U-2534

IXAZOMIB CITRATE - NINLARO N 208462 001 7442830 Nov 20, 2029 DS DP U-2434 A - 41 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

IXAZOMIB CITRATE - NINLARO N 208462 002 7442830 Nov 20, 2029 DS DP U-2434

IXAZOMIB CITRATE - NINLARO N 208462 003 7442830 Nov 20, 2029 DS DP U-2434

LAROTRECTINIB SULFATE - VITRAKVI N 210861 001 10172861 Nov 16, 2035 DS DP NCE Nov 26, 2023 10285993 Nov 16, 2035 U-2470

LAROTRECTINIB SULFATE - VITRAKVI N 210861 002 10172861 Nov 16, 2035 DS DP NCE Nov 26, 2023 10285993 Nov 16, 2035 U-2470

LAROTRECTINIB SULFATE - VITRAKVI N 211710 001 10172861 Nov 16, 2035 DS NCE Nov 26, 2023

LATANOPROST - XELPROS N 206185 001 9539262 Oct 15, 2028 U-2400

LATANOPROST; NETARSUDIL DIMESYLATE - ROCKLATAN N 208259 001 10174017 Jan 27, 2030 DS DP U-1524 NC Mar 12, 2022 8394826 Nov 10, 2030 DS DP U-1524 NCE Dec 18, 2022 8450344 Jul 11, 2026 DS DP U-1524 9096569 Jul 11, 2026 DS DP U-1524 9415043 Mar 14, 2034 DS 9931336 Mar 14, 2034 DS DP U-1524 9993470 Mar 14, 2034 DS DP U-1524

LEDIPASVIR; SOFOSBUVIR - HARVONI N 205834 001 10039779 Jan 30, 2034 DS DP U-2369 >A> D-177 Nov 15, 2022 10039779 Jan 30, 2034 DS DP U-2370 ODE-136 Apr 07, 2024 10039779*PED Jul 30, 2034 PED Oct 07, 2024 10456414 Sep 14, 2032 DP 7964580 Mar 26, 2029 DS DP U-1470 7964580*PED Sep 26, 2029 8088368 May 12, 2030 DS DP 8088368*PED Nov 12, 2030 8273341 May 12, 2030 U-1470 8273341*PED Nov 12, 2030 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8735372 Mar 21, 2028 U-1470 8735372*PED Sep 21, 2028 8822430 May 12, 2030 DS DP U-1470 8822430*PED Nov 12, 2030 8841278 May 12, 2030 DP U-1470 8841278*PED Nov 12, 2030 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031 9393256 Sep 14, 2032 U-1470 9393256*PED Mar 14, 2033 9511056 May 12, 2030 DP U-1470 9511056*PED Nov 12, 2030 A - 42 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LEDIPASVIR; SOFOSBUVIR - HARVONI N 205834 002 10039779 Jan 30, 2034 DS DP U-1470 >A> D-177 Nov 15, 2022 10039779*PED Jul 30, 2034 10456414 Sep 14, 2032 DP 7964580 Mar 26, 2029 DS DP U-1470 7964580*PED Sep 26, 2029 8088368 May 12, 2030 DS DP 8088368*PED Nov 12, 2030 8273341 May 12, 2030 U-1470 8273341*PED Nov 12, 2030 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8735372 Mar 21, 2028 U-1470 8735372*PED Sep 21, 2028 8822430 May 12, 2030 DS DP U-1470 8822430*PED Nov 12, 2030 8841278 May 12, 2030 DP U-1470 8841278*PED Nov 12, 2030 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031 9393256 Sep 14, 2032 U-1470 A - 43 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LEDIPASVIR; SOFOSBUVIR - HARVONI N 205834 002 9393256*PED Mar 14, 2033 9511056 May 12, 2030 U-1470 9511056*PED Nov 12, 2030

LEDIPASVIR; SOFOSBUVIR - HARVONI N 212477 001 10456414 Sep 14, 2032 DP >A> D-177 Nov 15, 2022 7964580 Mar 26, 2029 DS DP U-1470 ODE-262 Aug 28, 2026 7964580*PED Sep 26, 2029 ODE-263 Aug 28, 2026 8088368 May 12, 2030 DS DP ODE-264 Aug 28, 2026 8088368*PED Nov 12, 2030 8273341 May 12, 2030 U-1470 8273341*PED Nov 12, 2030 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8735372 Mar 21, 2028 U-1470 8735372*PED Sep 21, 2028 8822430 May 12, 2030 DS DP U-1470 8822430*PED Nov 12, 2030 8841278 May 12, 2030 DP U-1470 8841278*PED Nov 12, 2030 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031 9393256 Sep 14, 2032 U-1470 9393256*PED Mar 14, 2033 9511056 May 12, 2030 U-1470 9511056*PED Nov 12, 2030

LEDIPASVIR; SOFOSBUVIR - HARVONI N 212477 002 10456414 Sep 14, 2032 DP >A> D-177 Nov 15, 2022 7964580 Mar 26, 2029 DS DP U-1470 ODE-262 Aug 28, 2026 7964580*PED Sep 26, 2029 ODE-263 Aug 28, 2026 8088368 May 12, 2030 DS DP ODE-264 Aug 28, 2026 8088368*PED Nov 12, 2030 8273341 May 12, 2030 U-1470 8273341*PED Nov 12, 2030 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8735372 Mar 21, 2028 U-1470 8735372*PED Sep 21, 2028 8822430 May 12, 2030 DS DP U-1470 8822430*PED Nov 12, 2030 8841278 May 12, 2030 DP U-1470 8841278*PED Nov 12, 2030 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031 9393256 Sep 14, 2032 U-1470 A - 44 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LEDIPASVIR; SOFOSBUVIR - HARVONI N 212477 002 9393256*PED Mar 14, 2033 9511056 May 12, 2030 U-1470 9511056*PED Nov 12, 2030

LEFAMULIN ACETATE - XENLETA N 211672 001 6753445 Jul 09, 2021 DS DP U-2619 NCE Aug 19, 2024 8071643 Jan 16, 2029 DS DP GAIN Aug 19, 2029 8153689 Mar 19, 2028 DS DP 9120727 May 23, 2031 DS DP

LEFAMULIN ACETATE - XENLETA N 211673 001 6753445 Jul 09, 2021 DS DP U-2619 NCE Aug 19, 2024 8071643 Jan 16, 2029 DS DP GAIN Aug 19, 2029 8153689 Mar 19, 2028 DS DP

LENALIDOMIDE - REVLIMID N 021880 001 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 9393238 May 15, 2023 U-2550

LENALIDOMIDE - REVLIMID N 021880 002 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 9393238 May 15, 2023 U-2550

LENALIDOMIDE - REVLIMID N 021880 003 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 9393238 May 15, 2023 U-2550 A - 45 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LENALIDOMIDE - REVLIMID N 021880 004 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 9393238 May 15, 2023 U-2550

LENALIDOMIDE - REVLIMID N 021880 005 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 9393238 May 15, 2023 U-2550

LENALIDOMIDE - REVLIMID N 021880 006 7189740 Apr 11, 2023 U-1982 I-796 May 28, 2022 7468363 Oct 07, 2023 U-1983 I-797 May 28, 2022 7468363 Oct 07, 2023 U-2550 ODE-241 May 28, 2026 7468363 Oct 07, 2023 U-2551 ODE-245 May 28, 2026 7968569 Oct 07, 2023 U-1984 8404717 Apr 11, 2023 U-1982 8492406 Oct 07, 2023 U-2550 8530498 May 15, 2023 U-1984 8648095 May 15, 2023 U-1984 8741929 Mar 08, 2028 U-1983 9056120 Apr 11, 2023 U-1982 9101621 May 15, 2023 U-1985 9101622 May 15, 2023 U-1986 9155730 May 15, 2023 U-2550 A - 46 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LENALIDOMIDE - REVLIMID N 021880 006 9393238 May 15, 2023 U-2550

LENVATINIB MESYLATE - LENVIMA N 206947 001 10259791 Aug 26, 2035 DS I-807 Sep 17, 2022 10407393 Aug 26, 2035 DS

LENVATINIB MESYLATE - LENVIMA N 206947 002 10259791 Aug 26, 2035 DS I-807 Sep 17, 2022 10407393 Aug 26, 2035 DS

LESINURAD - ZURAMPIC N 207988 001 10183012 Nov 26, 2028 U-2311

LETROZOLE; RIBOCICLIB SUCCINATE - KISQALI FEMARA CO-PACK (COPACKAGED) N 209935 001 8962630 Dec 09, 2029 U-2505 9416136 Aug 20, 2029 U-2505 9868739 Nov 09, 2031 U-2505

LEVETIRACETAM - ELEPSIA XR N 204417 001 8470367 Oct 31, 2027 DP

LEVETIRACETAM - ELEPSIA XR N 204417 002 8470367 Oct 31, 2027 DP

LEVOCARNITINE - LEVOCARNITINE A 211676 001 CGT Apr 13, 2020

LEVOCARNITINE - LEVOCARNITINE SF A 211676 002 CGT Apr 13, 2020

LEVODOPA - INBRIJA N 209184 001 6514482 Sep 19, 2020 DP U-2484 NP Dec 21, 2021 6613308 Sep 19, 2020 U-2484 6858199 Nov 04, 2021 U-2485 6921528 Jun 19, 2020 U-2485 6979437 Sep 19, 2020 U-2484 7146978 Apr 16, 2021 U-2486 7182961 Feb 22, 2024 DP 7384649 Nov 20, 2022 DP 7556798 Nov 04, 2021 U-2485 8404276 Mar 19, 2023 U-2484 8545878 Nov 16, 2032 DP 8586093 Mar 19, 2023 U-2484 8628754 Jun 19, 2020 U-2485 8685442 Nov 16, 2032 DP 8945612 Nov 16, 2032 DP 9155699 Mar 19, 2023 DP 9393210 Nov 16, 2032 DP RE43711 Feb 03, 2029 U-2484

LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA N 204168 001 M-249 Oct 07, 2022

LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA N 204168 002 M-249 Oct 07, 2022

LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA N 204168 003 M-249 Oct 07, 2022 A - 47 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA N 204168 004 M-249 Oct 07, 2022

LEVOTHYROXINE SODIUM - TIROSINT N 021924 011 7691411 Mar 14, 2024 DP 7723390 Mar 14, 2024 DP

LEVOTHYROXINE SODIUM - TIROSINT N 021924 012 7691411 Mar 14, 2024 DP 7723390 Mar 14, 2024 DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM N 210632 001 10398669 Dec 01, 2036 DP 9782376 Dec 01, 2036 DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM N 210632 002 10398669 Dec 01, 2036 DP 9782376 Dec 01, 2036 DP

LEVOTHYROXINE SODIUM - LEVOTHYROXINE SODIUM N 210632 003 10398669 Dec 01, 2036 DP 9782376 Dec 01, 2036 DP

LIDOCAINE; TETRACAINE - PLIAGLIS N 021717 001 10350180 Jan 14, 2031 DP

LINACLOTIDE - LINZESS N 202811 001 8802628 Oct 30, 2031 DP

LINACLOTIDE - LINZESS N 202811 002 8802628 Oct 30, 2031 DP

LIRAGLUTIDE RECOMBINANT - VICTOZA N 022341 001 6268343 Aug 22, 2022 DS DP U-968 NPP Jun 17, 2022 6268343*PED Feb 22, 2023 PED Dec 17, 2022 7762994 May 23, 2024 DP 7762994*PED Nov 23, 2024 8114833 Aug 13, 2025 DS DP 8114833*PED Feb 13, 2026 8579869 Jun 30, 2023 DP 8579869*PED Dec 30, 2023 8846618 Jun 27, 2022 DP 8846618*PED Dec 27, 2022 9265893 Sep 23, 2032 DP 9265893*PED Mar 23, 2033 9968659 Jan 09, 2037 U-2313 9968659*PED Jul 09, 2037 RE41956 Jan 21, 2021 DP RE41956*PED Jul 21, 2021

LIRAGLUTIDE RECOMBINANT - SAXENDA N 206321 001 10220155 Jul 17, 2026 DP 10220155*PED Jan 17, 2027 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 6268343 Aug 22, 2022 DS DP U-1255 6268343*PED Feb 22, 2023 6899699 Jan 01, 2022 DP 6899699*PED Jul 01, 2022 7762994 May 23, 2024 DP 7762994*PED Nov 23, 2024 8114833 Aug 13, 2025 DP 8114833*PED Feb 13, 2026 8579869 Jun 30, 2023 DP A - 48 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LIRAGLUTIDE RECOMBINANT - SAXENDA N 206321 001 8579869*PED Dec 30, 2023 8672898 Jan 02, 2022 DP 8672898*PED Jul 02, 2022 8684969 Oct 20, 2025 DP 8684969*PED Apr 20, 2026 8846618 Jun 27, 2022 DP 8846618*PED Dec 27, 2022 8920383 Jul 17, 2026 DP 8920383*PED Jan 17, 2027 9108002 Jan 26, 2026 DP 9108002*PED Jul 26, 2026 9132239 Feb 01, 2032 DP 9132239*PED Aug 01, 2032 9457154 Sep 27, 2027 DP 9457154*PED Mar 27, 2028 9486588 Jan 02, 2022 DP 9486588*PED Jul 02, 2022 9616180 Jan 20, 2026 DP 9616180*PED Jul 20, 2026 9687611 Feb 27, 2027 DP 9687611*PED Aug 27, 2027 9775953 Jul 17, 2026 DP 9775953*PED Jan 17, 2027 9861757 Jan 20, 2026 DP 9861757*PED Jul 20, 2026 9968659 Jan 09, 2037 U-2438 9968659*PED Jul 09, 2037 RE46363 Aug 03, 2026 DP RE46363*PED Feb 03, 2027

LISINOPRIL - QBRELIS N 208401 001 10265370 Nov 06, 2035 DP 10406199 Nov 06, 2035 U-1723 10406199 Nov 06, 2035 U-185 10406199 Nov 06, 2035 U-1864 10406199 Nov 06, 2035 U-1991 10406199 Nov 06, 2035 U-3 10406199 Nov 06, 2035 U-71 10406199 Nov 06, 2035 U-8

LIXISENATIDE - ADLYXIN N 208471 001 10201663 Mar 10, 2034 DP

LIXISENATIDE - ADLYXIN N 208471 002 10201663 Mar 10, 2034 DP

LORCASERIN HYDROCHLORIDE - BELVIQ XR N 208524 001 10226471 Aug 31, 2031 DP 10463676 Aug 31, 2031 U-2661

LORLATINIB - LORBRENA N 210868 001 10420749 Jul 27, 2036 DS DP U-2633

LORLATINIB - LORBRENA N 210868 002 10420749 Jul 27, 2036 DS DP U-2633

LOTEPREDNOL ETABONATE - LOTEMAX SM N 208219 001 NS Feb 22, 2022

LOTEPREDNOL ETABONATE - INVELTYS N 210565 001 10058511 May 03, 2033 DP U-2492 9056057 May 03, 2033 DP U-2491 9393213 May 03, 2033 DP A - 49 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

LOTEPREDNOL ETABONATE - INVELTYS N 210565 001 9532955 May 03, 2033 U-2491 9737491 May 03, 2033 U-2492 9827191 May 03, 2033 DP U-2493

LUBIPROSTONE - AMITIZA N 021908 001 8779187 Jan 23, 2027 DP

MEROPENEM; VABORBACTAM - VABOMERE N 209776 001 10172874 Aug 08, 2031 DP 10183034 Aug 08, 2031 U-2490

METFORMIN HYDROCHLORIDE - RIOMET N 021591 001 6890957 Aug 07, 2021 DP

METFORMIN HYDROCHLORIDE - RIOMET ER N 212595 001 9962336 May 01, 2035 DP

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR N 200678 002 8628799 Jul 13, 2025 DP

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR N 200678 003 8628799 Jul 13, 2025 DP

METHOTREXATE SODIUM - XATMEP N 208400 001 10231927 Jan 02, 2033 U-1349 10231927 Jan 02, 2033 U-1699

METHYLNALTREXONE BROMIDE - RELISTOR N 021964 001 10376584 Apr 08, 2024 DP U-1185

METHYLNALTREXONE BROMIDE - RELISTOR N 021964 002 10376584 Apr 08, 2024 DP U-1185

METHYLNALTREXONE BROMIDE - RELISTOR N 021964 003 10376584 Apr 08, 2024 DP U-1185

METHYLNALTREXONE BROMIDE - RELISTOR N 208271 001 10307417 Mar 10, 2031 DP 10376505 Mar 10, 2031 DP

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 001 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020 A - 50 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 002 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 003 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 004 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 005 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP A - 51 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 005 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 006 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - APTENSIO XR N 205831 007 10039719 Dec 16, 2019 U-2357 10039719*PED Jun 16, 2020 10463624 Dec 16, 2019 DP 6419960 Dec 16, 2019 DP 6419960*PED Jun 16, 2020 7083808 Dec 16, 2019 DP 7083808*PED Jun 16, 2020 7247318 Dec 16, 2019 DP 7247318*PED Jun 16, 2020 7438930 Dec 16, 2019 DP Y 7438930*PED Jun 16, 2020 8580310 Dec 16, 2019 DP 8580310*PED Jun 16, 2020 9066869 Dec 16, 2019 DP 9066869*PED Jun 16, 2020 9801823 Dec 16, 2019 DP 9801823*PED Jun 16, 2020

METHYLPHENIDATE HYDROCHLORIDE - JORNAY PM N 209311 001 10182995 Mar 23, 2032 DP 10292937 Mar 23, 2032 U-2357

METHYLPHENIDATE HYDROCHLORIDE - JORNAY PM N 209311 002 10182995 Mar 23, 2032 DP 10292937 Mar 23, 2032 U-2357

METHYLPHENIDATE HYDROCHLORIDE - JORNAY PM N 209311 003 10182995 Mar 23, 2032 DP 10292937 Mar 23, 2032 U-2357

METHYLPHENIDATE HYDROCHLORIDE - JORNAY PM N 209311 004 10182995 Mar 23, 2032 DP 10292937 Mar 23, 2032 U-2357 A - 52 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

METHYLPHENIDATE HYDROCHLORIDE - JORNAY PM N 209311 005 10182995 Mar 23, 2032 DP 10292937 Mar 23, 2032 U-2357

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 001 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 002 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 003 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 004 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 005 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 006 10111839 Oct 30, 2035 U-2357 NP Feb 27, 2022 10292938 Oct 30, 2035 DP 10292939 Oct 30, 2035 DP U-2357 10449159 Oct 30, 2035 U-2357 >A> 10500162 Oct 30, 2035 U-2357 A - 53 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

METHYLPHENIDATE HYDROCHLORIDE - ADHANSIA XR N 212038 006 >A> 10507186 Oct 30, 2035 DP >A> 10512612 Oct 30, 2035 DP >A> 10512613 Oct 30, 2035 U-2357 9974752 Oct 30, 2035 DP

METRONIDAZOLE - NUVESSA N 205223 001 10238634 Jun 28, 2032 DP

MICAFUNGIN SODIUM - MYCAMINE N 021506 002 6774104 Jan 08, 2021 DP U-650 6774104 Jan 08, 2021 DP U-845 6774104*PED Jul 08, 2021

MICAFUNGIN SODIUM - MYCAMINE N 021506 003 6774104 Jan 08, 2021 DP U-650 6774104 Jan 08, 2021 DP U-845 6774104*PED Jul 08, 2021

MIDAZOLAM - NAYZILAM N 211321 001 8217033 Jan 18, 2028 DP U-2526 NP May 21, 2022 8809322 Jan 18, 2028 DP ODE-243 May 17, 2026 9289432 Jan 18, 2028 DP U-2526 9687495 Jan 18, 2028 DP U-2526

MIFEPRISTONE - KORLYM N 202107 001 10195214 Jun 19, 2037 U-1643 10231983 Aug 22, 2038 U-1643 10314850 Aug 22, 2038 U-1643 10495650 Aug 12, 2036 U-1643 10500216 Mar 05, 2033 U-1643

MIGALASTAT HYDROCHLORIDE - GALAFOLD N 208623 001 10251873 May 30, 2038 U-2371 10383864 May 16, 2027 U-2371 10406143 May 16, 2027 U-2371 10471053 May 30, 2038 U-2371

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE A 091424 002 PC Aug 21, 2019

MINOCYCLINE HYDROCHLORIDE - AMZEEQ N 212379 001 10086080 Oct 01, 2030 U-2647 10137200 Oct 01, 2030 U-2647 10213512 Oct 01, 2030 DP U-2647 10265404 Oct 01, 2030 DP 10398641 Sep 08, 2037 U-2647 8865139 Oct 01, 2030 DP U-2647 8945516 Oct 01, 2030 DP 8992896 Oct 01, 2030 DP U-2647 9675700 Oct 01, 2030 DP U-2647

MOMETASONE FUROATE - SINUVA N 209310 001 10232152 Nov 24, 2034 DP U-2272 >A> 10357640 Oct 03, 2031 U-2272 10406332 Mar 13, 2034 DP

MORPHINE SULFATE - MORPHABOND ER N 206544 001 10314788 Aug 12, 2028 DP

MORPHINE SULFATE - MORPHABOND ER N 206544 002 10314788 Aug 12, 2028 DP A - 54 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

MORPHINE SULFATE - MORPHABOND ER N 206544 003 10314788 Aug 12, 2028 DP

MORPHINE SULFATE - MORPHABOND ER N 206544 004 10314788 Aug 12, 2028 DP

NAFTIFINE HYDROCHLORIDE - NAFTIN N 204286 001 10166205 Jan 31, 2033 DP 10166206 Jan 31, 2033 DP

NALOXONE HYDROCHLORIDE - EVZIO N 205787 001 10220158 Mar 20, 2035 DP U-2500 10314977 Nov 23, 2024 DP 10322239 Feb 28, 2031 U-1907 10335549 Apr 30, 2025 DP

NALOXONE HYDROCHLORIDE - EVZIO (AUTOINJECTOR) N 209862 001 10143792 May 24, 2031 U-2476 10220158 Mar 20, 2035 DP U-2500 10314977 Nov 23, 2024 DP 10322239 Feb 28, 2031 U-1907 10335549 Apr 30, 2025 DP

NETARSUDIL DIMESYLATE - RHOPRESSA N 208254 001 10174017 Jan 27, 2030 DS DP U-1524

NETUPITANT; PALONOSETRON HYDROCHLORIDE - AKYNZEO N 205718 001 10233154 Sep 25, 2035 DS

NICOTINE POLACRILEX - NICOTINE POLACRILEX A 207868 001 PC Oct 01, 2019

NICOTINE POLACRILEX - NICOTINE POLACRILEX A 207868 002 PC Oct 01, 2019

NINTEDANIB ESYLATE - OFEV N 205832 001 10154990 Dec 20, 2025 U-2620 I-805 Sep 06, 2022 ODE-261 Sep 06, 2026

NINTEDANIB ESYLATE - OFEV N 205832 002 10154990 Dec 20, 2025 U-2620 I-805 Sep 06, 2022 ODE-261 Sep 06, 2026

NIRAPARIB TOSYLATE - ZEJULA N 208447 001 8071579 Aug 12, 2027 U-2655 I-813 Oct 23, 2022 8143241 Aug 12, 2027 U-2655 I-814 Oct 23, 2022 8859562 Aug 04, 2031 U-2655 >A> ODE-277 Oct 23, 2026 >A> ODE-278 Oct 23, 2026

NITISINONE - NITYR N 209449 001 10328029 Jan 05, 2035 DP U-1836

NITISINONE - NITYR N 209449 002 10328029 Jan 05, 2035 DP U-1836

NITISINONE - NITYR N 209449 003 10328029 Jan 05, 2035 DP U-1836

NUSINERSEN SODIUM - SPINRAZA N 209531 001 10266822 Dec 05, 2025 DP U-1942 10266822 Dec 05, 2025 DP U-1943 10266822 Dec 05, 2025 DP U-1944 A - 55 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

NUSINERSEN SODIUM - SPINRAZA N 209531 001 10436802 Sep 11, 2035 U-1941 10436802 Sep 11, 2035 U-1942 10436802 Sep 11, 2035 U-1943 10436802 Sep 11, 2035 U-1944 10436802 Sep 11, 2035 U-2093 10436802 Sep 11, 2035 U-2094

OLAPARIB - LYNPARZA N 208558 001 8143241 Aug 12, 2027 U-2101 >A> I-818 Dec 27, 2022 8143241 Aug 12, 2027 U-2103 ODE-226 Dec 19, 2025 8143241 Aug 12, 2027 U-2480 8143241 Aug 12, 2027 U-2481 8143241 Aug 12, 2027 U-2482 8143241 Aug 12, 2027 U-2483 8859562 Aug 04, 2031 U-2101 8859562 Aug 04, 2031 U-2480 8859562 Aug 04, 2031 U-2481 8859562 Aug 04, 2031 U-2482 8859562 Aug 04, 2031 U-2483 8912187 Mar 12, 2024 U-2101 8912187 Mar 12, 2024 U-2480 8912187 Mar 12, 2024 U-2481 8912187 Mar 12, 2024 U-2482 8912187 Mar 12, 2024 U-2483

OLAPARIB - LYNPARZA N 208558 002 8143241 Aug 12, 2027 U-2101 >A> I-818 Dec 27, 2022 8143241 Aug 12, 2027 U-2103 ODE-226 Dec 19, 2025 8143241 Aug 12, 2027 U-2480 8143241 Aug 12, 2027 U-2481 8143241 Aug 12, 2027 U-2482 8143241 Aug 12, 2027 U-2483 8859562 Aug 04, 2031 U-2101 8859562 Aug 04, 2031 U-2480 8859562 Aug 04, 2031 U-2481 8859562 Aug 04, 2031 U-2482 8859562 Aug 04, 2031 U-2483 8912187 Mar 12, 2024 U-2101 8912187 Mar 12, 2024 U-2480 8912187 Mar 12, 2024 U-2481 8912187 Mar 12, 2024 U-2482 8912187 Mar 12, 2024 U-2483

OLODATEROL HYDROCHLORIDE - STRIVERDI RESPIMAT N 203108 001 >A> 7727984 Jan 19, 2027 DS

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - STIOLTO RESPIMAT N 206756 001 >A> 7727984 Jan 19, 2027 DS

OMADACYCLINE TOSYLATE - NUZYRA N 209816 001 10383884 Oct 31, 2037 U-2576 7326696 Sep 24, 2023 DS 7553828 Jun 02, 2023 DS 8383610 Sep 23, 2030 DS 9265740 Mar 05, 2029 U-1569 9314475 Mar 18, 2031 DP 9365500 Jun 29, 2021 U-1569 9365500 Jun 29, 2021 U-2576 9724358 Mar 05, 2029 U-1569

OMADACYCLINE TOSYLATE - NUZYRA N 209817 001 10383884 Oct 31, 2037 U-2576 7326696 Sep 24, 2023 DS 7553828 Jun 02, 2023 DS A - 56 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

OMADACYCLINE TOSYLATE - NUZYRA N 209817 001 9265740 Mar 05, 2029 DP 9365500 Jun 29, 2021 U-1569 9365500 Jun 29, 2021 U-2576 9724358 Mar 05, 2029 U-1569

OMEGA-3-CARBOXYLIC ACIDS - EPANOVA N 205060 001 5792795 May 13, 2020 DP 5948818 May 13, 2020 DP >A> 7960370 Dec 20, 2026 DP

OSIMERTINIB MESYLATE - TAGRISSO N 208065 001 10183020 Jan 02, 2035 DP U-1777 10183020 Jan 02, 2035 DP U-2289

OSIMERTINIB MESYLATE - TAGRISSO N 208065 002 10183020 Jan 02, 2035 DP U-1777 10183020 Jan 02, 2035 DP U-2289

OSPEMIFENE - OSPHENA N 203505 001 6245819 Jul 21, 2025 U-1370 I-793 Jan 25, 2022 6245819 Jul 21, 2025 U-905 8236861 Aug 11, 2026 U-1369 8236861 Aug 11, 2026 U-1370 8236861 Aug 11, 2026 U-905 8470890 Feb 13, 2024 U-1369 8470890 Feb 13, 2024 U-1370 8470890 Feb 13, 2024 U-905 8772353 Feb 13, 2024 U-1369 8772353 Feb 13, 2024 U-1370 8772353 Feb 13, 2024 U-905 9241915 Feb 13, 2024 U-1369 9241915 Feb 13, 2024 U-1370 9241915 Feb 13, 2024 U-905 9855224 Feb 13, 2024 U-1369 9855224 Feb 13, 2024 U-1370 9855224 Feb 13, 2024 U-905

OXCARBAZEPINE - OXTELLAR XR N 202810 001 10220042 Apr 13, 2027 U-2501 7910131 Apr 13, 2027 U-2041 9119791 Apr 13, 2027 U-2041

OXCARBAZEPINE - OXTELLAR XR N 202810 002 10220042 Apr 13, 2027 U-2501 7910131 Apr 13, 2027 U-2041 9119791 Apr 13, 2027 U-2041

OXCARBAZEPINE - OXTELLAR XR N 202810 003 10220042 Apr 13, 2027 U-2501 7910131 Apr 13, 2027 U-2041 9119791 Apr 13, 2027 U-2041

OXYBUTYNIN CHLORIDE - GELNIQUE N 022204 001 10272061 Apr 26, 2020 U-2525 10449173 Nov 06, 2029 DP U-2637

OXYCODONE - XTAMPZA ER N 208090 001 10188644 Sep 02, 2036 DP U-1556 >A> 10525052 Jul 07, 2023 DP U-1556 >A> 10525053 Jul 07, 2023 DP A - 57 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

OXYCODONE - XTAMPZA ER N 208090 002 10188644 Sep 02, 2036 DP U-1556 >A> 10525052 Jul 07, 2023 DP U-1556 >A> 10525053 Jul 07, 2023 DP

OXYCODONE - XTAMPZA ER N 208090 003 10188644 Sep 02, 2036 DP U-1556 >A> 10525052 Jul 07, 2023 DP U-1556 >A> 10525053 Jul 07, 2023 DP

OXYCODONE - XTAMPZA ER N 208090 004 10188644 Sep 02, 2036 DP U-1556 >A> 10525052 Jul 07, 2023 DP U-1556 >A> 10525053 Jul 07, 2023 DP

OXYCODONE - XTAMPZA ER N 208090 005 10188644 Sep 02, 2036 DP U-1556 >A> 10525052 Jul 07, 2023 DP U-1556 >A> 10525053 Jul 07, 2023 DP

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 001 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS 9060976 Aug 06, 2022 DP Y

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 002 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 003 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 004 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 005 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 006 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - OXYCONTIN N 022272 007 10369109 Jun 16, 2023 DP 10407434 Mar 30, 2025 DS

OXYCODONE HYDROCHLORIDE - ROXYBOND N 209777 001 10314788 Aug 12, 2028 DP

OXYCODONE HYDROCHLORIDE - ROXYBOND N 209777 002 10314788 Aug 12, 2028 DP

OXYCODONE HYDROCHLORIDE - ROXYBOND N 209777 003 10314788 Aug 12, 2028 DP

OXYMETAZOLINE HYDROCHLORIDE - RHOFADE N 208552 001 10335391 Jun 11, 2035 U-2567 A - 58 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

OZENOXACIN - XEPI N 208945 001 6335447 Apr 06, 2020 DS

PACLITAXEL - ABRAXANE N 021660 001 7758891 Feb 21, 2026 U-1434 ODE-52 Sep 06, 2020 7758891*PED Aug 21, 2026 PED Mar 06, 2021 7820788 Oct 27, 2024 DP U-1092 7820788 Oct 27, 2024 DP U-1290 7820788 Oct 27, 2024 DP U-1434 7820788*PED Apr 27, 2025 7923536 Dec 09, 2023 U-1117 7923536 Dec 09, 2023 U-1290 7923536 Dec 09, 2023 U-1434 7923536*PED Jun 09, 2024 8138229 Dec 09, 2023 DP U-1092 8138229 Dec 09, 2023 DP U-1290 8138229 Dec 09, 2023 DP U-1434 8138229*PED Jun 09, 2024 8314156 Dec 09, 2023 U-1290 8314156 Dec 09, 2023 U-1434 8314156*PED Jun 09, 2024 8853260 Oct 10, 2020 DP U-1092 8853260 Oct 10, 2020 DP U-1290 8853260 Oct 10, 2020 DP U-1434 8853260*PED Apr 10, 2021 9101543 Feb 21, 2026 U-1434 9101543*PED Aug 21, 2026 9393318 Mar 04, 2032 U-1290 9393318*PED Sep 04, 2032 9511046 Jan 12, 2034 U-1434 9511046*PED Jul 12, 2034 9597409 Mar 04, 2032 U-1290 9597409*PED Sep 04, 2032

PALBOCICLIB - IBRANCE N 207103 001 7456168 Jan 16, 2023 U-1998 7456168 Jan 16, 2023 U-2515 >A> RE47739 Jan 16, 2023 DS DP

PALBOCICLIB - IBRANCE N 207103 002 7456168 Jan 16, 2023 U-1998 7456168 Jan 16, 2023 U-2515 >A> RE47739 Jan 16, 2023 DS DP

PALBOCICLIB - IBRANCE N 207103 003 7456168 Jan 16, 2023 U-1998 7456168 Jan 16, 2023 U-2515 >A> RE47739 Jan 16, 2023 DS DP

PALBOCICLIB - IBRANCE N 212436 001 6936612 Jan 22, 2023 DS DP NCE Feb 03, 2020 7456168 Jan 16, 2023 U-2515 RE47739 Jan 16, 2023 DS DP

PALBOCICLIB - IBRANCE N 212436 002 6936612 Jan 22, 2023 DS DP NCE Feb 03, 2020 7456168 Jan 16, 2023 U-2515 RE47739 Jan 16, 2023 DS DP

PALBOCICLIB - IBRANCE N 212436 003 6936612 Jan 22, 2023 DS DP NCE Feb 03, 2020 7456168 Jan 16, 2023 U-2515 RE47739 Jan 16, 2023 DS DP A - 59 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

PASIREOTIDE PAMOATE - SIGNIFOR LAR KIT N 203255 001 ODE-268 Jun 29, 2025

PASIREOTIDE PAMOATE - SIGNIFOR LAR KIT N 203255 002 ODE-268 Jun 29, 2025

PASIREOTIDE PAMOATE - SIGNIFOR LAR KIT N 203255 003 ODE-268 Jun 29, 2025

PASIREOTIDE PAMOATE - SIGNIFOR LAR KIT N 203255 004 7473761 Dec 14, 2026 DS DP ODE-268 Jun 29, 2025 7759308 Oct 25, 2026 DP 9351923 May 23, 2028 DP

PASIREOTIDE PAMOATE - SIGNIFOR LAR KIT N 203255 005 7473761 Dec 14, 2026 DS DP ODE-268 Jun 29, 2025 7759308 Oct 25, 2026 DP 9351923 May 23, 2028 DP

PATIROMER SORBITEX CALCIUM - VELTASSA N 205739 001 >A> 10485821 Mar 30, 2024 U-1766 >A> 8147873 Jun 20, 2028 DP >A> 8282913 May 29, 2027 DP

PATIROMER SORBITEX CALCIUM - VELTASSA N 205739 002 >A> 10485821 Mar 30, 2024 U-1766 >A> 8147873 Jun 20, 2028 DP >A> 8282913 May 29, 2027 DP

PATIROMER SORBITEX CALCIUM - VELTASSA N 205739 003 >A> 10485821 Mar 30, 2024 U-1766 >A> 8147873 Jun 20, 2028 DP >A> 8282913 May 29, 2027 DP

PENICILLAMINE - PENICILLAMINE A 210976 001 CGT Dec 22, 2019

PERAMIVIR - RAPIVAB N 206426 001 10391075 Feb 12, 2027 U-2622 >A> 6562861 Dec 16, 2023 DS 8778997 May 07, 2027 U-1627 8778997 May 07, 2027 U-2622

PEXIDARTINIB HYDROCHLORIDE - TURALIO N 211810 001 10189833 May 05, 2036 U-2606 NCE Aug 02, 2024 10435404 Jul 24, 2038 DP ODE-250 Aug 02, 2026 7893075 Oct 13, 2028 DS 8404700 Nov 21, 2027 DS 8461169 Apr 19, 2028 U-2606 8722702 Nov 21, 2027 DS 9169250 Nov 21, 2027 DS 9358235 Jun 08, 2033 U-2606 9802932 May 05, 2036 DS

PIMAVANSERIN TARTRATE - NUPLAZID N 207318 001 10028944 Jan 15, 2024 U-1974

PIMAVANSERIN TARTRATE - NUPLAZID N 207318 002 >A> 10517860 Mar 23, 2037 U-1974 NCE Apr 29, 2021 A - 60 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

PIMAVANSERIN TARTRATE - NUPLAZID N 210793 001 10028944 Jan 15, 2024 U-1974 10449185 Aug 27, 2038 DP 9566271 Jan 15, 2024 U-1974

PIRFENIDONE - ESBRIET N 022535 001 8383150 Sep 22, 2026 DP U-2361

PIRFENIDONE - ESBRIET N 208780 001 10188637 Mar 28, 2037 DP

PIRFENIDONE - ESBRIET N 208780 002 10188637 Mar 28, 2037 DP

PIRFENIDONE - ESBRIET N 208780 003 10188637 Mar 28, 2037 DP

PITAVASTATIN CALCIUM - LIVALO N 022363 001 5856336 Dec 25, 2020 DS U-998 NPP May 16, 2022 5856336*PED Jun 25, 2021 PED Nov 16, 2022 7022713 Feb 19, 2024 U-998 7022713*PED Aug 19, 2024 8557993 Feb 02, 2024 DP 8557993*PED Aug 02, 2024

PITAVASTATIN CALCIUM - LIVALO N 022363 002 5856336 Dec 25, 2020 DS U-998 NPP May 16, 2022 5856336*PED Jun 25, 2021 PED Nov 16, 2022 7022713 Feb 19, 2024 U-998 7022713*PED Aug 19, 2024 8557993 Feb 02, 2024 DP 8557993*PED Aug 02, 2024

PITAVASTATIN CALCIUM - LIVALO N 022363 003 5856336 Dec 25, 2020 DS U-998 NPP May 16, 2022 5856336*PED Jun 25, 2021 PED Nov 16, 2022 7022713 Feb 19, 2024 U-998 7022713*PED Aug 19, 2024 8557993 Feb 02, 2024 DP 8557993*PED Aug 02, 2024

PITOLISANT HYDROCHLORIDE - WAKIX N 211150 001 7169928 Feb 02, 2020 DS DP NCE Aug 14, 2024 7910605 Sep 23, 2022 U-1101 ODE-255 Aug 14, 2026 8207197 Feb 25, 2029 DS DP 8354430 Feb 26, 2026 U-1101 8486947 Sep 26, 2029 U-1101

PITOLISANT HYDROCHLORIDE - WAKIX N 211150 002 7169928 Feb 02, 2020 DS DP NCE Aug 14, 2024 7910605 Sep 23, 2022 U-1101 ODE-255 Aug 14, 2026 8207197 Feb 25, 2029 DS DP 8354430 Feb 26, 2026 U-1101 8486947 Sep 26, 2029 U-1101

PREGABALIN - LYRICA N 021446 001 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 002 NPP May 23, 2022 PED Nov 23, 2022 A - 61 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

PREGABALIN - LYRICA N 021446 003 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 004 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 005 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 006 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 007 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 021446 008 NPP May 23, 2022 PED Nov 23, 2022

PREGABALIN - LYRICA N 022488 001 NPP May 23, 2022 PED Nov 23, 2022

PRETOMANID - PRETOMANID N 212862 001 NCE Aug 14, 2024 ODE-253 Aug 14, 2026 GAIN Aug 14, 2029

PROPRANOLOL HYDROCHLORIDE - HEMANGEOL N 205410 001 8987262 Oct 16, 2028 U-1988

PYRIDOSTIGMINE BROMIDE - PYRIDOSTIGMINE BROMIDE A 211694 001 CGT Sep 04, 2019

RANOLAZINE - RANOLAZINE A 201046 001 PC May 27, 2019

RANOLAZINE - RANOLAZINE A 201046 002 PC May 27, 2019

REGADENOSON - LEXISCAN N 022161 001 RE47301 Feb 02, 2027 DP RE47351 Jun 22, 2019 DS DP U-869

REVEFENACIN - YUPELRI N 210598 001 10343995 Mar 10, 2025 U-2440 8541451 Aug 25, 2031 DS 9765028 Jul 14, 2030 DS

RIFAXIMIN - XIFAXAN N 022554 001 10314828 Oct 02, 2029 U-1481 10335397 Oct 02, 2029 U-2579 10456384 Feb 26, 2029 U-2643 10456384 Feb 26, 2029 U-2644 A - 62 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

RISPERIDONE - PERSERIS KIT N 210655 001 10376590 Feb 13, 2028 U-2608 10406160 Jun 26, 2026 DP U-2608

RISPERIDONE - PERSERIS KIT N 210655 002 10376590 Feb 13, 2028 U-2608 10406160 Jun 26, 2026 DP U-2608

RIVAROXABAN - XARELTO N 022406 001 7592339 Dec 11, 2020 U-1167 I-810 Oct 11, 2022 7592339 Dec 11, 2020 U-1200 7592339 Dec 11, 2020 U-1301 7592339 Dec 11, 2020 U-1302 7592339 Dec 11, 2020 U-1303 7592339 Dec 11, 2020 U-2142 7592339 Dec 11, 2020 U-2640 9415053 Nov 13, 2024 DP U-1167 9415053 Nov 13, 2024 DP U-1200 9415053 Nov 13, 2024 DP U-1301 9415053 Nov 13, 2024 DP U-1302 9415053 Nov 13, 2024 DP U-2142 9415053 Nov 13, 2024 DP U-2640 9539218 Feb 17, 2034 U-1953 9539218 Feb 17, 2034 U-1954 9539218 Feb 17, 2034 U-1955 9539218 Feb 17, 2034 U-1957 9539218 Feb 17, 2034 U-2143 9539218 Feb 17, 2034 U-2641

RIVAROXABAN - XARELTO N 022406 002 I-810 Oct 11, 2022

RIVAROXABAN - XARELTO N 022406 003 I-810 Oct 11, 2022

RIVAROXABAN - XARELTO N 022406 004 I-810 Oct 11, 2022

ROSUVASTATIN CALCIUM - EZALLOR N 208647 001 10413543 Feb 12, 2036 DP

ROSUVASTATIN CALCIUM - EZALLOR N 208647 002 10413543 Feb 12, 2036 DP

ROSUVASTATIN CALCIUM - EZALLOR N 208647 003 10413543 Feb 12, 2036 DP

ROSUVASTATIN CALCIUM - EZALLOR N 208647 004 10413543 Feb 12, 2036 DP

ROTIGOTINE - NEUPRO N 021829 001 10350174 Dec 22, 2030 DP

ROTIGOTINE - NEUPRO N 021829 002 10350174 Dec 22, 2030 DP

ROTIGOTINE - NEUPRO N 021829 003 10350174 Dec 22, 2030 DP

ROTIGOTINE - NEUPRO N 021829 004 10350174 Dec 22, 2030 DP A - 63 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

ROTIGOTINE - NEUPRO N 021829 005 10350174 Dec 22, 2030 DP

ROTIGOTINE - NEUPRO N 021829 006 10350174 Dec 22, 2030 DP

RUCAPARIB CAMSYLATE - RUBRACA N 209115 001 10278974 Feb 10, 2031 DP >A> 6495541 Jan 10, 2021 DS DP

RUCAPARIB CAMSYLATE - RUBRACA N 209115 002 10278974 Feb 10, 2031 DP >A> 6495541 Jan 10, 2021 DS DP

RUCAPARIB CAMSYLATE - RUBRACA N 209115 003 10278974 Feb 10, 2031 DP >A> 6495541 Jan 10, 2021 DS DP

RUXOLITINIB PHOSPHATE - JAKAFI N 202192 001 10016429 Jun 12, 2028 U-2536 I-799 May 24, 2022 9814722 Dec 12, 2026 U-2536 ODE-238 May 24, 2026

RUXOLITINIB PHOSPHATE - JAKAFI N 202192 002 10016429 Jun 12, 2028 U-2536 I-799 May 24, 2022 9814722 Dec 12, 2026 U-2536 ODE-238 May 24, 2026

RUXOLITINIB PHOSPHATE - JAKAFI N 202192 003 10016429 Jun 12, 2028 U-2536 I-799 May 24, 2022 9814722 Dec 12, 2026 U-2536 ODE-238 May 24, 2026

RUXOLITINIB PHOSPHATE - JAKAFI N 202192 004 10016429 Jun 12, 2028 U-2536 I-799 May 24, 2022 9814722 Dec 12, 2026 U-2536 ODE-238 May 24, 2026

RUXOLITINIB PHOSPHATE - JAKAFI N 202192 005 10016429 Jun 12, 2028 U-2536 I-799 May 24, 2022 9814722 Dec 12, 2026 U-2536 ODE-238 May 24, 2026

SACUBITRIL; VALSARTAN - ENTRESTO N 207620 001 7468390 Nov 27, 2023 DP NCE Jul 07, 2020 7468390*PED May 27, 2024 NPP Oct 01, 2022 8101659 Jan 14, 2023 DP PED Jan 07, 2021 8101659*PED Jul 14, 2023 PED Apr 01, 2023 8404744 Jan 14, 2023 DP 8404744*PED Jul 14, 2023 8796331 Jan 14, 2023 U-1723 8796331*PED Jul 14, 2023 8877938 May 27, 2027 DS DP 8877938*PED Nov 27, 2027 9388134 Nov 08, 2026 U-1723 9388134*PED May 08, 2027

SACUBITRIL; VALSARTAN - ENTRESTO N 207620 002 7468390 Nov 27, 2023 DP NCE Jul 07, 2020 7468390*PED May 27, 2024 NPP Oct 01, 2022 8101659 Jan 14, 2023 DP PED Jan 07, 2021 8101659*PED Jul 14, 2023 PED Apr 01, 2023 8404744 Jan 14, 2023 DP 8404744*PED Jul 14, 2023 8796331 Jan 14, 2023 U-1723 8796331*PED Jul 14, 2023 8877938 May 27, 2027 DS DP 8877938*PED Nov 27, 2027 A - 64 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SACUBITRIL; VALSARTAN - ENTRESTO N 207620 002 9388134 Nov 08, 2026 U-1723 9388134*PED May 08, 2027

SACUBITRIL; VALSARTAN - ENTRESTO N 207620 003 7468390 Nov 27, 2023 DP NCE Jul 07, 2020 7468390*PED May 27, 2024 NPP Oct 01, 2022 8101659 Jan 14, 2023 DP PED Jan 07, 2021 8101659*PED Jul 14, 2023 PED Apr 01, 2023 8404744 Jan 14, 2023 DP 8404744*PED Jul 14, 2023 8796331 Jan 14, 2023 U-1723 8796331*PED Jul 14, 2023 8877938 May 27, 2027 DS DP 8877938*PED Nov 27, 2027 9388134 Nov 08, 2026 U-1723 9388134*PED May 08, 2027

SECNIDAZOLE - SOLOSEC N 209363 001 10335390 Sep 04, 2035 U-2583

SELENIOUS ACID - SELENIOUS ACID N 209379 001 NCE Apr 30, 2024

SELINEXOR - XPOVIO N 212306 001 8999996 Sep 15, 2032 DS DP NCE Jul 03, 2024 9079865 Jul 26, 2032 U-2584 ODE-257 Jul 03, 2026 9714226 Jul 26, 2032 DS DP

SEMAGLUTIDE - OZEMPIC N 209637 001 10220155 Jul 17, 2026 DP 10335462 Jun 21, 2033 U-2580 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP

SEMAGLUTIDE - RYBELSUS N 213051 001 10086047 Dec 16, 2031 DP NCE Dec 05, 2022 10278923 May 02, 2034 U-2628 NP Sep 20, 2022 8129343 Jan 29, 2029 DS DP U-2628 8536122 Mar 20, 2026 DS DP U-2628 9278123 Dec 16, 2031 DP U-2628

SEMAGLUTIDE - RYBELSUS N 213051 002 10086047 Dec 16, 2031 DP NCE Dec 05, 2022 10278923 May 02, 2034 U-2628 NP Sep 20, 2022 8129343 Jan 29, 2029 DS DP U-2628 8536122 Mar 20, 2026 DS DP U-2628 9278123 Dec 16, 2031 DP U-2628

SEMAGLUTIDE - RYBELSUS N 213051 003 10086047 Dec 16, 2031 DP NCE Dec 05, 2022 10278923 May 02, 2034 U-2628 NP Sep 20, 2022 8129343 Jan 29, 2029 DS DP U-2628 8536122 Mar 20, 2026 DS DP U-2628 9278123 Dec 16, 2031 DP U-2628

SILDENAFIL CITRATE - SILDENAFIL CITRATE A 212260 001 CGT Nov 27, 2019

SIMVASTATIN - FLOLIPID N 206679 001 10300041 Apr 26, 2027 DP A - 65 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SIMVASTATIN - FLOLIPID N 206679 002 10300041 Apr 26, 2027 DP

SINECATECHINS - VEREGEN N 021902 001 10434059 Nov 18, 2022 DP U-172

SIPONIMOD FUMARIC ACID - MAYZENT N 209884 001 7939519 May 19, 2024 DS DP NCE Mar 26, 2024 8492441 Nov 30, 2030 U-2511

SIPONIMOD FUMARIC ACID - MAYZENT N 209884 002 7939519 May 19, 2024 DS DP NCE Mar 26, 2024 8492441 Nov 30, 2030 U-2511

SITAGLIPTIN PHOSPHATE - JANUVIA N 021995 001 M-244 Aug 12, 2022

SITAGLIPTIN PHOSPHATE - JANUVIA N 021995 002 M-244 Aug 12, 2022

SITAGLIPTIN PHOSPHATE - JANUVIA N 021995 003 M-244 Aug 12, 2022

SODIUM OXYBATE - XYREM N 021196 001 10213400 Mar 15, 2033 U-2499 ODE-231 Oct 26, 2025 7668730 Jun 16, 2024 U-1110 Y 7668730*PED Dec 16, 2024

SODIUM ZIRCONIUM CYCLOSILICATE - LOKELMA N 207078 001 10300087 Oct 14, 2035 DS U-2312 10335432 Feb 10, 2032 U-2312 10398730 Feb 10, 2032 U-2312 10413569 Feb 10, 2032 DS 9913860 Oct 22, 2033 DS U-2312

SODIUM ZIRCONIUM CYCLOSILICATE - LOKELMA N 207078 002 10300087 Oct 14, 2035 DS U-2312 10398730 Feb 10, 2032 U-2312 10413569 Feb 10, 2032 DS 9913860 Oct 22, 2033 DS U-2312

SOFOSBUVIR - SOVALDI N 204671 001 7964580 Mar 26, 2029 DS DP U-1470 NPP Apr 07, 2020 7964580*PED Sep 26, 2029 ODE-135 Apr 07, 2024 8334270 Mar 21, 2028 DS DP U-1470 PED Oct 07, 2024 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031 9549941 Mar 26, 2029 U-1958 9549941*PED Sep 26, 2029 A - 66 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SOFOSBUVIR - SOVALDI N 204671 002 7964580 Mar 26, 2029 DS DP U-1470 7964580*PED Sep 26, 2029 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031

SOFOSBUVIR - SOVALDI N 212480 001 7964580 Mar 26, 2029 DS DP U-1470 ODE-258 Aug 28, 2026 7964580*PED Sep 26, 2029 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031

SOFOSBUVIR - SOVALDI N 212480 002 7964580 Mar 26, 2029 DS DP U-1470 ODE-258 Aug 28, 2026 7964580*PED Sep 26, 2029 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DP U-1470 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031

SOFOSBUVIR; VELPATASVIR - EPCLUSA N 208341 001 7964580 Mar 26, 2029 DS DP U-1470 >A> D-177 Nov 15, 2022 7964580*PED Sep 26, 2029 8334270 Mar 21, 2028 DS DP U-1470 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-1470 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-1470 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-1470 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DP U-1470 A - 67 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SOFOSBUVIR; VELPATASVIR - EPCLUSA N 208341 001 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-1470 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-1470 9284342*PED Mar 13, 2031

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR - VOSEVI N 209195 001 7964580 Mar 26, 2029 DS DP U-2039 7964580 Mar 26, 2029 DS DP U-2040 7964580*PED Sep 26, 2029 8334270 Mar 21, 2028 DS DP U-2039 8334270 Mar 21, 2028 DS DP U-2040 8334270*PED Sep 21, 2028 8580765 Mar 21, 2028 DS DP U-2039 8580765 Mar 21, 2028 DS DP U-2040 8580765*PED Sep 21, 2028 8618076 Dec 11, 2030 DS DP U-2039 8618076 Dec 11, 2030 DS DP U-2040 8618076*PED Jun 11, 2031 8633309 Mar 26, 2029 DS DP U-2039 8633309 Mar 26, 2029 DS DP U-2040 8633309*PED Sep 26, 2029 8889159 Mar 26, 2029 DS DP U-2039 8889159 Mar 26, 2029 DS DP U-2040 8889159*PED Sep 26, 2029 9085573 Mar 21, 2028 DS DP U-2039 9085573 Mar 21, 2028 DS DP U-2040 9085573*PED Sep 21, 2028 9284342 Sep 13, 2030 DS DP U-2039 9284342 Sep 13, 2030 DS DP U-2040 9284342*PED Mar 13, 2031

SOLRIAMFETOL - SUNOSI N 211230 001 10195151 Sep 05, 2037 DP NCE Jun 17, 2024 10351517 Jun 07, 2026 U-2548 ODE-254 Jun 17, 2026 8440715 Aug 25, 2027 U-2548 8877806 Jun 07, 2026 U-2548 9604917 Jun 07, 2026 U-2548

SOLRIAMFETOL - SUNOSI N 211230 002 10195151 Sep 05, 2037 DP NCE Jun 17, 2024 10351517 Jun 07, 2026 U-2548 ODE-254 Jun 17, 2026 8440715 Aug 25, 2027 U-2548 8877806 Jun 07, 2026 U-2548 9604917 Jun 07, 2026 U-2548

SOMATROPIN - NORDITROPIN FLEXPRO N 021148 008 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

SOMATROPIN - NORDITROPIN FLEXPRO N 021148 009 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

SOMATROPIN - NORDITROPIN FLEXPRO N 021148 010 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP A - 68 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SOMATROPIN - NORDITROPIN FLEXPRO N 021148 010 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

SOMATROPIN - NORDITROPIN FLEXPRO N 021148 011 10220155 Jul 17, 2026 DP 10357616 Jan 20, 2026 DP 10376652 Jan 20, 2026 DP 7762994 May 23, 2024 DP 8579869 Jun 30, 2023 DP

SOTALOL HYDROCHLORIDE - SOTYLIZE N 205108 001 10206895 Apr 01, 2034 DP U-2096 10206895 Apr 01, 2034 DP U-2494

SPIRONOLACTONE - CAROSPIR N 209478 001 >A> 10493083 Oct 28, 2036 DP

SUCROFERRIC OXYHYDROXIDE - VELPHORO N 205109 001 >A> 6174442 Jun 12, 2020 DS U-1468

SUFENTANIL CITRATE - DSUVIA N 209128 001 10245228 Jan 05, 2027 DP U-1351 10342762 Jan 05, 2027 DP >A> 10507180 Jan 05, 2027 DP U-1351

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES - LUMASON N 203684 001 10232061 Jul 06, 2038 DP NPP Nov 13, 2022 10335502 Jul 06, 2038 DP

SUMATRIPTAN - TOSYMRA N 210884 001 8268791 May 09, 2026 DP 8440631 May 09, 2026 DP U-1719 9211282 Jul 19, 2031 DP U-1719 9283280 May 09, 2026 DP 9610280 Jun 16, 2030 DP U-1719 9974770 Jun 16, 2030 DP U-1719

SUMATRIPTAN SUCCINATE - ONZETRA XSAIL N 206099 001 10398859 Dec 19, 2027 DP 10478574 Nov 04, 2033 U-2404

SUNITINIB MALATE - SUTENT N 021938 001 6573293 Feb 15, 2021 DS DP U-1154 I-755 Nov 16, 2020 6573293 Feb 15, 2021 DS DP U-2171 PED May 16, 2021 6573293*PED Aug 15, 2021 7125905 Feb 15, 2021 DS DP 7125905*PED Aug 15, 2021 7211600 Dec 22, 2020 U-883 7211600*PED Jun 22, 2021

SUNITINIB MALATE - SUTENT N 021938 002 6573293 Feb 15, 2021 DS DP U-1154 I-755 Nov 16, 2020 6573293 Feb 15, 2021 DS DP U-2171 PED May 16, 2021 6573293*PED Aug 15, 2021 7125905 Feb 15, 2021 DS DP 7125905*PED Aug 15, 2021 7211600 Dec 22, 2020 U-883 7211600*PED Jun 22, 2021

SUNITINIB MALATE - SUTENT N 021938 003 6573293 Feb 15, 2021 DS DP U-1154 I-755 Nov 16, 2020 6573293 Feb 15, 2021 DS DP U-2171 PED May 16, 2021 A - 69 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

SUNITINIB MALATE - SUTENT N 021938 003 6573293*PED Aug 15, 2021 7125905 Feb 15, 2021 DS DP 7125905*PED Aug 15, 2021 7211600 Dec 22, 2020 U-883 7211600*PED Jun 22, 2021

SUNITINIB MALATE - SUTENT N 021938 004 6573293 Feb 15, 2021 DS DP U-1154 I-755 Nov 16, 2020 6573293 Feb 15, 2021 DS DP U-2171 PED May 16, 2021 6573293*PED Aug 15, 2021 7125905 Feb 15, 2021 DS DP 7125905*PED Aug 15, 2021 7211600 Dec 22, 2020 U-883 7211600*PED Jun 22, 2021

TACROLIMUS - ENVARSUS XR N 206406 001 10166190 May 30, 2028 DP >A> 8644239 Aug 30, 2028 DP U-2677 >A> 8644239 Aug 30, 2028 DP U-2678 >A> 8685998 Aug 30, 2028 DP U-1752 >A> 8685998 Aug 30, 2028 DP U-2677 >A> 8685998 Aug 30, 2028 DP U-2678

TACROLIMUS - ENVARSUS XR N 206406 002 10166190 May 30, 2028 DP >A> 8644239 Aug 30, 2028 DP U-2677 >A> 8644239 Aug 30, 2028 DP U-2678 >A> 8685998 Aug 30, 2028 DP U-1752 >A> 8685998 Aug 30, 2028 DP U-2677 >A> 8685998 Aug 30, 2028 DP U-2678

TACROLIMUS - ENVARSUS XR N 206406 003 10166190 May 30, 2028 DP >A> 8644239 Aug 30, 2028 DP U-2677 >A> 8644239 Aug 30, 2028 DP U-2678 >A> 8685998 Aug 30, 2028 DP U-1752 >A> 8685998 Aug 30, 2028 DP U-2677 >A> 8685998 Aug 30, 2028 DP U-2678

TACROLIMUS - PROGRAF N 210115 001 ODE-269 May 24, 2025

TACROLIMUS - PROGRAF N 210115 002 ODE-269 May 24, 2025

TAFAMIDIS - VYNDAMAX N 212161 001 7214695 Apr 27, 2024 DS DP NCE May 03, 2024 7214696 Dec 19, 2023 U-2524 ODE-237 May 03, 2026 9770441 Aug 31, 2035 DS DP U-2524

TAFAMIDIS MEGLUMINE - VYNDAQEL N 211996 001 7214695 Apr 27, 2024 DS DP NCE May 03, 2024 7214696 Dec 19, 2023 U-2524 ODE-237 May 03, 2026 8168663 Dec 19, 2023 DS DP 8653119 Jan 28, 2024 U-2524

TAFENOQUINE SUCCINATE - ARAKODA N 210607 001 10342791 Dec 02, 2035 U-2582

TALAZOPARIB TOSYLATE - TALZENNA N 211651 001 10189837 Oct 20, 2031 DS DP NCE Oct 16, 2023 A - 70 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

TALAZOPARIB TOSYLATE - TALZENNA N 211651 002 10189837 Oct 20, 2031 DS DP NCE Oct 16, 2023

TASIMELTEON - HETLIOZ N 205677 001 10376487 Jul 27, 2035 U-2615 10449176 Jan 25, 2033 U-2149

TAVABOROLE - KERYDIN N 204427 001 NCE Jul 07, 2019 PED Jan 07, 2020

TAZAROTENE - ARAZLO N 211882 001 >A> 6517847 Aug 03, 2020 DP U-2368 >A> NP Dec 18, 2022

TEDIZOLID PHOSPHATE - SIVEXTRO N 205435 001 10065947 Feb 03, 2030 DP 10442829 Feb 03, 2030 DS 9624250 Feb 03, 2030 DS DP U-2507 9988406 Feb 03, 2030 DP

TEDIZOLID PHOSPHATE - SIVEXTRO N 205436 001 10065947 Feb 03, 2030 DP 10442829 Feb 03, 2030 DS 9624250 Feb 03, 2030 DS DP U-2507 9988406 Feb 03, 2030 DP

TEDUGLUTIDE RECOMBINANT - GATTEX KIT N 203441 001 5789379 Apr 14, 2020 DS DP U-1320 ODE-240 May 16, 2026 5789379*PED Oct 14, 2020 ODE-37 Dec 21, 2019 7056886 Sep 18, 2022 DP U-1320 PED Jun 21, 2020 7056886*PED Mar 18, 2023 7847061 Nov 01, 2025 U-1320 7847061*PED May 01, 2026 9060992 Nov 01, 2025 U-1320 9060992*PED May 01, 2026 9539310 Nov 01, 2025 U-1320 9539310*PED May 01, 2026 9545434 Nov 01, 2025 U-1320 9545434*PED May 01, 2026 9545435 Nov 01, 2025 U-1320 9545435*PED May 01, 2026 9555079 Nov 01, 2025 U-1320 9555079*PED May 01, 2026 9572867 Nov 01, 2025 U-1320 9572867*PED May 01, 2026 9592273 Nov 01, 2025 U-1320 9592273*PED May 01, 2026 9592274 Nov 01, 2025 U-1320 9592274*PED May 01, 2026 9968655 Nov 01, 2025 U-2308 9968655*PED May 01, 2026 9968656 Nov 01, 2025 U-2308 9968656*PED May 01, 2026 9968658 Nov 01, 2025 U-1320 9968658*PED May 01, 2026 9974835 Nov 01, 2025 U-1320 9974835*PED May 01, 2026 9974837 Nov 01, 2025 U-1320 9974837*PED May 01, 2026 9981014 Nov 01, 2025 U-1320 9981014*PED May 01, 2026 9981016 Nov 01, 2025 U-1320 9981016*PED May 01, 2026 9987334 Nov 01, 2025 U-1320 9987334*PED May 01, 2026 A - 71 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

TEDUGLUTIDE RECOMBINANT - GATTEX KIT N 203441 001 9987335 Nov 01, 2025 U-1320 9987335*PED May 01, 2026 9993528 Nov 01, 2025 U-1320 9993528*PED May 01, 2026

TENAPANOR HYDROCHLORIDE - IBSRELA N 211801 001 8541448 Dec 30, 2029 DS DP NCE Sep 12, 2024 8969377 Dec 30, 2029 DS DP 9006281 May 02, 2030 U-2626 9408840 Dec 30, 2029 U-2626

TESTOSTERONE UNDECANOATE - JATENZO N 206089 001 8241664 Mar 29, 2029 DP U-2506 NP Mar 27, 2022 8492369 Dec 20, 2030 DP U-2506 8778916 Apr 12, 2030 DP

TESTOSTERONE UNDECANOATE - JATENZO N 206089 002 8241664 Mar 29, 2029 DP U-2506 NP Mar 27, 2022 8492369 Dec 20, 2030 DP U-2506 8778916 Apr 12, 2030 DP

TESTOSTERONE UNDECANOATE - JATENZO N 206089 003 8241664 Mar 29, 2029 DP U-2506 NP Mar 27, 2022 8492369 Dec 20, 2030 DP U-2506 8778916 Apr 12, 2030 DP

THIOTHIXENE - THIOTHIXENE A 211642 001 CGT Oct 02, 2019

THIOTHIXENE - THIOTHIXENE A 211642 002 CGT Oct 02, 2019

THIOTHIXENE - THIOTHIXENE A 211642 003 CGT Oct 02, 2019

THIOTHIXENE - THIOTHIXENE A 211642 004 CGT Oct 02, 2019

TICAGRELOR - BRILINTA N 022433 001 10300065 Jan 27, 2036 U-2541 10300065 Jan 27, 2036 U-2542

TICAGRELOR - BRILINTA N 022433 002 10300065 Jan 27, 2036 U-2541 10300065 Jan 27, 2036 U-2542

TIOPRONIN - THIOLA N 019569 001 ODE-267 Jun 28, 2026

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF N 207981 001 10456399 Feb 03, 2037 U-2642 I-794 Feb 22, 2022 10457666 Jun 17, 2034 DS DP ODE-229 Feb 22, 2026 RE46284 Dec 16, 2026 U-1751 RE46284 Dec 16, 2026 U-2503

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF N 207981 002 10456399 Feb 03, 2037 U-2642 I-794 Feb 22, 2022 10457666 Jun 17, 2034 DS DP ODE-229 Feb 22, 2026 RE46284 Dec 16, 2026 U-1751 RE46284 Dec 16, 2026 U-2503 A - 72 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

TOBRAMYCIN - TOBI PODHALER N 201688 001 10207066 Nov 04, 2030 DP U-909 8664187 Jun 20, 2025 U-909 8869794 Sep 12, 2028 DP U-909 9421166 Dec 19, 2022 DP U-909

TOFACITINIB CITRATE - XELJANZ XR N 208246 001 >A> 7842699 Dec 08, 2020 U-2322

TOFACITINIB CITRATE - XELJANZ XR N 208246 002 >A> 6956041 Dec 08, 2020 DP >A> 6965027 Mar 25, 2023 DS >A> 7265221 Dec 08, 2020 DS >A> 7301023 May 23, 2022 DS >A> 7842699 Dec 08, 2020 U-2322 >A> RE41783 Dec 08, 2025 DS

TOPIRAMATE - TROKENDI XR N 201635 001 10314790 Nov 16, 2027 DP U-1675 10314790 Nov 16, 2027 DP U-1992

TOPIRAMATE - TROKENDI XR N 201635 002 10314790 Nov 16, 2027 DP U-1675 10314790 Nov 16, 2027 DP U-1992

TOPIRAMATE - TROKENDI XR N 201635 003 10314790 Nov 16, 2027 DP U-1675 10314790 Nov 16, 2027 DP U-1992

TOPIRAMATE - TROKENDI XR N 201635 004 10314790 Nov 16, 2027 DP U-1675 10314790 Nov 16, 2027 DP U-1992

TOPIRAMATE - QUDEXY XR N 205122 001 10363224 Mar 19, 2033 U-766

TOPIRAMATE - QUDEXY XR N 205122 002 10363224 Mar 19, 2033 U-766

TOPIRAMATE - QUDEXY XR N 205122 003 10363224 Mar 19, 2033 U-766

TOPIRAMATE - QUDEXY XR N 205122 004 10363224 Mar 19, 2033 U-766

TOPIRAMATE - QUDEXY XR N 205122 005 10363224 Mar 19, 2033 U-766

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N 204114 001 8703781 Oct 15, 2030 DS DP U-1712 M-246 Oct 06, 2022 8703781 Oct 15, 2030 DS DP U-2020 8703781 Oct 15, 2030 DS DP U-2037 8703781 Oct 15, 2030 DS DP U-2302 8703781 Oct 15, 2030 DS DP U-2305 >A> 9399021 Jan 28, 2032 DP

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N 204114 002 8703781 Oct 15, 2030 DS DP U-1712 M-246 Oct 06, 2022 8703781 Oct 15, 2030 DS DP U-2020 8703781 Oct 15, 2030 DS DP U-2037 8703781 Oct 15, 2030 DS DP U-2302 8703781 Oct 15, 2030 DS DP U-2305 A - 73 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N 204114 002 >A> 9399021 Jan 28, 2032 DP

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N 204114 003 8703781 Oct 15, 2030 DS DP U-1712 M-246 Oct 06, 2022 8703781 Oct 15, 2030 DS DP U-2020 8703781 Oct 15, 2030 DS DP U-2037 8703781 Oct 15, 2030 DS DP U-2302 8703781 Oct 15, 2030 DS DP U-2305 >A> 9399021 Jan 28, 2032 DP

TREPROSTINIL - TREPROSTINIL A 203649 001 PC Sep 21, 2019

TREPROSTINIL - TREPROSTINIL A 203649 002 PC Sep 21, 2019

TREPROSTINIL - TREPROSTINIL A 203649 003 PC Sep 21, 2019

TREPROSTINIL - TREPROSTINIL A 203649 004 PC Sep 21, 2019

TREPROSTINIL DIOLAMINE - ORENITRAM N 203496 001 >A> I-820 Oct 18, 2022 >A> ODE-272 Oct 18, 2026

TREPROSTINIL DIOLAMINE - ORENITRAM N 203496 002 >A> I-820 Oct 18, 2022 >A> ODE-272 Oct 18, 2026

TREPROSTINIL DIOLAMINE - ORENITRAM N 203496 003 >A> I-820 Oct 18, 2022 >A> ODE-272 Oct 18, 2026

TREPROSTINIL DIOLAMINE - ORENITRAM N 203496 004 >A> I-820 Oct 18, 2022 >A> ODE-272 Oct 18, 2026

TREPROSTINIL DIOLAMINE - ORENITRAM N 203496 005 >A> I-820 Oct 18, 2022 >A> ODE-272 Oct 18, 2026

TRETINOIN - ALTRENO N 209353 001 6517847 Aug 03, 2020 DP U-2368

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE A 212384 001 CGT May 30, 2020

TRICLABENDAZOLE - EGATEN N 208711 001 NCE Feb 13, 2024 ODE-228 Feb 13, 2026

TRIFAROTENE - AKLIEF N 211527 001 7807708 Oct 01, 2026 DS DP NCE Oct 04, 2024 8227507 Dec 21, 2025 U-818 8470871 Dec 21, 2025 U-2639 9084778 May 30, 2033 DP U-134 A - 74 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

TRIPTORELIN PAMOATE - TRELSTAR N 022437 001 10166181 Feb 10, 2029 DP

TRIPTORELIN PAMOATE - TRIPTODUR KIT N 208956 001 10166181 Feb 10, 2029 DP

UBROGEPANT - UBRELVY N 211765 001 >A> NCE Dec 23, 2024

UBROGEPANT - UBRELVY N 211765 002 >A> NCE Dec 23, 2024

ULIPRISTAL ACETATE - ELLA N 022474 001 10159681 Apr 13, 2030 U-2510 9844510 Dec 08, 2028 DP

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA N 203975 001 M-245 Jun 09, 2022

UPADACITINIB - RINVOQ N 211675 001 8962629 Jan 15, 2031 DS U-2616 NCE Aug 16, 2024 9951080 Oct 17, 2036 DS DP 9963459 Oct 17, 2036 DP RE47221 Dec 01, 2030 DS

URIDINE TRIACETATE - VISTOGARD N 208159 001 6258795 Jul 10, 2023 DP

URIDINE TRIACETATE - XURIDEN N 208169 001 6258795 Jul 10, 2023 DP

VANCOMYCIN HYDROCHLORIDE - FIRVANQ KIT N 208910 001 10493028 Mar 13, 2035 DP

VANCOMYCIN HYDROCHLORIDE - FIRVANQ KIT N 208910 002 10493028 Mar 13, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE N 211962 001 10039804 Nov 06, 2035 DP U-282 10188697 Nov 06, 2035 DP U-282

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE N 211962 002 10039804 Nov 06, 2035 DP U-282 10188697 Nov 06, 2035 DP U-282

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE N 211962 003 10039804 Nov 06, 2035 DP U-282 10188697 Nov 06, 2035 DP U-282

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE N 211962 004 10039804 Nov 06, 2035 DP U-282 10188697 Nov 06, 2035 DP U-282

VARENICLINE TARTRATE - CHANTIX N 021928 001 M-237 Feb 22, 2022 PED Aug 22, 2022

VARENICLINE TARTRATE - CHANTIX N 021928 002 M-237 Feb 22, 2022 PED Aug 22, 2022 A - 75 PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2019 See List footnote for information regarding List content

APPL/PROD PATENT PATENT EXCLUSIVITY NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION DATE CODES REQUESTED CODE(S) DATE

VENETOCLAX - VENCLEXTA N 208573 001 9174982 May 26, 2030 U-2323 I-795 May 15, 2022 9174982 May 26, 2030 U-2445 ODE-239 May 15, 2026 9174982 May 26, 2030 U-2446 9174982 May 26, 2030 U-2537 9539251 Sep 06, 2033 U-2538

VENETOCLAX - VENCLEXTA N 208573 002 9174982 May 26, 2030 U-2323 I-795 May 15, 2022 9174982 May 26, 2030 U-2445 ODE-239 May 15, 2026 9174982 May 26, 2030 U-2446 9174982 May 26, 2030 U-2537 9539251 Sep 06, 2033 U-2538

VENETOCLAX - VENCLEXTA N 208573 003 9174982 May 26, 2030 U-2323 I-795 May 15, 2022 9174982 May 26, 2030 U-2445 ODE-239 May 15, 2026 9174982 May 26, 2030 U-2446 9174982 May 26, 2030 U-2537 9539251 Sep 06, 2033 U-2538

VORICONAZOLE - VFEND N 021266 001 NPP Jan 29, 2022

VORICONAZOLE - VFEND N 021266 002 NPP Jan 29, 2022

VORICONAZOLE - VFEND N 021267 001 NPP Jan 29, 2022

VORICONAZOLE - VFEND N 021630 001 NPP Jan 29, 2022

VOXELOTOR - OXBRYTA N 213137 001 NCE Nov 25, 2024

ZANUBRUTINIB - BRUKINSA N 213217 001 9447106 Apr 22, 2034 DS DP U-2145 NCE Nov 14, 2024 >A> ODE-276 Nov 14, 2026

Footnote:

1. Patents are published upon receipt by the Orange book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).

2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. They may not be flagged with respect to other claims which may apply.

B-1

PATENT AND EXCLUSIVITY TERMS

Due to space limitations in the patent and exclusivity columns, abbreviations and references have been developed. Refer to the APPROVED DRUG th PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 39 Edition for a full listing of patent and exclusivity terms (Abbreviations, Dosing Schedule, Indications, and Patent Use Codes).

The current complete list of patent terms is available at http://www.accessdata.fda.gov/scripts/cder/ob/results_patent.cfm

The current complete list of exclusivity terms is available at http://www.accessdata.fda.gov/scripts/cder/ob/results_exclusivity.cfm