APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS
23RD EDITION
Cumulative Supplement 12 -1 December 2003
CONTENTS
PAGE
1.0 INTRODUCTION ...... iii 1.1 How to Use the Cumulative Supplement ...... iii 1.2 Applicant Name Changes ...... ,...... iv 1.3 Nitroglycerin, Film, Extended Release; Transdermal23rd Annual Edition ...... v 1.4 NDA Patent 30-month Rule ...... Vi 1.5 Availability of the Edition...... vi 1.6 Report of Counts for the Prescription Drug Product List...... vii 1. 7 Cumulative Supplement Change Legend ...... viii
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 INFORMA nON ADDENDUM A. Patent and Exclusivity Lists...... A-I B. Patent and Exclusivity Terms...... B-1 I~'. APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS
23rd EDITION
.1 CUMULATIVE SUPPLEMENT 12 December 2003
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, 23rd Edition (the List). The List is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations, over-the-counter (OTC) drug products that require approved applications as a condition of marketing, drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research and products that have never been marketed, are for exportation, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons.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, 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 ~urrent 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, have lJeen discontinued from marketing 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 the 23rd Edition List will then be added to the "Discontinued Drug ProduCt List"· appearing in the 24th Edition. The current edition Section 2. How To Use The Drug Product Lists describes the layout and usage of the List.
iii The Patent and Exclusivity Lists are arranged in alphabetical order by active ingredient name. For those products with multiple active ingredients, only the first active ingredient (in alphabetical sort) will appear. In addition, the trade name will be displayed to the right of the active ingredient name for each product. 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. 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 A, in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations.
New additions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >A>. The Patent and Exclusivity Data are indicated by the symbol >ADD> to the left of the line on which new information exists. The >ADD> 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.
1.2 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
iv APPLICANT NAME CHANGES
FORMER APPLICANT NAME NEW APPLICANT NAME (FORMER ABBREVIATED NAME) (NEW ABBREVIATED NAME)
AAIPHARMA INC AAIPHARMA LLC .(AAIPHARMA) (AAIPHARMA LLC) BAYER CORP BAYER PHARMACEUTICALS CORP (BAYER) (BAYER PHARMS) BAYER CORP CONSUMER CARE DIY BAYER CORP CONSUMER CARE LLC (BA YER CORP CONSUMER) (BAYER) BAYER CORP PHARMACEUTICALS DIY BA YER PHARMACEUTICALS CORP (BAYER) (BAYER PHARMS) ESI LEDERLE INC CLONMEL HEALTHCARE INC (ESI LEDERLE) (CLONMEL HEALTHCARE) FAULDING PHARMACEUTICAL CO MAYNE PHARMA USA INC (FAULDING) (MAYNE PHARMA USA) FAULDING PHARMACEUTICALS INC ALPHARMA PHARMACEUTICALS INC (FAULDING PHARMS) (ALPHARMA USPD) FH FAULDING AND CO LTD MAYNE PHARMA USA INC (FAULDING) (MAYNE PHARMA USA) GENEVA PHARMACEUTICALS INC SANDOZ INC (GENEVA PHARMS) (SANDOZ) ICN PHARMACEUTICALS INC VALEANT PHARMACEUTICALS INTERNATIONAL (ICN) (VALEANT PHARM INTL) LEK SERVICES INC LEK PHARMACEUTICALS DD (LEKSVCS) (LEK PHARM DD) LEK UUBUANA PHARMACEUTICAL AND CHEMICAL CO LEK PHARMACEUTICALS DD (LEK UUBUANA) (LEK PHARM DD) LEK PHARMACEUTICAL AND CHEMICAL DD LEK PHARMACEUTICALS DD (LEKPHARM) (LEK PHARM DD) NEOSAN PHARMACEUTICALS AAIPHARMA LLC (NEOSAN PHARMS) (AAIPHARMA LLC) NOV ARTIS OPHTHALMICS INC NOV ARTIS PHARMACEUTICALS CORPORATION (NOVARTlS) (NOVARTIS PHARMS) ORGANON INC ORGANON USA INC (ORGANON INC) . (ORGANON USA INC) ORGANON INC SUB AKZO INC ORGANON USA INC (ORGANON) (ORGANON USA INC) ORGANON INC SUB AKZO NOBEL INC ORGANON USA INC (ORGANON INC) (ORGANON USA INC) SIDMAK LABORATORIES INC PLIYA INC (SIDMAK LABS) (PLlVA) SYNTEX (USA) INC LLC ROCHE PALO ALTO LLC (SYNTEX USA INC) (ROCHE PALO) WALLACE LABORATORIES DIY CARTER WALLACE INC MEDPOINTE PHARMACEUTICALS MEDPOINTE (WALLACE LABS) HEALTH CARE INC (MEDPOINTE PH ARM HLC) WALLACE PHARMACEUTICALS DIY CARTER WALLACE INC MEDPOINTE PHARMACEUTICALS MEDPOINTE (WALLACE PHARMS) HEALTH CARE INC (MEDPOINTE PHARM HLC)
1.3 NITROGLYCERIN, FILM, EXTENDED RELEASE; TRANSDERMAL 23 RD ANNUAL EDITION
The Approved Drug Products with Therapeu,tic Equivalence Evaluations 23,d annual edition, page 3-265 omitted the 3 character Therapeutic Equivalence (TE) Codes for Nitroglycerin, Film, Extended Release; Transdermal products. The correct codes are listed below by product name, applicant holder, TE code, strength, NDA number, and product number.
PRODUCT TE NAME APPLICANT CODE STRENGTH NDA PRODUCT MINITRAN 3M ABI O.IMG/HR N89771 001 MlNITRAN 3M ABI 0.2MG/HR N89772 001
v MINITRAN 3M AB1 0.4MGIHR N89773 001 MlNITRAN .3M AB1 0.6MGIHR N89774 001 NITRO-DUR KEYPHARMS AB1 O.lMG/HR N20145 001 NITRO-DUR KEYPHARMS AB1 0.2MG/HR N20145 002 NITRO-DUR KEYPHARMS AB1 O.4MGIHR N20145 004 NITRO-DUR KEYPHARMS AB1 0.6MGIHR N20145 005 NITROGLYCERIN HERCONLABS AB2 O;2MGIHR ·N89884 001 NITROGLYCERIN HERCONLABS AB2 O.4MGIHR N89885 001 NITROGLYCERIN HERCONLABS AB2 0.6MGIHR N89886 001 NITROGLYCERIN MYLAN AB2 O.lMGIHR N75033 001 NITROGLYCERIN MYLAN AB2 0.2MG/HR N74609 001 NITROGLYCERIN MYLAN AB2 O.4MGIHR N74607 001
1.4 NDA PATENT 30-MONTH RULE
The Food and Drug Administration has amended its patent submission and listing requirements for new drug applications (NDAs). This final rule became effective on August 18,2003. The final rule, among other things, limits to one per ANDA or 505(b)(2) application the maximum number of statutory 30-month stays of approval to which an innovator will be entitled when multiple patents are submitted for the same NDA.
Patents listed prior to August 18, 2003 will be designated by a "#" sign and are considered listed under the previous regulations that permitted mUltiple 30-month stays for an NDA. Patents listed after the effective date of the final rule will not have the # designation displayed and are considered listed under the new rule.
1.5 A V AlLABlLITY OF THE EDITION
The 23rd Edition of the Orange Book and its monthly cumulative supplements are available by subscription from the Government Printing Office:
Superintendent of Documents Government Printing Office P.O. Box 371954 Pittsburgh, PA 15250-7954
The telephone number to charge your subscription is 202-512-1800 or toll free 866-512-1800. The cost is $108.00 annually. A GPO Orange Book Subscription form is provided at the end of each cumulative supplement.
The Approved Drug Products with Therapeutic Equivalence Evaluation (Orange Book) and related drug information is also available on the Internet at the Food and Drug Administration, Center for Drug Evaluation and Research, Drug Info page.
There is an Electronic Orange Book Query (EOB) at http://www.fda.gov/cder/ob. The Query provides searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. Product search categories are: prescription, over-the-counter, discontinued drugs.
vi There are links to patent and exclusivity information that may be applicable to each product. The data is updated concurrently with the publication of the monthly cumulative supplements.
The Internet version of the Orange Book annual edition is at http://www.fda.gov/cder/orange/adp.htm
The Internet version of the monthly supplement is at http://www.fda.govlcder/orange/supplementlcspreface.htm
There are ASCII text files of the Orange Book drug product data at http://www.fda.gov/cder/orange/obreadme.htm. The drug product text files are zipped into iipobtxt.exe. The files are updated concurrently with the publication of the monthly cumulative supplements. Appendix A and Appendix B are updated quarterly.
The 23rd annual edition of the 2002 Orange Book Patent and Exclusivity List is at http://www.fda.gov/cder.orange/23bookpub.pdf
The current year Patentand Exclusivity cumulative supplement list that denotes the current month additions is at http://www.fda.gov/cder/orange/supplementlpatents.pdf
The Patent Term Extension and new Patents, Docket Number *95S-0 117, is at http://www.fda.gov/cder/orange/docket.pdf.ltis updated monthly as soon as available and as otherwise needed.
The Drug Price Competition and Patent Term Restoration Act requires that'patent information be filed with all newly submitted Section 505 drug applications. To facilitate industry submission of the information, a patent submission sample format is available in HTML and PDF format at: http://www.fda.gov/cder/orange/patdecl.pdf http://www.fda.gov/cder/orange/patdecl.htm
The current listing of the Orphan Product Designations and Approvals is available at http://www.fda.gov/orphan/designatllist.htm
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 (Dec 2002) 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.
vii 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 2002 JUN 2003 SEP 2003 DEC 2003
DRUG PRODUCTS LISTED 10465 10514 10624 10665 SINGLE SOURCE 2420 (23.1%) 2417 (23.0%) 2406(22.7%) 2423(22.7%) MULTI SOURCE 7939 (75.9%) 7989 (76.0%) 8110(76.3%) 8134(76.3%)
THERAPEUTICALLY 7659 (73.2%) 7708 (73.3%) 7830(73.7%) 7856(73.7%) EQUIVALENT NOT THERAPEUTICALLY .280 (2.7%) 281 (2.7%) 280(2.6%) 278(2.6%) EQUIVALENT EXCEPTIONS 106 (1. 0%) 108 (1.0%) 108(1.0%) 108(1.0%)
NEW MOLECULAR ENTITIES 6 6 6 6 APPROVED NUMBER OF APPLICANTS 598 604 602 601
'Amino acid-containing products of varying composition (see Introductio:n. 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 and then by trade name.
The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Approval number, product number, and approval date. 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; route(s), 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 NEW A. 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
viii 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. CARN Applicant holder fIrm name has changed. 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. CMS! Change. Miscellaneous addition to list. CMS2 Change. Miscellaneous deletion from list. CPOT Change. Potency amount/unit. CRLD Change. Reference Listed Drug. CTEC Change. Therapeutic Equivalence Code. CTNA Change, Trade Name. DISC Discontinued. The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition. WDAG Withdrawn. The applicant holder has notifIed the FDA in writing that the product in no longer being marketed resulting in the product approval being withdrawn by mutual agreement. The product will be listed in the Discontinued Section. WDRP Withdrawn. The application approval has been withdrawn for failure to provide Annual Reports. The product will be moved to the Discontinued Section in the next edition.
ix
PRESCRIPTION DRUG PRODUCT LIST - 23RD EDITION RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-1
ABARELIX INJECTABLE; INTRAMUSCULAR PLENAXIS + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE SOLUTION; ORAL ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE + . MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA TABLET; ORAL BUT ALB IT AL , ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA AB VINTAGE PHARMS 325MG;50MGi40MG N40511 001 AUG 27, 2003 AUG NEWA AB 500MG;50MG;40MG N40513 001 AUG 25, 2003 AUG NEWA BUTALBITAL, APAP, AND CAFFEINE AB AXIOM. PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ESGIC-PLUS AB + MIKART 500MG;50MG;40MG N89451 001 MAY 23, 1988 AUG CTNA FIORICET AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL; ACETAMINOPHEN; CAFFEINE AND CODEINE PHOSPHATE . AB ABLE 325MG;50MG;40MG;30MG N76528 001 AUG 21, 2003 AUG NEWA FIORICET WI CODEINE AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN
ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE; ORAL PHENAPHEN WI CODEINE NO. 3 @ ROBINS AH 325MG;30MG N84445 001 JUN DISC PHENAPHEN WI CODEINE NO. 4 @ ROBINS AH 325MG;60MG N84446 001 JUN DISC TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA AA 300MG;30MG N40443 002 JAN 22, 2003 JAN NEWA AA 300MG;60MG N40443 003 JAN 22, 2003 JAN NEWA AA + DURAMED PHARMS BARR 300MG;15MG N40223 001 NOV 18, 1997 AUG CRLD AA RANBAXY 300MG;60MG N87083 001 JAN CAHN ACETAMINOPHEN WI CODEINE PHOSPHATE #3 AA RANBAXY 300MG;30MG N85868 001 JAN CAHN CODRIX + ANDRX PHARMS 500MG;30MG N40441 001 MAR 27, 2003 MAR NEWA + 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA + 500MG;60MG N40488 001 MAR 28, 2003 MAR NEWA TYLENOL WI CODEINE NO. @ ORTHO MCNEIL PHARM 300MG;7.5MG N85055 001 AUG DISC TYLENOL WI CODEINE NO. 2 @ ORTHO MCNEIL PHARM 300MG;15MG N85055 002 AUG DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-2
ACETAMINOPHENj CODEINE PHOSPHATE TABLET; ORAL TYLENOL WI CODEINE NO. 4 @ ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC
ACETAMINOPHENj HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN AA + MALLI NCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC AA + 500MG/15ML;5MG/15ML N89557 001 APR 29, 1992 AUG CTI;C AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA HYDROCODONE BITARTRATE AND ACETAMINOPHEN AA ABLE 500MG;7.5MG N40490 001 MAY 21, 2003 MAY NEWA AA 650MG;7.5MG N40474 001 JAN 02, 2003 JAN NEWA AA ANDRX PHARMS 500MG;5MG N40493 001 MAY 28, 2003 MAY NEWA AA 660MG;10MG N40495 001 MAY 28, 2003 MAY NEWA AA 750MG;7.5MG N40494 001 MAY 28, 2003 MAY NEWA AA AXIOM PHARM 500MG;5MG N40236 001 SEP 25, 1997 MAY CAHN AA 650MG;10MG N40240 001 NOV 26, 1997 MAY CAHN AA 650MG;7.5MG N40240 002 NOV 26, 1997 MAY CAHN AA 750MG;7.5MG N40236 002 SEP 25, 1997 MAY CAHN AA MIKART 325MG;7.5MG N40432 001 JAN 22, 2003 JAN NEWA
ACETAMINOPHENj OXYCODONE HYDROCHLORIDE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN AA AXIOM PHARM 500MG;5MG N40219 001 JAN 22, 1998 MAY CAHN TABLET; ORAL AA WATSON LABS 325MG;7.5MG N40535 001 SEP OS, 2003 SEP NEWA AA 325MG;10MG N40535 002 SEP OS, 2003 SEP NEWA PERCOCET AA + ENDQ PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 SEP CFTG AA + 325MG;10MG N40434 002 NOV 23, 2001 SEP CFTG
ACETAMINOPHENj PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA
ACETAMINOPHENj PROPOXYPHENE NAPSYLATE TABLET; ORAL >A> DARVOCET A500 >A> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA + 500MG;100MG N76429 001 SEP 10, 2003 SEP NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 ~ DEC 2003 1-3
ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX @ DURAMED PHARMS BARR 500MG N12945 001 JUN CAHN + 500MG N12945 003 APR 25, 1995 jUN CAHN TABLET; ORAL AB DURAMED PHARMS BARR 125MG N08943 001 JUN CAHN AB + 250MG N08943 002 JUN CAHN
ACETAZOLAMIDE SODIUM INJECTABLE; INJECTION AP + DURAMED PHARMS BARR EQ 500MG BASE/VIAL N09388 001 DEC OS, 1990 JUN CAHN
ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE SUSPENSION/DROPS; OTIC NEO-CORT-DOME @ BAYER PHARMS 2%;1%;EQ 0.35% BASE N50238 001 JUN DISC
ACYCLOVIR CAPSULE; ORAL ACYCLOVIR AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN TABLET; ORAL @ CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC @ 800MG N74834 002 APR 24, 1997 JUL DISC
ACYCLOVI R SOD IUM INJECTABLE; I~JECTION ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE + BAXTER HLTHCARE EQ 500MG BASE/VIAL N74885 001 DEC 19, 1997 AUG CAHN EQ 1GM BASE/VIAL N74885 002 DEC 19, 1997 AUG CAHN ACYCLOVIR SODIUM AP BAXTER HLTHCARE EQ 500MG BASE/VIAL N74913 001 OCT 15, 1997 AUG CAHN AP EQ 1GM BASE/VIAL N74913 002 OCT 15, 1997 AUG CAHN
ALBUMIN HUMAN INJECTABLE; INJECTION OPTISON + AMERSHAM HLTH 10MG/ML N20899 001 DEC 31, 1997 JUN CAHN
ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA AN NOVEX EQ 0.5% BASE N76391 001 APR 01, 2003 APR NEWA SYRUP; ORAL PROVENTIL @ SCHERING EQ 2MG BASE/5ML N18062 001 JAN 19, 1983 AUG DISC TABLET; ORAL ALBUTEROL SULFATE @ CLONMEL HLTHCARE EQ 2MG BASE N72859 001 DEC 20, 1989 JUN DISC @ EQ 4MG BASE N72860 001 DEC 20, 1989 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-4
AB + MYLAN EQ 2MG BASE N72893 001 JAN 17, 1991 AUG CRLD AB + EQ 4MG BASE N72894 001 JAN 17, 1991 AUG CRLD PROVENTIL iil SCHERING EQ 2MG BASE N17853 001 . MAY 07, 1982 AUG DISC iil EQ 4MG BASE N17853 002 MAY 07, 1982 AUG DISC TABLET, EXTENDED RELEASEi ORAL iil SCHERING EQ 4MG BASE N19383 001 JUL 13, 1987 OCT DISC
ALENDRONATE SODIUM SOLUTI ON; ORAL FOSAMAX + MERCK EQ 70MG ACID/75ML N21575 001 SEP 17, 2003 SEP NEWA
ALFENTANIL HYDROCHLORIDE INJECTABLEi INJECTION ALFENTA AP + AKORN EQ 0.5MG BASE/ML N19353 001 DEC 29, 1986 MAR CAHN
ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASEi ORAL UROXATRAL + SANOFI SYN RES 10MG N21287 001 JUN 12, 2003 JUN NEWA
ALLOPURINOL TABLETi ORAL ALLOPURINOL AB VINTAGE PHARMS 100MG N75798 001 JUN 27, 2003 JUN NEWA AB 300MG N75798 002 JUN 27, 2003 JUN NEWA
ALMOTRIPTAN MALATE TABLETi ORAL AXERT JANSSEN ORTHO EQ 6.25MG BASE N21001 001 MAY 07, 2001 APR CAHN + EQ 12.5MG BASE N21001 002 MAY 07, 2001 APR CAHN
ALOSETRON HYDROCHLORIDE TABLETi ORAL LOTRONEX >A> GLAXOSMITHKLlNE EQ 0.5MG BASE N21107 002 DEC 23, 2003 DEC NEWA
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K INJECTABLEi INJECTION INFUVITE ADULT + SABEX 2002 2 IU/MLi40MG/MLi12UGM/MLi40 IU/MLi 1UGM/MLi3MG/MLi 120UGM/MLi8MG/ MLi1.2MG/MLiO.72MG/MLi1.2MG/MLi660 IU/MLiO.03MG/ML N21163 001 MAY 18, 2000 JUN CPOT INJECTABLEi IV (INFUSION) + SABEX 2002 2 IU/MLi40MG/MLi12UGM/MLi40 IU/MLi1UGM/MLi3MG/MLi120UGM/MLi8MG/ MLi1.2MG/MLiO.72MG/MLi1.2MG/MLi660 RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-5
IU/MLi30UGM/ML N21559 001 JUN 16, 2003 JUN NEWA
ALPHA-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A INJECTABLE; INJECTION CERNEVIT-12 @ BAXTER HLTHCARE 11.2 IU/VIAL;125MG/VIAL;60UGM/VIAL;200 IU/VIAL;5.5MG/VIAL;414UGM/VIAL;46MG /VIAL;17.25MG/VIAL;4.53MG/VIAL;4.14 MG/VIAL;3.51MG/VIAL;3,500 IU/VIAL N20924 001 APR 06, 1999 MAR DISC
ALPRAZOlAM TABLET; ORAL ALPRAZOLAM @ CLONMEL HLTHCARE 0.25MG N74174 001 OCT 19, 1993 JUN DISC @ 0.5MG N74174 002 OCT 19, 1993 JUN DISC @ 1MG N74174 003 OCT 19, 1993 JUN DISC @ 2MG N74174 004 OCT 19, 1993 JUN DISC TABLET, EXTENDED RELEASE; ORAL XANAX XR PHARMACIA AND UPJOHN 0.5MG N21434 001 JAN 17, 2003 JAN NEWA 1MG N21434 002 JAN 17, 2003 JAN NEWA 2MG N21434 003 JAN 17, 2003 JAN NEWA + 3MG N21434 004 JAN 17, 2003 JAN NEWA
ALPROSTADIL INJECTABLE; INJECTION CAVERJECT· @ PHARMACIA AND UP JOHN 0.01MG/ML N20755 002 OCT 01, 1997 OCT DISC AP + 0.02MG/VIAL N20379 002 JUL 06, 1995 OCT CRLD @ 0.02MG/ML N20755 003 OCT 01, 1997 OCT DISC
AMANTADINE HYDROCHLORIDE CAPSULE; ORAL AMANTADINE HCL AB GENEVA PHARMS 100MG N71293 001 FEB· 18, 1987 APR CAHN
AMCINONIDE CREAM; TOPICAL AMCINONIDE AB ALTANA 0.1% N76065 001 MAY 15, 2003 MAY NEWA AB TARO PHARM INDS 0.1% N76229 001. MAY 31, 2002 - MAY CTEC AT 0.1% N76229 001 .MAY 31, 2002 APR NEWA CYCLOCORT AT + FUJISAWA HLTHCARE 0.1% N18116 002 APR CFTG AB + 0.1% N18116 002 MAY CTEC OINTMENT; TOPICAL AMCINONIDE AB TARO PHARM INDS 0.1% N76367 001 MAR 19, 2003 MAR NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2DD3 1-6
AMINO ACIDS INJECTABLE; INJECTION PREMASOL 1D% IN PLASTIC CONTAINER BAXTER HLTHCARE 1D% (1DGM/1DOML) N75880 002 JUN 19, 2003 JUN NEWA PREMASOL 6% IN PLASTIC CONTAINER BAXTER HLTHCARE 6% (6GM/100ML) N75880 001 JUN 19, 2003 JUN NEWA
AMINOCAPROIC ACID INJECTABLE; INJECTION AMINOCAPROIC ACID @ BAXTER HLTHCARE 250MG/ML N18590 001 OCT 29, 1982 AUG CAHN @ ELKINS SINN 250MG/ML N18590 001 OCT 29, 1982 JUN DISC
AMINOPHYLLINE INJECTABLE; INJECTION AMINOPHYLLINE AP + ABBOTT 25MG/ML N87601 001 JUL 23, 1982 JUN CRLD @ ELKINS SINN 25MG/ML N87239 001 JUN DISC TABLET; ORAL >D> @ GENEVA PHARMS 100MG N85261 003 DEC DISC >D> AB 100MG N85262 002 DEC DISC >D> AB 200MG N85261 002 DEC DISC >A> @ SANDOZ 100MG N85261 003 DEC DISC >A> @ 100MG N85262 002 DEC DISC >A> @ 200MG N85261 002 DEC DISC
AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION AMIODARONE HCL AP APOTEX 50MG/ML N76394 001 APR 25, 2003 APR NEWA AP SICOR PHARMS 50MG/ML N76163 001 SEP OS, 2003 SEP NEWA CORD ARONE AP + WYETH PHARMS INC 50MG/ML N20377 001 AUG 03, 1995 MAR CAHN TABLET; ORAL AM I ODARONE HCL AB EON 400MG N75315 002 JUN 30, 2000 SEP CRLD TARO 100MG N75424 002 DEC 18, 2002 SEP CRLD >A> 300MG N76362 002 DEC 02, 2003 DEC NEWA AB + 400MG N76362 001 NOV 29, 2002 SEP CRLD CORD ARONE AB WYETH PHARMS INC 200MG N18972 001 DEC 24, 1985 MAR CAHN
AMITRIPTYLINE HYDROCHLORIDE CONCENTRATE; ORAL ENDEP @ ROCHE 40MG/ML N85749 001 JUN DISC
AMITRIPTYLI.NE HYDROCHLORIDE, PERPHENAZINE TABLET; ORAL ETRAFON 2-10 @ SCHERING 10MG;2MG N14713 007 MAR DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-7
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE TABLET; ORAL ETRAFON 2-25 @ SCHERING 25MG;2MG N14713 004 MAR DISC ETRAFON-FORTE @ SCHERING 25MG;4MG N14713 006 MAR DISC
AMLEXANOX PASTE; DENTAL APHTHASOL + ACCESS PHARMS 5;' N20511 001 DEC 17, 1996 JUL CAHN
AMLODIPINE MALEATE TABLET; ORAL AMVAZ DR REDDYS LABS INC 2.5MG N21435 001 OCT 31, 2003 OCT NEWA 5MG N21435 002 OCT 31, 2003 OCT NEWA + 10MG N21435 003 OCT 31, 2003 OCT NEWA
AMMONIUM LACTATE CREAM; TOPICAL AMMONIUM LACTATE AB TARO EQ 12% BASE N75883 001 APR 10, 2003 APR NEWA
AMOXICI LLiN FOR SUSPENSION; ORAL AMOXIL AB GLAXOSMITHKLlNE 50MG/ML N62226 005 JUL CRLD WYMOX @ WYETH AYERST 125MG/5ML N62131 001 JUN DISC @ 250MG/5ML N62131 002 JUN DISC TABLET, FOR SUSPENSION; ORAL DISPERMOX RANBAXY 200MG N65080 002 AUG 11, 2003 AUG NEWA + 400MG N65080 001 AUG 11, 2003 AUG NEWA >A> + 600MG N65159 001 DEC 04, 2003 DEC NEWA
AMOXICILLINj CLARITHROMYCINj LANSOPRAZOLE CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL PREVPAC + TAP PHARM 500MG;500MG;30MG N50757 001 DEC 02, 1997 MAY CDFR
AMOXICILLINj CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM AB RANBAXY 200MG/5ML;EQ 28.5MG BASE/5ML N65132 001 MAR 19, 2003 MAR NEWA AB 400MG/5ML;EQ 57MG BASE/5ML N65132 002 MAR 19, 2003 MAR NEWA TABLET, CHEWABLE; ORAL >A> AB RANBAXY 200MG;EQ 28.5MG BASE N65161 001 DEC 03, 2003 DEC NEWA >A> AB 400MG;EQ 57MG BASE N65161 002 DEC 03, 2003 DEC NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-8
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL ADDERALL XR 10 SHIRE LABS 2.5MG;2.5MG;2.5MG;2.5MG N21303 001 OCT 11, 2001 JAN CAHN ADDERALL XR 15 SHIRE LABS 3.75MG;3.75MGi3.75MG;3.75MG N21303 006 MAY 22, 2002 JAN CAHN ADDERALL XR 20 SHIRE LABS 5MG;5MG;5MGi5MG N21303 002 OCT 11, 2001 JAN CAHN ADDERALL XR 25 SHIRE LABS 6.25MG;6.25MG;6.25MG;6.25MG N21303 004 MAY 22, 2002 JAN CAHN ADDERALL XR 30 + SHIRE LABS 7.5MG;7.5MG;7.5MG;7.5MG N21303 003 OCT 11, 2001 JAN CAHN ADDERALL XR 5 SHIRE LABS 1.25MG;1.25MG:1.25MG:1.25MG N21303 005 MAY 22, 2002 JAN CAHN TABLET: ORAL ADDERALL 12.5 AB SHIRE LABS 3.125MG:3.125MG:3.125MG:3.125MG N11522 012 AUG 31, 2000 MAR CFTG ADDERALL 15 AB SHIRE LABS 3.75MG:3.75MG:3.75MG:3.75MG N11522 013 AUG 31, 2000 MAR CFTG ADDERALL 7.5 AB SHIRE LABS 1.875MG: 1.875MG; 1.875MG; 1.875MG N11522 011 AUG 31, 2000 MAR CFTG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE AB ABRIKA PHARMS 1.25MG;1.25MG:1.25MG;1.25MG N40472 001 SEP 30, 2003 SEP NEWA AB 2.5MG;2.5MG:2.5MG:2.5MG N40472 002 SEP 30, 2003 SEP NEWA AB 5MG:5MG:5MG:5MG N40472 003 SEP 30, 2003 SEP NEWA AB 7.5MG;7.5MG:7.5MG;7.5MG N40472 004 SEP 30, 2003 SEP NEWA AB BARR 1.875MG:1.875MG;1.875MG;1.875MG N40422 005 MAR 19, 2003 MAR NEWA AB 3.125MG;3.125MG;3.125MG;3.125MG N40422 006 MAR 19, 2003 MAR NEWA AB 3.75MG;3.75MG:3.75MG;3.75MG N40422 007 MAR 19, 2003 MAR NEWA AB MALLI NCKRODT 1.25MG:1.25MG:1.25MG;1.25MG N40440 001 OCT 07, 2003 OCT NEWA AB 1.875MG:1.875MG;1.875MG;1.875MG N40440 002 OCT 07, 2003 OCT NEWA AB 2.5MG;2.5MG;2.5MG;2.5MG N40440 003 OCT 07, 2003 OCT NEWA AB 3. 125MG:3. 125MG; 3. 125MG:3. 125MG N40440 004 OCT 07, 2003 OCT NEWA AB 3.75MG;3.75MG:3.75MG;3.75MG N40440 005 OCT 07, 2003 OCT NEWA AB 5MG:5MG:5MG:5MG N40440 006 OCT 07, 2003 OCT NEWA AB 7.5MG:7.5MG;7.5MG:7.5MG N40440 007 OCT 07, 2003 OCT NEWA AB MUTUAL PHARM 1.25MG:1.25MG:1.25MG:1.25MG N40480 001 SEP 09, 2003 SEP NEWA AB 1.875MG:1.875MG;1.875MG;1.875MG. N40480 002 SEP 09, 2003 SEP NEWA AB 2.5MG;2.5MG:2.5MG:2.5MG N40480 003 SE'P 09, 2003 SEP NEWA AB 3.125MG;3.125MG;3.125MG:3.125MG N40480 004 SEP 09, 2003 SEP NEWA AB 3.75MG:3.75MG:3.75MG;3.75MG N40480 005 SEP 09, 2003 SEP NEWA AB 5MG:5MG:5MG;5MG N40480 006 SEP 09, 2003 SEP NEWA AB 7.5MG;7.5MGi7.5MGi7.5MG N40480 007 SEP 09~ 2003 SEP NEWA' AB WATSON LABS 1.25MGi1.25MGi1.25MGi1.25MG N40456 001 MAY 06, 2003 MAY NEWA AB 2.5MGi2.5MGi2.5MGi2.5MG N40456 002 MAY 06, 2003 MAY NEWA AB 5MGi5MGi5MG;5MG N40456 003 MAY 06, 2003 MAY NEWA AB 7.5MG:7.5MGi7.5MGi7.5MG N40456 004 MAY 06, 2003 MAY NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-9
AMPICILLIN SODIUM INJECTABLE; INJECTION AMPICILLIN SODIUM >D> AP APOTHECON EQ 125MG BASE/VIAL N61395 001 DEC CRLD >A> AP + EQ 125MG BASE/VIAL N61395 001 DEC CRLD EQ 125MG BASE/VIAL N62860 001 FEB 05, 1988 OCT WDAG >D> AP EQ 250MG BASE/VIAL N61395 002 DEC CRLD >A> AP + EQ 250MG BASE/VIAL N61395 002 DEC CRLD @ EQ 250MG BASE/VIAL N62860 002 FEB 05, 1988 OCT WDAG >D> AP EQ 500MG BASE/VIAL N61395 003 DEC CRLD >A> AP + EQ 500MG BASE/VIAL N61395 003 DEC CRLD EQ 500MG BASE/VIAL N62860 003 FEB 05, 1988 OCT WDAG >D> AP EQ 1GM BASE/VIAL N61395 004 DEC CRLD >A> AP + EQ 1GM BASE/VIAL N61395 004 DEC CRLD EQ 1GM BASE/VIAL N62B60 004 FEB 05, 1988 OCT WDAG >D> AP EQ 2GM BASE/VIAL N61395 005 DEC CRLD >A> AP + EQ 2GM BASE/VIAL N61395 005 DEC CRLD EQ 2GM BASE/VIAL N62860 005 FEB 05, 1988 OCT WDAG >D> AP EQ 10GM BASE/VIAL N61395 006 DEC CRLD >A> AP + EQ 10GM BASE/VIAL N61395 006 DEC CRLD @ BAXTER HLTHCARE EQ 125MG BASE/VIAL N62692 001 JUN 24, 1986 AUG CAHN @ EQ 250MG BASE/VIAL N62692 002 JUN 24, 1986 AUG CAHN @ EQ 500MG BASE/VIAL N62692 003 JUN 24, 1986 AUG CAHN @ EQ 1GM BASE/VIAL N62692 004 JUN 24, 1986 AUG CAHN @ EQ 2GM BASE/VIAL N62692 005 JUN 24, 1986 AUG CAHN @ EQ 10GM BASE/VIAL N62692 006 JUN 24, 1986 AUG CAHN >D> AP MARSAM PHARMS LLC EQ 125MG BASE/VIAL N62816 001 OCT 24, 1988 DEC DISC >A> @ EQ 125MG BASE/VIAL . N62816 001 OCT 24, 1988 DEC DISC >D> AP EQ 250MG BASE/VIAL N62816 002 OCT 24, 1988 DEC DISC >A> EQ 250MG BASE/VIAL N62816 002 OCT 24, 1988 DEC DISC >D> AP EQ 500MG BASE/VIAL N62816 003 OCT 24, 1988 DEC DISC >A> EQ 500MG BASE/VIAL N62816 003 OCT 24, 1988 DEC DISC >0> AP EQ 1GM BASE/VIAL N62816 004 OCT 24, 1988 DEC DISC >A> EQ 1GM BASE/VIAL N62816 004 OCT 24, 1988 DEC DISC >0> AP EQ 2GM BASE/VIAL N62816 005 OCT 24, 1988 DEC DISC >A> @ EQ 2GM BASE/VIAL N62816 005 OCT 24, 1988 DEC DISC OMNIPEN-N @ WYETH AYERST EQ 125MG BASE/VIAL N60626 001 JUN. DISC @ EQ 250MG BASE/VIAL N60626 002 JUN DISC @ EQ 500MG BASE/VIAL N60626 003 JUN DISC @ EQ 1GM BASE/VIAL N60626 004 JUN DISC @ EQ 2GM BASE/VIAL N60626 005 JUN DISC >0> TOTACILLIN-N >0> AP + GLAXOSMITHKLINE EQ 125MG BASE/VIAL N60677 001 DEC DISC >A> @ EQ 125MG BASE/VIAL N60677 001 DEC DISC AP + EQ 125MG BASE/VIAL N60677 001 JUN CRLD >0> AP + EQ 250MG BASE/VIAL N60677 002 DEC DISC >A> @ EQ 250MG BASE/VIAL N60677 002 DEC DISC AP + EQ 250MG BASE/VIAL N60677 002 JUN CRLD >0> AP + EQ 500MG BASE/VIAL N60677 003 DEC DISC >A> @ EQ 500MG BASE/VIAL N60677 003 DEC DISC AP + EQ 500MG BASE/VIAL N60677 003 JUN CRLD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-10
>0> AP + EQ 1GM BASE/VIAL N60677 004 DEC DISC >A> @ EQ 1GM BASE/VIAL N60677 004 DEC DISC AP + EQ 1GM BASE/VIAL N60677 004 JUN CRLD >0> AP + EQ 2GM BASE/VIAL N60677 005 DEC DISC >A> @ EQ 2GM BASE/VIAL N60677 005 DEC DISC AP + EQ 2GM BASE/VIAL N60677 005 JUN CRLD >0> EQ 10GM BASE/VIAL N60677 006 DEC DISC >A> @ EQ 10GM BASE/VIAL N60677 006 DEC DISC
AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE; ORAL OMNIPEN (AMPICILLIN) @ WYETH AYERST 250MG N60624 001 JUN DISC @ 500MG N60624 002 JUN DISC FOR SUSPENSION; .ORAL @ WYETH AYERST 100MG/ML N60625 001 JUN DISC @ 125MG/5ML N60625 002 JUN DISC @ 250MG/5ML N60625 003 JUN DISC PRINCIPEN APOTHECON EQ 100MG BASE/ML N61394 001 JUN CTEC
AMPRENAVIR CAPSULE; ORAL AGENERASE GLAXOSMITHKLlNE 50MG N21007 001 APR 15, 1999 MAR CMFD + 150MG N21007 002 APR 15, 1999 MAR CMFD SOLUTION; ORAL + GLAXOSM ITHKLI NE 15MG/ML N21039 001 APR 15, 1999 MAR CMFD
APREPITANT CAPSULE; ORAL EMEND MERCK 80MG N21549 001 MAR 26, 2003 MAR NEWA + 125MG N21549 002 MAR 26, 2003 MAR NEWA
ARGATROBAN INJECTABLE; INJECTION ARGATROBAN + ENCYSIVE 100MG/ML N20883 001 JUN 30, 2000 JUN CAHN
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E INJECTABLE; INJECTION M.V.I.-12 + AAIPHARMA 10MG/ML;0.006MG/ML;0.5UGM/ML;1.5MG/. ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.3 6MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML N08809 004 AUG 08, 1985 JUN CTEC RX DRUG PRODUCT LIST· CUMULATIVE SUPPLEMENT 12 . DEC 2003 1·11
ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE; ORAL ~IORINAL AB + WATSON PHARMS 325MG;50MG;40MG N17534 005 APR 16, 1986 MAR CAHN TABLET; ORAL AB + WATSON PHA~MS 325MG;50MG;40MG N17534 003 APR 16, 1986 MAR CAHN
ASPIRIN; BUTALBITALj CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORINAL W/CODEINE NO 3 AB + WATSON PHARMS 325MG;50MG;40MG;30MG N19429 003 OCT 26, 1990 MAR CAHN
ASPIRIN; MEPROBAMATE TABLET; ORAL EQUAGESIC + WOMEN FIRST HLTHCARE 325MG;200MG N11702 003 DEC 29, 1983 JUN CTEC MICRAININ @ MEDPOINTE PHARM HLC 325MG;200MG N84978 001 JUN DISC
ASPIRIN; METHOCARBAMOL TABLET; ORAL METHOCARBAMOL AND ASPIRIN AB + IVAX PHARMS 325MG;400MG N87211 001 DEC 22, 1982 JUN CRLD ROBAXISAL @ ROBINS AH 325MG;400MG N12281 001 JUN DISC
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET; ORAL OXYCODONE AND ASPIRIN AA AXIOM PHARM 325MG;4.5MG;0.38MG N40260 001 JUL 17, 1998 MAY CAHN
ASPIRIN; PRAVASTATIN SODIUM TABLET; ORAL PRAVIGARD PAC (COPACKAGED) BRISTOL MYERS SQUIBB 81MG;20MG N21387 001 JUN 24, 2003 JUN NEWA 81MG;40MG N21387 002 JUN 24, 2003 JUN NEWA 81MG;80MG N21387 003 JUN 24, 2003 JUN NEWA 325MG;20MG N21387 004 JUN 24, 2003 JUN NEWA 325MG;40MG N21387 005 JUN 24, 2003 JUN NEWA + 325MG;80MG N21387 006 JUN 24, 2003 JUN NEWA
ASPIRIN; PROPOXYPHENE HYDROCHLORIDE CAPSULE; ORAL DAR VON WI ASA @ AAIPHARMA LLC 325MG;65MG N10996 005 JUL DISC
ATAZANAVIR SULFATE CAPSULE; ORAL REYATAZ BRISTOL MYERS SQUIBB EQ 100MG BASE N21567 001 JUN 20, 2003 JUN NEWA EQ 150MG BASE N21567 002 JUN 20, 2003 JUN NEWA + EQ 200MG BASE N21567 003 JUN 20, 2003 JUN· NEWA ,. / RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-12
ATOMOXETINE HYDROCHLORIDE CAPSULE; ORAL STRATTERA @ LI LLY 5MG N21411 001 NOV 26, 2002 MAY DISC
ATROPINE INJECTABLE; INJECTION ATROPEN + MERIDIAN MEDCL TECHN EQ 0.5MG SULFATE/O.7ML N17106 003 JUN 19, 2003 JUL NEWA + EQ 1MG SULFATE/0.7ML N17106 002 JUN 19, 2003 JUL NEWA
ATROPINE SULFATEj MEPERIDINE HYDROCHLORIDE INJECTABLE; INJECTION ATROPINE AND DEMEROL @ ABBOTT 0.4MG/ML;75MG/ML N87847 001 NOV 26, 1982 OCT WDAG @ 0.4MG/ML;100MG/ML N87848 001 NOV 26, 1982 OCT WDAG @ 0.4MG/ML;50MG/ML N87853 001 NOV 26, 1982 OCT WDAG
AZATHIOPRINE TABLET; ORAL AZASAN AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA AB 50MG N75252 001 JUN 07, 1999 FEB NEWA 75MG N75252 003 FEB 03, 2003 FEB NEWA 100MG N75252 004 FEB 03, 2003 FEB NEWA
AZELASTINE HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC OPTIVAR + MEDPOINTE 0.05% N21127 001 MAY 22, 2000 APR CAHN
AZITHROMYCIN TABLET; ORAL ZITHROMAX PFIZER EQ 500MG BASE N50784 001 MAY 24; 2002 AUG CRLD
BACLOFEN TABLET; ORAL BACLOFEN >D> AB IVAX PHARMS 20MG N72235 001 JUL 21, 1988 DEC CRLD >A> AB + 20MG N72235 001 JUL 21, 1988 DEC CRLD >D> AB WATSON LABS 10MG N74698 001 AUG 20, 1996 DEC DISC >A> @ 10MG N74698 001 AUG 20, 1996 DEC DISC >D> AB + 20MG N73093 001 JAN 28, 1994 DEC DISC >A> @ 20MG N73093 001 JAN 28, 1994 DEC DISC >D> AB 20MG N74698 002 AUG 20, 1996 DEC DISC >A> @ 20MG N74698 002 AUG 20, 1996 DEC DISC TABLET, ORALLY DISINTEGRATING; ORAL SCHWARZ PHARMA 10MG N21589 001 OCT 30, 2003 OCT NEWA + 20MG N21589 002 OCT 30, 2003 OCT NEWA KEMSTRO SCHWARZ PHARMA 10MG N21~89 001 OCT 30, 2003 NOV CTNA RX DRUG PRODUCT LIST- CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-13
+ 20MG N21589 002 OCT 30, 2003 NOV CTNA
BECLOMETHASONE DIPROPIONATE AEROSOL, METERED; INHALATION BECLOVENT @ GLAXOSMITHKLINE o• 042MG/I NH N18153 001 MAR DISC AEROSOL, METERED; NASAL BECONASE @ GLAXOSMITHKLINE o. 042MG/I NH N18584 001 MAR DISC VANCENASE @SCHERING O. 042MG/I NH N18521 001 MAR DISC
BENZYL PENICILLOYL-POLYLYSINE INJECTABLE; INJECTION PRE-PEN + HOLLISTER STIER LABS 60UMOLAR N50114 001 JUL CAHN
BEPRIDIL HYDROCHLORIDE TABLET; ORAL VASCOR + ORTHO MCNEIL PHARM 200MG N19002 001 DEC 28, 1990 NOV CRLD @ 300MG N19002 002 DEC 28, 1990 NOV DISC
BETAMETHASONE TABLET; ORAL CELESTONE @ SCHERING 0.6MG N12657 003 FEB DISC
BETAMETHASONE DIPROPIONATE CREAM; TOPICAL ALPHATREX AB + SAVAGE LABS EQ 0.05% BASE N19138 001 JUN 26, 1984 MAY CRLD DIPROSONE @ SCHERING EQ 0.05% BASE N17536 001 MAY DISC CREAM, AUGMENTED; TOPICAL >A> BETAMETHASONE DIPROPIONATE >A> AB ALTANA EQ 0.05% BASE N76215 001 D~C 09, 2003 DEC NEWA >A> AB CLAY PARK EQ 0.05% BASE N76592 001 DEC 09; 2003 DEC NEWA >A> AB TARO EQ 0.05% BASE N76543 001 DEC 09, 2003 DEC NEWA DIPROLENE AF >D> + SCHERING EQ 0.05% BASE N19555 001 APR 27, 1987 DEC CFTG >A> AB + EQ 0.05% BASE N19555 001 APR 27, 1987 cDEC CFTG GEL, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE AB ALTANA EQ 0.05% BASE N75276 001 MAY 13, 2003 MAY NEWA >A> AB TARO EQ 0.05% BASE N76508 001 DEC 02, 2003 DEC NEWA DIPROLENE AB + SCHERING EQ 0.05% BASE N19408 002 NOV 22, 1991 MAY CFTG
BETHANECHOL CHLORIDE TABLET; ORAL . BETHANECHOL CHLORIDE AA WOCKHARDT 5MG N40532 001 SEP 29, 2003 SEP NEWA RX DRUG PRODUCT LIST • CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-14
AA 10MG N40533 001 SEP 29, 2003 SEP NEWA AA 25MG N40534 001 SEP 29, 2003 SEP NEWA AA 50MG N40518 001 SEP 29, 2003 SEP NEWA URECHOLINE AA + ODYSSEY PHARMS 5MG N89095 001 DEC 19, 1985 SEP CFTG AA + 10MG N88440 001 MAY 29, 1984 SEP CFTG AA + 25MG· N88441 001 MAY 29, 1984 SEP CFTG AA + 50MG N89096 001 DEC 19, 1985 SEP CFTG
BISOPROLOL FUMARATE TABLET; ORAL ZEBETA AB DURAMED PHARMS BARR 5MG N19982 002 JUL 31, 1992 JUN CAHN AB + 10MG N19982 001 JUL 31, 1992 JUN CAHN AB WYETH PHARMS INC 5MG N19982 002 JUL 31, 1992· MAR CAHN AB + 10MG N19982 001 JUL 31, 1992 MAR CAHN
BISOPROLOL FUMARATEj HYDROCHLOROTHIAZIDE TABLET; ORAL ZIAC AB DURAMED PHARMS BARR 2.5MG;6.25MG N20186 003 MAR 26, 1993 JUN CAHN AB 5MG;6.25MG N20186 001 MAR 26, 1993 JUN CAHN AB + 10MG;6.25MG N20186 002 MAR 26, 1993 JUN CAHN AB WYETH PHARMS INC 2.5MG;6.25MG N20186 003 MAR 26, 1993 MAR CAHN AB 5MG;6.25MG N20186 001 MAR 26, 1993 MAR CAHN AB + 10MG;6.25MG N20186 002 MAR .26, 1993 MAR CAHN
BIVAlIRUDIN INJECTABLE; INTRAVENOUS ANGIOMAX + MEDICINES CO 250MG/VIAL N20873 001 DEC 15, 2000 OCT CAHN
BLEOMYCIN SULFATE INJECTABLE; INJECTION BLEOMYCIN SULFATE AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N64084 001 JUN 01, 1996 AUG CAHN AP EQ 30 UNITS BASE/VIAL N64084 002 JUN 01, 1996 AUG CAHN
BORTEZOMIB INJECTABLE; INTRAVENOUS VELCADE + MILLENNIUM PHARMS 3.5MG/VIAL N21602 001 MAY 13, 2003 MAY NEWA
BRETYLIUM TOSYLATE INJECTABLE; INJECTION BRETYLJUM TOSYLATE @ BAXTER HLTHCARE 50MG/ML N70545 001 MAY 14, 1986 AUG CAHN @ 50MG/ML N70546 001 MAY 14, 1986 AUG CAHN @ ELKINS SINN 50MG/ML N70545 001 MAY 14, 1986 JUN DISC @ 50MG/ML N70546 001 MAY 14, 1986 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-15
BRIMONIDINE TARTRATE SOLUTION/DROPS; OPHTHALMIC BRIMONIDINE TARTRATE AT . ALCON 0.2% N76254" 001 SEP 16, 2003 SEP NEWA AT + BAUSCH AND LOMB 0.2% N76260 001 MAY 28, 2003 SEP CFTG + 0.2% N76260 001 MAY 28, 2003 MAY NEWA
BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLPROPANOLAMINE HYDROCHLORIDE SYRUP; ORAL BROMANATE DC @ ALPHARMA 2MG/5ML; 10MG/5ML; 12.5MG/5ML N88723 001 FEB 25, 1985 NOV DISC
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUPi ORAL DIMETANE-DX @ ROBINS AH 2MG/5MLi10MG/5MLi30MG/5ML N19279 001 AUG 24, 1984 MAR DISC MYPHETANE DX AA + MORTON GROVE 2MG/5MLi10MG/5MLi30MG/5ML N88811 001 JUN 07, 1985 MAR CTEC
BUDESONIDE AEROSOL, METEREDi NASAL RHINOCORT @ ASTRAZENECA 0.032MG/INH N20233 001 FEB 14, 1994 SEP DISC
BUPIVACAINE HYDROCHLORIDEj LIDOCAINE HYDROCHLORIDE INJECTABLEi INJECTION DUOCAINE + AMPHASTAR 0.375% (37.5MG/10ML)i1% (1 OOMG/1 OML) N21496 001 MAY 23, 2003 MAY NEWA
BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASEi ORAL BUPROPRION HCL AB EON 100MG N75932 001 NOV 25, 2003 NOV NEWA WELLBUTRIN SR AB GLAXOSMITHKLINE 100MG N20358 002. OCT 04, 1996 NOV CFTG + 150MG N20358 003 OCT 04, 1996 OCT C:RLD 200MG N20358 004 JUN 14, 2002 OCT CRLD WELLBUTRIN XL >D> SMITHKLINE BEECHAM 150MG N21515 001 AUG 28, 2003 DEC CRLD >A> + 150MG N21515 001 AUG 28, 2003 DEC: CRLD ~EWA 150MG N21515 001 .AUG 28, 2003.. AU!> >D> + 300MG N21515 002 AUG 28, 2003 DEC CRLD >A> 300MG N21515 002 AUG 28, 2003., " DEC CRLD + 300MG 1-12;515 002 AUG 28, 2003 AUG NEWA
BUSPIRONE HYDROCHLORIDE TABLEt; ORAL BUSPIRONE HCL AB EGIS 15MG N75119 003 JAN 23, 2003 JAN NEWA RX DRUG PRODUCT 'LIST " CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-16
BUSULFAN INJECTABLE; INJECTION BUSULFEX + ESP PHARMA 6MG/ML N20954 001 FEB 04, 1999 JUN CAHN
CAFFEINE CITRATE SOLUTION; INTRAVENOUS, ORAL CAFCIT + MEAD JOHNSON EQ 10MG BASE/ML N20793 001 SEP 21, 1999 JUN CAHN
CALCITRIOL INJECTABLE; INJECTION CALCITRIOL AP AAIPHARMA 0.001MG/ML N75766 001 FEB 20, 2003 FEB NEWA AP 0.002MG/ML N75766 002 FEB 20, 2003 FEB NEWA AP GENSIA SICOR PHARMS 0.OO1MG/ML N75823 001 MAR 31, ,2003 MAR NEWA AP 0.002MG/ML N75823 002 MAR 31, 2003 MAR NEWA AP LUITPOLD 0.001MG/ML N75746 001 SEP 26, 2003 SEP NEWA AP 0.002MG/ML N75746 002 SEP 26, 2003 SEP NEWA AP LYNE 0.001MG/ML N76206 001 SEP 17, 2003 SEP NEWA SOLUTION; ORAL AA ROXANE 1UGM/ML N76242 001 JUL 18, 2003 JUL NEWA ROCALTROL AA + ROCHE 1UGM/ML N21068 001 NOV 20, 1998 JUL CFTG
CALCIUM ACETATE CAPSULE; ORAL PHOSLO @ NABI EQ 84.5MG CALCIUM N21160 001 APR 02, 2001 AUG CAHN @ EQ 169MG CALCIUM N21160 002 APR 02, 2001 AUG CAHN PHOSLO GELCAPS + NABI EQ 169MG CALCIUM N21160 003 APR 02, 2001 AUG CAHN TABLET; ORAL PHOSLO + NABI EQ 169MG CALCIUM N19976 001 DEC 10, 1990 AUG CAHN
CALCIUM CHLORIDE; ,DEXTROSEj MAGNESIUM SULFATEj POTASSIUM CHLORIDE; SODIUM BICARBONATEj SODIUM CHLORIDEj SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INJECTABLE; INTRATHECAL ELLIOTTS B SOLUTION + QOL MEDCL 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML ;1.9MG/ML;7.3MG/ML;0.2MG/ML N20577 001 SEP 27,1996 MAY CAHN
CARBAMAZEPINE TABLET; ORAL TERIL AB TARO 200MG N76525 001 SEP 26, 2003 SEP NEWA
CARBIDOPAj ENTACAPONEj LEVODOPA TABLET: ORAL STALEVO 100 ORION PHARMA INC 25MG:200MG;100MG N21485 002 JUN 11, 2003 JUN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-17
CARBIDOPA; ENTACAPONE; LEVODOPA TABLET; ORAL STALEVO 150 + ORION PHARMA INC 37.5MG;200MG;150MG N21485 003 JUN 11, 2003 JUN NEWA STALEVO 50 ORION PHARMA INC 12.5MG;200MG;50MG N21485 001 JUN 11, 2003 JUN NEWA
CARBINOXAMINE MALEATE SOLUTION; ORAL CARBINOXAMINE MALEATE + MIKART 4MG/5ML N40458 001 APR 25, 2003 APR NEWA TABLET; ORAL + MIKART 4MG N40442 001 MAR 19, 2003 MAR NEWA
CARBOPLATIN INJECTABLE; IV (INFUSION) PARAPLATIN + BRISTOL MYERS SQUIBB EQ 50MG /5ML(10MG/ML) N20452 001 JUL 14, 2003 JUL NEWA + EQ 150MG /15ML(10MG/ML) N20452 002 JUL 14, 2003 JUL NEWA + EQ 450MG /45ML(10MG/ML) N20452 003 JUL 14, 2003 JUL NEWA
CARVEDILOL TABLET; ORAL COREG + GLAXOSMITHKLlNE 12.5MG N20297 002 SEP 14, 1995 APR CRLD 25MG N20297 001 SEP 14, 1995 APR CRLD
CEFACLOR CAPSULE; ORAL CEFACLOR AB CEPH INTL EQ 250MG BASE N62205 001 OCT CTNA AB EQ 500MG BASE N62205 002 OCT CTNA >A> TABLET, CHEWABLE; ORAL >A> RANICLOR >A> RANBAXY EQ 125MG BASE N65092 001 DEC 22, 2003 DEC NEWA >A> EQ 187MG BASE N65092 002 DEC 22, 2003 DEC NEWA >A> EQ 250MG BASE N65092 003 DEC 22, 2003 DEC NEWA >A> + EQ 375MG BASE N65092 004 DEC 22, 2003 DEC NEWA
CEFADROXIL/CEFADROXIL HEMIHYDRATE CAPSULE; ORAL CEFADROXIL AB RANBAXY EQ 500MG BASE N65015 001 JUN 22, 1999 OCT CAHN FOR SUSPENSION; ORAL AB RANBAXY EQ 125MG BASE/5ML N65115 001 MAR 26, 2003 MAR NEWA AB EQ 250MG BASE/5ML N65115 002 MAR 26, 2003 MAR NEWA AB EQ 500MG BASE/5ML N65115 003 MAR 26, 2003 MAR NEWA DURICEF AB WARNER CHILCOTT EQ 125MG BASE/5ML N50527 002 MAR CFTG AB EQ 250MG BASE/5ML N50527 003 MAR CFTG AB + EQ 500MG BASE/5ML N50527 001 MAR CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-18
CEFAZOLIN SODIUM INJECTABLE; INJECTION CEFAZOLIN SODIUM AP HIKMA FARMACEUTICA EQ 500MG BASE/VIAL N65047 001 SEP 18, 2001 OCT CAHN AP EQ 1GM BASE/VIAL N65047 002 SEP 18, 2001 OCT CAHN
CEFDITOREN PIVOXIL TABLET; ORAL SPECTRACEF + PURDUE PHARMA LP 200MG N21222 001 AUG 29, 2001 MAY CAHN
CEFIXIME FOR SUSPENSION; ORAL SUPRAX @ LEDERLE 100MG/5ML N50622 001 APR 28, 1989 APR DISC TABLET; ORAL @ LEDERLE 200MG N50621 001 APR 28, 1989 APR DISC @ 400MG N50621 002 APR 28, 1989 APR DISC
CEFOTAXIME SODIUM INJECTABLE; INJECTION CEFOTAXIME SODIUM AP LUPIN EQ 500MG BASE/VIAL N65124 001 SEP 24, 2003 SEP NEWA AP EQ 1GM BASE/VIAL N65124 002 SEP 24, 2003 SEP NEWA AP EQ 2GM BASE/VIAL N65124 003 SEP 24, 2003 SEP NEWA CLAFORAN AP AVENTI S PHARMS EQ 1GM BASE/VIAL N62659 001 JAN 13, 1987 SEP CTEC AP EQ·2GM BASE/VIAL N62659 002 JAN 13, 1987 SEP CTEC >0> CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER >0> + AVENTI S PHARMS EQ 20MG BASE/ML N50596 001 MAY 20, 1985 DEC DISC >A> @ EQ 20MG BASE/ML N50596 001 MAY 20, 1985 DEC DISC >0> + EQ 40MG BASE/ML N50596 003 MAY 20, 1985 DEC DISC >A> @ EQ 40MG BASE/ML N50596 003 MAY 20, 1985 DEC DISC
CEFOXITIN SODIUM INJECTABLE; INJECTION CEFOXITIN AP BAXTER HLTHCARE EQ 10GM BASE/VIAL N65050 001 SEP 11, 2000 AUG CAHN MEFOXIN IN PLASTIC CONTAINER + MERCK EQ 20MG BASE/ML N63182 001 JAN 25, 1993 MAR CRLD + EQ 40MG BASE/ML N63182 002 JAN 25, 1993· MAR CRLD
CEFPODOXIME PROXETIL TABLET; ORAL CEFPODOXIME PROXETIL AB RANBAXY EQ 100MG BASE N65083 001 AUG 20, 2003 AUG NEWA AB EQ 200MG BASE N65083 002 AUG 20, 2003 AUG NEWA VANTIN AB PHARMACIA AND UPJOHN EQ 100MG BASE N50674 001 AUG 07, 1992 AUG CFTG AB + EQ 200MG BASE N50674 002 AUG 07, 1992 AUG CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-19
CEFTIZOXIME SODIUM INJECTABLE; INJECTION CEFIZOX FUJISAWA HLTHCARE EQ 1GM BASE/VIAL N63294 002 MAR 31, 1994 AUG CAHN EQ 2GM BASE/VIAL N63294 003 MAR 31, 1994 AUG CAHN
CEFTRIAXONE SODIUM INJECTABLE; 1M-IV CEFTRIAXONE AP LUPIN EQ 250MG BASE/VIAL N65125 001 SEP 30, 2003 SEP NEWA AP EQ 500MG BASE/VIAL N65125 002 SEP 30, 2003 SEP NEWA AP EQ 1GM BASE/VIAL N65125 003 SEP 30, 2003 SEP NEWA AP EQ 2GM BASE/VIAL N65125 004 SEP 30, 2003 SEP NEWA ROCEPHIN AP + HLR EQ 250MG BASE/VIAL N50585 001 DEC 21, 1984 SEP CFTG AP + EQ 500MG BASE/VIAL N50585 002 DEC 21, 1984 SEP CFTG AP + EQ 1GM BASE/VIAL N50585 003 DEC 21, 1984 SEP CFTG AP + EQ 2GM BASE/VIAL N50585 004 DEC 21, 1984 SEP CFTG
CEFUROXIME AXETIL TABLET; ORAL CEFUROXIME AXETIL AB BIOCHEMIE US EQ 250MG BASE N65126 001 OCT 28, ?003 OCT NEWA AB EQ 500MG BASE N65126 002 OCT 28, 2003 OCT NEWA AB LUPIN EQ 250MG BASE N65135 001 JUL 25, 2003 JUL NEWA AB EQ 500MG BASE N65135 002 JUL 25, 2003 JUL NEWA AB RANBAXY EQ 125MG BASE N65118 001 APR 25, 2003 APR NEWA AB EQ 250MG BASE N65118 002 APR 25, 2003 APR NEWA AB EQ 500MG BASE N65118 003 APR 25, 2003 APR NEWA
CEPHALEXIN CAPSULE; ORAL CEPHALEXIN AB CEPH INTL EQ 250MG BASE N62118 001 OCT CTNA AB EQ 500MG BASE N62118 002 OCT CTNA @ TEVA EQ 250MG BASE N62821 001 FEB 05, 1988 OCT WDAG FOR SUSPENSION; ORAL + CEPH INTL EQ 100MG BASE/ML N62117 001 OCT CTNA AB EQ 125MG BASE/5ML N62117 002 OCT CTNA AB + EQ 250MG BASE/5ML N62117 003 OCT CTNA TABLET, FOR SUSPENSION; ORAL PANIXINE DISPERDOSE RANBAXY EQ 125MG BASE N65100 002 SEP 11, 2003 SEP NEWA + EQ 250MG BASE N65100 001 SEP 11, 2003 SEP NEWA
CEPHALOTHIN SODIUM INJECTABLE; INJECTION CEPHALOTHIN SODIUM + BRISTOL EQ 1GM BASE/VIAL N62464 001 MAY 07, 1984 MAR CRLD + EQ 2GM BASE/VIAL N62464 002 MAY 07, 1984 MAR CRLD + EQ 4GM BASE/VIAL N62464 003 MAY 07, 1984 MAR CRLD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-20
CEPHALOTHIN SODIUM INJECTABLE; INJECTION KEFLIN @ LILLY EQ 1GM BASE/VIAL N50482 001 MAR DISC @ EQ 2GM BASE/VIAL N50482 002 MAR DISC @ EQ 4GM BASE/VIAL N50482 003 MAR DISC
CEPHAPIRIN SODIUM INJECTABLE; INJECTION CEPHAPIRIN SODIUM @ BAXTER HLTHCARE EQ 500MG BASE/VIAL N62720 001 JUL 02, 1987 AUG CAHN @ EQ 1GM BASE/VIAL N62720 002 JUL 02, 1987 AUG CAHN @ EQ 2GM BASE/VIAL N62720 003 JUL 02, 1987 AUG CAHN @ EQ 20GM BASE/VIAL N62720 004 JUL 02, 1987 AUG CAHN
CHLORAMBUCIL TABLET; ORAL LEUKERAN + SMITHKLINE BEECHAM 2MG N10669 002 OCT CAHN
CHLORAMPHENICOL CAPSULE; ORAL MYCHEL @ ARMENPHARM 250MG N60851 001 JUL DISC OINTMENT; OPHTHALMIC CHLORAMPHENICOL AT + ALTANA 1% N60133 001 MAY CRLD CHLOROMYCETIN @ PARKEDALE 1% N50156 001 MAY DISC CHLOROPTIC S.O.P. @ ALLERGAN 1% N61187 001 JUN DISC SOLUTI ON/DROPS; OPHTHALMIC CHLOROPTIC @ ALLERGAN 0.5% N50091 001 JUN DISC SOLUTION/DROPS; OTIC CHLOROMYCETI N @ PARKEDALE 0.5% N50205 001 MAY DISC
CHLORAMPHENICOL SODIUM SUCCINATE INJECTABLE; INJECTION CHLORAMPHENICOL SODIUM SUCCINATE @ GRUPPO LEPETIT EQ 1GM BASE/VIAL N62278 001 JUL DISC
>0> CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN >0> OINTMENT; TOPICAL >0> ELASE-CHLOROMYCETIN >0> + PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM N50294 001 DEC DISC >A> @ 10MG/GM;666 UNITS/GM;1 UNITS/GM N50294 001 DEC DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-21
CHLOROQUINE HYDROCHLORIDE INJECTABLE; INJECTION ARALEN HCL @ SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC
CHLOROQUINE PHOSPHATE TABLET; ORAL CHLOROQUINE PHOSPHATE AA IMPAX LABS EQ 300MG BASE N40516 001. AUG 29, 2003 AUG NEWA @ WATSON LABS EQ 150MG BASE N87979 001 DEC 21, 1982 SEP DISC @ EQ 300MGBASE N88030 001 DEC 21, 1982 SEP DISC AA + . WEST WARD EQ 150MG BASE N83082 001 SEP CRLD
CHLOROTHIAZIDEj METHYLDOPA TABLET; ORAL ALDOCLOR-150 @ MERCK 150MG;250MG N16016 001 MAY DISC ALDOCLOR-250 @ MERCK 250MG;250MG N16016 002 MAY DISC
CHLORPROMAZINE HYDROCHLOR IDE INJECTABLE; INJECTION CHLORPROMAZINE HCL AP BAXTER HLTHCARE 25MG/ML N83329 001 JUN CAHN TABLET; ORAL @ LEDERLE 10MG N84803 001 JUN DISC
CHLORTHALIDONE TABLET; ORAL CHLORTHALIDONE @ CLONMEL HLTHCARE 25MG N87451 001 JUL CAHN @ 50MG N87450 001 JUL CAHN >0> AB IVAX PHARMS 25MG N88164 001 JAN 09, 1984 DEC DISC >A> @ 25MG N88164 001 JAN 09, 1984 DEC DISC >0> AB 50MG N87176 001 DEC DISC >A> @ 50MG N87176 001 DEC DISC >0> AB MUTUAL PHARM 25MG N89285 001 JUL 21, 1986 DEC DISC >A>. @ 25MG N89285 001 JUL 21; 1986 DEC DISC >0> AB 50MG N89286 001 JUL 21, 1986 DEC DISC >A> @ 50MG N89286 001 JUL21, 1986 DEC DISC AB + MYLAN 50MG N86831 001 OCT CRLD >0> AB WATSON LABS 25MG N87100 001 DEC DISC >A> @ 25MG N87100 001 DEC DISC HYGROTON @ AVENTIS PHARMS 25MG N12283 004 OCT DISC @ 50MG N12283 003 OCT DISC THALITONE @ MONARCH PHARMS 25MG N19574 002 FEB 12, 1992 MAY DISC ·RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-22
CHORIOGONADOTROPIN ALFA >A> INJECTABLE; SUBCUTANEOUS >A> OVIDREL >A> + SERONO INC 0.25MG/0.5ML(0.5MG/ML) N21149 002 OCT 06, 2003 DEC NEWA
CICLOPIROX SHAMPOO; TOPICAL LOPROX + MEDICIS 1% N21159 001 FEB 28, 2003 FEB NEWA SUSPENSION; TOPICAL + MEDICIS 0.77"1. N19824 001 DEC 30, 1988 NOV COFR
CILOSTAZOL TABLET; ORAL PLETAL + OTSUKA 50MG N20863 001 JAN 15, 1999 OCT CRLD
CIMETIDINE SOLUTION; ORAL CIMETIDINE HCL AA DURAMED PHARM BARR 300MG/5ML N75110 001 JUN 18, 1998 AUG CAIN
CIMETIDINE HYDROCHLORIDE SOLUTION; ORAL AA + ALPHARMA EQ 300MG BASE/5ML N74176 001 JUN 01, 1994 AUG CRLD AA DURAMED PHARMS BARR EQ 300MG BASE/5ML N75110 001 JUN 18, 1998 AUG CAIN TAGAMET @ GLAXOSMITHKLINE EQ 300MG BASE/5ML N17924 001 AUG DISC
CIPROFLOXACINi CIPROFLOXACIN HYDROCHLORIDE TABLET; ORAL CIPRO XR + BAYERPHARMS 425.2MG;EQ 574.9MG BASE N21473 002 AUG 28, 2003 AUG NEWA
CIPROFLOXACINi DEXAMETHASONE SUSPENSION/DROPS; OTIC CIPRODEX + ALCON 0.3%;0.1% N21537 001 JUL 18, 2003 JUL NEWA
CITRIC ACID; UREA, C-13 FOR SOLUT ION; TABLET, FOR SOLUTION; ORAL IDKIT:HP @ ORIDION 4GM;75MG N21314 001 DEC 17, 2002 JUL DISC
CLADRIBINE INJECTABLE; INJECTION LEUSTATIN AP + ORTHO BIOTECH 1MG/ML N20229 001 FEB 26, 1993 APR CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-23
CLEMASTINE FUMARATE SYRUP; ORAL CLEMASTINE FUMARATE AA + TEVA EQ 0.5MG BASE/5ML N73399 001 JUN 30, 1994 JUN CRLD TAVIST @ NOVARTIS EQ 0.5MG BASE/5ML N18675 001 JUN 28, 1985 ·JUN DISC
CLINDAMYCIN HYDROCHLORIDE CAPSULE; ORAL CLiNDAMYCIN HCL AB WATSON LABS EQ 300MG BASE N63083 002 MAR 18, 2003 MAR NEWA
CLINDAMYCIN PHOSPHATE INJECTABLE; INJECTION CLINDAMYCIN PHOSPHATE @ BAXTER HLTHCARE EQ 150MG BASE/ML N62806 001 OCT 15, 1987 AUG CAHN AP EQ 150MG BASE/ML N62889 001 APR 25, 1988 AUG CAHN @ EQ 150MG BASE/ML N63068 001 AUG 28, 1989 AUG CAHN
CLOBETASOL PROPIONATE LOTION; TOPICAL CLOBEX + GALDERMA LABS LP 0.05% N21535 001 JUL 24, 2003 JUL NEWA
CLOFIBRATE CAPSULE; ORAL ATROMID-S @ WYETH AYERST 500MG N16099 002 JUN DISC
CLONAZEPAM TABLET, ORALLY DISINTEGRATING; ORAL KLONOPIN RAPIDLY DISINTEGRATING ROCHE 0.125MG N20813 001 DEC 23, 1997 APR CMFD 0.25MG N20813 002 DEC 23, 1997 APR CMFD 0.5MG N20813 003 DEC 23, 1997 APR CMFD + 1MG N20813 004 DEC 23, 1997 APR CMFD 2MG N20813 005 DEC 23, 1997 APR CMFD
CLONIDINE HYDROCHLORIDE INJECTABLE; INJECTION DURACLON >A> + AAIPHARMA 0.1MG/ML N20615 001 OCT 02, 1996 DEC CAHN >0> + ELAN PHARMS 0.1MG/ML N20615 001 OCT 02, 1996 DEC CAHN
CLORAZEPATE DIPOTASSIUM CAPSULE; ORAL CLORAZEPATE DIPOTASSIUM @ CLONMEL HLTHCARE 3.75MG N71742 001 DEC 14, 1987 JUN DISC @ 7.5MG N71.743 001 DEC 14, 1987 . JUN DISC @ 15MG N71744 001 . DEC 14, 1987 JUN DISC RX DRUG PRODUCT LIST -.CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-24
CLOZAPINE TABLET; ORAL CLOZAPINE IVAX PHARMS 12.5MG N74949 003 JUl n, 2003 JUL NEWA AB + 100MG N74949 002 NOV 26, 1997 SEP CRLD CLOZARIL AB NOVARTIS 100MG N19758 002 .SEP 26; 1989 SEP CRLD
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP; ORAL PHENERGAN VC WI CODEINE @ WYETH AYERST 10MG/5ML;5MG/5ML;6.25MG/5ML N08306005 APR 02, 1984 JUN DISC PROMETH VC WI CODEINE AA + ALPHARMA 10MG/5ML;5MG/5ML;6.25MG/5ML N88764 001 OCT 31, 1984 JUN CRLD
CODEINE PHOSPHATE;. PROMETHAZINE HYDROCHLORIDE SYRUP; ORAL PHENERGAN WI CODEINE @ WYETH AYERST 10MG/5ML;6.25MG/5ML N08306 004 APR 02, 1984 JUN DISC PROMETH WI CODEINE AA + ALPHARMA 10MG/5ML;6.25MG/5ML N88763 001 OCT 31, 1984 JUN CRLD
COLESTIPOL HYDROCHLORIDE TABLET; ORAL COLESTID + PHARMACIA AND UPJOHN 1GM N20222 001 JUL 19, 1994 MAY CRLD
COPPER INTRAUTERINE DEVICE; INTRAUTERINE COPPER T MODEL TCU 380A + FEI 309MG/COPPER N18680 001 NOV 15, 1984 MAR CAHN
CORTI COTROP IN INJECTABLE; INJECTION CORTICOTROPIN @ ORGANICS LAGRANGE 40 UNITS/ML N10831 001 NOV DISC @ 80 UNITS/ML N10831 002 NOV DISC H.P. ACTHAR GEL + QUEST COR PHARMS 80 UNITS/ML N08372 008 NOV CTEC
CORTISONE ACETATE TABLET; ORAL CORTISONE ACETATE BP + PHARMACIA AND UPJOHN 25MG N08126 001 APR CRLD COR TONE @ MERCK 25MG N07750 003 APR DISC
COSYNTROPIN INJECTABLE; INJECTION CORTROSYN + AMPHASTAR 0.25MG/VIAL N16750 001 JUN CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12- DEC 2003 1-25
CRQMOL YN SOD IUM SOLUTION/DROPS; OPHTHALMIC CROMOPTIC @ KING. PHARMS 4% N75088 001 APR 27, 1999 MAY DISC
CYANOCOBALAMIN GEL, METERED; NASAL NASCOBAL + QUESTCOR PHARMS 0.5MG/INH N19722 001 NOV OS, 1996 JUN CAHN INJECTABLE; INJECTION CYANOCOBALAMIN @ BAXTER HLTHCARE 1MG/ML N80515 002 AUG CAHN @ ELKINS SINN 1MG/ML N80515 002 JUN DISC AP PHARMAFORCE 1MG/ML N40451 001 SEP 23, 2003 SEP NEWA @ WYETH AYERST 0.1MG/ML N80554 001 JUN DISC @ 1MG/ML N80554 002 JUN DISC
CYCLOBENZAPRINE HYDROCHLORIDE TABLET; ORAL FLEXERIL AA MCNEIL CONS SPECLT 5MG N17821 001 MAR CMFD 5MG N17821 001 APR CTEC
CYCLOPHOSPHAMIDE INJECTABLE; INJECTION NEOSAR @ GENSIA SICOR PHARMS 100MG/VIAL N40015 001 APR 29, 1993 AUG DISC AP 100MG/VIAL N87442 001 FEB 16, 1982 AUG CAHN @ 200MG/VIAL N40015 002 APR 29, 1993 AUG DISC AP 200MG/VIAL N87442 002 FEB 16, 1982 AUG CAHN @ 500MG/VIAL N40015 003 APR 29, 1993 AUG DISC AP 500MG/VIAL N87442 003 FEB 16, 1982 AUG CAHN @ 1GM/VIAL N40015 004 APR 29, 1993 AUG DISC AP 1GM/VIAL N87442 004 JUL 08, 1983 AUG CAHN @ 2GM/VIAL N40015 005 APR 29, 1993 AUG DISC AP 2GM/VIAL N87442 005 MAR 30, 1989 AUG CAHN
CYCLOSPORINE CAPSULE; ORAL GENGRAF AB1 ABBOTT 25MG N65003 001 MAY 12, 2000 FEB CTNA BX 50MG N65003 002 MAY 12, 2000 FEB CTNA AB1 100MG N65003 003 MAY 12, 2000 FEB CTNA EMULSION; OPHTHALMIC RESTASIS + ALLERGAN 0.05% N50790 001 DEC 23, 2002 MAR CMS1 INJECTABLE; INJECTION CYCLOSPORINE AP pHARMAFORCE 50MG/ML N6~J51 001 OCT 07, 2003 OCT NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-26
CYPROHEPTADINE HYDROCHLORIDE TABLET; ORAL CYPROHEPTADINE HCL AA COREPHARMA 4MG N40537 001 SEP 30, 2003 SEP NEWA
CYTARABINE INJECTABLE; INJECTION CYTARABINE @ SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC AP 100MG/VIAL N75206 001 DEC 30, 1998 JUL CAHN @ 500MG/VIAL N16793 002 NOV DISC AP + 500MG/VIAL N75206 002 DEC 30, 1998 JUL CAHN @ lGM/VIAL N16793 003 DEC 21, 1987 NOV DISC AP 1GM/VIAL N75206 004 DEC 30, 1998 JUL CAHN @ 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC AP 2GM/VIAL N75206 003 DEC 30, 1998 JUL CAHN CYTOSAR-U AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 JUN CAHN AP + 500MG/VIAL N16793 002 JUN CAHN AP + 1GM/VIAL N16793 003 DEC 21, 1987 JUN CAHN AP + 2GM/VIAL N16793 004 DEC 21, 1987 JUN CAHN AP SICOR PHARMS 100MG/VIAL N75206 001 DEC 30, 1998 NOV CTNA AP + 500MG/VIAL N75206 002 DEC 30, 1998 NOV CTNA AP + lGM/VIAL N75206 004 DEC 30, 1998 NOV CTNA AP + 2GM/VIAL N75206 003 DEC 30, 1998 NOV CTNA
DALFOPRISTlNi QUINUPRISTIN INJECTABLE; IV (INFUSION) SYNERCID + KING PHARMS 350MG/VIAL;150MG/VIAL N50748 001 SEP 21, 1999 FEB CAHN @ 420MG/VIAL;180MG/VIAL N50748 002 AUG 24, 2000 FEB CAHN
DAPTOMYCIN INJECTABLE; IV (INFUSION) CUBICIN CUBIST 250MG/VIAL N21572 001 SEP 12, 2003 SEP NEWA + 500MG/VIAL N21572 002 SEP 12, 2003 SEP NEWA
DEMECLOCYCLINE HYDROCHLORIDE TABLET; ORAL DECLOMYCIN @ ESP PHARMA 75MG N50261 001 OCT CAHN 150MG N50261 002 OtT CAHN + 300MG N50261 003 OCT CAHN @ WYETH PHARMS INC 75MG N50261 001 MAR CAHN 150MG N50261 002 MAR CAHN + 300MG N50261 003 MAR CAHN
DESIRUDIN INJECTABLE; SUBCUTANEOUS IPRIVASK + AVENTI S PHARMS 15MG/VIAL N21271 001 APR 04,'2003 APR NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-27
DESMOPRESSIN ACETATE SPRAY, METERED; NASAL DESMOPRESSIN ACETATE AB + FERRING 0.01MG/SPRAY N21333 001 SEP 16, 2002 MAY CMS1 MINIRIN AB + FERRING 0.01MG/SPRAY N21333 001 SEP 16, 2002 JUN CTNA
DESOGESTRELi ETHINYL ESTRADIOL TABLET; ORAL-21 ORTHO-CEPT @ ORTHO MCNEIL PHARM 0.15MG;0.03MG N20301 001 DEC 14, 1992 MAR DISC TABLET: ORAL-28 AB + ORTHO MCNEIL PHARM 0.15MG;0.03MG N20301 002 DEC 14, 1992 MAR CRLD
DESOXIMETASONE CREAM; TOPICAL DESOXIMETASONE AB CLAY PARK 0.25% N76510 001 JUL 01, 2003 JUL NEWA
DEXAMETHASONE ELIXIR; ORAL DECADRON @ MERCK 0.5MG/5ML N12376 002 APR DISC HEXADROL AA + ORGANON 0.5MG/5ML N12674 001 APR CRLD
DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE; INJECTION DEXAMETHASONE AP BAXTER HLTHCARE EQ 4MG PHOSPHATE/ML N84282 001 AUG CAHN DEXAMETHASONE SODIUM PHOSPHATE AP AM PHARM EQ 10MG PHOSPHATE/ML N40491 001 APR 11, 2003 APR NEWA
DEXAMETHASONE SODIUM PHOSPHATEi NEOMYCIN SULFATE SOLUTION/DROPS: OPHTHALMIC NEODECADRON @ MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML N50322 001 MAY DISC
DEXCHLORPHENIRAMINE MALEATE SYRUP; ORAL MYLARAMINE + MORTON GROVE 2MG/5ML N88251 001 MAR 23, 1984 OCT CRLD POLARAMINE @ SCHERING 2MG/5ML N86837 001 JUL 19, 1982 OCT DISC TABLET; ORAL DEXCHLORPHENIRAMINE MALEATE + PLiVA 2MG N88682 001 JAN 17, 1986 OCT CRLD POLARAMINE @ SCHERING 2MG N8{,835 001 OCT DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003
DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL DEXEDRINE AB GLAXOSMITHKLI NE 5MG N17078 001 JUL CRLD AB 10MG N17078 002 JUL CRLD DEXTROAMPHETAMINE SULFATE AB MALL I NCKRODT 5MG N76353 001 MAY 06, 2003 MAY NEWA AB 10MG N76353 002 MAY 06; 2003 MAY NEWA AB 15MG N76353 003 MAY 06, 2003 MAY NEWA
DEXTROMETHORPHAN HYDROBROMIDEj PROMETHAZINE HYDROCHLORIDE SYRUP; ORAL PHENERGAN WI DEXTROMETHORPHAN @ WYETH AYERST 15MG/5ML;6.25MG/5ML N11265 002 APR 02, 1984 JUN DISC PROMETH WI DEXTROMETHORPHAN AA + ALPHARMA 15MG/5ML;6.25MG/5ML N88762 001 OCT 31, 1984 JUN CRLD
DIAZEPAM GEL; RECTAL DIASTAT XCEL PHARMS 2.5MG/0.5ML N20648 001 JUL 29, 1997 OCT CRLD INJECTABLE; INJECTION DIAZEPAM @ BAXTER HLTHCARE 5MG/ML N71308 001 JUL 17, 1987 AUG CAHN AP 5MG/ML N71309 001 JUL 17, 1987 AUG CAHN AP 5MG/ML N71310 001 JUL 17, 1987 AUG CAHN @ ELKINS SINN 5MG/ML N70311 001 DEC 16, 1985 JUN DISC @ 5MG/ML N70312 001 DEC 16, 1985 JUN DISC @ 5MG/ML N70313 001 DEC 16, 1985 JUN DISC TABLET; ORAL @ CLONMEL HLTHCARE 5MG N70227 001 SEP 26, 1985 AUG DISC @ 10MG N70228 001 SEP 26, 1985 AUG DISC
DICHLORPHENAMIDE TABLET; ORAL DARANIDE @ MERCK 50MG N11366 001 MAY DISC
DICLOXACILLIN SODIUM CAPSULE; ORAL PATHOCIL @ WYETH AYERST EQ 250MG BASE N50011 002 JUN DISC @ EQ 500MG BASE N50011 003 MAR 28, 1983 JUN DISC FOR SUSPENSION; ORAL DICLOXACILLIN SODIUM· + APOTHECON EQ 62.5MG BASE/5ML N61455 001 JUN CTEC PATHOCIL @ WYETH AYERST EQ 62.5MG BASE/5ML N50092 001 JUN DISC RX DRUG PRODUCT LI~T -. CUMULATIVE SUPPLEMENT 12·- DEC 2003 1-29
DICYCLOMINE HYDROCHLORIDE CAPSULE: ORAL BENTYL >D> AB + AVENTI S PHARMS 10MG N07409 003 OCT 15, 1984 DEC CAHN >A> AB + AX CAN SCANDIPHARM 10MG N07409 003 OCT 15, 1984 DEC CAHN INJECTABLE: INJECTION AP + AXCAN SCANDIPHARM 10MG/ML N08370 001 OCT 15, 1984 NOV CAHN BENTYL PRESERVATIVE FREE AP + AXCAN SCANDIPHARM 10MG/ML N08370 002 OCT 15, 1984 NOV CAHN DICYCLOMINE HCL (PRESERVATIVE-FREE) AP BEDFORD 10MG/ML N40465 001 JUN. 30, 2003 JUN NEWA SYRUP: ORAL BENTYL + AXCAN SCANDIPHARM 10MG/5ML N07961 002 OCT 15, 1984 NOV CAHN TABLET: ORAL >D> AB + AVENTI S PHARMS 20MG N07409 001 OCT 15, 1984 D.EC CAHN >A> AB + AX CAN SCANDIPHARM 20MG N07409 001 OCT 15, 1984 DEC CAHN
DIENESTROL CREAM; VAGINAL DIENESTROL @ ORTHO MCNEIL· 0_01% N06110005 AUG DISC
DIGOXIN INJECTABLE; INJECTION DIGOXIN AP SABEX 2002 0.25MG/ML N40481 001 AUG 21, 2003 AUG NEWA . @ WYETH AYERST 0.25MG/ML N84386 001 JUN DISC TABLET; ORAL AB CARACO 0.125MG N76363 001 JAN 31, 2003 JAN NEWA AB 0.25MG N76363 002 JAN 31, 2003 JAN NEWA
DIHYDROERGOTAMINE MESYLATE INJECTABLE; INJECTION D.H .E. 45 AP + XCEL PHARMS 1MG/ML N05929 001 APR CFTG DIHYDROERGOTAMINE MESYLATE AP BEDFORD 1MG/ML N40453 001 JUN 09, 2003 JUN NEWA AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA
DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE: ORAL CARDIZEM CD >D> AB3 + AVENTI S PHARMS 120MG N20062 001 AUG 10, 1992 DEC CAHN >D> AB3 + 180MG N20062 002 DEC 27, 1991 DEC CAHN >D> AB3 + 240MG N20062 003 DEC 27, 1991 DEC CAHN >D> AB3 + 300MG N20062 004 DEC 27, 1991 DEC CAHN >D> BC + 360MG N20062 005 AUG 24, 1999 DEC CAHN BC + 360MG N20062 005 AUG 24, 1999 OCT NEWA >A> AB3 + BIOVAIL 120MG N20062 001 . AUG 10, 1992 DEC CAHN >A> AB3 + 180MG N20062 002 DEC 27, 1991 DEC CAHN >A> AB3 + 240MG N20062 003 DEC 27, 1991 DEC CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-30
>A> AB3 + 300MG N20062 004 DEC 27, 1991 DEC CAHN >A> BC + 360MG N20062 005 AUG 24, 1999 DEC CAHN TAZTIA XT AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA AB4 180MG N75401 002 APR 10, 2003 APR NEWA AB4 240MG N75401 003 APR 10, 2003 APR NEWA AB4 300MG N75401 004 APR 10, 2003 APR NEWA AB4 360MG N75401 005 APR 10, 2003 APR NEWA TIAZAC AB4 + BIOVAIL 120MG N20401 001 SEP 11, 1995 APR CFTG AB4 120MG N20401 001 SEP 11, 1995 AUG CRLD AB4 + 180MG N20401 002 SEP 11, 1995 APR CFTG AB4 180MG N20401 002 SEP 11, 1995 AUG CRLD AB4 + 240MG N20401 003 SEP 11, 1995 APR CFTG AB4 240MG N20401 003 SEP 11, 1995 AUG CRLD AB4 + 300MG N20401 004 SEP 11, 1995 APR CFTG AB4 300MG N20401 004 SEP 11, 1995 AUG CRLD AB4 + 360MG N20401 005 SEP 11, 1995 APR CFTG AB4 360MG N20401 005 SEP 11, 1995 AUG CRLD INJECTABLE; INJECTION DILTIAZEM HCL AP + BEDFORD 5MG/ML N74617 001 FEB 28, 1996 AUG CRLD TABLET, EXTENDED RELEASE; ORAL CARDIZEM LA + BIOVAIL 120MG N21392 001 FEB 06, 2003 FEB NEWA + 180MG N21392 002 FEB 06, 2003 FEB NEWA + 240MG N21392 003 FEB 06, 2003 FEB NEWA + 300MG N21392 004 FEB 06, 2003 FEB NEWA + 360MG N21392 005 FEB 06, 2003 FEB NEWA + 420MG N21392 006 FEB 06, 2003 FEB NEWA
DILTIAZEM MALATE TABLET, EXTENDED RELEASE; ORAL TIAMATE @ MERCK EQ 120MG HCL N20506 001 OCT 04, 1996 MAY DISC @ EQ 180MG HCL N20506 002 OCT 04, 1996 MAY DISC @ EQ 240MG HCL N20506 003 OCT 04, 1996 MAY DISC
DIMENHYDRINATE INJECTABLE; INJECTION DIMENHYDRINATE @ BAXTER HLTHCARE 50MG/ML N84767 001 AUG CAHN + STERIS 50MG/ML N80615 001 JUN CTEC @ WYETH AYERST 50MG/ML N84316 001 JUN DISC
DIMETHYL SULFOXIDE SOLUTION; INTRAVESICAL RIMSO-50 AT + EDWARDS LIFESCIENCES 50% N17788 001 JUL CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-31
DIMYRISTOYL LECITHINj PERFLEXANE INJECTABLE; INTRAVENOUS IMAGENT + IMCOR 0.92MG/VIAL;0.092MG/VIAL N21191 001 MAY 31, 2002 AUG CAHN
DIPHENHYDRAMINE HYDROCHLORIDE INJECTABLE; INJECTION DIPHENHYDRAMINE HCL AP BAXTER HLTHCARE SOMG/ML N80817 002 JUN CAHN @ SOMG/ML N83183 001 AUG CAHN @ WYETH AYERST SOMG/ML N80S77 001 JUN DISC
DIPYRIDAMOLE INJECTABLE; INJECTION DIPYRIDAMOLE >D> AP BEDFORD SMG/ML N74939 001 APR 13, 1998 DEC CRLD >A> AP + SMG/ML N74939 001 APR 13, 1998 DEC CRLD >D> IV PERSANTINE >D> AP + BOEHRINGER INGELHEIM SMG/ML N19817 001 DEC 13, 1990 DEC DISC >A> @ SMG/ML N19817 001 DEC 13, 1990 DEC DISC TABLET; ORAL DIPYRIDAMOLE AB CLONMEL HLTHCARE 2SMG N88999 001 FEB OS, 1991 JUL CAHN @ 2SMG N88999 001 FEB OS, 1991 AUG DISC AB SOMG N89000 001 FEB OS, 1991 JUL CAHN AB 7SMG N89001 001 FEB OS, 1991 JUL CAHN @ 7SMG N89001 001 FEB OS, 1991 AUG DISC
DOBUTAMINE HYDROCHLORIDE INJECTABLE; INJECTION DOBUTAMINE HCL @ BAXTER HLTHCARE EQ 12.SMG BASE/ML N74381 001 SEP 26, 1996 AUG CAHN @ ELKINS SINN EQ 12.SMG BASE/ML N74381 001 SEP 26, 1996 JUN DISC
DOLASETRON MESYLATE MONOHYDRATE INJECTABLE; INJECTION ANZEMET AVENTIS PHARMS EQ 12.SMG BASE/0.62SML N20624 002 SEP 11, 1997 JUL CPOT EQ 12.SMG BASE/0.62SML N20624 002 SEP 11, 1997 SEP CPOT + EQ 100MG BASE/SML N20624 001 SEP 11, 1997 SEP CPOT + EQ SOOMG BASE/2SML N20624 003 DEC 11, 2001 SEP NEWA
DOPAMINE HYDROCHLORIDE INJECTABLE; INJECTION DOPAMINE HCL @ BAXTER HLTHCARE 40MG/ML N18398 001 JUN DISC @ 80MG/ML N18398 002 MAR 22, 1982 JUN DISC
DOXAPRAM HYDROCHLORIDE INJECTABLE; INJECTION DOPRAM AP + BAXTER HLTHCARE CORP 20MG/ML N14879 001 JAN CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-32
DOXAPRAM HYDROCHLORIDE INJECTABLE; INJECTION DOXAPRAM HCL AP BEDFORD 20MG/ML N76266 001 JAN 10, 2003 JAN NEWA
DOXORUBICIN HYDROCHLORIDE INJECTABLE; INJECTION ADRIAMYCIN RDF @ PHARMACIA AND UPJOHN 150MG/VIAL N50467 004 JUL 22, 1987 JUL DISC
DOXYCYCLINE CAPSULE; ORAL DOXYCYCLINE AB AXIOM PHARM EQ 50MG BASE N65041 001 APR 28, 2000 MAY CAHN AB EQ 100MG BASE N65041 002 APR 28, 2000 MAY CAHN + RANBAXY EQ 75MG BASE N65053 003 SEP 10, 2003 OCT NEWA
DOXYCYCLINE HYCLATE CAPSULE; ORAL DOXYCYCLINE HYCLATE AB AXIOM PHARM EQ 50MG BASE N61717 001 MAY CAHN AB EQ 100MG BASE N61717 002 MAY CAHN CAPSULE, COATED PELLETS; ORAL DORYX FAULDING EQ 75MG BASE N50582 002 AUG 13, 2001 FEB NEWA INJECTABLE; INJECTION DOXY 100 + AM PHARM PARTNERS EQ 100MG BASE/VIAL N62475 001 DEC 09, 1983 MAR CRLD DOXY 200 + AM PHARM PARTNERS EQ 200MG BASE/VIAL N62475 002 DEC 09, 1983 MAR CRLD DOXYCYCLINE @ BAXTER HLTHCARE EQ 100MG BASE/VIAL N62450 001 OCT 27, 1983 AUG CAHN @ EQ 200MG BASE/VIAL N62450 002 OCT 27, 1983 AUG CAHN DOXYCYCLINE HYCLATE @ BAXTER HLTHCARE EQ 100MG BASE/VIAL N62992 001 FEB 16, 1989 AUG CAHN @ EQ 200MG BASE/VIAL N62992 002 FEB 16, 1989 AUG CAHN VIBRAMYCIN @ PFIZER EQ 100MG BASE/VIAL N50442 002 MAR DISC @ EQ 200MG BASE/VIAL N50442 001 MAR DISC TABLET; ORAL DOXYCYCLI NE HYCLATE AB AXIOM PHARM EQ 100MG BASE N62269 002 NOV 08, 1982 MAY CAHN AB WEST WARD EQ 100MG BASE N65095 001 JUL 02, 2003 JUL NEWA DOXYCYCLINE HYLATE @ AXIOM PHARM EQ 50MG BASE N62269 003 MAY CAHN
EDROPHONIUM CHLORIDE INJECTABLE; INJECTION REVERSOL @ ORGANON 10MG/ML N89624 001 MAY 13, 1988 MAY DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-33
ELETRIPTAN HYDROBROMIDE TABLET; ORAL RELPAX PFIZER IRELAND EQ 20MG BASE N21016 001 DEC 26, 2002 MAR CAHN + EQ 40MG BASE N21016 002 DEC 26, 2002 MAR CAHN
EMTR I CIT AB I NE CAPSULE; ORAL EMTRIVA + GILEAD 200MG N21500 001 JUL 02, 2003 JUL NEWA
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET: ORAL ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE AB IVAX PHARMS 5MG:12.5MG N75736 001 MAR 25, 2003 MAR NEWA AB 10MG:25MG N75736 002 MAR 25, 2003 MAR NEWA
ENFUVIRTIDE INJECTABLE: SUBCUTANEOUS FUZEON + ROCHE 90MG/VIAL N21481 001 MAR 13, 2003 MAR NEWA
ENOXAPARIN SODIUM INJECTABLE: SUBCUTANEOUS LOVENOX + AVENTIS 300MG/3ML N20164 009 JAN 23, 2003 JAN NEWA
EPINASTINE HYDROCHLORIDE SOLUTION/DROPS: OPHTHALMIC ELESTAT + ALLERGAN 0.05% N21565 001 OCT 16, 2003 OCT NEWA
EPINEPHRINE INJECTABLE: IM-SC TWINJECT + HOLLISTER STIER LABS 0.3MG /DElIVERY N20800 001 MAY 30, 2003 MAY NEWA
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE INJECTABLE: INJECTION DURANEST @ ASTRAZENECA 0.005MG/ML:1% N17751 006 OCT WDAG @ DENTSPLY PHARM 0.005MG/ML:1.5% N21384 001 MAR DISC
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE INJECTABLE: INJECTION LIDOCAINE HCL AND EPINEPHRINE @ ELKINS SINN 0.01MG/ML:1% N80406 001 JUN DISC @ 0.01MG/ML:2% N80406 002 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-34
EPIRUBICIN HYDROCHLORIDE INJECTABLE; INJECTION ELLENCE + PHARMACIA AND UPJOHN 2MG/ML N50778 001 SEP 15, 1999 NOV CTEC
EPROSARTAN MESYLATE TABLET; ORAL TEVETEN BIOVAIL EQ 300MG BASE N20738 004 DEC 22, 1997 JUL CAHN EQ 400MG BASE N20738 005 DEC 22, 1997 JUL CAHN + EQ 600MG BASE N20738 006 MAY 27, 1999 JUL CAHN
EPROSARTAN MESYLATEi HYDROCHLOROTHIAZIDE TABLET; ORAL TEVETEN HCT BIOVAIL 600MG;12.5MG N21268 001 NOV 01, 2001 JUL CAHN + 600MG;25MG N21268 002 NOV 01, 2001 JUL CAHN
ERGOTAMINE TARTRATE TABLET; SUBLINGUAL ERGOMAR + HARVEST PHARMS 2MG N87693 001 FEB 24, 1983 MAR CAHN
ERYTHROMYCIN SOLUTION; TOPICAL STATICIN + WESTWOOD SQUIBB 1.5% N50526 001 APR CTEC
ERYTHROMYCIN LACTOBIONATE INJECTABLE; INJECTION ERYTHROMYCIN @ ELKINS SINN EQ 500MG BASE/VIAL N62563 001 MAR 28, 1985 JUN DISC @ EQ 1GM BASE/VIAL N62563 002 MAR 28, 1985 JUN DISC ERYTHROMYCIN LACTOBIONATE AP BAXTER HLTHCARE EQ 500MG BASE/VIAL N62993 001 MAY 09, 1989 AUG CAHN AP EQ 1GM BASE/VIAL N62993 002 MAY 09; 1989 AUG CAHN
ESCITALOPRAM OXALATE TABLET; ORAL LEXAPRO @ FOREST LABS 5MG N21323 001 AUG 14, 2002 NOV DISC
ESMOLOL HYDROCHLORIDE INJECTABLE; INJECTION BREVIBLOC + BAXTER HLTHCARE CORP 10MG/ML N19386 006 FEB 25, 20'03 JUN NEWA + 20MG/ML N19386 007 MAY 28, 2003 JUN NEWA BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER + BAXTER HLTHCARE CORP 2GM/100Ml N19386 005 JAN 27, 2003 MAR NEWA BREVI BLOC IN PLASTIC CONTAINER + BAXTER HLTHCARE CORP 1GM/1OOML N19386 004 FEB 16, 2001 MAR NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-35
ESTRADIOL FILM, EXTENDED RELEASE; TRANSDERMAL CLIMARA BX + BERLEX LABS 0.0375MG/24HR N20375 005 MAY 27, 2003 JUN NEWA + 0.06MG/24HR N20375 006 MAY 27, 2003 JUN NEWA TABLET; ORAL ESTRADIOL @ CLONMEL HLTHCARE 0.5MG N40275 001 DEC 29, 1998 AUG DISC @ 1MG N40275 002 DEC 29, 1998 AUG DISC @ 2MG N40275 003 DEC 29, 1998 AUG DISC
ESTRADIOL ACETATE INSERT, EXTENDED RELEASE; VAGINAL FEMRING GALEN LTD 0.05MG/24HR N21367 001 MAR 20, 2003 MAR NEWA + 0.1MG/24HR N21367 002 MAR 20, 2003 MAR NEWA
ESTRADIOL CYPIONATEi MEDROXYPROGESTERONE ACETATE INJECTABLE; INTRAMUSCULAR LUNELLE @ PHARMACIA AND UP JOHN 5MG/0.5ML;25MG/O.5ML N20874 001 OCT 05, 2000 AUG DISC
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE INJECTABLE; INJECTION DEPO-TESTADIOL @ PHARMACIA AND UPJOHN 2MG/ML;50MG/ML N17968 001 MAY WDAG
ESTRADIOL HEMIHYDRATE EMULSION; TOPICAL ESTRASORB + NOVAVAX 0.25% N21371 001 OCT 09, 2003 OCT NEWA
ESTRADIOL; LEVONORGESTREL FILM, EXTENDED RELEASE; TRANSDERMAL CLIMARA PRO + BERLEX LABS 0.045MG/24HR;0.015MG/24HR N21258 001 NOV 21, 2003 NOV NEWA
ESTRADIOL; NORGESTIMATE TABLET; ORAL PRE FEST + KING PHARMS 1MG;1MG;0.09MG N21040 001 OCT 22, 1999 MAY CTNA
ESTROGENS, CONJUGATED CREAM; TOPICAL, VAGINAL PREMARIN + WYETH PHARMS INC 0.625MG/GM N20216 001 MAR CAHN INJECTABLE; INJECTION + WYETH PHARMS INC 25MG/VIAL N10402 001 MAR CAHN TABLET; ORAL WYETH PHARMS INC 0.3MG N04782 003· MAR CAHN 0.45MG N04782 006 JUL 16, 2003 JUL NEWA + 0.625MG N04782 004 MAR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-36
0.9MG N04782 005 JAN 26, 1984 MAR CAHN + 1.25MG N04782 001 MAR CAHN 2.5MG N04782 002 ' MAR CAHN
ESTROGENS, CONJUGATEDi MEDROXYPROGESTERONE ACETATE TABLET; ORAL-28 PREMPHASE (PREMARINiCYCRIN 14/14) @ WYETH PHARMS INC 0.625MGiO.625MGi 5MG N20303 002 DEC 30, 1994 MAR CAHN PREMPHASE 14/14 + WYETH PHARMS INC 0.625MGiO.625MGi5MG N20527 002 NOV 17, 1995 MAR CAHN PREMPRO + WYETH PHARMS INC 0.3MGi1.5MG N20527 005 JUN 04, 2003 JUN NEWA + 0.45MGi1.5MG N20527 004 MAR 12, 2003 MAR NEWA + 0.625MGiO.625MGi2.5MGi2.5MG N20527 001 NOV 17, 1995 MAR CAHN + 0.625MGiO.625MGi5MGi5MG N20527 003 JAN 09, 1998 MAR CAHN PREMPRO (PREMARINiCYCRIN) @ WYETH PHARMS INC 0.625MG;0.625MGi2.5MGi2.5MG N20303 001 DEC 30, 1994 MAR CAHN
ESTROGENS, ESTERIFIED TABLETi ORAL MENEST MONARCH PHARMS 0.3MG N84951 001 JAN CRLD
ETHACRYNIC ACID TABLETi ORAL EDECRIN + MERCK 25MG N16092 001 MAY CRLD @ 50MG N16092 002 MAY DISC
ETHAMBUTOL HYDROCHLORIDE TABLETi ORAL ETHAMBUTOL HCL AB + WEST WARD 400MG N75095 002 NOV 30, 1999 JUN CRLD MYAMBUTOL @ LEDERLE 100MG N16320 001 JUN DISC @ 400MG N16320 003 JUN DISC
ETHINYL ESTRADIOLi ETHYNODIOL DIACETATE TABLETi ORAL-28 DEMULEN 1/35-28 AB + GD SEARLE LLC 0.035MGi 1MG N18160 001 JUL CRLD
ETHINYL ESTRADIOLi ETONOGESTREL RINGi VAGINAL NUVARING + ORGANON USA INC 0.015MGiO.12MG N21187 001 OCT 03, 2001 JUN CAHN
ETHINYL ESTRADIOLi LEVONORGESTREL TABLETi ORAL SEASONALE + BARR 0.03MGiO.15MG N21544, 00,1""SER05,,2003 SEP NEWA RX DRUG PRODUCT LIST .. CUMULATIVE SUPPLEMENT 12- DEC 2003 1-37
ETHINYL ESTRADIOLjLEVONORGESTREL TABLET; ORAL-21 ALESSE AB1 + WYETH PHARMS INC 0.02MG;0.1MG N20683 001 MAR 27, 1997 MAR CAHN LEVONORGESTREL AND ETHINYL ESTRADIOL AB1 BARR 0.02MG;0.1MG N75862. 001 APR 29, 2003 APR NEWA NORDETTE-21 >A> AB + MONARCH PHARMS 0.03MG;0.15MG N18668 001 MAY 10, 1982 DEC CAHN >D> AB + WYETH PHARMS INC 0.03MG;0.15MG N18668 001 MAY 10, 1982 DEC CAHN AB + 0.03MG;0.15MG N18668 001 MAY 10, 1982 MAR CAHN TRIPHASIL-21 AB + WYETH PHARMS INC 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG ;0.075MG N19192 001 NOV 01, 1984 MAR CAHN TABLET; ORAL-28 ALE SSE AB1 WYETH PHARMS INC 0.02MG;0.1MG N20683 002 MAR 27, 1997 MAR CAHN LEVONORGESTREL AND ETHINYL ESTRADIOL AB1 BARR 0.02MG;0.1MG N75862 002 APR 29, 2003 APR NEWA NORDETTE·28 >A> AB MONARCH PHARMS 0.03MG;0.15MG N18782 001 JUL 21, 1982 DEC CAHN >D> AB WYETH PHARMS INC 0.03MG;0.15MG N18782 001 JUL 21, 1982 DEC CAHN AB 0.03MG;0.15MG N18782 001 JUL 21, 1982 MAR CAHN TRIPHASIL-28 AB WYETH PHARMS INC 0.03MG;0.04MG;0.03MG;0.05MG;0.125MG ;0.075MG N19190 001 NOV 01, 1984 MAR CAHN
ETHINYL ESTRADIOL; NORELGESTROMIN FILM, EXTENDED RELEASE; TRANSDERMAL ORTHO EVRA + ORTHO MCNEIL PHARM 0.02MG/24HR;0.15MG/24HR N21180 001 NOV 20, 2001 NOV CPOT
ETHINYL ESTRADIOL; NORETHINDRONE TABLET; ORAL·21 BREVICON 21-DAY AB + WATSON LABS 0.035MGi O.5MG N17566 001 AUG CRLD MODICON 21 @ ORTHO MCNEIL PHARM 0.035MG;0.5MG N17488 001 AUG DISC ORTHO-NOVUM 1/35-21 @ ORTHO MCNEIL PHARM 0.035MG;1MG N17489 002 AUG DISC ORTHO·NOVUM 10/11-21 @ ORTHO MCNEIL PHARM O.035MG,0.035MG;0.5MG,1MG N18354 001 JAN 11, 1982 AUG DISC ORTHO-NOVUM 7/7/7·21 @ ORTHO MCNEIL PHARM 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0 .75MG N18985 001 APR 04, 1984 AUG DISC TRI-NORINYL 21-DAY @ WATSON LABS 0.035MG, 0.035MG,0 .035MG;0 •. 5MG, 1MG, 0 .5MG N18977 001 APR 13, 1984 MAR CPOT @ 0.035MG,0.035MG;0.5MG,1MG N18977 001 APR 13, 1984 FEB DISC TABLET; ORAL-28 ORTHO-NOVUM 7/7/7-28 AB + ORTHO MCNEIL PHARM 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0 .75MG N18985 002 APR 04, 1984 FEB CRLD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-38
·OVCON-35 + WARNER CHILCOTT 0.035MGiO.4MG N17716 001 JAN CRLD OVCON-50 + WARNER CHILCOTT 0.05MG i1MG N17576 001 JAN CRLD TRI-NORINYL 28-DAY + WATSON LABS 0.035MG,O.035MG,O.035MGiO.5MG,1MG,O .5MG N18977 002 APR 13, 1984 MAR CPOT + 0.035MG,O.035MGiO.5MG,1MG N18977 002 APR 13, 1984 JAN CRLD TABLET, CHEWABLEi ORAL-28 OVCON-35 + WARNER CHILCOTT 0.035MGiO.4MG N21490 001 NOV 14, 2003 NOV NEWA
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLETi ORAL FEMHRT + GALEN CHEM 0.005MGi1MG N21065 002 OCT 15, 1999 MAY CAHN TABLETi ORAL-21 ESTROSTEP 21 @ GALEN CHEM 0.02MGiO.03MGiO.035MGi1MGi1MGi1MG N20130 001 OCT 09, 1996 APR CAHN JUNEL 1.5/30 AB BARR 0. 03MG i1.5MG N76381 001 MAY 30, 2003 MAY NEWA JUNEL 1/20 AB BARR 0.02MGi1MG N76380 001 MAY 30, 2003 MAY NEWA LOESTRIN 21 1.5/30 + GALEN CHEM 0.03MGi1.5MG N17875 001 APR CAHN AB + 0.03MGi1.5MG N17875 001 MAY CFTG LOESTRIN 21 1/20 + GALEN CHEM 0.02MGi1MG N17876 001 APR CAHN AB + 0.02MGi1MG N17876 001 MAY CFTG TABLETi ORAL-28 ESTROSTEP FE + GALEN CHEM 0.02MGiO.03MGiO.035MGi1MGi1MGi1MG N20130 002 OCT 09, 1996 APR CAHN JUNEL FE 1.5/30 AB BARR 0. 03MG i1.5MG N76064 001 SEP 18, 2003 SEP NEWA JUNEL FE 1/20 AB BARR 0.02MGi1MG N76081 001 SEP 18, 2003 SEP NEWA LOESTRIN FE 1.5/30 AB + GALEN CHEM 0.03MGi1.5MG N17355 001 APR CAHN LOESTRIN FE 1/20 AB + GALEN CHEM 0.02MGi1MG N17354 001 APR CAHN
ETHINYL ESTRADIOL; NORGESTIMATE TABLETi ORAL-28 >A> TRI-SPRINTEC >A> AB BARR 0.035MG,O.035MG,O.035MGiO.18MG,O.21 5MG,O.25MG N75808 001 DEC 29, 2003 DEC NEWA
ETHINYL ESTRADIOL; NORGESTREL TABLETi ORAL-21 LO/OVRAL AB + WYETH PHARMS INC 0.03MGiO.3MG N17612 001 MAR CAHN OGESTREL 0.5/50-21 AB WATSON LABS 0.05MGiO.5MG N75406 001 DEC 15, 1999 FEB CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 ~ DEC 2003 1-39
ETHINYL ESTRADIOL; NORGESTREL TABLET; ORAL-21 OVRAL AB + WYETH PHARMS INC 0.05MG;0.5MG N16672 001 MAR CAHN TABLET; ORAL-28 LO/OVRAL-28 AB WYETH PHARMS INC 0.03MG;0.3MG N17802 001 MAR CAHN OGESTREL 0.5/50-28 AB WATSON LABS 0.05MG;0.5MG N75406 002 DEC 15, 1999 FEB CAHN OVRAL-28 AB WYETH PHARMS INC 0.05MG;0.5MG N16806 001 MAR CAHN
ETHIONAMIDE TABLET; ORAL TRECATOR-SC + WYETH PHARMS INC 250MG N13026 002 MAR CAHN
ETHOSUXIMIDE SYRUP; ORAL ETHOSUXIMIDE >A> AA MIKART 250MG/5ML N40506 001 DEC 22, 2003 DEC NEWA
ETHOTOIN TABLET; ORAL PEGANONE + OVATION PHARMS 250MG N10841 001 MAR CAHN @ 500MG N10841 003 MAR CAHN
ETIDRONATE DISODIUM TABLET; ORAL DIDRONEL AB PROCTER AND GAMBLE 200MG N17831 001 JUL CTEC AB + 400MG N17831 002 JUL CTEC ETIDRONATE DISODIUM AB GENPHARM 200MG N75800 001 JAN 24, 2003 JAN NEWA AB 400MG N75800 002 JAN 24, 2003 JAN NEWA
ETODOLAC CAPSULE; ORAL LODINE AB WYETH PHARMS INC 200MG N18922 002 JAN 31, 1991 MAR CAHN AB + 300MG N18922 003 JAN 31, 1991 MAR CAHN TABLET; ORAL AB WYETH PHARMS INC 400MG N18922 004 JUL 29, 1993 MAR CAHN AB + 500MG N18922 005 JUN 28, 1996 MAR CAHN TABLET, EXTENDED RELEASE; ORAL ETODOLAC AB TARO 400MG N76174 001 MAR 13, 2003 MAR NEWA AB 500MG N76174 002 MAR 13, 2003 MAR NEWA AB 600MG N76174 003 MAR 13, 2003 MAR NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-40
ETODOLAC TABLET, EXTENDED RELEASE; ORAL LODINE XL AB + WYETH PHARMS INC 400MG N20584 001 OCT 25, 1996 MAR CAHN AB + 500MG N20584 003 JAN 20, 1998 MAR CAHN AB + 600MG N20584 002 OCT 25, 1996 MAR CAHN
ETOPOSIDE INJECTABLE; INJECTION ETOPOSIDE AP SICOR PHARMS 20MG/ML N74284 001 FEB 10, 1994 JUL CAHN AP 20MG/ML N74529 001 JUL 24, 1996 JUL CAHN TOPOSAR AP GENSIA SICOR PHARMS 20MG/ML N74166 001 FEB 27, 1995 JUL CAHN
FAMOTIDINE INJECTABLE; INJECTION FAMOTIDINE AP BAXTERHLTHCARE 10MG/ML N75488 001 APR 16, 2001 AUG CAHN FAMOTIDINE PRESERVATIVE FREE AP BAXTER HLTHCARE 10MG/ML N75486 001 APR 16, 2001 JUN CAHN
FELBAMATE SUSPENS ION; ORAL FELBATOL + MEDPOINTE 600MG/5ML N20189 003 JUL 29, 1993 MAR CAHN TABLET; ORAL MEDPOINTE 400MG N20189 .001 JUL 29, 1993 MAR CAHN + 600MG N20189 002 JUL 29, 1993 MAR CAHN
FENOFIBRATE CAPSULE; ORAL FENOFIBRATE (MICRONIZED) AB IMPAX LAB:; 67MG N75868 001 OCT 27, 2003 OCT NEWA AB 134MG N75868 002· OCT 27, 2003 OCT NEWA AB 200MG N75868 003 OCT 27, 2003 OCT NEWA AB TEVA 67MG N75753 001 SEP 03, 2002 OCT CFTG 67MG N75753 001 SEP 03, 2002 MAR CTEC AB 134MG N75753 002 APR 09, 2002 OCT CFTG 134MG N75753 002 APR 09, 2002 MAR CTEC AB + 200MG N75753 003 APR 09, 2002 OCT CFTG + 200MG N75753 003 APR 09, 2002 MAR CRLD TRICOR (MICRONIZED) @ ABBOTT 67MG N19304 002 FEB 09, 1998 MAR DISC @ 134MG N19304 003 JUN 30, 1999 MAR DISC @ 200MG N19304 004 JUN 30, 1999 MAR DISC
FENOLDOPAM MESYLATE INJECTABLE; INJECTION CORLOPAM >0> + ABBOTT EQ 10MG BASE/ML N19922 001 SEP 23, 1997 DEC CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-41
>A> AP + EQ 10MG BASE/ML N19922 001 SEP 23, 1997 DEC CFTG >A> FENOLDOPAM MESYLATE >A> AP PHARMAFORCE EQ 10MG BASE/ML N76656 001 DEC 01, 2003 DEC NEWA
FENTANYL FILM, EXTENDED RELEASE; TRANSDERMAL DURAGESIC AB + ALZA 0.6MG/24HR N19813 004 AUG 07, 1990 NOV CFTG AB 1.2MG/24HR N19813 003 AUG 07, 1990 NOV CFTG AB 1.8MG/24HR N19813 002 AUG 07, 1990 NOV CFTG AB 2.4MG/24HR N19813 001 AUG 07, 1990 NOV CFTG FENTANYL AB MYLAN TECHNOLOGIES 0.6MG/24HR N76258 001 NOV 21, 2003 NOV NEWA AB 1.2MG/24HR N76258 002 NOV 21, 2003 NOV NEWA AB 1.8MG/24HR N76258 003 NOV 21, 2003 NOV NEWA AB 2.4MG/24HR N76258 004 NOV 21, 2003 NOV NEWA
FENTANYL CITRATE INJECTABLE; INJECTION FENTANYL CITRATE PRESERVATIVE FREE AP + BAXTER HLTHCARE EQ 0.05MG BASE/ML N19101 001 JUL 11, 1984 AUG CAHN
FERRIC AMMONIUM CITRATE FOR SOLUTI ON; ORAL FERRISELTZ @ OTSUKA 600MG/PACKET N20292 001 OCT 14, 1997 AUG CAHN
FERRIC HEXACYANOFERRATE(II) CAPSULE; ORAL RADIOGARDASE (PRUSSIAN BLUE) + HEYDT 500MG N21626 001 OCT 02, 2003 OCT NEWA + HEYL CHEMISCH 500MG N21626 001 OCT 02, 2003 NOV CAHN
FLAVOXATE HYDROCHLORIDE TABLET; ORAL FLAVOXATE HCL AB IMPAX PHARMS 100MG N76234 001 AUG 28, 2003 AUG NEWA URISPAS + ORTHO MCNEIL PHARM 100MG N16769 001 MAR CAHN AB + 100MG N16769 001 AUG CFTG
FLECAINIDE ACETATE TABLET; ORAL FLECAINIDE ACETATE AB GENEVA PHARMS 50MG N76030 001 OCT 28, 2002 JUN CAHN AB 100MG N76030 002 OCT 28, 2002 JUN CAHN AB 150MG N76030 003 OCT 28, 2002 JUN CAHN AB RANBAXY 50MG N76421 001 MAR 28, 2003 MAR NEWA AB 100MG N76421 002 MAR 28, 2003 MAR NEWA AB 150MG N76421 003 MAR 28, 2003 MAR NEWA AB ROXANE 50MG N76278 001 .JAN 14, 2003 JAN NEWA AB 100MG N76278 002 JAN 14, 2003 JAN NEWA AB 150MG N76278 003 JAN 14, 2003 JAN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-42
FLUDARABINE PHOSPHATE INJECTABLE; INJECTION FLUDARA AP + BERLEX 50MG/VIAL N20038 001 APR 18, 1991 AUG CFTG FLUDARABINE PHOSPHATE AP GENSIA SICOR PHARMS 50MG/VIAL N76349 001 AUG 28, 2003 AUG NEWA
FLUDROCORTISONE ACETATE TABLET; ORAL FLUDROCORTISONE ACETATE AB BARR 0.1MG N40425 001 JAN 21, 2003 JAN NEWA
FLUNISOLIDE SPRAY, METERED; NASAL NASAREL + IVAX RES 0.029MG/SPRAY N20409 001 MAR 08, 1995 JUL CPOT
FLUOCINONIDE CREAM; TOPICAL FLUOCINONIDE AB1 ALPHARMA US PHARM 0.05% N73085 001 FEB 14, 1992 MAY CTEC AB1 FOUGERA 0.05% N73030 001 OCT 17, 1994 MAY CTEC AB1 TARO 0.05% N19117 001 JUN 26, 19B4 MAY CTEC AB1 0.05% N71500 001 JUN 10, 1987 MAY CTEC AB1 TEVA 0.05% N72488 001 FEB 06, 1989 MAY CTEC FLUOCINONIDE EMULSIFIED BASE AB2 ALPHARMA US PHARM 0.05% N74204 001 JUN 13, 1995 MAY CTEC AB2 DRAXIS HLTH 0.05% N72494 001 JAN 19, 1989 MAY CTEC AB2 TARO 0.05% N72494 001 JAN 19, 1989 JUN CAHN AB2 TEVA 0.05% N72490 001 FEB 07, 1989 MAY CTEC LIDEX AB1 + MEDICIS 0.05% N16908 002 MAY CTEC LIDEX-E AB2 + MEDICIS 0.05% N16908 003 MAY CRLD
FLUORESCEIN SODIUM INJECTABLE; INJECTION FUNDUSCEIN-25 @ NOVARTIS 25% N17869 001 JAN DISC
FLUOROURACIL INJECTABLE; INJECTION ADRUCIL AP GENSIA SICOR PHARMS 50MG/ML N40023 001 OCT 18, 1991 JUL CAHN AP + 50MG/ML N81225 001 AUG 28, 1991 JUL CAHN FLUOROURACIL AP SICOR PHARMS 50MG/ML N40333 001 JAN 27, 2000 JUL CAHN AP 50MG/ML N40334 001 FEB 25, 2000 J.UL CAHN SOLUTION; TOPICAL EFUDEX AT + ICN 2% N16831 001 NOV CFTG AT + 5% N16831 002 NOV CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-43
FLUOROURACIL SOLUTION; TOPICAL FLUOROPLEX .@ ALLERGAN HERBERT 1% N16765 001 JUN DISC FLUOROURACIL AT TARO 2% N76526 001 NOV OS, 2003 NOV NEWA AT 5% N76526 002 NOV OS, 2003 NOV NEWA
>A> FLUOXETINE HYDROCHLORIDEj OLANZAPINE >A> CAPSULE; ORAL >A> SYMBYAX >A> LILLY EQ 25MG BASE;EQ 6MG BASE N21520002 DEC 24, 2003 DEC NEWA >A> EQ 25MG BASE;EQ 12MG BASE N21520 004 DEC 24, 2003 DEC NEWA >A> + EQ 50MG BASE;EQ 6MG BASE N21520 003 DEC 24, 2003 DEC NEWA >A> EQ 50MG BASE;EQ 12MG BASE N21520 005 DEC 24, 2003 DEC NEWA
FLUPHENAZINE DECANOATE INJECTABLE; INJECTION FLUPHENAZINE DECANOATE @ KING PHARMS 25MG/ML N74966 001 APR 16, 1998 MAY DISC
FLURANDRENOLIDE LOTION; TOPICAL CORD RAN + OCLASSEN 0.05% N13790 001 MAY CTEC + WATSON LABS 0.05% N13790 001 OCT CAHN
FLUTAMIDE CAPSULE; ORAL FLUTAMIDE AB GENPHARM 125MG N76224 001 MAY 09, 2003 MAY NEWA
FLUVOXAMINE MALEATE TABLET; ORAL FLUVOXAMINE MALEATE AB GENEVA PHARMS 25MG N75887 001 JAN OS, 2001 APR CAHN AB 50MG N75887 002 JAN OS, 2001 APR CAHN AB 100MG N75887 003 JAN OS, 2001 APR CAHN
FOLIC ACID INJECTABLE; INJECTION FOLIC ACID AP + AM PHARM PARTNERS 5MG/ML N89202 001 FEB 18, 1986 JUN CRLD FOLVITE AP + WYETH PHARMS INC 5MG/ML N05897 008 MAR CAHN @ 5MG/ML N05897 008 JUN DISC TABLET; ORAL @ WYETH PHARMS INC 1MG N05897 004 MAR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-44
FOSAMPRENAVIR CALCIUM TABLET; ORAL LEX IVA + GLAXOSMITHKlINE EQ 700MG BASE N21548 001 OCT 20, 2003 OCT NEWA
FOSINOPRIL SODIUM TABLET; ORAL FOSINOPRIL SODIUM AB TEVA 10MG N76139 001 NOV 25, 2003 NOV NEWA AB 20MG N76139 002 NOV 25, 2003 NOV NEWA AB 40MG N76139 003 NOV 25, 2003 NOV NEWA MONOPRIL AB BRISTOL MYERS SQUIBB 10MG N19915 002 MAY 16, 1991 NOV CFTG AB 20MG N19915 003 MAY 16, 1991 NOV CFTG AB + 40MG N19915 004 MAR 28, 1995 NOV CFTG
FUROSEMIDE INJECTABLE; INJECTION FUROSEMIDE @ BAXTER HLTHCARE 10MG/ML N18267 001 JUN DISC AP 10MG/ML N71439 001 SEP 14, 1990 AUG CAHN TABLET; ORAL AB CLONMEL HLTHCARE 20MG N18415 001 JUL 27, 1982 JUL CAHN @ 20MG N18415 001 JUL 27, 1982 AUG DISC AB 40MG N18415 002 JUL 27, 1982 JUL CAHN @ 40MG N18415 002 JUL 27, 1982 AUG DISC AB 80MG N18415 003 NOV 26, 1984 JUL CAHN @ 80MG N18415 003 NOV 26, 1984 AUG DISC
GABAPENTIN CAPSULE; ORAL GABAPENTIN AB PUREPAC PHARM 100MG N75350 001 SEP 12, 2003 SEP NEWA AB 300MG N75350 002 SEP 12, 2003 SEP NEWA AB 400MG N75350 003 SEP 12, 2003 SEP NEWA NEURONTIN AB PFIZER PHARMS 100MG N20235 001 DEC 30, 1993 SEP CFTG AB 300MG N20235 002 DEC 30, 1993 SEP CFTG AB + 400MG N20235 003 DEC 30, 1993 SEP CFT.G
GADOTERIDOL INJECTABLE; INJECTION PROHANCE MULTIPACK + BRACCO 279.3MG/ML N21489 001 OCT 09, 2003 OCT NEWA
GALANTAMINE HYDROBROMIDE TABLET; ORAL REMINYl + JANSSEN PHARMA EQ 4MG BASE N21169 001 FEB 28, 2001 APR CRLD EQ 12MG BASE N21169 003 FEB 28, 2001 APR CRLD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-45
GANCICLOVIR CAPSULE; ORAL CYTOVENE AB ROCHE PALO 250MG N20460 001 DEC 22, 1994 JUN CFTG AB + 500MG N20460 002 DEC 12, 1997 JUN CFTG GANCICLOVIR AB RANBAXY 250MG N76457 001 JUN 27, 2003 JUN NEWA AB 500MG N76457 002 JUN 27, 2003 JUN NEWA
GANCICLOVIR SODIUM INJECTABLE; INJECTION CYTOVENE IV AP + ROCHE PALO EQ 500MG BASE/VIAL N19661 001 JUN 23, 1989 JUL CFTG GANCICLOVIR SODIUM AP. BEDFORD EQ 500MG BASE/VIAL N76222 001 JUL 16, 2003 JUL NEWA
GATIFLOXACIN INJECTABLE; INJECTION TEQUIN + BRISTOL MYERS SQUIBB EQ 2MG /ML(200MG/100ML) N21062 001 DEC 17, 1999 APR CRLD + EQ 2MG /ML(400MG/200ML) N21062 002 DEC 17, 1999 APR CRLD + EQ 10MG /ML(200MG) N21062 003 DEC 17, 1999 APR CRLD SOLUTI ON/DROPS; OPHTHALMIC ZYMAR + ALLERGAN 0.3% N21493 001 MAR 28, 2003 MAR NEWA
GEFITI NI B TABLET; ORAL IRESSA + ASTRAZENECA 250MG N21399 001 MAY 05, 2003 MAY NEWA
GEMFIBROZIL TABLET; ORAL GEMFIBROZIL @ CLONMEL HLTHCARE 600MG N74270 001 SEP 27, 1993 ·AUG DISC
GEMIFLOXACIN MESYLATE TABLET; ORAL FACTIVE + GENESOFT PHARMS EQ 320MG BASE N21158 001 APR 04, 2003 MAY CAHN + LG LI FE EQ 320MG BASE N21158 001 APR 04, 2003 APR NEWA
GEMTUZUMAB OZOGAMICIN INJECTABLE; INJECTION MYLOTARG + WYETH PHARMS INC 5MG/VIAL N21174 001 MAY 17, 2000 MAR CAHN
GENTAMICIN ,SULFATE CREAM; TOPICAL GARAMYCIN @ SCHERING EQ 0.1% BASE N60462 001 FEB DISC GENTAMICIN SULFATE RXDRUG PRODUCT LIST -CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-46
. GENTAM.ICIN SULFATE CREAM; TOPICAL GENTAMICIN SULFATE AT + FOUGERA .. EQ 0.1% BASE N62531 001 JUL OS, 1984 FEB CRLD iNJECTABLE; INJECTION AP + AM PHARM .PARTNERS EQ 10MG BASE/ML N62356 001 MAR 04, 1982 JUN CRLD @ BAXTER HLTHCARE EQ 10MG BASE/ML N62251 002 JUN DISC @ EQ 40MG BASE/ML N62251 001 JUN DISC OINTMENT; OPHTHALMIC GARAMYCIN @ SCHERING EQ 0.3% BASE N50425 001 APR DISC GENTAMICIN SULFATE + AKORN EQ 0.3% BASE N64093 001 AUG 31, 1995 APR CRLD
GLiMEPIRIDE TABLET; ORAL AMARYL + AVENTI S PHARMS 1MG N20496 001 NOV 30, 1995 JAN CRLD 4MG N20496 003 NOV 30, 1995 JAN CRLD
GLiPIZIDE TABLET, EXTENDED RELEASE; ORAL GLiPIZIDE AB WATSON LABS 5MG N76467 001 SEP 08, 2003 SEP NEWA AB 10MG N76467 002 NOV 07, 2003 NOV NEWA GLUCOTROL XL AB PFIZER 5MG N20329 001 APR 26, 1994 SEP CFTG >0> + 10MG N20329 002 APR 26, 1994 DEC CTEC >A> AB + 10MG N20329 002 APR 26, 1994 DEC CTEC
GLYBURIDE TABLET; ORAL GLYBURIDE (MICRONIZED) @ AVENTIS PHARMS 1.5MG N20055 001 APR 17, 1992 OCT DISC @ 3MG N20055 002 APR 17, 1992 OCT DISC @ 6MG N20055 003 MAR 08, 2000 OCT DISC AB HIKMA 1.5MG N75890 001 JUL 31, 2003 JUL NEWA AB 3MG N75890 002 JUL 31, 2003 JUL NEWA AB 6MG N75890 003 JUL 31, 2003 JUL NEWA
GLYCOPYRROLATE INJECTABLE; INJECTION ROBINUL AP + BAXTER HLTHCARE CORP 0.2MG/ML N17558 001 AUG CAHN
GONADORELIN HYDROCHLORIDE INJECTABLE; INJECTION FACTREL + BAXTER HLTHCARE CORP EQ O.1MG BASE/VIAL N18123 001 SEP 30, 1982 MAY CAHN @ EQ 0.2MG BASE/VIAL N18123 002 SEP 30, 1982 MAY CAHN iil EQ 0.5MG BASE/VIAL N18123 003 SEP 30, 1982 MAY CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-47
GONADOTROPIN. CHORIONIC INJECTABLE; INJECTION A.P.L. iii FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN iii 10,000 UNITS/VIAL N17055 002 JUL CAHN iii 20,000 UNITS/VIAL N17055 003 JUL CAHN iii WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC iii 10,000 UNITS/VIAL N17055 002 JUN DISC . CHORIONIC GONADOTROPIN iii STERIS 5,000 UNITS/VIAL N17016 006 SEP DISC
GRAMICIDINi NEOMYCIN SULFATEi POLYMYXIN B SULFATE SOLUTION/DROPS; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN AT + BAUSCH AND LOMB 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML N64047 001 JAN 31, 1996 OCT CRLD
GRANISETRON HYDROCHLORIDE SOLUTI ON; ORAL KYTRIL + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUL CMFD
GREPAFLOXACIN HYDROCHLORIDE TABLET; ORAL RAXAR iii OTSUKA EQ 200MG BASE N20695 001 NOV 06, 1997 MAY DISC iii EQ 400MG BASE N20695 002 MAY 14, 1998 MAY DISC iii EQ 600MG BASE N20695 003 MAY 14, 1998 MAY DISC
GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE AB + WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD WYTENSIN iii WYETH AYERST EQ 4MG BASE N18587 001 SEP 07, 1982 JUN DISC iii EQ 8MG BASE N18587 002 SEP 07, 1982 JUN DISC
HALOPERIDOL DECANOATE INJECTABLE; INJECTION HALOPERIDOL DECANOATE iii KING PHARMS EQ 50MG BASE/ML N75176 001 FEB 09, 2000 MAY DISC iii EQ 100MG BASE/ML N75176 002 FEB 09, 2000 MAY DISC
HEPARIN SODIUM INJECTABLE; INJECTION HEP-LOCK AP + BAXTER HLTHCARE 10 UNITS/ML N17037 007 JUN CAHN AP + 100 UN ITS/ML N17037 006 JUN CAHN HEP-LOCK U/P AP BAXTER HL THCARE 10 UNITS/ML N17037 010 JUN 10; 1983 JUN CAHN AP 100 UN ITS/ML N17037 011 JUN 10, 1983 JUN CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 1.2 - DEC 2003 1-48
HEPAR I N SOD IUM INJECTABLE; INJECTION HEPARIN LOCK FLUSH @ BAXTER HLTHCARE CORP 10 UNITS/ML N17007 008 MAY CAHN @ 100 UN ITS/ML N17007 009 MAY CAHN HEPARIN SODIUM AP BAXTER HLTHCARE 1 ,000 UN ITS/ML N17037 001 JUN CAHN AP 5,000 UNITS/ML N17037 002 JUN CAHN AP 5,000 UNITS/0.5ML N17037 013 APR 07, 1986 JUN CAHN AP 10,000 UNITS/ML N17037 003 JUN CAHN @ BAXTER HLTHCARE CORP 1,000 UNITS/ML N17007 001 MAY CAHN @ 2,500 UNITS/ML N17007 007 MAY CAHN @ 5,000 UNITS/ML N17007 002 MAY CAHN @ 5,000 UNITS/0.5ML N17007 010 MAY CAHN @ 7,500 UNITS/ML N17007 003 MAY CAHN @ 10,000 UNITS/ML N17007 004 MAY CAHN @ 15,000 UNITS/ML N17007 005 MAY CAHN @ 20,000 UN ITS/ML N17007 006 MAY CAHN SODIUM HEPARIN @ BAXTER HLTHCARE' 1,000 UNITS/ML N17036 001 MAR 04, 1988 OCT DISC
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP; ORAL HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE AA AXIOM PHARM 1.5MG/5ML;5MG/5ML N40285 001 JUL 19, 1999 MAY CAHN
HYALURONIDASE INJECTABLE; INJECTION WYDASE @ BAXTER HLTHCARE 150 UN ITS/ML N06343 002 AUG CAHN @ 150 UNITS/VIAL N06343 006 AUG CAHN @ 1,500 UNITS/VIAL N06343 005 AUG CAHN
HYDRALAZINE HYDROCHLORIDE TABLET; ORAL HYDRALAZINE HCL @ CLONMEL HLTHCARE 25MG N86243 001 AUG DISC @ 50MG N862.42 002 AUG DISC @ IMPAX LABS 50MG N84923 001 NOV DISC
HYDROCHLOROTHIAZIDE TABLET; ORAL HYDROCHLOROTHIAZIDE AB CLONMEL HLTHCARE 25MG N87059 001 JUL CAHN AB 50MG N87068 001 JUL CAHN @ 100MG N87060 001 JUL CAHN
HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET; ORAL METHYLDOPA AND HYDROCHLOROTHIAZIDE @ CLONMEL HLTHCARE 15MG;250MG N72507 001 JUN 02, 1989 JUL DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-49
@ 25MG;250MG N72508 001 JUN 02, 1989 JUL DISC @ 30MG;500MG N72509 001 JUN 02, 1989 JUL DISC @ 50MG;500MG N72510 001 JUN 02, 1989 JUL DISC
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TABLET; ORAL BENICAR HCT SANKYO 12.5MG;20MG N21532 002 JUN OS, 2003JUN NEWA 12.5MG;40MG N21532 003 JUN OS, 2003 JUN NEWA + 25MG;40MG N21532 005 JUN OS, 2003 JUN NEWA
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE TABLET; ORAL INDERIDE-40/25 AB WYETH PHARMS INC 25MG;40MG N18031 001 MAR CAHN I NDER IDE -80/25 AB + WYETH PHARMS INC 25MG;80MG N18031 002 MAR CAHN
HYDROCHLOROTHIAZIDE; VALSARTAN TABLET; ORAL DIOVAN HCT NOVARTIS 25MG;160MG N20818 003 JAN 17, 2002 JUL NEWA
HYDROCODONE BITARTRATE; IBUPROFEN TABLET; ORAL HYDROCODONE BITARTRATE AND IBUPROFEN >A> AB ANDRX PHARMS 7.5MG;200MG N76604 001 DEC 31, 2003 DEC NEWA AB TEVA 7.5MG;200MG N76023 001 APR 11, 2003 APR NEWA VICOPROFEN AB + ABBOTT 7.5MG;200MG N20716 001 SEP 23, 1997 APR CFTG
HYDROCORTI SONE LOTION; TOPICAL HYDROCORTISONE AT VINTAGE PHARMS 2.5% N40417 001 JUL 30, 2003 JUL NEWA
HYDROCORTISONE CYPIONATE SUSPENSION; ORAL CORTEF @ PHARMACIA AND UPJOHN EQ 10MG BASE/5ML N09900 001 AUG DISC
HYDROCORTISONE SODIUM PHOSPHATE INJECTABLE; INJECTION HYDROCORTONE @ MERCK EQ 50MG BASE/ML N12052 001 APR DISC
HYDROCORTISONE SODIUM SUCCINATE INJECTABLE; INJECTION HYDROCORTISONE SODIUM SUCCINATE @ BAXTER HLTHCARE EQ 100MG BASE/VIAL N86619 001 AUG CAHN @ EQ 250MG BASE/VIAL N87567 001 AUG CAHN @ EQ 500MG BASE/VIAL N87568 001 AUG CAHN @ EQ 1GM BASE/VIAL N87569 001 AUG CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-50
HYDROCORTISONE; NEOMYCIN SULFATE CREAM; TOPICAL NEO-CORT-DOME &') BAYER PHARMS 0.5%;EQ 3.5MG BASE/GM N50237 006 JUN OS, 1984 JUN DISC &') 1%;EQ 3.5MG BASE/GM N50237 005 JUN OS, 1984 JUN DISC
HYDROCORTI SONE i NEOMYCIN SULFATEi POLYMYXIN B SULFATE SOLUTION/DROPS; OTIC NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE AT ALCON 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62423 001 AUG 25, 1983 FEB CMFD SUSPENSION/DROPS; OPHTHALMIC AT ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62874 001 MAY 11, 1988 FEB CMFD SUSPENSION/DROPS; OTIC AT ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62488 001 NOV 06, 1985 FEB CMFD
HYDROCORTISONEi POLYMYXIN B SULFATE SOLUTI ON/DROPS; OTIC OTOB.lOTIC &') SCHERING 5MG/ML;EQ 10,000 UNITS BASE/ML N62302 001 OCT WDAG
HYDROFLUMETHIAZIDE TABLET; ORAL DIUCARDIN &') WYETH AYERST 50MG N83383 001 JUN DISC
HYDROFLUMETHIAZIDEi RESERPINE TABLET; ORAL SALUTENSIN &') SHIRE LABS 50MG;0.125MG N12359 003 JUL DISC
HYDROMORPHONE HYDROCHLORIDE INJECTABLE; INJECTION HYDROMORPHONE HCL AP FAULDING 10MG/ML N76444 001 APR .25, 2003 APR NEWA
HYDROXYZINE HYDROCHLORIDE INJECTABLE; INJECTION HYDROXYZINE &') ELKINS SINN 50MG/ML N85551 002 JUN DISC HYDROXYZINE HCL &') ELKINS SINN 25MG/ML N85551 001 JUN DISC TABLET; ORAL ATARAX @ PFIZER 10MG N10392 001 FEB DISC &') 25MG N10392 004 FEB DISC &') 50MG N10392 006 FEB DISC &') 100MG N10392 005 FEB DISC HYDROXYZINE HCL AB + SIDMAK LABS NJ 10MG N88617 001 JAN 10, 1986 FEB CRLD AB + 25MG N88618 001 JAN 10, 1986 FEB CRLD AB + 50MG N88619 001 JAN 10, 1986 FEB CRLD &') 100MG N81054 001 SEP 25, 1995 FEB DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-51
HYDROXYZINE PAMOATE SUSPENSION; ORAL VISTARIL + PFIZER EQ 25MG HCL/5ML N11795 001 OCT CRLD
IBANDRONATE SODIUM TABLET; ORAL BON IVA @ ROCHE EQ 2.5MG BASE N21455 001 MAY 16, 2003 JUL DISC + EQ 2.5MG BASE N21455 001 MAY 16, 2003 MAY NEWA
IFOSFAMIDE INJECTABLE; INJECTION IFOSFAMIDE + AM PHARM PARTNERS 1GM/VIAL N76078 001 MAY 28, 2002 SEP CTNA + 3GM/VIAL N76078 002 MAY 28, 2002 SEP CTNA
IMATINIB MESYLATE CAPSULE; ORAL GLEEVEC @ NOVARTIS 50MG N21335 001 MAY 10, 2001 JUN DISC TABLET; ORAL NOVARTIS 100MG N21588 001 APR 18, 2003 APR NEWA + 400MG N21588 002 APR 18, 2003 APR NEWA
INDOMETHACIN CAPSULE; ORAL INDOMETHACIN >A> AB ABLE 25MG N76666 001 DEC 17, 2003 DEC NEWA >A> AB 50MG N76666 002 DEC 17, 2003 DEC NEWA
INULIN INJECTABLE; INJECTION INULIN AND SODIUM CHLORIDE >A> @ ISO TEX 100MG/ML N02282 001 DEC CAHN >D> @ QUEST COR PHARMS 100MG/ML N02282 001 DEC CAHN @ 100MG/ML N02282 001 SEP DISC
IOPAMIDOL INJECTABLE; INJECTION I OPAM IDOL @ BAXTER HLTHCARE 41% N74629 001 NOV 06, 1996 AUG CAHN @ 51% N74629 004 MAR 31, 1998 AUG CAHN @ 61% N74629 002 NOV 06, 1996 AUG CAHN @ 76% N74629 003 NOV 06, 1996 AUG CAHN @ ELKINS SINN PHARM 41% N74629 001 NOV 06, 1996 JUN DISC @ 51% N74629.004 MAR 31, 1998 JUN DISC @ 61% N74629 002 NOV 06, 1996 JUN DISC @ 76% N74629 003 NOV 06, 1996 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12- DEC 2003 1-52
10VERSOL INJECTABLE; INJECTION OPTIRAY 240 Iii MALLINCKRODT 51% N20923 001 MAY 28, 1998 JUN DISC OPTIRAY 300 + MALLINCKRODT 64% N20923 004 MAY 13, 1999 JUN NEWA OPTIRAY 320 @ MALLINCKRODT 68% N20923 002 MAY 29, 1998 JUN DISC
IPRATROPIUM BROMIDE SPRAY, METERED; NASAL ATROVENT AB + BOEHRINGER INGELHEIM 0.021MG/SPRAY N20393 001 OCT 20, 1995 MAR CFTG AB + 0.042MG/SPRAY N20394 001 OCT 20, 1995 MAR CFTG IPRATROPIUM BROMIDE AB BAUSCH AND LOMB 0.021MG/SPRAY N76025 001 MAR 31, 2003 MAR NEWA AB 0.042MG/SPRAY N76103 001 MAR 31, 2003 MAR NEWA AB DEY 0.021MG/SPRAY N75552 001 MAR 31, 2003 MAR NEWA AB 0.042MG/SPRAY N75553 001 MAR 31, 2003 MAR NEWA AB NOVEX 0.021MG/SPRAY N76156 001 APR 18, 2003 APR NEWA AB 0.042MG/SPRAY N76155 001 APR 18, 2003 APR NEWA AB ROXANE 0.021MG/SPRAY N76664 001 NOV OS, 2003 NOV NEWA AB 0.042MG/SPRAY N76598 001 NOV OS, 2003 NOV NEWA
ISONIAZID TABLET; ORAL ISONIAZID @ AXIOM PHARM 100MG N80136 001 MAY CAHN AA 300MG N83633 001 MAY CAHN
ISOPROTERENOL HYDROCHLORIDE INJECTABLE; INJECTION ISOPROTERENOL HCL @ BAXTER HLTHCARE 0.2MG/ML N83486 001 JUN DISC
ISOSORBIDE·DINITRATE CAPSULE, EXTENDED RELEASE; ORAL DILATRATE-SR BC + SCHWARZ PHARMA 40MG N19790 001 SEP 02, 1988 JUN CRLD + 40MG N19790 001 SEP 02, 1988 JUL CTEC ISORDIL @ WYETH AYERST 40MG N12882 002 JUL 29, 1988 JUN DISC TABLET; ORAL AB BIOVAIL 5MG N12093 007 JUL 29, 1988 JUN CAHN AB 10MG N12093 002 JUL 29, 1988 JUN CAHN AB 20MG N12093 006 JUL 29, 1988 JUN CAHN AB + 30MG N12093 005 JUL 29, 1988 JUN CAHN AB 40MG N12093 001 JUL 29, 1988 JUN CAHN + 40MG N12093 001 JUL 29, 1988 OCT CRLD AB WYETH PHARMS INC 5MG N12093 007 JUL 29, 1988 MAR CAHN AB 10MG N12093 002 JUL 29, 1988 MAR CAHN AB 20MG N12093 006 JUL 29, 1988 MAR CAHN Rl( DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 " DEC 2003 1-53
AB + 30MG N12093 005 JUL 29, 1988 MAR CAHN AB 40MG N12093 001 JUL 29, 1988 MAR CAHN SORBITRATE @ ASTRAZENECA 20MG N86405 002 AUG 21, 1990 OCT WDAG , @. 40MG N88125 001 AUG 21, 1990 OCT WDAG TABLET; SUBLINGUAL ISORDIL AB BIOVAIL 2.5MG N12940 004 JUL 29, 1988 JUN CAHN AB 5MG N12940 003 JUL 29, 1988 JUN CAHN + 10MG N12940 005 JUL 29, 1988 JUN CAHN AB WYETH PHARMS INC 2.5MG N12940 004 JUL 29, 1988 MAR CAHN AB 5MG N12940 003 JUL 29, 1988 MAR CAHN + 10MG N12940 005 JUL 29, 1988 MAR CAHN TABLET, CHEWABLE; ORAL SORBITRAT,E @ ASTRAZENECA 10MG N16776 003 APR 01, 1996 OCT WDAG
ISOSORBIDE MONONITRATE TABLET', EXTENDED RELEASE; ORAL IMDUR AB + SCHERING PLOUGH 30MG N20225 001 AUG 12, 1993 OCT CAHN AB + 60MG N20225 002 AUG 12, 1993 OCT CAHN AB + 120MG N20225 003 MAR'30, 1995 OCT CAHN
ISOTRETINOIN CAPSULE; ORAL CLARAVIS AB BARR 10MG N76356 001 APR 11, 2003 APR NEWA AB 20MG N76135 002 APR , 1 , 2003 APR NEWA AB 40MG N76135 001 APR 11, 2003 APR NEWA SOT RET RANBAXY 30MG N76503 001 JUN 20, 2003 JUN NEWA
ISRADIPINE CAPSULE; ORAL DYNACIRC RELIANT PHARMS 2.5MG N19546 001 DEC 20, 1990 MAY CAHN + 5MG N19546 002 DEC 20, 1990 MAY CAHN TABLET, EXTENDED RELEASE; ORAL DYNACIRC CR + RELIANT PHARMS 5MG N20336 001 JUN 01, 1994 MAY CAHN + 10MG N20336 002 JUN 01, 1994 MAY CAHN
KANAMYCIN SULFATE INJECTABLE; INJECTION KANAMYCIN @ BAXTER HLTHCARE EQ 75MG BASE/2ML N62324 001 AUG CAHN @ EQ 500MG BASE/2ML N62324 002 AUG CAHN @ EQ 1GM BASE/3ML N62324 003 AUG CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-54
KETOPROFEN CAPSULE; ORAL KETOPROFEN AB CLONMEL HLTHCARE 75MG N74014 003 JAN 29, 1993 JUN CAHN AB + TEVA 75MG N73517 001 DEC 22, 1992 JUN CRLD ORUDIS @ WYETH AYERST 25MG N18754 001 JUL 31, 1987 JUN DISC @ 50MG N18754 002 JAN 09, 1986 JUN DISC @ 75MG N18754 003 JAN 09, 1986 JUN DISC CAPSULE, EXTENDED RELEASE; ORAL ORUVAIL AB WYETH PHARMS INC 100MG N19816 003 FEB 08, 1995 MAR CAHN AB 150MG N19816 002 FEB 08, 1995 MAR CAHN AB + 200MG N19816 001 SEP 24, 1993 MAR CAHN
KETOROLAC TROMETHAMINE INJECTABLE; INJECTION KETOROLAC TROMETHAMINE @ ABBOTT 15MG/ML N74801 001 JUN 05, 1997 OCT DISC @ 30MG/ML N74801 002 JUN OS, 1997 OCT DISC AP + BEDFORD 30MG/ML N75228 001 APR 26, 1999 OCT CRLD SOLUTI ON/DROPS; OPHTHALMIC ACULAR LS + ALLERGAN 0.4% N21528 001 MAY 30, 2003 MAY NEWA
LABETALOL HYDROCHLORIDE TABLET; ORAL LABETALOL HCL @ APOTHECON 100MG N75223 001 NOV 20, 1998 OCT WDAG @ 200MG N75223 002 NOV 20, 1998 OCT WDAG @ 300MG N75223 003 NOV 20, 1998 OCT WDAG
LACTULOSE SOLUTION; ORAL CHRONULAC @ AVENTIS PHARMS 10GM/15ML N17884 001 AUG DISC CON STU LOSE AA + ALPHARMA 10GM/15ML N70288 001 AUG 15, 1988 AUG CRLD LACTULOSE AA VISTAPHARM 10GM/15ML N74138 001 SEP 30, 1992 MAR CAHN SOLUTI ON; ORAL, RECTAL AA NOVEX 10GM/15ML N76645 001 JUL 28, 2003 JUL NEWA
LAMIVUDINE TABLET; ORAL EPIVIR GLAXOSMITHKLINE 300MG N20564 003 JUN 24, 2002 SEP NEWA
LANSOPRAZOLEi NAPROXEN >A> CAPSULE, DELAYED REL PELLETS; TABLET; ORAL >A> NAPRAPAC 250 (COPACKAGED) >A> TAP PHARM 15MG;250MG N21507 002 NOV 14, 2003 DEC NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-55
LANSOPRAZOLEi NAPROXEN >A> CAPSULE, DELAYED REL PELLETS; TABLET; ORAL >A> NAPRAPAC 375 (COPACKAGED) >A> TAP PHARM 15MG;375MG N21507 003 NOV 14, 2003 DEC NEWA >A> NAPRAPAC 500 (COPACKAGED) >A> + TAP PHARM 15MG;500MG N21507 004 NOV 14, 2003 DEC NEWA
LEFLUNOMIDE TABLET; ORAL ARAVA + AVENTIS PHARMS 20MG N20905 002 SEP 10, 1998 MAR CRLD @ 100MG N20905 003 SEP 10, 1998 MAR DISC
LEUCOVORIN CALCIUM FOR SOLUTION; ORAL LEUCOVORIN CALCIUM @ FAULDING EQ 60MG BASE/VIAL N08107 003 JAN 30, 1987 OCT CAHN INJECTABLE; INJECTION @ ELKINS SINN EQ 50MG BASE/VIAL N70480 001 JAN 02, 1987 JUN DISC @ EQ 100MG BASE/VIAL N81224 001 JUN 03, 1994 JUN DISC @ FAULDING EQ 3MG BASE/ML N08107 001 OCT CAHN AP + EQ 50MG BASE/VIAL N08107 002 OCT CAHN AP + EQ 100MG BASE/VIAL N08107 004 MAY 23, 1988 OCT CAHN AP + EQ 350MG BASE/VIAL N08107 005 APR OS, 1989 OCT CAHN
LEUPROLIDE ACETATE INJECTABLE; SUBCUTANEOUS ELiGARD + ATRIX 30MG/VIAL N21488 001 FEB 13, 2003 FEB NEWA
LEVALBUTEROL HYDROCHLORIDE SOLUTION; INHALATION XOPENEX + SEPRACOR EQ 0.0103% BASE N20837 003 JAN 30, 2002 JUL CPOT + EQ 0.25% BASE N20837 004 JUL 18, 2003 JUL NEWA
LEVAMISOLE HYDROCHLORIDE TABLET; ORAL ERGAMISOL @ JANSSEN PHARMA EQ 50MG BASE N20035 001 JUN 18, 1990 NOV DISC
LEVETIRACETAM SOLUTION; ORAL KEPPRA + UCB 100MG/ML N21505 001 JUL 15, 2003 JUL NEWA
LEVOBETAXOLOL HYDROCHLORIDE SUSPENSION/DROPS; OPHTHALMIC BETAXON @ ALCON EQ 0.5% BASE N21114 001 FEB 23, 2000 JUL CAHN + MEDPOINTE EQ 0.5% BASE N21114 001 FEB 23, 2000 MAR CAHN RX DRUGp,RODUCT LIST - CUMULATIVE .SUPP.LE.MENT 1.2' - DEC 2003 1-56
LEVOFLOXACIN INJECTABLE; INJECTION LEVAQUIN + ORTHO MCNEIL PHARM 500MG /20ML(25MG/ML) N20635 001 DEC 20, 1996 OCT CPOT + 750MG /30ML(25MG/ML) N20635 004 DEC 20, 1996 OCT NEWA LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER + ORTHO MCNEIL PHARM 250MG /50ML(5MG/ML) N20635 002 DEC 20,. 1996 OCT CPOT + 500MG /100ML(5MG/M~) N20635 003 DEC 20, 1996 OCT CPOT + 750MG /150ML(5MG/ML) N20635 005 DEC 20, 1996 OCT NEWA
LEVONORGESTREL IMPLANT; IMPLANTATION LEVONORGESTREL BX + WYETH PHARMS INC 75MG/IMPLANT N20627 001 AUG 15, 1996 MAR CAHN @ 75MG/IMPLANT N20627 001 AUG 15, 1996 JUN DISC NORPLANT II BX + POPULATION COUNCIL 75MG/IMPLANT N20544 001 NOV 01, 1996 JUN CRLD NORPLANT SYSTEM IN PLASTIC CONTAINER + WYETH PHARMS INC 36MG/IMPLANT N20088 001 DEC 10, 1990 MAR CAHN @ 36MG/IMPLANT N20088 001 DEC '10, 1990 JUN DISC
LEVORPHANOL TARTRATE TABLET; ORAL LEVO-DROMORAN @ ICN 2MG N08720 001 DEC'19, 1991 FEB DISC LEVORPHANOL TARTRATE + ROXANE 2MG N74278 001 MAR 31, 2000 FEB CRLD
LEVOTHYROXINE SODIUM TABLET; ORAL. LEVO-T BX ALARA PHARM 0.025MG N21342 001 MAR 01, 2002 APR CAHN BX 0.05r~G N21342 002 MAR 01, 2002 APR CAHN BX 0.075MG N21342 003 MAR 01, 2002 APR CAHN BX 0.088MG N21342 004 MAR 01, 2002 APR CAHN BX 0.1MG N21342 005 MAR 01, 2002 APR CAHN BX 0.112MG N21342 006 MAR 01, 2002 APR CAHN BX 0.125MG N21342 007 MAR 01 , 2002 APR CAHN >A> BX 0.137MG N21342 012 DEC 08, 2003 DEC NEWA BX 0.15MG N21342 008 MAR 01, 2002 APR CAHN BX 0.175MG N21342 009 MAR 01, 2002 APR CAHN BX 0.2MG N21342 010 MAR 01, 2002 APR CAHN BX + 0.3MG N21342 011 MAR 01, 2002 APR CAHN LEVOLET BX VINTAGE PHARMS 0.025MG N21137 001 JUN 06, 2003 JUN NEWA BX 0.05MG N21137 002 JUN 06, 2003 JUN NEWA BX 0.075MG N21137 003 JUN 06, 2003 JUN NEWA BX 0.088MG N21137 004 JUN 06, 2003 JUN NEWA BX 0.1MG N21137 005 JUN 06, 2003 JUN NEWA BX 0.112MG N21137 006 JUN 06, 2003 JUN NEWA BX 0.125MG N21137 007 JUN 06, 2003 JUN NEWA BX 0.137MG N21137 008 JUN 06, 2003 JUN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-57
BX 0.15MG N21137 009 JUN 06, 2003 JUN NEWA BX 0.175MG N21137 010 JUN 06, 2003 JUN NEWA BX 0.2MG N21137 011 JUN 06, 2003 JUN NEWA BX 0.3MG N21137 012 JUN 06, 2003 JUN NEWA
LIDOCAINE SOLUTION; TOPICAL XYLOCAINE 6l ASTRAZENECA 5% N14127 001 AUG DISC
LIDOCAINE HYDROCHLORIDE INJECTABLE; INJECTION LIDOCAINE HCL 6l ELKINS SINN 1% N80407 001 JUN DISC 6l 2% N80407 002 JUN DISC 6l WYETH AYERST 1% N83083 001 JUN DISC 6l 2% N83083 002 JUN DISC LIDOCAINE HCL PRESERVATIVE FREE 6l ELKINS SINN 1% N84625 001 JUN DISC 6l 2% N84625 002 JUN DISC JElLY; TOPICAL LIDOCAINE HCL AT AKORN 2% N40433 001 FEB 12, 2003 FEB NEWA
LIDOCAINEi PRILOCAINE CREAM; TOPICAL EM LA AB +. ASTRAZENECA 2.5%;2.5% N19941 001 DEC 30, 1992 AUG CFTG LIDOCAINE AND PRILOCAINE AB ALTANA 2.5%;2.5% N76453 001 AUG 18, 2003 AUG NEWA AB ATRIX 2.5%;2.5% N76320 001 AUG 27, 2003 AUG NEWA AB HI TECH PHARMA 2.5%;2.5% N76290 001 SEP 25, 2003 SEP NEWA >A> GEL; PERIODONTAL >A> ORAQIX >A> + DENTSPLY PHARM 2.5%;2.5% N21451 001 DEC 19, 2003 DEC NEWA
L1SINOPRIL TABLET; ORAL L1SINOPRIL AB RANBAXY 30MG N75944 006 FEB 11, 2003 FEB NEWA AB WEST· WARD 30MG N76063 006 JUN 27, 2003 JUN NEWA ZESTRIL AB ASTRAZENECA 30MG N19777 006 JAN 20, 1999 APR CRLD
LITHIUM CARBONATE CAPSULE; ORAL LITHIUM CARBONATE AB ROXANE 150MG N17812 002 JAN 28, 1987 FEB CTEC AB WEST WARD 150MG N76243 002 FEB 24, 2003 FEB NEWA TABLET, EXTENDED RELEASE; ORAL ESKALITH CR AB + GLAXOSMITHKLlNE 450MG N18152 001 MAR 29, 1982 JUN CFTG LITHIUM CARBONATE RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-58
LITHIUM CARBONATE TABLET, EXTENDED RELEASE; ORAL LITHIUM CARBONATE AB ABLE 300MG N76382 001 APR 21, 2003 APR NEWA AB BARR 450MG N76366 001 AUG 21, 2003 AUG NEWA AB WEST WARD 450MG N76490 001 JUN 17, 2003 JUN NEWA
LORAZEPAM CONCENTRATE; ORAL LORAZEPAM INTENSOL + ROXANE 2MG/ML N72755 001 JUN 28, 1991 MAY CRLD INJECTABLE; INJECTION ATiVAN AP + BAXTER HLTHCARE CORP 2MG/ML N18140 001 FEB CAHN AP + 4MG/ML N18140 002 FEB CAHN TABLET; ORAL AB BIOVAIL 0.5MG N17794 001 JUN CAHN AB 1MG N17794 002 JUN CAHN AB + 2MG N17794 003 JUN CAHN
MECAMYLAMINE HYDROCHLORIDE TABLET; ORAL INVERSINE + TARGACEPT 2.5MG N10251 001 APR CAHN
MECLOFENAMATE SODIUM CAPSULE; ORAL MECLOFENAMATE SODIUM AB + MYLAN EQ 100MG BASE N71081 001 SEP 03, 1986 MAY CRLD MECLOMEN @ PARKE DAVIS EQ 50MG BASE N18006 001 MAY DISC @ EQ 100MG BASE N18006 002 MAY DISC
MEFLOQUINE HYDROCHLORIDE TABLET; ORAL MEFLOQUINE >A> AB BARR 250MG N76392 001 DEC 29, 2003 DEC NEWA MEFLOQUINE HCL AB GENEVA PHARMS 250MG N76175 001 FEB 20, 2002 APR CAHN
MEGESTROL ACETATE SUSPENSION; ORAL MEGESTROL ACETATE AB COPLEY PHARM 40MG/ML N75681 001 MAY OS, 2003 MAY NEWA
MEMANTINE HYDROCHLORIDE TABLET; ORAL NAMENDA FOREST LABS 5MG N21487 001 OCT 16, 2003 OCT NEWA + 10MG N21487 002 OCT 16, 2003 OCT NEWA @ 15MG N21487 003 OCT 16, 2003 OCT DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12- DEC 2003 1-59
@ 20MG N21487 004 OCT 16, 2003 OCT DISC
MENOTROPINS (FSHjLH) INJECTABLE; INJECTION REPRONEX BX + FERRING 75 IU/VIAL;75 IU/VIAL N21047 D01 AUG 27, 1999 MAY CRLD @ 150 IU/VIAL;150 IU/VIAL N21047 002 AUG 27, 1999 MAY DISC
MEPERIDINE HYDROCHLORIDE INJECTABLE; INJECTION MEPERIDINE HCL @ BAXTER HLTHCARE 25MG/ML NB8279 001 JUN 15, 1984 AUG CAHN @ 50MG/ML N88280 001 JUN 15, 1984 AUG CAHN' @ 75MG/ML N88281 001 JUN 15, 1984 AUG CAHN @ 100MG/ML N88282 001 JUN 15, 1984 AUG CAHN I\P BAXTER HLTHCARE CORP 25MG/ML N80455 007 MAY CAHN I\P 50MG/ML N80455 008 MAY CAHN I\P 75MG/ML N80455 009 MAY CAHN I\P 100MG/ML N80455 010 MAY CAHN TABLET; ORAL 1\1\ AXIOM PHARM 50MG N80448 001 MAY CAHN 1\1\ 100MG N80448 002 MAY CAHN @ WYETH AYERST 50MG N80454 001 JUN DISC
MEPERIDINE HYDROCHLORIDEj PROMETHAZINE HYDROCHLORIDE INJECTABLE; INJECTION MEPERGAN @ BAXTER HLTHCARE CORP 25MG/ML;25MG/ML N11730 001 MAY CAHN
MEPHENTERMINE SULFATE INJECTABLE; INJECTION WYAMINE SULFATE @ BAXTER HLTHCARE CORP EQ 15MG BASE/ML N08248 002 FEB CAHN @ EQ 30MG BASE/ML N08248 001 FEB CAHN
MEPROBAMATE TABLET; ORAL EQUANIL @ WYETH AYERST 200MG N10028 005 JUN DISC @ 400MG N10028 004 JUN DISC MEPROBAMATE @ MYLAN 400MG N83618 001 NOV DISC + ROXANE 600MG N84332 001 JUN CRLD @ WEST WARD 200MG N15417 003 NOV DISC @ 400MG N15417 002 NOV DISC MILTOWN AA + MEDPOINTE 600MG N83919 001 APR CAHN @ MEDPOINTE PHARM HLC 600MG N83919 001 JUN DISC
MERCAPTOPURINE TABLET; ORAL PURINETHOL + TEVA 50MG N09053 002 AUG CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-60
MESORIDAZINE BESYLATE TABLET; ORAL SERENTIL iil NOVARTIS EQ 10MG BASE N16774 001 JUN DISC iil EQ 50MG BASE N16774 003 JUN DISC
MESTRANOLj NORETHINDRONE TABLET; ORAL-21 NORINYL 1+50 21-DAY AB + WATSON LABS (UTAH) 0.05MG;1MG N13625 002 AUG CRLD ORTHO-NOVUM 1/50 21 iil ORTHO MCNEIL PHARM 0.05MG;1MG N12728 004 AUG DISC
METAXALONE TABLET; ORAL SKELAXIN JONES PHARMA INC 400MG N13217 001 JUN CAHN + 800MG N13217 003 AUG 30, 2002 JUN CAHN
METFORMIN HYDROCHLORIDE SOLUTION; ORAL RIOMET + RANBAXY 500MG/5ML N21591 001 SEP 11, 2003 SEP NEWA TABLET; ORA.L METFORMIN HCL AB PUREPAC PHARM 1GM N76033 003 JAN 24, 2002 FEB CMS1 TABLET, EXTENDED RELEASE; ORAL GLUCOPHAGE XR BRISTOL MYERS SQUIBB 500MG N21202 001 OCT 13, 2000 AUG CRLD + 750MG N21202 004 APR 11, 2003 APR NEWA
METFORMIN HYDROCHLORIDEj ROSIGLITAZONE MALEATE TABLET; ORAL AVANDAMET SB PHARMCO 500MG;EQ 1MG BASE N21410 001 OCT 10, 2002 APR CAHN 500MG;EQ 2MG BASE N21410 002 OCT 10, 2002 APR CAHN + 500MG;EQ 4MG BASE N21410 003 OCT 10, 2002 APR CAHN 500MG;EQ 4MG BASE N21410 003 OCT 10, 2002 AUG CRLD 1GM;EQ 2MG BASE N21410 004 AUG 25, 2003 AUG NEWA + 1GM;EQ 4MG BASE N21410 005 AUG 25, 2003 AUG NEWA
METHACHOLINE CHLORIDE FOR SOLUTION; INHALATION PROVOCHOLINE + MET HAP HARM 100MG/VIAL N19193 001 OCT 31, 1986 OCT CRLD
METHADONE HYDROCHLORIDE INJECTABLE; INJECTION DOLOPHINE HCL + AAIPHARMA 10MG/ML N21624 001 APR CAHN + ROXANE 10MG/ML N21624 001 FEB CMS1 RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 -DEC 2003 1-61
METHAZOLAMIDE TABLET; ORAL METHAZOLAMIDE AB + MIKART 50MG N40062 002 JAN .27, 1994 JUN CRLD NEPTAZANE @ LEDERLE 25MG N11721 002 NOV 25, 1991 JUN DISC @ 50MG N11721 001 JUN DISC
METHENAMINE HIPPURATE TABLET; ORAL METHENAMINE HIPPURATE AB COREPHARMA 1GM N76411 001 JUN 20, 2003 JUN NEWA
METHIMAZOLE TABLET; ORAL TAPAZOLE AB LILLY 10MG N07517 004 JUN CRLD
METHOCARBAMOL INJECTABLE; INJECTION ROBAXIN AP + BAXTER HLTHCARE CORP 100MG/ML N11790 001 AUG CAHN TABLET; ORAL METHOCARBAMOL AA ABLE 500MG N40413 001 MAR 17, 2003 MAR NEWA AA 750MG N40413 002 MAR 17, 2003 MAR NEWA @ CLONMEL HLTHCARE 500MG N85961 001 JUN DISC @ 750MG N85963 001 JUN DISC AA LAN NETT 500MG N84756 002 MAR 31, 2003 MAR NEWA @ NYLOS . 750MG N85033 001 NOV DISC AA VINTAGE PHARMS 500MG N40489 001 JAN 29, 2003 JAN NEWA AA 750MG N40489 002 JAN 29, 2003 JAN NEWA
METHOTREXATE SODIUM INJECTABLE; INJECTION METHOTREXATE LPF AP + FAULDING EQ 25MG BASE/ML N11719 007 MAR 31, 1982 OCT CAHN AP + WYETH PHARMS INC EQ 25MG BASE/ML N11719 007 MAR 31, 1982 MAR CAHN METHOTREXATE SODIUM @ FAULDING EQ 2.5MG BASE/ML N11719 004 OCT CAHN + EQ 20MG BASE/VIAL N11719 001 OCT CAHN AP + EQ 25MG BASE/ML N11719 005 OCT CAHN @ EQ 50MG BASE/VIAL N11719 003 OCT CAHN @ EQ 100MG BASE/VIAL N11719 006 OCT CAHN @ WYETHPHARMS INC EQ 2.5MG BASE/ML N11719 004 MAR CAHN + EQ 20MG BASE/VIAL N11719 001 MAR CAHN AP + EQ 25MG BASE/ML N11719 005 MAR CAHN @ EQ 50MG BASE/VIAL N11719 003 MAR CAHN @ EQ 100MG BASE/VIAL N11!19 006 MAR CAHN METHOTREXATE SODIUM PRESERVATIVE FREE AP + FAULDING EQ 1GM. BASE/VIAL N11719 009 APR 07, 1988 OCT CAHN AP + WYETH PHARMS INC EQ 1GM BASE/VIAL N11719 009 APR 07, 1988 MAR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12" DEC 2003 1-62
METHSCOPOLAMINE BROMIDE TABLET; ORAL PAMINE FORTE + BRADLEY PHARMS 5MG N08848 002 MAR 25, 2003 MAR NEWA
METHYCLOTHIAZIDE TABLET; ORAL AQUATENSEN @ MEDPOINTE PHARM HLC 5MG N17364 001 JUN DISC
METHYLDOPA TABLET; ORAL ALDOMET @ MERCK 125MG N13400 003 MAY DISC @ 250MG N13400 001 MAY DISC METHYLDOPA @ CLONMEL HLTHCARE 125MG N70070 003 OCT 15, 1985 JUN DISC
METHYLDOPATE HYDROCHLORIDE INJECTABLE; INJECTION METHYLDOPATE HCL @ BAXTER HLTHCARE 50MG/ML N70291 001 JUL 01, 1986 AUG CAHN @ ELKINS SINN 50MG/ML N70291 001 JUL01, 1986 JUN DISC
METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL METADATE CD CELLTECH PHARMS 10MG N21259 003 MAY 27, 2003 JUL NEWA BX 20MG N21259 001 APR 03, 2001 JUL CRLD BX + 30MG N21259 002 JUN19, 2003 JUL CTEC + 30MG N21259 002 JUN 19, 2003 JUN NEWA RITALIN LA BX NOVARTIS 30MG N21284 002 JUN OS, 2002 JUL CTEC TABLET, CHEWABLE; ORAL METHYLIN MALL I NCKRODT 2.5MG N21475 001 APR 15, 2003 APR NEWA 5MG N21475 002 APR 15, 2003 APR NEWA + 10MG N21475 003 APR 15, ,2003 APR NEWA TABLET, EXTENDED RELEASE; ORAL CONCERTA >A> ALZA 18MG N21121 001 AUG 01, 2000 DEC CAHN >A> 27MG N21121 004 APR 01, 2002 DEC CAHN >A> 36MG N21121 002 AUG 01, 2000 DEC CAHN >A> + 54MG N21121 003 DEC 08, 2000 DEC CAHN >D> MCNEIL CONS SPECLT 18MG N21121 001 AUG 01, 2000 DEC CAHN + 18MG N21121 001 AUG 01, 2000 MAY CAHN 18MG N21121 001 AUG 01, 2000 OCT CRLD >D> 27MG N21121 004 APR 01, 2002 DEC CAHN + 27MG N21121 004 APR 01, 2002 MAY CAHN 27MG N21121 004 APR 01, 2002 OCT CRLD >D> 36MG N21121 002 AUG 01, 2000 DEC CAHN + 36MG N21121 002 AUG 01, 2000 MAY CAHN RX DRUG PRODUCT LIST" CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-63
36MG N21121 002 AUG 01, 2000 OCT CRLD >0> + 54MG N21121 003 DEC 08, 2000 DEC CAHN + 54MG N21121 003 DEC 08, 2000 MAY CAHN
METHYLPREDNISOLONE TABLET; ORAL MEDROL @ PHARMACIA AND UP JOHN 2MG N11153 002 JUL DISC
METHYLPREDNISOLONE ACETATE INJECTABLE; INJECTION DEPO-MEDROL + PHARMACIA AND UPJOHN 20MG/ML N11757 002 NOV CRLD + 40MG/ML N11757 001 NOV CRLD OINTMENT; TOPICAL MEDROL ACETATE @ PHARMACIA AND UP JOHN 0.25% N12421 001 JUN DISC
METHYSERGIDE MALEATE TABLET; ORAL SANSERT @ NOVARTIS 2MG N12516 001 JUN DISC
METOCLOPRAMIDE HYDROCHLORIDE INJECTABLE; INJECTION REGLAN AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML N17862 001 AUG CAHN @ EQ 10MG BASE/ML N17862 004 MAY 28, 1987 AUG CAHN SOLUTION; ORAL METOCLOPRAMIDE AA VISTAPHARM EQ 5MG BASE/5ML N75051 001 JAN 26, 2001 APR CAHN TABLET; ORAL METOCLOPRAMIDE HCL @ CLONMEL HLTHCARE EQ 10MG BASE N72639 001 MAY 09, 1991 JUN DISC
METOLAZONE TABLET; ORAL >A> METOLAZONE >A> AB EON 2.5MG N76732 001 DEC 19, 2003 DEC NEWA >A> AB 5MG N76466 001 DEC 19, 2003 DEC NEWA >A> AB 10MG N76466 002 DEC 19, 2003 DEC NEWA >A> AB MYLAN 2.5MG N76698 001 DEC 23, 2003 DEC NEWA >A> AB TEVA 10MG N75543 003 DEC 24, 2003 DEC NEWA ZAROXOLYN >0> CELLTECH PHARMS 2.5MG N17386 001 DEC CFTG >A> AB 2.5MG N17386 001 DEC CFTG 2.5MG N17386 001 JUL CRLD >0> + 5MG N1738~ 002 DEC CFTG >A> AB + 5MG N17386 002 DEC CFTG + 5MG N17386 002 JUL CRLD >0> + 10MG N17386 003 DEC CFTG >A> AB + 10MG N17386 003 DEC CFTG , RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 ~ DEC 2003 '-64
METOPROLOL TARTRATE INJECTABLE; INJECTION METOPROLOL TARTRATE AP BEDFORD LABS 1MG/ML N76495 001 'JUL 07; 2003 JUL NEWA
METRONIDAZOLE CAPSULE; ORAL FLAGYL AB + GD SEARLE LLC 375MG N20334 001 MAY 03, 1995 NOV CFTG METRONIDAZOLE AB ABLE 375MG N76505 001 NOV 13, 2003 NOV NEWA , TABLET; ORAL AB ABLE 250MG N76519 001 JUN 27, 2003 JUN NEWA AB 500MG N76519 002 JUN 27, 2003 JUN NEWA TABLET, EXTENDED RELEASE; ORAL FLAGYL ER AB + GD SEARLE LLC 750MG N20868 001 NOV 26, 1997 JUN CFTG METRONIDAZOLE AB ABLE 750MG N76462 001 JUN 25,' 2003 " JUN NEWA
'MEZLOCILLIN SODIUM MONOHYDRATE INJECTABLE; INJECTION MEZLlN @ BAYER PHARMS EQ 1GM BASE/VIAL N50549 001 JUN DISC @ EQ 2GM BASE/VIAL N50549 002 JUN DISC @ EQ 3GM BASE/VIAL N50549 003 JUN DISC @ EQ 4GM BASE/VIAL N50549 004 JUN DISC @ EQ 20GM BASE/VIAL N50549 005 MAR 02, 1988 JUN DISC
MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL AP BAXTER HLTHCARE EQ 1MG BASE/ML N75243 001 JUN 20, 2000 JUN CAHN AP EQ 5MG BASE/ML N75243 002 JUN 20, 2000 JUN CAHN SYRUP; ORAL AA HI TECH PHARMA EQ 2MG BASE/ML N75958 001 SEP 04, 2003 SEP NEWA
MI DODR I NE., HYDROCHLOR IDE TABLET; ORAL MIDODRINE HCL AB EON 2.5MG N76514 001 SEP 11, 2003 SEP NEWA AB 5MG N76514 002 SEP 11, 2003 SEP NEWA AB MYLAN 2.5MG N76577 001 SEP 10, 2003 SEP NEWA AB 5MG N76577 002 SEP 10, 2003 SEP NEWA AB 10MG N76577 003 SEP 10, 2003 SEP NEWA PROAMATINE AB SHIRE PHARM 2.5MG N19815 001 SEP 06, 1996 SEP CFTG AB + 5MG N19815 002 SEP 06, 1996 SEP CFTG AB 10MG N19815 003 MAR 20, 2002 SEP CFTG RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-65
MIGLUSTAT CAPSULE; ORAL ZAVESCA + ACTELION PHARMS 100MG N21348 001 JUL 31, 2003 JUL NEWA
MILRINONE LACTATE INJECTABLE; INJECTION MILRINONE LACTATE AP BAXTER HLTHCARE EQ 1MG BASE/ML N75530 001 MAY 28, 2002 JUN CAHN AP BIONICHE (CANADA) EQ 1MG BASE/ML N76428 001 JUN 16, 2003 JUN . NEWA MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER AP BAXTER HLTHCARE EQ 20MG BASE/100ML N75510 001 MAY 28, 2002 AUG CAHN MILRINONE LACTOSE IN 5% DEXTROSE AP BAXTER HLTHCARE EQ 20MG BASE/100ML N76259 001 AUG 08, 2002 AUG CAHN PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER AP + SANOFI SYNTHELABO EQ 20MG BASE/100ML N20343 003 AUG 09, 1994 MAY CRLD
MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL MINOCIN AB WYETH PHARMS INC EQ 50MG BASE N50649 001 MAY 31, 1990 MAR CAHN AB EQ 75MG BASE N50649 003 FEB 12, 2001 MAR CAHN AB + EQ 100MG BASE N50649 002 MAY 31, 1990 MAR CAHN MINOCYCLINE HCL AB TEVA EQ 75MG BASE N63009 002 AUG 12, 2003 AUG NEWA VECTRIN AB MEDICIS EQ 75MG BASE N63067 002 SEP 15, 1999 OCT CMFD AB EQ 100MG BASE N63067 001 JUL 31, 1990 OCT CMFD INJECTABLE; INJECTION MINOCIN + WYETH PHARMS INC EQ 100MG BASE/VIAL N50444 001 MAR CAHN TABLET; ORAL MI NOCYCLI NE HCL MEDICIS EQ 50MG BASE N65131 001 APR 16, 2003 AUG CAHN EQ 75MG BASE N65131 002 APR 16, 2003 AUG CAHN + EQ 100MG BASE N65131 003 APR 16, 2003 AUG CAHN PAR PHARM EQ 50MG BASE N65131 001 APR 16, 2003 APR NEWA EQ 75MG BASE N65131 002 APR 16; 2003 APR NEWA + EQ 100MG BASE N65131 003 APR 16, 2003 APR NEWA
MIRTAZAPINE TABLET; ORAL MIRTAZAPINE AB ALPHAPHARM j5MG N76176 001 JUN 19, 2003 JUN NEWA AB 30MG N76176 002 JUN 19, 2003 JUN NEWA AB 45MG N76176 003 JUN 19, 2003 JUN NEWA AB AMIDE PHARM 15MG N76241 001 JUN 25, 2003 JUN NEWA AB 30MG N76241 002 JUN 25, 2003 JUN NEWA AB 45MG N76241 003 JUN 25, 2003 JUN NEWA AB ANDRX PHARMS 15MG N76336 001 JUN 20, 2003 JUN NEWA AB 30MG N76336 002 JUN 20, 2003 JUN NEWA AB 45MG N76336 003 JUN 20, 2003 JUN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-66
AB EON 15MG N76219 001 JUN 19, 2003 JUN NEWA AB 30MG N76219 002 JUN 19, 2003 JUN NEWA AB 45MG N76219 003 JUN 19, 2003 JUN NEWA AB GENEVA PHARMS 15MG N761B9 001 JUN 19, 2003 JUN NEWA AB 30MG N761B9 002 JUN 19, 2003 JUN NEWA AB 45MG N761B9 003 JUN 19, 2003 JUN NEWA >A> AB IVAX PHARMS 15MG N76244 001 DEC 22, 2003 DEC NEWA >A> AB 30MG N76244 002 DEC 22, 2003 DEC NEWA >A> AB 45MG N76244 003 DEC 22, 2003 DEC NEWA AB MYLAN 15MG N76122 001 JUN 19, 2003 JUN NEWA AB 30MG N76122 002 JUN 19, 2003 JUN NEWA AB 45MG N76122 003 JUN 19, 2003 JUN NEWA AB PURE PAC. PHARM 15MG Nr630B 001 JUN 20, 2003 JUN NEWA AB 30MG N7630B 002 JUN 20, 2003 JUN NEWA AB 45MG N7630B 003 JUN 20, 2003 JUN NEWA AB ROXANE 15MG N76270 001 JUN 19, 2003 JUN NEWA AB 30MG N76270 002 JUN 19, 2003 JUN NEWA AB 45MG N76270 003 JUN 19, 2003 JUN NEWA AB TEVA 15MG N76119 001 JAN 24, 2003 JAN NEWA AB 30MG N76119 002 JAN 24, 2003 JAN NEWA AB 45MG N76119 003 JUN 19, 2003 JUN NEWA AB WATSON LABS 15MG N76312 001 JUN 19, 2003 JUN NEWA AB 30MG N76312 002 JUN 19, 2003 JUN NEWA AB 45MG N76312 003 JUN 19, 2003 JUN NEWA REMERON AB + ORGANON 15MG N20415 001 JUN 14, 1996 JAN CFTG AB 30MG N20415 002 JUN 14, 1996 JAN CFTG TABLET, ORALLY DISINTEGRATING; ORAL >A> MIRTAZAPINE >A> AB BARR 15MG N76307001 DEC 17, 2003 DEC NEWA· >A> AB 30MG N76307 002 DEC 17, 2003 DEC NEWA REMERON SOL TAB >0> + ORGANON USA INC 15MG N2120B 001 JAN 12, 2001 DEC CFTG >A> AB + 15MG N2120B 001 JAN 12, 2001 DEC CFTG >0> 30MG N2120B 002 JAN 12, 2001 DEC CFTG >A> AB 30MG N2120B 002 JAN 12, 2001 DEC CFTG
MITOMYCIN INJECTABLE; INJECTION MITOMYCIN AP BAXTER HLTHCARE 5MG/VIAl N641BO 001 DEC 23, 1999 AUG CAHN AP 20MG/VIAL N641BO 002 DEC 23, 1999 AUG CAHN
MOEXIPRIL HYDROCHLORIDE TABLET; ORAL MOEXIPRIL HCL AB TEVA 7.5MG N76204 001 MAY OB, 2003 MAY NEWA AB 15MG N76204 002 MAY OB, 2003 MAY NEWA UNIVASC AB SCHWARZ PHARMA 7.5MG N20312 001 APR 19, 1995 MAY CFTG AB + 15MG N20312 002 APR 19, 1995 MAY CFTG RX DRUG PRODUCT LIST ,- CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-67
MOMETASONE FUROATE OINTMENT; TOPICAL MOMETASONE FUROATE AB ATRIX 0.1% N76481 001 NOV 14, 2003 NOV NEWA
MORPHINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL AVINZA BX + LIGAND 30MG N21260 001 MAR 20, 2002 JUN CAHN BX + 60MG N21260 002 MAR 20, 2002 JUN CAHN + 90MG N21260 003 MAR 20, 2002 JUN CAHN + 120MG N21260 004 MAR 20, 2002 JUN CAHN INJECTABLE; INJECTION DURAMORPH PF AP + BAXTER HLTHCARE 1MG/ML N18565 002 SEP 18, 1984 AUG CAHN INFUMORPH + BAXTER HLTHCARE 10MG/ML N18565 003 JUL 19, 1991 AUG CAHN + 25MG/ML N18565 004 JUL 19, 1991 AUG CAHN TABLET, EXTENDED RELEASE; ORAL MORPHINE SULFATE @ CLONMEL HLTHCARE 15MG N75407 001 JAN 28, 2000 JUL DISC AB MALLI NCKRODT 15MG N76412 001 JUL 31, 2003 JUL NEWA AB 30MG N76412 002 JUL 31, 2003 JUL NEWA AB 60MG N76412 003 JUL 31, 2003 JUL NEWA AB 100MG N76438 001 JUL 03, 2003 JUL NEWA AB 200MG N76438 002 JUL 03, 2003 JUL NEWA ORAMORPH SR >A> BC AAIPHARMA 15MG N19977 004 NOV 23, 1994 DEC CAHN >A> BC 30MG N19977 001 AUG 15, 1991 DEC CAHN >A> BC 60MG N19977 002 AUG 15, 1991 DEC CAHN >A> BC 100MG N19977 003 AUG 15, 1991 DEC CAHN >D> BC ELAN PHARMS 15MG N19977 004 NOV 23, 1994 DEC CAHN >D> BC 30MG N19977 001 AUG 15, 1991 DEC CAHN >D> BC 60MG N19977 002 AUG 15, 1991 DEC CAHN >D> BC 100MG N19977 003 AUG 15, 1991 DEC CAHN
MOXIFLOXACIN HYDROCHLORIDE SOLUTI ON/DROPS; OPHTHALMIC VIGAMOX + ALCON 0.5% N21598 001 APR 15, 2003 APR NEWA
MUPIROCIN OINTMENT; TOPICAL BACTROBAN AB + GLAXOSMITHKLlNE 2% N50591 001 DEC 31, 1987 NOV CTEC >A> CENT ANY >A> BX 'JOHNSON AND JOHNSON 2% N50788 001 DEC 04, 2002 DEC CTNA MUPIROCIN AB CLAY PARK 2% N65123 001 NOV 07, 2003 NOV NEWA BX CLAY PARK LABS 2% N50788 001 DEC 04, 2002 JAN CTEC >D> BX JOHNSON AND JOHNSON 2% N50788 001 DEC 04, 2002 DEC CTNA BX 2% N50788 001 DEC 04, 2002 APR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12- DEC 2003 1-68
AB TEVA 2% N65085 001 NOV 07, 2003 NOV NEWA
MYCOPHENOLATE MOFETIL CAPSULE; ORAL CELLCEPT + ROCHE PALO 250MG N50722 001 MAY 03, 1995 FEB CAHN SUSPENSION; ORAL + ROCHE PALO 200MG/ML N50759 001 OCT 01, 1998 FEB CAHN TABLET; ORAL + ROCHE PALO 500MG N50723 001 JUN 19, 1997 FEB CAHN
MYCOPHENOLATE MOFETIL HYDROCHLORIDE INJECTABLE; INJECTION + ROCHE PALO 500MG/VIAL N50758 001 AUG 12, 1998 FEB CAHN
NABUMETONE TABLET; ORAL NABUMETONE AB IVAX PHARMS 500MG N76009 001 JAN 24, 2003 JAN NEWA AB 750MG N76009 002 JAN 24, 2003 JAN NEWA
NAFTI FINE HYDROCHLORIDE CREAM; TOPICAL NAFTIN ALLERGAN HERBERT 1% N19599 001 FEB 29, 1988 OCT CMFD @ 1% N19599 001 FEB 29, 1988 JUN DISC GEL; TOPICAL + ALLERGAN HERBERT 1% N19356 001 JUN 18, 1990 OCT CMFD @ 1% N19356 001 JUN 18, 1990 JUN DISC
NALBUPHINE HYDROCHLORIDE INJECTABLE; INJECTION NALBUPHINE HCL @ KING PHARMS 10MG/ML N74471 001 MAR 19, 1998 MAY DISC @ 20MG/ML N74471 002 MAR 19, 1998 MAY DISC
NALOXONE HYDROCHLORIDE INJECTABLE; INJECTION NALOXONE @ BAXTER HLTHCARE 0.4MG/ML N70496 001 SEP 24, 1986 AUG CAHN @ ELKINS SINN 0.4MG/ML N70299 001 SEP 24, 1986 JUN DISC @ ELKINS SINN PHARM' 0.4MG/ML N70298 001 SEP 24, 1986 JUN DISC NALOXONE HCL @ BAXTER HLTHCARE 0.02MG/ML N71272 001 MAY 24; 1988 AUG CAHN @ 1MG/ML N71273 001 MAY 24, 1988 AUG CAHN @ 1MG/ML N71274 001 MAY 24, 1988 AUG CAHN @ 1MG/ML N71287 001 MAY 24, 1988 AUG CAHN @ ELKINS SINN 0.02MG/ML N71272 001 MAY 24, 1988 JUN DISC @ 1MG/ML N71273 001 MAY 24, 1988 JUN DISC @ 1MG/ML N71274 001 MAY 24, 1988 JUN DISC @ 1MG/ML N71287 001 MAY 24, 1988 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE'SUPPLEMENT 12 - DEC 2003 1-69
NANDROLONE DECANOATE INJECTABLE; INJECTION DECA-DURABOLIN @ ORGANON USA INC sOMG/ML N13132 001 JUN 12,1986 MAY DISC @ 100MG/ML N13132 002 JUN 12, 1986 MAY DISC @ 200MG/ML N13132 003 JUN 12, 1986 MAY DISC NANDROLONE DECANOATE ' + STERIS sOMG/ML N8638s 001 JAN 13, 1984 MAY CRLD + 100MG/ML N86s98 001 JAN 13, 1984 MAY CRLD + 200MG/ML N88128 001 DEC OS, 1983 MAY CRLD
NAPROXEN SOD lUM TABLET;, ORAL. NAPROXEN SOD lUM AB ABLE EQ 2s0MG BASE N76s44 001 AUG 22, 2003 AUG NEWA AB EQ sOOMG BASE N76s44 002 AUG 22, 2003 AUG NEWA AB HIKMA EQ 2s0MG BASE N74480 002 FEB 18; 1998 OCT CAHN AB' EQ sOOMG BASE N74480 001 MAY 14, 1996 OCT CAHN TABLET, EXTENDED RELEASE;, ORAL NAPRELAN AB + ELAN PHARM EQ 37sMG BASE N20353 001 JAN 05, 1996 APR CFTG AB + EQ sOOMG BASE N20353 002 JAN 05, 1996 MAR CFTG AB + ELAN PHARMA EQ 37sMG BASE N20353 001 JAN OS, 1996 JUN CAHN AB +' EQ 500MG BASE N20353 002 JAN 05, 1996 JUN CAHN @ EQ 750MG BASE N20353 003 JAN 05, 1996 JUN CAHN NAPROXEN SOD lUM AB ANDRX PHARMS EQ 375MG BASE N75416 002 'APR 23, 2003 APR NEWA AB EQ 500MG BASE N75416 001 AUG 27, 2002 MAR NEWA
NEFAZODONE HYDROCHLORIDE TABLET: ORAL NEFAZODONE HCL AB DR REDDYS LABS INC 50MG N76309 001 SEP 16, 2003 SEP NEWA AB 100MG N76309 002 SEP 16, 2003 SEP NEWA AB 150MG N76309 003 SEP 16, 2003 SEP NEWA AB 200MG N76309 004 SEP 16; 2003 SEP NEWA AB 250MG N76309 005 SEP 16, 2003 SEP NEWA AB EON 50MG N76302 001 SEP 16, 2003 SEP NEWA AB 100MG N76302 002 SEP 16, 2003 SEP NEWA AB 1s0MG N76302 003 SEP 16, 2003 SEP NEWA AB 200MG N76302 004 SEP 16, 2003 SEP NEWA AB 250MG N76302 005 SEP 16, 2003 SEP NEWA AB GENEVA PHARMS 50MG N76072 001 SEP 16, 2003 SEP NEWA AB 100MG N76072 002 SEP 16, 2003 SEP NEWA AB 150MG N76072 003 SEP 16, 2003 SEP NEWA AB 200MG N76072 004 SEP 16, 2003 SEP NEWA AB 250MG N76072 005 SEP 16, 2003 SEP NEWA AB IVAX PHARMS 50MG N75763 001 SEP 16, 2003 SEP NEWA AB 100MG N75763 002 SEP 16, 2003 SEP NEWA AB 150MG N75763 003 SEP 16, 2003 SEP NEWA AB 200MG N75763 004 SEP 16, 2003 SEP NEWA AB 250MG N7s763 005 SEP 16, 2003 SEP NEWA RX DRUG PRODUCT LIST· CUMULATIVE SUPPlEMENT 12 - DEC 2003 1-70
AB MYLAN 100MG N76129 002 SEP 16, 2003 SEP NEWA AB 150MG N76129 003 SEP 16, 2003 SEP NEWA AB 200MG N76129 004 SEP 16, 2003 SEP NEWA AB 250MG N76129 005 SEP 16,. 2003 SEP NEWA AB RANBAXY 50MG N76409 001 SEP 16, 2003 SEP NEWA AB 100MG N76409 002 SEP 16, 2003 SEP NEWA AB 150MG N76409 003 SEP 16, 2003 SEP NEWA AB 200MG N76409 004 SEP 16, 2003 SEP NEWA AB 250MG N76409 005 SEP 16, 2003 SEP NEWA AB ROXANE 50MG N76196 001 SEP 16, 2003 SEP NEWA AB 100MG N76196 002 SEP 16, 2003 SEP NEWA AB 150MG N76196 003 SEP 16, 2003 SEP NEWA AB 200MG N76196 004 SEP 16, 2003 SEP NEWA AB 250MG N76196 005 SEP 16, 2003 SEP NEWA AB TEVA 50MG N76037 001 SEP 16, 2003 SEP NEWA AB 100MG N76037 002 SEP 16~ 2003 SEP NEWA AB 150MG N76037 003 SEP 16, 2003 SEP NEWA AB 200MG N76037 004 SEP 16, 2003 SEP NEWA AB 250MG N76037 005 SEP 16, 2003 SEP NEWA AB WATSON LABS 100MG N76073 002 SEP 16, 2003 SEP NEWA AB 150MG N76073 003 SEP 16, 2003 SEP NEWA AB 200MG N76073 004 SEP 16, 2003 SEP NEWA AB 250MG N76073 005 SEP 16, 2003 SEP NEWA SERZONE AB BRISTOL MYERS SQUIBB 50MG N20152 001 DEC 22, 1994 SEP CFTG AB 100MG N20152 002 DEC 22, 1994 SEP CFTG AB 150MG N20152 003 DEC 22, 1994 SEP CFTG AB 200MG N20152 004 DEC 22, 1994 SEP CFTG AB + 250MG N20152 005 DEC 22, 1994 SEP CFTG
NELFINAVIR MESYLATE TABLET; ORAL VIRACEPT + AGOURON EQ 625MG BASE N21503 001 APR 30, 2003 APR NEWA
NICOTINE INHALANT; ORAL NICOTROL >D> @ PHARMACIA AND UPJOHN 4MG/CARTRIDGE N20714 001 MAY 02, 1997 DEC CMFD >A> + 4MG/CARTRIDGE N20714 001 MAY 02, 1997 DEC CMFD
NIFEDIPINE CAPSULE; ORAL ADALAT @ BAYER PHARMS 10MG N19478 001 NOV 27, 1985 JUN DISC @ 20MG N19478 002 SEP 17, 1986 JUN DISC TABLET, EXTENDED RELEASE; ORAL PROCARDIA XL AB2 PFIZER 30MG N19684 001 SEP 06, 1989 JUL CRLD AB2 60MG N19684 002 SEP 06, 1989 JUL CRLD RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-71
NITROFURANTOIN TABLET; ORAL FURADANTIN @ PROCTER AND GAMBLE 50MG N08693 001 APR DISC @ 100MG N08693 002 APR DISC NITROFURANTOIN @ WATSON LABS 50MG N80447 001 APR DISC @ WHITEWORTH TOWN PLSN 100MG N84085 002 APR DISC
NITROFURAZONE OINTMENT; TOPICAL FURACIN @ SHIRE PHARM 0.2% N05795 001 MAR DISC
NITROGL YCER I N FILM, EXTENDED RELEASE; TRANSDERMAL* NITROGLYCERIN AB2 MYLAN TECHNOLOGIES 0.1MG/HR N75033 001 FEB 06, 1998 APR CAHN AB2 + 0.1MG/HR N75033 001 FEB 06, 1998 AUG CRLD AB2 0.2MG/HR N74609 001 AUG 30, 1996 APR CAHN AB2 + 0.2MG/HR N74609 001 AUG 30, 1996 AUG CRLD AB2 0~4MG/HR N74607 001 AUG 30, 1996 APR CAHN AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD AB2 0.6MG/HR N74559 001 AUG 30, 1996 APR CAHN AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD TRANSDERM-NITRO @ NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC @ 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC @ 0.4MG/HR N20144 003 FEB 27, 1996 AUG DISC @ 0.6MG/HR N20144 004 FEB 27, 1996 AUG DISC @ 0.8MG/HR N20144 005 FEB 27, 1996 AUG DISC INJECTABLE; INJECTION TRIDIL @ FAULDING 0.5MG/ML N18537 002 JUN 16, 1983 MAY DISC @ 5MG/ML N18537 001 MAY DISC OINTMENT; TRANSDERMAL NITROGLYCERIN + FOUGERA 2% N87355 001 JUL 08, 1988 APR CAHN
NIZATIDINE CAPSULE; ORAL NIZATIDINE AB TORPHARM 150MG N76383 001 JAN 23, 2003 JAN NEWA AB 300MG N76383 002 JAN 23, 2003 JAN NEWA
NOREPINEPHRINE BITARTRATE INJECTABLE; INJECTION LEVOPHED AP + ABBOTT EQ 1MG BASE/ML N07513 001 MAR CFTG NOREPINEPHRINE BITARTRATE AP BEDFORD EQ 1MG BASE/ML N40462 001 OCT 31, 2003 OCT NEWA AP GENSIA SICOR PHARMS EQ 1MG BASE/ML N40455 001 MAR 03, 2003 MAR NEWA *SEE SECTION 1.3 NITROGLYCERIN, FILM, EXTENDED RELEASE; TRANSDERMAL RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-72
NORETHINDRONE ACETATE TABLET; ORAL AYGESTIN AB + ·DURAMED PHARMS BARR 5MG N18405 001 APR 21, 1982 JUN CAHN AB + WYETH PHARMS INC 5MG N18405 001 APR 21, 1982 MAR CAHN
NORFLOXACIN SOLUTI ON/DROPS; OPHTHALMIC CHIBROXIN @ MERCK 0.3% N19757 001 JUN 17, 1991 MAY DISC
NORGESTREL TABLET; ORAL OVRETTE + WYETH PHARMS INC 0.075MG N17031 001 MAR CAHN
NYSTATIN POWDER; ORAL NILSTAT @ CLONMEL HLTHCARE 100% N50576 001 DEC 22, 1983 JUL DISC NYSTATI N + PADDOCK 100% N62613 001 . NOV 26, 1985 JUL CRLD
OFLOXACIN INJECTABLE; INJECTION FLOXIN @ ORTHO MCNEIL PHARM 40MG/ML N20087 003 MAR 31 , 1992 NOV DISC FLOXIN IN DEXTROSE 5% @ ORTHO MCNEIL PHARM 400MG/100ML N20087 001 MAR 31, 1992 NOV DISC FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER @ ORTHO MCNEIL PHARM 400MG/100ML N20087 005 MAR 31, 1992 NOV DISC OFLOXACIN + BEDFORD 40MG/ML N75762 001 JAN 16, 2002 NOV CRLD TABLET; ORAL FLOXIN AB ORTHO MCNEIL PHARM 200MG N19735 001 DEC 28, 1990 SEP CFTG A.B 300MG N19735 002 . DEC 28, 1990 SEP CFTG AB + 400MG N19735 003 DEC 28, 1990 SEP CFTG OFLOXACIN AB PAR PHARM 200MG N76093 001 SEP 02, 2003 SEP NEWA AB 300MG N76093 002 SEP 02, 2003 SEP NEWA AB 400MG N76093 003 SEP 02, 2003 SEP NEWA AB RANBAXY 200MG N76220 001 SEP 02, 2003 SEP NEWA AB 300MG N76220 002 SEP 02, 2003 SEP NEWA AB 400MG N76220 003 SEP 02, 2003 SEP NEWA AB TEVA 200MG N76182 001 SEP 02, 2003 SEP NEWA AB 300MG N76182 002 SEP 02, 2003 SEP NEWA AB 400MG N76182 003 SEP 02, 2003 SEP NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-73
OLANZAPINE TABLET; ORAL ZYPREXA + LILLY 5MG N20592 002 SEP 30, 1996 MAY CRLD 20MG N20592 006 SEP 09, 1997 MAY CRLD TABLET, ORALLY DISINTEGRATING; ORAL ZYPREXA ZYDIS + LILLY 5MG N21086 001 APR 06, 2000 AUG CRLD. 20MG N21086 004 APR 06, 2000 AUG CRLD
OMEPRAZOLE CAPSULE, DELAYED REL PELLETS; ORAL OMEPRAZOLE AB LEK SVCS 10MG N75757 001 JAN 28, 2003 JAN NEliA AB 20MG N75757 002 JAN 28, 2003 JAN NEliA AB MYLAN 10MG N75876 001 MAY 29, 2003 MAY NEliA AB 20MG N75876 002 MAY 29, 2003 MAY NEliA AB TORPHARM 10MG N76048 001 OCT 06, 2003 OCT NEliA AB 20MG N76048 002 OCT 06, 2003 OCT NEliA
ORPHENADRINE CITRATE INJECTABLE; INJECTION ORPHENADRINE CITRATE AP BEDFORD LABS 30MG/ML N40463 001 MAR 04, 2003 MAR NEliA
OXANDROLONE TABLET; ORAL OXANDRIN >0> . BIO TECH GEN 2.5MG N13718 001 DEC CAHN >0> + 10MG N13718 002 NOV OS, 2001 DEC CAHN >A> SAVIENT PHARMS 2.5MG N13718 001 DEC CAHN >A> + 10MG N13718 002 NOV OS, 2001 DEC CAHN
OXYBUTYNIN FILM, EXTENDED RELEASE; TRANSDERMAL OXYTROL + IIATSON LABS (UTAH) 3.9MG/24HR N21351 002 FEB 26, 2003 FEB NEliA
OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE; ORAL DITROPAN XL ALZA 5MG N20897 001 DEC 16, 1998 MAY CRLD 10MG N20897 002 DEC 16, 1998 MAY CRLD
OXYCODONE HYDROCHLORIDE TABLET; ORAL ROXICODONE >A> + AAIPHARMA 15MG N21011 001 AUG 31, 2000 DEC CAHN >A> 30MG N21011 002 AUG 31, 2000 DEC CAHN >0> + ELAN PHARMS 15MG N21011 001 AUG 31, 2000 DEC CAHN + 15MG N21011 001 AUG 31, 2000 OCT CRLD >0> 30MG N21011 002 AUG 31, 2000 DEC CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-74
30MG N21011 002 AUG 31, 2000 OCT CRLD
OXYTOCIN INJECTABLE; INJECTION OXYTOCIN @ BAXTER HLTHCARE CORP 10USP UNITS/ML N18243 001 MAY CAHN
PALONOSETRON HYDROCHLORIDE INJECTABLE; INTRAVENOUS ALOXI + HELSINN HLTHCARE EQ 0.25MG BASE/5ML(EQ 0.05MG BASE/ML) N21372 001 JUL 25, 2003 JUL NEWA
PANCURONIUM BROMIDE INJECTABLE; INJECTION PANCURONIUM BROMIDE AP + GENSIA SICOR PHARMS 1MG/ML N72759 001 JUL 31, 1990 MAY CRLD AP + 2MG/ML N72760 001 JUL 31, 1990 MAY CRLD PAVULON @ ORGANON 1MG/ML N17015 002 MAY DISC @ 2MG/ML N17015 001 MAY DISC
PANTOPRAZOLE SODIUM INJECTABLE; IV (INFUSION) PROTONIX IV + WYETH PHARMS INC EQ 40MG BASE/VIAL N20988 001 MAR 22, 2001 MAR CAHN TABLET, DELAYED RELEASE; ORAL PROTONIX + WYETH PHARMS INC EQ 20MG BASE N20987 002 JUN 12, 2001 MAR CAHN EQ 20MG BASE N20987 002 JUN 12, 2001 APR CRLD + EQ 40MG BASE N20987 001 FEB 02, 2000 MAR CAHN
PAROMOMYCIN SULFATE CAPSULE; ORAL HUMATIN AA + KING PHARMS EQ 250MG BASE N62310 001 MAY CAHN
PAROXETINE HYDROCHLORIDE TABLET; ORAL PAROXETINE HCL AB TORPHARM EQ 10MG BASE N75356 001 JUL 30, 2003 JUL NEWA AB EQ 20MG BASE N75356 002 JUL 30, 2003 JUL NEWA AB EQ 30MG BASE N75356 003 JUL 30, 2003 JUL NEWA AB EQ 40MG BASE N75356 004 JUL 30, 2003 JUL NEWA PAXIL AB GLAXOSMITHKLINE EQ 10MG BASE N20031 001 DEC 29, 1992 JUL CFTG AB EQ 20MG BASE N20031 002 DEC 29, 1992 JUL CFTG AB EQ 30MG BASE N20031 003 DEC 29, 1992 JUL CFTG AB + EQ 40MG BASE N20031 005 DEC 29, 1992 JUL CFTG
PAROXETINE MESYLATE TABLET; ORAL PAROXETINE MESYLATE SYNTHON PHARMS EQ 10MG BASE N21~99 001 JUL 03, 2003 JUL NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-75
EQ 20MG BASE N21299 002 JUL 03, 2003 JUL NEWA EQ 30MG BASE N21299 003 JUL 03, 2003 JUL NEWA + EQ 40MG BASE N21299 004 JUL 03, 2003 JUL NEWA
PEGVISOMANT INJECTABLE; SUBCUTANEOUS SOMAVERT + PHARMACIA AND UPJOHN 10MG/VIAL N21106 001 MAR 25, 2003 MAR NEWA + 15MG/VIAL N21106 002 MAR 25, 2003 MAR NEWA + 20MG/VIAL N21106 003 MAR 25, 2003 MAR NEWA
PENICILLIN G POTASSIUM INJECTABLE; INJECTION PENICILLIN G POTASSIUM @ MARSAM PHARMS LLC 1,000,000 UNITS/VIAL N62991 001 SEP 13, 1988 JUL DISC @ 5,000,000 UNITS/VIAL N62991 002 SEP 13, 1988 JUL DISC @ 10,000,000 UNITS/VIAL N62991 003 SEP 13, 1988 JUL DISC @ 20,000,000 UNITS/VIAL N62991 004 SEP 13, 1988 JUL DISC TABLET; ORAL @ WYETH AYERST 200,000 UNITS N60413 001 JUN DISC @ 250,000 UN ITS N60413 002 JUN DISC @ 400,000 UNITS N60413 003 JUN DISC
PENICILLIN V POTASSIUM FOR SOLUTION; ORAL BEEPEN-VK >D> AA GLAXOSMITHKlINE EQ 125MG BASE/5ML N62270 001 DEC DISC >A> @ EQ 125MG BASE/5ML N62270 001 DEC DISC >D> AA EQ 250MG BASE/5ML N62270 002 DEC DISC >A> @ EQ 250MG BASE/5ML N62270 002 DEC DISC LEDERCI LlIN VK @ LEDERLE EQ 125MG BASE/5ML N60136 001 JUN DISC @ EQ 250MG BASE/5ML N60136 002 JUN DISC TABLET; ORAL BEEPEN-VK >D> AB GLAXOSM ITHKlI NE EQ 250MG BASE N62273 001 DEC DISC >A> @ EQ 250MG BASE N62273 001 DEC DISC >D> AB EQ 500MG BASE N62273 002 DEC DISC >A> @ EQ 500MG BASE N62273 002 DEC DISC >D> BETAPEN-VK >D> AB BRISTOL EQ 250MG BASE N61150 001 DEC DISC >A> @ EQ 250MG BASE N61150 001 DEC DISC >D> AB EQ 500MG BASE N61150 002 DEC DISC >A> @ EQ 500MG BASE N61150 002 DEC DISC LEDERC I L1I N VK @ LEDERLE EQ 250MG BASE N60134 001 JUN DISC @ EQ 500MG BASE N60134 002 JUN DISC PEN-VEE K @ WYETH AYERST EQ 250MG BASE N60006 002 JUN DISC @ EQ 500MG BASE N60006 003 JUN DISC PENICILLIN V POTASSIUM >D> AB CONSOLIDATED PHARM EQ 250MG BASE N61528 001 DEC DISC >A> @ EQ 250MG BASE N61528 001 DEC DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-76
>0> AB EQ 500MG BASE N61528 002 DEC DISC >A> 61 EQ 500MG BASE N61528 002 DEC DISC >0> UTlCILLlN VK >0> AB PHARMACIA AND UPJOHN EQ 250MG BASE N61651 001 DEC DISC >A> 61 EQ 250MG BASE N61651 001 DEC DISC
PENTAMIDINE ISETHIONATE INJECTABLE; INJECTION PENTAMIDINE ISETHIONATE 61 BAXTER HLTHCARE 300MG/VIAL N73617 001 DEC 18, 1995 AUG CAHN 61 ELKINS SINN 300MG/VIAL N73617 001 DEC 18, 1995 JUN DISC
PENTOBARB IT AL ELIXIR; ORAL NEMBUTAL >0> 61 ABBOTT 18.2MG/5ML N83244 001 DEC CAHN >A> 61 OVATION PHARMS 18.2MG/5ML N83244 001 DEC CAHN
PENTOBARBITAL SODIUM CAPSULE; ORAL NEMBUTAL SODIUM >0> + ABBOTT 30MG N84095 001 DEC CAHN >0> 61 50MG N84093 001 DEC CAHN >0> AA + 100MG N83245 001 DEC CAHN >A> + OVATION PHARMS 30MG N84095 001 DEC CAHN >A> 61 50MG N84093 001 DEC CAHN >A> AA + 100MG N83245 001 DEC CAHN INJECTABLE; INJECTION >0> + ABBOTT 50MG/ML N83246 001 DEC CAHN + 50MG/ML N83246 001 JUN CTEC >A> + OVATION PHARMS 50MG/ML N83246 001 DEC CAHN SODIUM PENTOBARBITAL 61 WYETH AYERST 50MG/ML N83261 001 JUN DISC SUPPOSITORY; RECTAL NEMBUTAL >0> 61 ABBOTT 60MG N.83247 002 JAN 25, 1982 DEC CAHN >0> 61 120MG N83247 003 JAN 25, 1982 DEC CAHN >0> 61 200MG N83247 004 JAN 25, 1982 DEC CAHN >A> 61 OVATION PHARMS 60MG N83247 002 JAN 25, 1982 DEC CAHN >A> 61 120MG N83247 003 JAN 25, 1982 DEC CAHN >A> 61 200MG N83247 004 JAN 25, 1982 DEC CAHN
PERGOLIDE MESYLATE TABLET; ORAL PERGOLIDE MESYLATE AB IVAX PHARMS EQ 0.05MG BASE N76094 001 SEP 04, 2003 SEP NEWA AB EQ 0.25MG BASE N76094 002 SEP 04, 2003 SEP NEWA AB EQ 1MG BASE N76094 003 SEP 04, 2003 SEP NEWA
PERMETHRIN CREAM; TOPICAL PERMETHRIN AB CLAY PARK 5% N76~69 001 APR 21, 2003 APR NEWA RX DRUG PRODUCT LisT- CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-77
PERPHENAZINE TABLET; ORAL PERPHENAZINE AB '+ IVAX PHARMS 16MG N89457 001 SEP 10, 1987 FEB CRLD TRILAFON @ SCHERING 2MG N10775 001 FEB DISC @ 4MG N10775 002 FEB DISC @ 8MG N10775 003 FEB DISC @ 16MG N10775 004 FEB DISC
PHENTERMINE HYDROCHLORIDE CAPSULE; ORAL PHENTERMINE HCL AA ABLE 15MG N40497 001 MAR 13, 2003 MAR NEWA AA AMBI PHARMS 30MG N40083 001 MAR 07, 1997 MAY CAHN AA AMIDE PHARM 15MG N40460 001 JAN 14, 2003 JAN NEWA AA 30MG N40448 001 JAN 22, 2003 JAN NEWA AA MUTUAL PHARM 30MG N40525 001 OCT 23, 2003 OCT NEWA AA 37.5MG N40527 001 OCT 23, 2003 OCT NEWA TABLET; ORAL AA + EON 30MG N88605 001 SEP 28, 1987 JAN CFTG AA MUTUAL PHARM 37.5MG N40526 001 OCT 23, 2003 OCT NEWA
PHENYLEPHRINE HYDRbCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP; ORAL PHENERGAN VC @ WYETH AYERST 5MG/5ML;6.25MG/5ML N08604'003 APR 02, 1984 APR DISC PROMETH VC PLAIN AA + ALPHARMA 5MG/5ML;6.25MG/5ML N88761 001 NOV 08, 1984 APR CRLD
PHENYTOIN SUSPENSION; ORAL PHENYTOIN AB VISTAPHARM 125MG/5ML N40342 001 JAN 31, 2001 MAR CAHN
PHENYTO I N SOD IUM INJECTABLE; INJECTION DILANTIN @ PARKE DAVIS 50MG/ML N10151 001 MAR DISC PHENYTOIN + ELKINS SINN 50MG/ML N84307 001 MAR CRLD PHENYTOIN SODIUM @ ABBOTT 50MG/ML N89521 001 MAR 17, 1987 MAR DISC @ 50MG/ML N89744 001 DEC 18, 1987 MAR DISC
PHENYTOIN SODIUM, EXTENDED CAPSULE; ORAL DILANTIN PARKE DAVIS 30MG N84349 001 FEB CRlD + 30MG N84349 001 JUN CRlD EXTENDED PHENYTOIN SODIUM AB BARR 100MG N40435 001 JUN 20, 2003 JUN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-78
PILOCAR~INE HYDROCHLORIDE TABLET; ORAL SALAGEN MGI PHARMA INC 5MG N20237 001 MAR 22, 1994 APR CRLD + 7.5MG N20237 002 APR 18, 2003 APR NEWA
PIPERAC.ILLIN SODIUM INJECTABLE; INJECTION PIPERACILLIN + AM PHARM EQ 2GM BASE/VIAL N65114 001 NOV 14, 2003 NOV NEWA + EQ 3GM BASE/VIAL N65114 002 NOV 14, 2003 NOV NEWA + EQ 4GM BASE/VIAL N65114 003 NOV 14, 2003 NOV NEWA PIPRACIL + WYETH PHARMS INC EQ 2GM BASE/VIAL N50545 002 MAR CAHN @ EQ 2GM BASE/VIAL N50545 002 JUN DISC EQ 2GM BASE/VIAL N62750 001 OCT 13, 1987 MAR CAHN @ EQ 2GM BASE/VIAL N62750 001 OCT 13, 1987 JUN DISC + EQ 3GM BASE/VIAL N50545 003 MAR CAHN @ EQ 3GM BASE/VIAL N50545 003 JUN DISC EQ 3GM BASE/VIAL N62750 002 OCT 13, 1987 MAR CAHN @ EQ 3GM BASE/VIAL N62750 002 OCT 13, 1987 JUN DISC + EQ 4GM BASE/VIAL N50545.004 MAR CAHN @ EQ 4GM BASE/VIAL N50545 004 JUN DISC EQ 4GM BASE/VIAL N62750 003 OCT 13, 1987 MAR CAHN @ EQ 4GM BASE/VIAL N62750 003 OCT 13, 1987 JUN DISC @ EQ 40GM BASE/VIAL N50545 006 SEP 30, 1985 MAR CAHN
PIPERACILLIN SODIUMi TAZOBACTAM SODIUM INJECTABLE; INJECTION ZOSYN + WYETH PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL N50684 001 OCT 22, 1993 MAR CAHN + EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL N50684 002 OCT 22, 1993 MAR CAHN + EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL N50684 003 OCT 22, 1993 MAR CAHN + EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL N50684 004 OCT 22, 1993 MAR CAHN ZOSYN IN PLASTIC CONTAINER + WYETH PHARMS INC EQ 40MG BASE/ML;EQ 5MG BASE/ML N50750 001 FEB 24, 1998 MAR CAHN + EQ 60MG BASE/ML;EQ 7.5MG BASE/ML N50750 002 FEB 24, 1998 MAR CAHN + EQ 4GM BASE/100ML;EQ 500MG BASE/100ML N50750 003 FEB 24, 1998 MAR CAHN
piRBUTEROL ACETATE AEROSOL, METERED; INHALATION MAXAIR @ 3M EQ 0.2MG BASE/INH N19009 001 DEC 30, 1986 MAY DISC
PI ROXI CAM CAPSULE; ORAL PIROXICAM @ SCS 10MG N74036 001 MAY 29, 1992 OCT WDAG @ 20MG N74036 002 MAY 29, 1992 OCT WDAG RX DRUG PRODUCT LIST - .CUMULATIVE SUPPLEMENT 12 - DEC 2.0.03 1-79
POTASSIUM CHLORIDE INJECTABLE; INJECTION POTASSIUM CHLORIDE Q BAXTER HLTHCARE 2MEQ/ML N8D2D3 .0.01 AUG CAHN TABLET, EXTENDED RELEASE; ORAL KLOR-CON M15 UPSHER SMITH 15MEQ N74726 .0.03 JUN .06, 2.0.03 JUN NEWA
PRALIDOXIME CHLORIDE INJECTABLE; INJECTION PRALIDOXIME CHLORIDE Q BAXTER HLTHCARE CORP 3DDMG/ML N18799 .0.01 DEC 13, 1982 MAR CAHN PROTOPAM CHLORIDE + BAXTER HLTHCARE CORP 1GM/VIAL N14134 .0.01 JUL CAHN
PRAMIPEXOLE DIHYDROCHLORIDE TABLET; ORAL MIRAPEX >A> BOEHRINGER INGELHEIM D.125MG N2D667 .0.01 JUL .01, 1997 DEC CAHN >A> + D.25MG N2D667 .0.02 JUL .01, 1997 DEC CAHN >A> D.5MG N2D667 .0.06 .. FEB 12, 1998 bEC CAHN >A> 1MG N2D667 .0.03 JUL .01, 1997 DEC CAHN >A> Q 1. 25MG N2D667 .0.04 JUL .01, 1997 DEC CAHN >A> 1.5MG N2D667 .0.05 JUL .01, 1997 DEC CAHN >D> PHARMACIA AND UP JOHN D.125MG N2D667 .0.01 JUL .01, 1997 DEC CAHN D.125MG N2D667 .0.01 JUL .01, 1997 NOV CRLD >D> + D.25MG N2D667 .0.02 JUL .01, 1997 DEC CAHN + D.25MG N2D667 .0.02 JUL .01, 1997 OCT CRLD >D> D.5MG N2D667 .0.06 FEB 12, 1998 DEC CAHN >D> 1MG N2D667 .0.03 JUL .01, 1997 DEC CAHN >D> Q 1.25MG N2D667 .0.04 JUL .01, 1997 DEC CAHN >D> 1.5MG N2D667 .0.05 JUL .01, 1997 DEC CAHN 1.5MG N2D667 .0.05 JUL .01, 1997 OCT CRLD
PRAZOSIN HYDROCHLORIDE CAPSULE; ORAL PRAZOSIN HCL Q CLONMEL HLTHCARE EQ 2MG BASE N727D6 .0.01 MAY 16, 1989 JUL DISC
PREDNICARBATE CREAM; TOPICAL DERMATOP E EMOLLIENT + DERMIK LABS .0.1% N2D279 .0.01 OCT 29, 1993· APR CTNA
PREDNISOLONE SYRUP; ORAL PREDNISOLONE AA AXIOM PHARM 15MG/5ML N4D287 .0.01 MAY 28, 1999 MAY CAHN AA HI TECH PHARMA 15MG/5ML N4D4D1 .0.01 FEB 27, 2.0.03 FEB NEWA + KV PHARM 5MG/5ML N4D423 .0.01 OCT 22, 2.0.01 JUL CRLD AA + 15MG/5ML N4D364 .0.01 APR 1.0, 2.0.02 JUL CRLD AA MORTON GROVE 15MG/5ML N4D313 .0.01 SEP 1.0, 2.0.03 SEP NEWA ,RX DRUG PRODUCT LIST -CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-80
AA PHARM ASSOC 1SMG/SML N40399 001 MAR OS, 2003 MAR NEWA PRE LONE iil MURO SMG/SML N896S4 001 JAN 17, 1989 JUL DISC AA + TEVA 1SMG/SML N89081 001 FEB 04, 1986 MAY CAHN AA 1SMG/SML N89081 001 FEB 04, 1986 JUL CRLD
PREDNISOLONE ACETATE SUSPENSION/DROPS; OPHTHALMIC ECONOPRED iil ALCON 0.12S% N17468 001 JUN DISC
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM OINTMENT; OPHTHALMIC CETAPRED iil ALCON 0.2S%;10% N87771 001 AUG 06,1993 JUN DISC
PREDNISOLONE SODIUM PHOSPHATE SOLUT ION; ORAL PREDNISOLONE SODIUM PHOSPHATE AA HI TECH PHARMA EQ SMG BASE/5ML N75183 001 MAR 26, 2003 MAR NEWA
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM SOLUTION/DROPS; OPHTHALMIC SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE AT ALCON .EQ 0.23% PHOSPHATE;10% N73630 001 MAY 27, 1993 APR CAHN
PREDNISONE TABLET; ORAL PREDNISONE AB VINTAGE PHARMS 20MG N40392 001 FEB 12, 2003 FEB NEWA >0> AB WEST WARD SOMG N8846S 001 JUN 01, 1984 DEC DISC >A> iil 50MG N88465 001 JUN 01, 1984 DEC DISC
PRIMIDONE TABLET; ORAL MYSOLINE AB + XCEl PHARMS SOMG N09170 003 JUL CRLD AB 250MG N09170 002 JUL CRLD
PROCAINAMIDE HYDROCHLORIDE INJECTABLE; INJECTION PROCAINAMIDE HCL iil BAXTER HLTHCARE 100MG/ML N89029 001 APR 17, 1986 AUG CAHN iil 500MG/ML N89030 001 APR 17, 1986 AUG CAHN iil ELKINS SINN 100MG/ML N89029 001 APR 17, 1986 JUN DISC iil 500MG/ML N89030 001 APR 17, 1986 JUN DISC
PROCAINE HYDROCHLORIDE' INJECTABLE; INJECTION PROCAINE HCL iil AM PHARM PARTNERS 1% N80421 001 OCT DISC iil 2% N80421 002 OCT DISC iil ELKINS SINN 1% N83315 001 OCT DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-81
iil 2% N8331S 002 OCT DISC iil STERIS 2% N806S8 002 OCT DISC
PROCHLORPERAZINE EDISYLATE INJECTABLE; INJECTION PROCHLORPERAZINE AP BAXTER HLTHCARE EQ SMG BASE/ML N877S9 001 OCT 01, 1982 AUG CAHN PROCHLORPERAZINE EDISYLATE iil BAXTER HLTHCARE EQ SMG BASE/ML N89S23 001 MAY 03, 1988 AUG CAHN AP GENSIA SICOR PHARMS EQ SMG BASE/ML N40S0S 001 MAY 30, 2003 MAY NEWA
PROMAZINE HYDROCHLORIDE INJECTABLE; INJECTION SPARINE iil BAXTER HLTHCARE CORP 2SMG/ML N10349 008 AUG CAHN iil SOMG/ML N10349 006 AUG CAHN
PROMETHAZINE HYDROCHLORIDE INJECTABLE; INJECTION PHENERGAN iil WYETH AYERST 2SMG/ML N088S7 002 JUN DISC iil SOMG/ML N088S7 003 APR DISC PROMETHAZINE HCL AP BAXTER HLTHCARE 2SMG/ML N83312 001 JUN CAHN AP SOMG/ML N83312 002 JUN CAHN AP + GENSIA SICOR PHARMS 2SMG/ML N404S4 001 AUG 22, 2002 APR CRLD AP + SOMG/ML N404S4 002 AUG 22, 2002 APR CRLD AP PHARMAFORCE 2SMG/ML N40S1S 001 MAR 19, 2003 MAR NEWA SUPPOSITORY; RECTAL PHENERGAN AB + WYETH AYERST SOMG N11689 001 FEB CTEC AB WYETH PHARMS INC 12.SMG Nl0926 002 MAR CAHN AB + 2SMG Nl0926 001 MAR CAHN AB + SOMG N11689 001 MAR CAHN PROMETHAZINE HCL AB ABLE 12.SMG N40S04 001 APR 11, 2003 APR NEWA AB 2SMG N40S04 002 APR 11, 2003 APR NEWA AB SOMG N40449 001 FEB 27, 2003 FEB NEWA AB CLAY PARK 12.SMG N40S00 001 JUN 30, 2003 JUN NEWA AB 2SMG N40S00 002 JUN 30, 2003 JUN NEWA AB G AND W LABS 12.SMG N40428 002 MAR 31, 2003 MAR NEWA AB PADDOCK 12.SMG N40479 001 JUN 24, 2003 JUN NEWA AB 2SMG N40479 002 JUN 24, 2003 JUN NEWA SYRUP; ORAL PHENERGAN PLAIN iil WYETH AYERST 6.2SMG/SML ND8381 004 APR 18, 1984 JUN DISC PROMETH PLAIN AA + ALPHARMA 6.2SMG/SML N8S9S3 001 JUN CRLD TABLET; ORAL PHENERGAN WYETH PHARMS INC 12.SMG N0793S 002 MAR CAHN BP 2SMG N0793S 003 MAR CAHN BP + SOMG N0793S 004 MAR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12· - DEC 2003 1-82
PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL RYTHMOL SR ABBOTT 225MG N21416 001 SEP 04, 2003 SEP NEWA 325MG N21416 002 SEP 04, 2003 SEP NEWA + 425MG N21416 003 SEP 04, 2003 SEP NEWA RELIANT PHARMS 225MG N21416 001 SEP 04, 2003 NOV CAHN 325MG N21416 002 SEP 04, 2003 NOV CAHN + 425MG N21416 003 SEP 04, 2003 NOV CAHN TABLET; ORAL RYTHMOL AB RELIANT PHARMS 150MG N19151 001 NOV 27, 1989 NOV CAHN AB 225MG N19151 003 NOV 20, 1992 NOV CAHN AB + 300MG N19151 002 NOV 27, 1989 NOV CAHN
PROPIOMAZINE HYDROCHLORIDE INJECTABLE; INJECTION LARGON @ BAXTER HLTHCARE CORP 20MG/ML N12382 002 MAY CAHN
PROPOXYPHENE HYDROCHLORIDE CAPSULE; ORAL DAR VON + AAIPHARMA LLC 32MG N10997 001 NOV CTEC DOLENE @ CLONMEL HLTHCARE 65MG N80530 001 AUG DISC PROPOXYPHENE HCL @ MYLAN 32MG N83528 001 NOV DISC
PROPOXYPHENE NAPSYLATE SUSPENSION; ORAL DARVON-N @ AAIPHARMA LLC 50MG/5ML N16861 001 JUL DISC
PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL INDERAL LA WYETH PHARMS INC 60MG N18553 004 MAR 18, 1987 MAR CAHN BX 80MG N18553 002 APR 19, 1983 MAR CTEC BX 120MG N18553 003 APR 19, 1983 MAR CTEC + 160MG N18553 001 APR 19, 1983 MAR CAHN INNOPRAN XL BX RELIANT PHARMS 80MG N21438 001 MAR 12, 2003 MAR NEWA BX 120MG N21438 002 MAR 12, 2003 MAR NEWA INJECTABLE; INJECTION INDERAL AP + BAXTER HLTHCARE CORP 1MG/ML N16419 001 MAY CAHN PROPRANOLOL HCL AP + BAXTER HLTHCARE CORP 1MG/ML N16419 001 AUG CTNA AP SABEX 2002 1MG/ML N76400 001 FEB 26, 2003 FEB NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-83
PROPRANOLOL HYDROCHLORIDE TABLET; ORAL INDERAL AB, + WYETH PHARMS INC 10MG N16418 001 MAR CAHN AB 20MG N16418 003 MAR CAHN AB 40MG N16418 002 MAR CAHN AB 60MG N16418 009 OCT 18, 1982 MAR CAHN AB + 80MG N16418 004 MAR CAHN @ 90MG N16418 010 OCT 18, 1982 MAR CAHN
PROTAMINE SULFATE INJECTABLE; INJECTION PROTAMINE SULFATE @ BAXTER HLTHCARE 10MG/ML N89474 001 NOV OS, 1986 AUG CAHN @ 10MG/ML N89475 001 NOV OS, 1986 AUG CAHN @ ELKINS SINN 10MG/ML N89474 001 NOV OS, 1986 JUN DISC @ 10MG/ML N8947s 001 NOV OS, 1986 JUN DISC
PROTIRELIN INJECTABLE; INJECTION THYREL TRH @ FERRING O.sMG/ML N18087 001 JUL DISC
PYRIDOSTIGMINE BROMIDE INJECTABLE; INJECTION REGONOL @ ORGANON sMG/ML N17398 001 MAY DISC @ SABEX 2002 sMG/ML N17398 001 JUN CAHN AP 5MG/ML N17398 001 OCT CMFD TABLET; ORAL PYRIDOSTIGMINE BROMIDE AB BARR 60MG N40s12 001 OCT 08, 2003 OCT NEWA AB IMPAX LABS 60MG N40s02 001 APR 24, 2003 APR NEWA @ US ARMY 30MG N20414 001 FEB OS, 2003 FEB NEWA
QUETIAPINE FUMARATE TABLET; ORAL SEROQUEL + ASTRAZENECA EQ 2sMG BASE N20639 001 SEP 26, 1997 MAR CRLD
QUINAPRIL HYDROCHLORIDE TABLET; ORAL ACCUPRIL AB PFIZER PHARMS EQ sMG BASE N1988s 001 NOV 19, 1991 MAY CFTG AB EQ 10MG BASE N19885 002 NOV 19, 1991 MAY CFTG AB EQ 20MG BASE N1988s 003 NOV 19, 1991 MAY CFTG AB + EQ 40MG BASE N1988s 004 NOV 19, 1991 MAY CFTG QUINAPRIL HCL AB TEVA EQ sMG BASE N7ss04 001 MAY 30, 2003 MAY NEWA AB EQ 10MG BASE N7ss04 002 MAY 30, 2003 MAY NEWA AB EQ 20MG BASE N7ss04 003 MAY 30, 2003 MAY NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-84
AB EQ 40MG BASE N75504 004 NOV 20, 1998 MAY NEWA
QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE; ORAL QUINAGLUTE fil BERLEX LABS 324MG N16647 001 MAR DISC QUINIDINE GLUCONATE BX + MUTUAL PHARM 324MG N89338 001 FEB 11, 1987 APR CRLD + 324MG N89338 001 FEB 11, 1987 MAY CTEC + WATSON LABS 324MG N87810 001 SEP 29, 1982 MAR CRLD BX 324MG N87810 001 SEP 29, 1982 APR CRLD fil 324MG N87810 001 SEP 29, 1982 MAY DISC
QUINIDINE SULFATE TABLET; ORAL QUINIDINE SULFATE AB CLONMEL HLTHCARE· 200MG N87011 001 JUL CAHN TABLET, EXTENDED RELEASE; ORAL QUINIDEX AB + WYETH PHARMS INC 300MG N12796 002 MAR CAHN fil 300MG N12796 002 JUN DISC QUINIDINE SULFATE + COPLEY PHARM 300MG N40045 001 JUN 30, 1994 JUN CTEC
RANITIDINE HYDROCHLORIDE CAPSULE; ORAL RANITIDINE HCL AB TEVA EQ 150MG BASE N75557 001 OCT 31, 2003 OCT NEWA AB EQ 300MG BASE N75557 002 OCT 31, 2003 OCT NEWA
RESERPINEj TRICHLORMETHIAZIDE TABLET; ORAL METATENSIN #2 fil AVENTI S PHARMS 0.1MG;2MG N12972 001 MAY DISC METATENSIN #4 fil AVENTIS PHARMS 0.1MG;4MG N12972 002 MAY DISC
RIBAVIRIN SOLUTION; ORAL REBETOL + SCHERING 40MG/ML N21546 001 JUL 29, 2003 JUL NEWA
RILUZOLE TABLET; ORAL RILUTEK AB + AVENTIS 50MG N20599 001 DEC 12, 1995 JAN CFTG RILUZOLE AB IMPAX LABS 50MG N76173 001 JAN 29, 2003 JAN NEWA
RIMANTADINE HYDROCHLORIDE TABLET; ORAL RIMANTADINE·HCL AB AMIDE PHARM 100MG N76375 001 JAN 14, 2003 JAN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-85
RISPERIDONE INJECTABLE; INTRAMUSCULAR RISPERDAL CONSTA JOHNSON .AND JOHNSON 25MG/VIAL N21346 001 OCT 29, 2003 OCT NEWA 37_5MG/VIAL N21346 002 OCT 29, 2003 OCT NEWA + 50MG/VIAL N21346 003 OCT 29, 2003 OCT NEWA TABLET, ORALLY DISINTEGRATING; ORAL RISPERDAL JOH.NSONAND JOHNSON 0.5MG N21444 001 APR 02, 2003 APR NEWA + 1MG N21444 002 APR 02, 2003 APR NEWA 2MG N21444 003 APR 02, 2003 APR NEWA
ROSIGLITAZONE MALEATE TABLET; ORAL AVANDIA SB PHARMCO EQ 2MG BASE N21071 002 MAY 25, 1999 APR CAHN EQ 4MG BASE N21071 003 MAY 25, 1999 APR CAHN + EQ 8MG BASE N21071 004 MAY 25, 1999 APR CAHN
ROSUVASTATIN CALCIUM TABLET; ORAL CRESTOR ASTRAZENECA 5MG N21366 002 AUG 12, 2003 AUG NEWA 10MG N21366 003 AUG 12, 2003 AUG NEWA 20MG N21366 004 AUG 12, 2003 AUG NEWA + 40MG N21366 005 AUG 12, 2003 AUG NEWA
SACROSIDASE SOLUTI ON; ORAL SUCRAID + QOL MEDCL 8,500 IU/ML N20772 001 APR 09, 1998 MAY CAHN
SECOBARBITAL SODIUM CAPSULE; ORAL >0> SODIUM SECOBARBITAL >0> AA WEST WARD 100MG N84926 001 DEC DISC >A> lil 100MG N84926 001 DEC DISC INJECTABLE; INJECTION lil WYETH AYERST 50MG/ML N83262 001 JUN DISC
SECRETIN FOR SOLUTION; INTRAVENOUS SECREFLO + CHIRHOCLIN 16UGM/VIAL N21136 001 APR 04, 2002 NOV NEWA
SELEGILINE HYDROCHLORIDE CAPSULE; ORAL SELEGELI NE HCL AB AAIPHARMA LLC 5MG N75145 001 SEP 15,2003 SEP NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-86
SERMORELIN ACETATE INJECTABLE; INJECTION GEREF @ SERONO EQ 0.5MG BASE/VIAL N20443 001 SEP 26, 1997 JUN DISC @ EQ 1MG BASE/VIAL N20443 002 SEP 26, 1997 JUN DISC
>A> SERTACONAZOLE NITRATE >A> CREAM; TOPICAL >A> ERTACZO >A> + JOHNSON JOHNSON 2% N21385 001 DEC 10, 2003 DEC NEWA
SEVELAMER HYDROCHLORIDE CAPSULE; ORAL RENAGEL + GENZYME 403MG N20926 001 OCT 30, 1998 APR CAHN TABLET; ORAL GENZYME 400MG N21179 001 JUL 12, 2000 APR CAHN + 800MG N21179 002 JUL 12, 2000 APR CAHN
SILDENAFIL CITRATE TABLET; ORAL VIAGRA PFIZER IRELAND 25MG N20895 001 MAR 27, 1998 OCT CAHN 50MG N20895 002 MAR 27, 1998 OCT CAHN + 100MG N20895 003 MAR 27, 1998 OCT CAHN
SIROLIMUS SOLUTION; ORAL RAPAMUNE + WYETH PHARMS INC 1MG/ML N21083 001 SEP 15, 1999 MAR CAHN TABLET; ORAL WYETH PHARMS INC 1MG N21110 001 AUG 25, 2000 MAR CRLD + 2MG N21110 002 AUG 22, 2002 MAR NEWA
SODIUM IODIDE, 1-131 CAPSULE; ORAL SODIUM IODIDE I 131 + DRAXIMAGE 1-250mCi N21305 002 JAN 24, 2003 JAN NEWA + 1-500mCi N21305 003 JAN 24, 2003 JAN NEWA SOLUT ION; ORAL SODIUM IODIDE I 131, KIT + DRAXIMAGE 1-250mCi/0.25ML N21305 002 JAN 24, 2003 FEB CDFR + 1-500mCi/0.5ML N21305 003 JAN 24, 2003 FEB CDFR
SODIUM NITROPRUSSIDE INJECTABLE; INJECTION NITROPRESS AP + ABBOTT 50MG/VIAL N70566 001 JUN 09, 1986 JUN CRLD + 50MG/VIAL N70566 001 JUN 09, 1986 AUG CTEC SODIUM NITROPRUSSIDE @ BAXTER HLTHCARE 50MG/VIAL N18581 001 JUL 28, 1982 AUG CAHN @ ELKINS SINN 50MG/VIAL N18581 001 JUL 28, 1982 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-B7
SOMATROPIN INJECTABLE; INJECTION ZORBTIVE >A> BX SERONO INC 4MG/VIAL N21597 001 DEC 01, 2003 DEC NEWA >A> BX 5MG/VIAL N21597002 DEC 01, 2003 DEC NEWA >A> BX 6MG/VIAL N21597 003 DEC 01, 2003 DEC NEWA >A> + B.BMG/VIAL N21597 004 DEC 01, 2003 DEC NEWA
SOMATROPIN RECOMBINANT INJECTABLE; INJECTION BIO-TROPIN >D> @ BIO TECH GEN 4.BMG/VIAL N19774 001 MAY 25, 1995 DEC CAHN @ 4.BMG/VIAL N19774 001 MAY 25, 1995 MAR DISC >A> @ SAVIENT PHARMS 4.BMG/VIAL N19774 001 MAY 25, 1995 DEC CAHN NORD ITROP I N BX NOVO NORDISK 4MG/VIAL N19721 001 MAY OB, 1995 JUL CMFD BMG/VIAL N19721 002 MAY OB, 1995 JUL CMFD SEROSTIM SERONO 4MG/VIAL N20604 003 JUL 25, 1997 NOV CRLD TEV-TROPIN >D> BX + BIO TECH GEN 5MG/ML N19774 002 JAN 04, 2002 DEC CAHN BX + 5MG/ML N19774 002 JAN 04, 2002 FEB CTNA >A> BX + SAVIENT PHARMS 5MG/ML N19774 002 JAN 04, 2002 DEC CAHN
SOTALOL HYDROCHLORIDE TABLET; ORAL BETAPACE AB1 BERLEX LABS BOMG N19B65 001 OCT 30, 1992 AUG CTEC AB1 120MG N19B65 005 APR 20, 1994 AUG CTEC AB1 + 160MG N19B65 002 OCT 30, 1992 AUG CTEC AB1 240MG N19B65 003 OCT 30, 1992 AUG CTEC BETAPACE AF. @ BERLEX LABS 40MG N21151 006 APR 02, 2003 MAY DISC 40MG N21151 006 APR 02, 2003 APR NEWA @ 60MG N21151 007 APR 02, ~003 MAY DISC 60MG N21151 007 APR 02, 2003 APR NEWA AB2 BOMG N21151 001 FEB 22, 2000 AUG CFTG @ 100MG N21151 005 MAR 14, 2003 MAY DISC 100MG N21151 005 MAR 14, 2003 MAR NEWA AB2 120MG N21151 002 FEB 22, 2000 AUG CFTG AB2 + 160MG N21151 003 FEB 22, 2000 AUG CFTG SORINE AB1 UPSHER SMITH BOMG N75500 001 APR 27, 2001 AUG CTEC AB1 120MG N75500 004 APR 27, 2001 AUG CTEC AB1 160MG N75500 002 APR 27, 2001 AUG CTEC AB1 240MG N75500 003 APR 27, 2001 AUG CTEC SOTALOL HCL AB1 APOTEX BOMG N76140 001 SEP 26, 2002 AUG CTEC AB1 120MG N76J40 002 SEP 26, 2002 AUG CTEC AB1 160MG N76140 003 SEP 26, 2002 AUG CTEC AB1 240MG N76140 004 SEP 26, 2002 AUG CTEC AB1 EON BOMG N75366 001 MAY 01, 2000 AUG CTEC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12:- DEC 2003 1-88
AB1 120MG N75366 002 MAY 01, 2000 AUG CTEC AB1 160MG N75366 003 MAY 01, 2000 AUG CTEC AB1 240MG N75366 004 MAY 01, 2000 AUG CTEC AB1 GENPHARM 80MG N75237 001 MAY 01, 2000 AUG CTEC AB1 120MG N75237 002 MAY 01,· 2000 AUG CTEC AB1 160MG N75237 003 MAY 01, 2000 AUG CTEC AB1 240MG N75237 004 MAY 01, 2000 AUG CTEC AB1 IMPAX PHARMS 80MG N75663 001 .NOV 07, 2000 AUG CTEC AB1 120MG N75663 002 NOV 07; 2000 AUG CTEC AB1 160MG N75663 003 NOV 07, 2000 AUG CTEC AB1 240MG N75663 004 NOV 07, 2000 AUG CTEC AB1 MUTUAL PHARM 80MG N75515 001 OCT 15, 2Q01 AUG CTEC AB1 120MG N75515 004 OCT 15, 2001 AUG CTEC AB1 160MG N75515 002 OCT 15, 2001 AUG CTEC AB1 240MG N75515 003 OCT 15,' 2001 AUG CTEC AB1 MYLAN 80MG N75725 001 DEC 19, 2000 AUG CTEC AB1 120MG N75725 002 DEC 19, 2000 AUG CTEC AB1 160MG N75725 003 DEC 19, 2000 AUG CTEC AB1 240MG N75725 004 DEC 19, 2000 AUG CTEC AB1 TEVA 80MG N75429 001 MAY 01, 2000 AUG CTEC AB1 120MG N75429 002 MAY 01, 2000 AUG CTEC AB1 160MG N75429 003 MAY 01, 2000 AUG CTEC AB1 240MG N75429 004 MAY 01, 2000 AUG CTEC AB2 TORPHARM 80MG N76214 001 AUG 27, 2003 AUG NEWA AB2 120MG N76214 002 AUG 27, 2003 AUG NEWA AB2 160MG N76214 003 AUG 27, 2003 AUG NEWA AB1 VINTAGE PHARMS 80MG N75563 001 NOV 07, 2003 NOV NEWA AB1 120MG N75563 002 NOV 07, 2003 NOV NEWA AB1 160MG N75563 003 NOV 07, 2003 NOV NEWA AB1 240MG N75563 004 NOV 07, 2003 NOV NEWA AB1 WATSON LABS 80MG N75238 001 JUL 13, 2000 AUG CTEC AB1 120MG N75238 002 JUL 13, 2000 AUG CTEC AB1 160MG N75238 003 JUL 13, 2000 AUG CTEC AB1 240MG N75238 004 JUL 13, 2000 AUG CTEC
STANOZOLOL TABLET; ORAL WINSTROL + OVATION PHARMS 2MG N12885 001 MAY 14, 1984 JUL CAHN 61 2MG N12885 001 MAY 14, 1984 ·AUG DISC
STREPTOZOCIN INJECTABLE; INJECTION ZANOSAR . + GENSIA SICOR PHARMS 1GM/VIAL N50577.001 MAY 07, 1982 JUN CAHN
. STRONTIUM CHLORIDE, SR-89 INJECTABLE; INJECTION METASTRON AP + AMERSHAM HLTH 1mCi/ML N20134 001 JUN 18, 1993 JAN CFTG STRONTIUM CHLORIDE SR-89 AP BID NUCLEONICS 1mCi/ML N75941 001 'JAN 06, 2003 JAN NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-89
SUCCIMER CAPSULE; ORAL CHEMET + OVATION PHARMS 100MG N19998 002 JAN 30, 1991 JUL CAHN
SUCRALFATE SUSPENSION; ORAL CARAFATE + AXCAN SCANDIPHARM 1GM/10ML N19183 001 DEC 16, 1993 NOV CAHN
SULFAMETHOXAZOLEi· TRIMETHOPRIM INJECTABLE; INJECTION SEPTRA @ MONARCH PHARMS . 80MG/ML;16MG/ML N18452 001 MAY DISC
SULFANILAMIDE SUPPOSITORY; VAGINAL AVC @ NOVA VAX 1.05GM N06530 004 JAN "2:7, 1987 SEP DISC
SULINDAC. TABLET; ORAL SULINDAC @ CLONMEL HLTHCARE 150MG N73261 001 SEP 06, 1991 JUN DISC @ 200MG N73262 001 SE.P 06, 1991 JUN DISC
TADALAFIL TABLET; ORAL CIALIS LILLY ICOS 5MG N21368 001 NOV 21, 2003 NOV NEWA 10MG N21368 002 NOV 21, 2003 NOV NEWA + 20MG N21368 003 NOV 21, 2003 NOV NEWA
TALC >A> POWDER; INTRAPLEURAL >A> TALC >A> + BRYAN 5GM/BOT N21388 001 DEC 15, 2003 DEC NEWA
TAMOXIFEN CITRATE· TABLET; ORAL NOLVADEX AB ASTRAZENECA EQ 10MG BASE N17970 001 FEB CTEC AB + EQ 20MG BASE N17970 002 MAR 21, 1994 FEB CTEC TAMOXIFEN CITRATE AB AEGIS PHARMS EQ 10MG BASE N76398 001 MAR 31, 2003 MAR NEWA AB EQ 20MG BASE N76398.002 MAR 31, 2003 MAR NEWA AB ANDRX PHARMS EQ 10MG BASE N76179 001 FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N76179 002 FEB 20, 2003 FEB NEWA AB BARR EQ 10MG BASE N7Q929 001 FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N70929 002 . FEB 20, 2003 FEB NEWA AB IVAX PHARMS EQ 10MG BASE N75740 001 FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N75740 002 FEB 20, 2003 FEB NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12·" DEC 2003 1-90
AB MYLAN EQ 10MG BASE N74732 002 FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N74732 001 FEB 20, 2003 FEB NEWA AB PHARMACHEMIE EQ 10MG BASE N74539 001 MAR 31, 2003 APR CAHN AB EQ 20MG BASE N74858 001 FEB 20,2003 FEB NEWA AB ROXANE EQ 10MG BASE N76027 OOl FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N76027 002 FEB 20, 2003 FEB NEWA AB TEVA EQ 10MG BASE N74504 001 APR 28, 2003 APR NEWA AB EQ 10MG BASE N74539 001 MAR 31 , 2003 MAR NEWA AB EQ 10MG BASE N75797 001 FEB 20, 2003 FEB NEWA AB EQ 20MG BASE N74504 002 APR 28, 2003 APR NEWA
TECHNETIUM TC-99M MEDRONATE KI T INJECTABLE; INJECTION TECHNESCAN MDP KIT AP + DRAXIMAGE N/A N18035 001 MAR CRLD
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT INJECTABLE; INJECTION PYROLITE @CIS " N/A N17684 001 MAY DISC
TELMISARTAN TABLET; ORAL MICARDIS BOEHRINGER INGELHEIM 20MG N20850 003 APR 04, 2000 JUL CRLD
>D> TERIPARATIDE ACETATE >D> INJECTABLE; SUBCUTANEOUS >D> FORTEO >D> + LI LLY EQ 0.75MG/3ML(0.25MG/ML) N21318 001 NOV 26, 2002 DEC CAIN
>A>. TERIPARATIDE RECOMBINANT HUMAN >A> INJECTABLE; SUBCUTANEOUS >A> FORTEO >A> + LILLY EQ 0.75MG/3ML(0.25MG/ML) N21318 001 NOV 26, 2002 DEC CAIN
TESTOSTERONE GEL; TOPICAL AND ROGEL BX + UNIMED PHARMS 1% N21015 001 FEB 28, 2000 APR CTEC TESTIM BX + AUXILIUM A2 1% N21454 001 OCT 31, 2002 APR CTEC TABLET, EXTENDED RELEASE; BUCCAL STRIANT + COLUMBIA LABS 30MG N21543 001 JUN 19, 2003 JUN NEWA
TESTOSTERONE ENANTHATE INJECTABLE; INJECTION DELATESTRYL @ SAVIENT PHARMS 200MG/ML N09165 001 OCT CAHN AO + 200MG/ML N09165 003 OCT CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-91
TETRACYCLINE HYDROCHLORIDE CAPSULE; ORAL ACHROMYCIN V @ CLONMEL HLTHCARE 250MG N50278 003 JUN DISC @ 500MG N50278 001 JUN DISC SUMYCIN AB + APOTHECON 500MG N60429 003 JUN CRLD TETRACYCLINE HCL AB AXIOM PHARM 250MG N60736 001 MAY CAHN AB 500MG N60736 002 MAY CAHN @ ROXANE 500MG N61214 002 OCT DISC FIBER,. EXTENDED RELEASE; PERIODONTAL ACTISITE @ ALZA 12_7MG/FIBER N50653 001 MAR 25 , 1994 JUN DISC
THALIDOMIDE CAPSULE; ORAL THALOMID CELGENE 50MG N20785 001 JUL 16, 1998 AUG CRLD 100MG N20785 002 JAN 17, 2003 JAN NEWA + 200MG N20785 003 JAN 17, 2003 JAN NEWA
THALLOUS CHLORIDE, TL-201 INJECTABLE; INTRAVENOUS THALLOUS CHLORIDE TL 201 + BRISTOL MYERS SQUIBB 2mCi/ML N17806 002 OCT 09, 1998 OCT NEWA
THEOPHYLLINE SYRUP; ORAL SLO-PHYLLIN @ AVENTIS 80MG/15ML N85187 001 AUG DISC TABLET; ORAL @ AVENTIS 100MG N85202 001 AUG DISC @ 200MG N85204 001 AUG DISC TABLET, EXTENDED RELEASEi ORAL THEO-DUR @ SCHERING 100MG N85328 001 SEP .DISC @ 200MG N86998 001 SEP DISC @ 300MG N85328 002 SEP DISC @ 450MG N89131 001 JUN 25, 1986 SEP DISC THEOPHYLLINE AB PLiVA 300MG N89763 001 APR 30, 1990 AUG CRLD UNI-DUR @ SCHERING 600MG N89823 001 JAN 04, 1995 SEP DISC
THIAMINE HYDROCHLORIDE INJECTABLE; INJECTION THIAMINE HCL @ WYETH AYERST 100MG/ML N80553 001 JUN DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12· - DEC 2003 1-92
THIETHYLPERAZINE MALEATE SUPPOSITORY; RECTAL TORECAN iil NOVARTIS 1DMG N13247 001 JUN DISC
THIOTEPA INJECTABLE; INJECTION THIOPLEX iil IMMUNEX 15MG/VIAL N20058 001 DEC 22, 1994 JUL DISC THIOTEPA AP + GENSIA SICOR PHARMS 15MG/VIAL N75730 001 APR 20, 2001 JUL CRLD
THIOTHIXENE CAPSULE;·ORAL NAVANE AB PFIZER 1MG N16584 001 FE8 CAHN AB 2MG N16584 002 FEB CAHN AB + 5MG N16584 003 FEB CAHN AB 10MG N16584 004 FEB CAHN 20MG N16584 005 FEB CAHN
THIOTHIXENE HYDROCHLORIDE CONCENTRATE; ORAL AA + PFIZER EQ 5MG BASE/ML N16758 001 FEB CAHN INJECTABLE; INJECTION iil PFIZER EQ 2MG BASE/ML N16904 001 FEB CAHN + EQ 10MG BASE/VIAL N16904 002 FEB CAHN
T1MOLOL MALEATE SOLUTION/DROPS;· OPHTHALMIC T1MOLOL MALEATE AT FALCON PHARMS EQ 0.25% BASE N74261 001 APR 28, 1995 NOV CMFD AT EQ 0.5% BASE N74262 001 APR 28, 1995 NOV CMFD
TIROFIBAN HYDROCHLORIDE INJECTABLE; INJECTION AGGRASTAT + GUILFORD PHARMS EQ 0.05MG BASE/ML N20913 001 MAY 14, 1998 OCT CAHN + EQ 0.25MG BASE/ML N20912 001 MAY 14, 1998 OCT CAHN
TIZANIDINE HYDROCHLORIDE TABLET; ORAL T1ZANIDINE HCL >A> AB ALPHAPHARM EQ 2MG BASE N76282 001 DEC 16, 2003 DEC NEWA >A> AB EQ 4MG BASE N76282 002 DEC 16, 2003 DEC NEWA AB AMIDE PHARM EQ 2MG BASE N76281 001 OCT 20, 2003 OCT NEWA AB EQ 4MG BASE N76281 002 OCT 20, 2003 OCT NEWA AB BARR EQ 2MG BASE N76371 001 APR 09, 2003 APR NEWA AB EQ 4MG BASE N76371 002 APR 09, 2003 APR NEWA AB CARACO EQ 2MG BASE N76416 001 SEP 29, 2003 SEP NEWA AB EQ 4MG BASE N76416 002 SEP 29, 2003 SEP NEWA AB MYlAN EQ 2MG BASE N76354 001 MAR 28, 2003 MAR NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-93
AB EQ 4MG BASE N76354 002 MAR 28, 2003 MAR NEWA
TOBRAMYCIN SULFATE INJECTABLE; INJECTION TOBRAMYCIN SULFATE @ BAXTER HLTHCARE EQ 10MG BASE/ML N63113 001 APR 26, 1991 AUG CAHN @ EQ 10MG BASE/ML N63128 001 NOV 27, 1991 AUG CAHN AP EQ 40MG BASE/ML N63117 001 APR 26, 1991 AUG CAHN AP EQ 40MG BASE/ML N63118 001 JUL 29, 1991 AUG CAHN @ EQ 40MG BASE/ML N63127 001 NOV 27, 1991 AUG CAHN
TOLBUTAMIDE TABLET; ORAL TOLBUTAMIDE @ CLONMEL HLTHCARE 500MG N86926 001 JUL DISC
TOLBUTAMIDE SODIUM INJECTABLE; INJECTION· ORINASE DIAGNOSTIC @ PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N12095 001 JUN DISC
TORSEMIDE TABLET; ORAL TORSEMIDE AB PAR PHARM 5MG N76226 001 MAY 27, 2003 MAY NEWA AB 10MG N76226 002 MAY 27, 2003 MAY NEWA AB 20MG N76226 003 MAY 27, 2003 MAY NEWA AB 100MG N76226 004 MAY 27, 2003 MAY NEWA AB PLiVA PHARM IND 5MG N76346 001 MAY 30, 2003 MAY NEWA AB 10MG N76346 002 MAY 30, 2003 MAY NEWA AB 20MG N76346 003 MAY 30, 2003 MAY NEWA
TRAMADOL HYDROCHLORIDE TABLET; ORAL TRAMADOL HCL AB IVAX PHARMS 50MG N75963 001 JUl 03, 2002 MAR CAHN
TRIAMCINOLONE ACETONIDE AEROSOL, METERED; NASAL NASACORT @ AVENTIS 0.055MG/INH N19798 001 JUL 11, 1991 JUL DISC LOTION; TOPICAL TRIAMCINOLONE ACETONIDE AT ALTANA 0.025% N40467 001 APR 21, 2003 APR NEWA AT 0.1% N40467 002 APR 21, 2003 APR NEWA SPRAY, METERED; NASAL TRI-NASAL @ COLLEGIUM 0.05MG/SPRAY N20120 001 FEB 04, 2000 JUL CAHN
TRIAMCINOLONE DIACETATE INJECTABLE; .INJECTION ARISTOCORT >0> + FUJISAWA HLTHCARE 25MG/ML N11685 003 DEC CAHN RX DRUG PRODUCT LIST -CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-94
>D> + -I+OMG/ML N12802 001 DEC CAHN >A> + SABEX 2002 25MG/ML N11685 003 DEC CAHN >A> + 40MG/ML N12802 001 DEC CAHN
TRIAMCINOLONE HEXACETONIDE INJECTABLE; INJECTION ARISTOSPAN >D> + FUJISAWA HLTHCARE 5MG/ML N16466 001 DEC CAHN >D> + 20MG/ML N16466 002 DEC CAHN >A> + SABEX 2002 5MG/ML N16466 001 DEC CAHN >A> + 20MG/ML N16466 002 . DEC CAHN
TRICHLORMETHIAZIDE. TABLET; ORAL METAHYDRIN @ AVENTIS PHARMS 2MG N12594 001 JUN 16, 1988 MAY DISC @ 4MG N12594 002 JUN 16, 1988 MAY DISC
TRIHEXYPHENIDYL HYDROCHLORIDE ELIXIR; ORAL ARTANE @ LEDERLE 2MG/5ML N06773 009 JUN DISC TRIHEXYPHENIDYL HCL AA + PHARM VENTURES 2MG/5ML N89514 001 APR 07, 1989 JUN CRLD TABLET; ORAL ARTANE @ LEDERLE 2MG N06773 005 JUN DISC @ 5MG N06m 003 JUN DISC TRIHEXYPHENIDYL HCL @ NY LOS 5MG N85622 001 NOV DISC AA + WATSON LABS 2MG N84363 001 JUN CRLD AA + 5MG N84364 001 JUN CRLD
TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE; ORAL TIGAN AB + KING PHARMS 300MG N17531 006 DEC 13, 2001 AUG CFTG TRIMETHOBENZAMIDE HCL AB AMIDE PHARM 300MG N76546 001 AUG 20, 2003 AUG NEWA AB MUTUAL PHARMA 300MG N76570 001 AUG 28, 2003 AUG NEWA
TRIMETHOPRIM TABLET; ORAL PROLOPRIM @ MONARCH PHARMS 200MG N17943 003 JUL 14, 1982 MAY DISC TRIMETHOPRIM + TEVA 200MG N71259 001 JUN 18, 1987 MAY CRLD
TRIPELENNAMINE HYDROCHLORIDE TABLET; ORAL PBZ @ NOVARTIS 25MG N83149 001 NOV DISC RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-95
TRIPELENNAMINE HYDROCHLORIDE TABLET; ORAL TRIPELENNAMINE HCL
iii LAN NETT 50MG N83557 001 NOV DISC
iii NYLOS 50MG N85412 001 NOV DISC
iii WATSON LABS 50MG N80713 001 NOV DISC
TRIPLE SULFA ~SULFABENZAMIDEiSULFACETAMIDEiSULFATHIAZOLE) CREAM; VAGINAL GYNE-SULF
iii G AND W LABS 3.rlo;2.86%;3.42% N88607 001 JUN 09, 1986 OCT DISC SULTRIN
iii ORTHO MCNEIL PHARM 3.7%;2.86%;3.42% N05794 001 AUG DISC TRIPLE SULFA
iii ALPHARMA 3.7%;2.86%;3.42% N87864 001 SEP 01, 1982 OCT WDAG
iii CLAY PARK 3.rlo;2.86%;3.42% N87285 001 NOV 15, 1982 OCT DISC TRYSUL
iii SAVAGE LABS 3.rlo;2.86%;3.42% N87887 001 JUL 23, 1982 OCT DISC
UREA, C-13 FOR SOLUTI ON; ORAL HELICOSOL
iii METABOLIC SOLUTIONS 125MG/VIAL N21092 OD1 DEC 17, 1999 MAY DISC PYLORI-CHEK BREATH TEST
iii DXS DEVICES 100MG/VIAL N20900 001 FEB 04, 1999 MAR CAHN
VALACYCLOVIR HYDROCHLORIDE TABLET; ORAL VALTREX
>D> iii GLAXOSMITHKLINE EQ 500MG BASE N20487 001 JUN 23, 1995 DEC CMFD >A> EQ 500MG BASE N20487 001 JUN 23, 1995 DEC CMFD
>D> iii EQ 1GM BASE N20487 002 JUN 23, 1995 DEC CMFD >A> EQ 1GM BASE N20487 002 JUN 23, 1995 DEC CMFD
VALPROATE SODIUM INJECTABLE; INJECTION VALPROATE SODIUM AP AM PHARM EQ 100MG BASE/ML N76539 001 JUN 26, 2003 JUN NEWA
VALSARTAN TABLET; ORAL DIOVAN NOVARTIS 40MG N21283 004 AUG 14, 2002 JUL NEWA
VANCOMYCIN HYDROCHLORIDE FOR SOLUTION; ORAL VANCOCIN HCL + LILLY EQ 250MG BASE/5ML. N61667 002 JUL 13, 1983 JUN CTEC VANCOLED
iii LEDERLE EQ 250MG BASE/5ML N63321 002 OCT 15, 1993 JUN DISC RX DRUG PRODUCT LIST -CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-96
VANCOMYCIN HYDROCHLORIDE INJECTABLE; INJECTION VANCOLED AP, + BAXTER HLTHCARE EQ 500MG BASE/VIAL N62682 001 JUL 22, 1986 AUG CAHN AP + EQ 1GM BASE/VIAL N62682 002 MAR 30, 1988 AUG CAHN + EQ 2GM BASE/VIAL N62682 003 MAY 11,' 1988 AUG CAHN AP + EQ 5GM BASE/VIAL N62682 004 MAY 11, 1988 AUG CAHN AP + EQ 10GM BASE/VIAL N62682 005 MAY 11; 1988 AUG CAHN VANCOMYCIN HCL @ BAXTER HLTHCARE EQ 500MG BASE/VIAL N62879 001 AUG 02, 1988 AUG CAHN @ EQ 1GM BASE/VIAL N62879 002 AUG 02, 1988 AUG CAHN
VARDENAFIL HYDROCHLORIDE TABLET; ORAL LEVITRA BAYER PHARMS 2.5MG N21400 003 AUG 19, 2003 AUG NEWA 5MG N21400 001 AUG 19, 2003 AUG NEWA 10MG N21400 002 AUG 19, 2003 AUG NEWA + 20MG N21400 004 AUG 19, 2003 AUG NEWA
VECURONIUM BROMIDE INJECTABLE; INJECTION NORCURON @ ORGANON 10MG/VIAL N18776 002 APR 30, 1984 MAY DISC VECURONIUM BROMIDE AP BAXTER HLTHCARE 10MG/VIAL N75218 001 AUG 23, 1999 AUG CAHN AP 20MG/VIAL N75218 002 AUG 23, 1999 AUG CAHN AP + BEDFORD 10MG/VIAL N75549 001 JUN 13, 2000 MAY CRLD
VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL EFFEXOR XR WYETH PHARMS INC EQ 37. 5MG BASE N20699 001 OCT 20, 1997 MAR CAHN EQ 75MG BASE N20699 002 OCT 20, 1997 MAR CRLD @ EQ 100MG BASE N20699 003 OCT 20, 1997 MAR CAHN + EQ 150MG BASE N20699 004 OCT 20, 1997 MAR CRLD TABLET; ORAL EFFEXOR @ WYETH PHARMS INC EQ 12.5MG BASE N20151 001 DEC 28, 1993 MAR CAHN EQ 25MG BASE N20151 002 DEC 28, 1993 MAR CRLD EQ 37.5MG BASE N20151 006 DEC 28, 1993 MAR CAHN >D> EQ 50MG BASE N20151 003 DEC 28, 1993 DEC CRLD >A> + EQ 50MG BASE N20151 003 DEC 28, 1993 DEC CRLD EQ 50MG BASE N20151 003 DEC 28, 1993 MAR CAHN EQ 75MG BASE N20151 004 DEC 28, 1993 MAR CAHN >D> + EQ 100MG BASE N20151 005 DEC 28, 1993 DEC CRLD >A> EQ 100MG BASE N20151 005 DEC 28, 1993 DEC CRLD + EQ 100MG BASE N20151 005 DEC 28, 1993 MAR CAHN RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12-·DEC 2003 1-97
VERAPAMIL HYDROCHLORIDE TABLET; ORAL VERAPAMIL HCL a CLONMEL HLTHCARE 80MG N71880 001 APR OS, 198B JUL DISC a 120MG N71881 001 APR OS, 1988 JUL DISC
VIDARABINE OINTMENT; OPHTHALMIC VIRA-A a PARKEDALE 3% N50486 001 MAY DISC
VINCRISTINE SULFATE INJECTABLE; INJECTION VINCASAR PFS AP GENSIA SICOR PHARMS 1MG/ML N71426 001 JUL 17, 1987 JUL CAHN VINCRISTINE SULFATE AP AM PHARM 1MG/ML N76401 001 OCT 28, 2003 OCT NEWA AP + AM PHARM PARTNERS 1MG/ML N76296 001 DEC 20, 2002 OCT CTEC VINCRISTINE SULFATE PFS AP SICOR PHARMS 1MG/ML N75493 001 SEP 01, 1999 JUL CAHN
VINORELBINE TARTRATE INJECTABLE; INJECTION NAVELBINE AP + GLAXOSMITHKLlNE EQ 10MG BASE/ML N20388 001 DEC 23, 1994 FEB CFTG VINORELBINE TARTRATE >A> AP BEDFORD EQ 10MG BASE/ML N76461 001 DEC 11, 2003 DEC NEWA AP ESI LEDERLE EQ 10MG BASE/ML N75992 001 JUN 10, 2003 JUN NEWA AP GENSIA SICOR PHARMS EQ 10MG BASE/ML N76028 001 FEB 03, 2003 FEB NEWA
>0> VITAMIN A >0> CAPSULE; ORAL >0> VITAMIN A >0> + WEST WARD 50,000USP UNITS N80985 001 DEC DISC >A> a 50,000USP UN ITS N80985 001 DEC DISC
VORI CONAZOLE >A> FOR SUSPENSION; ORAL >A> VFEND >A> + PFIZER 200MG/5ML N21630 001 'DEC 19, 2003 DEC NEWA
WARFARIN SODIUM TABLET; ORAL JANTOVEN AB USL PHARMA 1MG N40416 001 OCT 02, 2003 OCT NEWA AB 2MG N40416 002 OCT 02, 2003 OCT NEWA AB 2.5MG N40416 003 OCT 02, 2003 OCT NEWA AB 3MG N40416 004 OCT 02, 2003 OCT NEWA AB 4MG N40416 005 OCT 02, 2003 OCT NEWA AB 5MG N40416 006 OCT 02, 2003 OCT NEWA AB 6MG N40416 007 OCT 02, 2003 OCT NEWA AB 7.5MG N40416 008 OCT 02, 2003 OCT NEWA RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 1-98
AB 10MG N40416 009 OCT 02, 2003 OCT NEWA
XENON. XE-133 GAS; INHALATION 'XENON XE 133 GEN ELECTRIC 5-100 CI/CYLINDER N17550 001 JUL CPOT 0.25-5 CI/AMP N17550 003 JUL CPOT
ZALEPLON CAPSULE; ORAL SONATA JONES PHARMA 5MG N20859 001 AUG 13, 1999 JUN CAHN + 10MG N20859 002 AUG 13, 1999 JUN CAHN
ZOLEDRONIC ACID INJECTABLE; IV (INFUSION) ZOMETA + NOVARTIS EQ 4MG BASE/5ML N21223 002 MAR 07, 2003 MAR NEWA
ZOLMITRIPTAN SPRAY; NASAL ZOMIG + ASTRAZENECA 5MG/SPRAY N21450 004 SEP 30, 2003 SEP NEWA
ZONISAMIDE CAPSULE; ORAL ZONEGRAN DAINIPPON 25MG N20789 003 AUG 22, 2003 AUG NEWA 50MG N20789 002 AUG 22, 2003 AUG NEWA PRESCRIPTION DRUG PRODUCT LIST - 23RD EDITION OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 2-1
ACETAMINOPHEN TABLET, EXTENDED RELEASE; ORAL TYLENOL (CAPLET) + MCNEIL CONS SPECLT 650MG N19872 001 JUN 08, 1994 JUN CTNA TYLENOL (GELTAB) + MCNEIL CONS SPECLT 650MG N19872 002 JAN 11, 2001 JUN NEWA
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE TABLET, CHEWABLE; ORAL FOAM I CON NOVARTIS 80MG;20MG N72687 001 JUN 28, 1989 MAR CAHN iii 80MG;20MG N72687 001 JUN 28, 1989 OCT WDAG
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL PSEUDOEPHEDRINE HCL AND CHLORPHENIRAMINE MALEATE @ CENT PHARMS. 8MG;120MG N19428 001 AUG 02, 1988 MAR DISC
CIMETIDINE TABLET; ORAL CIMETIDINE @ LEK PHARMS 100MG N75122 001 JUN 19, 1998 MAR CAHN 200MG N75122 002 JUN 19, 1998 MAR CAHN
EPINEPHRINE AEROSOL, METERED; INHALATION BRONKAID MIST @ STERLING 0.25MG/INH N16803 001 MAY DISC
FAMOTIDINE TABLET; ORAL PEPCID AC MERCK 10MG N20325 001 APR 28, 1995 SEP CRLD + 20MG N20325 002 SEP 23, 2003 SEP NEWA PEPCID AC (GELTAB) MERCK 10MG N20902 001 AUG OS, 1999 AUG CTNA TABLET, CHEWABLE; ORAL FAMOTIDINE PERRIGO 10MG N75715 001 AUG 22, 2003 AUG NEWA
GUAI FENESIN TABLET, EXTENDED RELEASE; ORAL MUCINEX ADAMS LABS 600MG N21282 001 JUL 12, 2002 JAN CRLD + 1.2GM N21282 002 DEC 18, 2002 JAN NEWA
IBUPROFEN TABLET; ORAL IBUPROFEN NEIL 200MG N76460 001 NOV 26, 2003 NOV NEWA JUNIOR STRENGTH MOTRIN MCNEIL 100MG N20602 001 JUN 10, 1996 JUN CRLD OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - DEC 2003 2-2
IBUPROFENi PSEUDOEPHEDRINE HYDROCHLORIDE SUSPENSION; ORAL IBUPROFEN AND PSEUDOEPHEDRINE HCL PERRIGO 100MG/5ML;15MG/5ML N76478 001 NOV OS, 2003 NOV NEWA
.>D> INSULIN SUSP ISOPHANE BEEF >D> INJECTABLE; INJECTION >D> NPH INSULIN >D> + NOVO NORDISK 100 UN ITS/ML N17929 003 DEC DISC >A> @ 100 UN ITS/ML N17929 003 DEC DISC
LOPERAMIDE HYDROC!!LOR IDE TABLET; ORAL LOPERAMIDE HCL LNK 2MG N76497 001 JUN 10, 2003 JUN NEWA
LOPERAMIDE HYDROCHLORIDEi SIMETHICONE TABLET; ORAL IMODIUM ADVANCED + MCNEIL CONS SPECLT 2MG;125MG N21140 001 NOV 30, 2000 JAN CRLD
LORATADINE SYRUP; ORAL CLARITIN + SCHERING 1MG/ML N20641 002 NOV 27, 2002 APR CRLD 1MG/ML N20641 002 NOV 27, 2002 MAR NEWA CLARITIN HIVES RELIEF + SCHERING 1MG/ML N20641 003 NOV 19, 2003 NOV NEWA LORATADINE TEVA 1MG/ML N75505 001 NOV 07, 2003 ,NOV NEWA TABLET; ORAL CLARITIN + SCHERING 10MG N19658 002 NOV 27, 2002 APR CRLD 10MG N19658 002 NOV 27, 2002 MAR NEWA CLARITIN HIVES RELIEF + SCHERING 10MG N19658 003 NOV 19, 2003 NOV NEWA LORATADINE GENEVA PHARMS 10MG N75209 001 JAN 21, 2003 JAN NEWA GENPHARM 10MG N76154 001 AUG 20, 2003 AUG NEWA RANBAXY 10MG N76134 001 AUG 18, 2003 AUG NEWA TABLET, ORALLY DISINTEGRATING; ORAL ALAVERT WYETH CONS 10MG N21375 001 DEC 19, 2002 APR CRLD CLARITIN HIVES RELIEF REDITAB + SCHERING 10MG N20704 003 NOV 19, 2003 NOV NEWA CLARITIN REDITABS + SCHERING 10MG N20704 002 NOV 27, 2002 APR CRLD 10MG N20704 002 NOV 27, 2002 MAR NEWA LORATADINE ANDRX PHARMS 10MG N75990 001 NOV 03, 2003 NOV NEWA IMPAX LABS 10MG N76011 001 SEP 29, 2003 SEP NEWA WYETH CONS 10MG N75822 001 FEB 10, 2003 FEB NEWA OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - 'DEC 2003 2-3
LORATADINEj PSEUDOEPHEDRINE SULFATE TABLET. EXTENDED RELEASE; ORAL CLARITIN-D + SCHERING 5MG;120MG N19670 002 NOV 27. 2002 APR CRLD 5MG;120MG N19670 002 NOV 27. 2002 MAR NEWA CLARITIN-D 24 HOUR + SCHERING 10MG;240MG N20470 002 NOV 27. 2002 APR CRLD 10MG;240MG N20470 002 NOV 27. 2002 MAR NEWA LORATADINE AND PSEUDOEPHEDRINE HCL ANDRX PHARMS 10MG;240MG N75706 001 FEB 21. 2003 FEB NEWA LORATADINE AND PSEUDOEPHEDRINE SULFATE ANDRX PHARMS 10MG;240MG N75706 001 FEB 21. 2003 OCT CTNA IMPAX LABS 5MG;120MG N76050 001 JAN 30. 2003 JAN NEWA
MICONAZOLE NITRATE CREAM; TOPICAL. VAGINAL MONISTAT 3 COMBINATION PACK + PERSONAL PRODS 2%.4% N21261 003 JUN 17. 2003 JUN NEWA MONISTAT 3 COMBINATION PACK (PREFILLED) + PERSONAL PRODS 2%.4% N21261 001 FEB 02. 2001 JUN CTNA CREAM. SUPPOSITORY; TOPICAL. VAGINAL MONISTAT 1 COMBINATION PACK + PERSONAL PRODS 1.2GM.2% N21308 001 JUN 29. 2001 NOV NEWA
MINOXIDIL SOLUTION; TOPICAL MINOXIDIL EXTRA STRENGTH (FOR MEN) MORTON GROVE 5% N75438 001 FEB 27. 2003 FEB NEWA
NICOTINE FILM. EXTENDED RELEASE; TRANSDERMAL PROSTEP + AVEVA 11MG/24HR N19983 003 DEC 23, 1998 OCT CAHN + 22MG/24HR N19983 004 DEC 23. 1998 OCT CAHN
NICOTINE POLACRILEX TROCHE/LOZENGE; ORAL COMMIT GLAXOSMITHKLINE CONS EQ 2MG BASE N21330 001 OCT 31. 2002 SEP CPOT +' EQ 4MG BASE N21330 002 OCT 31. 2002 SEP CPOT
OMEPRAZOLE MAGNESIUM TABLET. DELAYED RELEASE; ORAL PRILOSEC + ASTRAZENECA EQ 20MG BASE N21229 001 JUN 20. 2003 JUN NEWA PRILOSEC OTC + ASTRAZENECA EQ 20MG BASE N21229 001 JUN 20. 2003 NOV CTNA
PERMETHRIN LOTION; TOPICAL NIX + INSIGHT PHARMS 1% N19918 001 MAY 02. 1990 MAR CAHN
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 '03
NO DECEMBER 2003 APPROVALS
4-1
This data is provided to the Office of Generic Drugs from the Office of Orphan Products Development and it is not edited prior to publication.
Orphan Products Designations and Approvals List December 2003
Generic Namel Date Designated = DD Trade Name (if present): Date Approved= MA Indication Designated: Sponsor and Address
( +1-)-7-[3-(4-acetyl-3-methoxy-2-prop DO: 3/31/2003 Prevention of serious adverse events BioMedicines, Inc. ylphenoxy)propoxy]-3,4-dihydro-8- associated with vascular leak syndrome 2000 Powell Street propyl-2H-1-benzopyran-2-carboxy caused by Interleukln-2 therapy lie acid
MA: Suite 1640 Emeryville CA 94608
(R)-N-[2-(6-Chloro-methoxy-1 H-Ind DO: 7/3/2003 Treatment of neuroleptic-induced tardive Phase 2 Discovery, Inc, ol-3yl)propyl]acetamlde dyskinesia in schizophrenia patients 3130 Highland Ave. MA: Third Floor Cincinnati OH 45219
1,1 '-[1 ,4-phenylenebls(methylene)-b DO: 7/10/2003 For combination use with filgrastim to AnorMED Inc. Is-1 ,~,8, 11-tetraazacyclotetradecan improve the yield of progentor cells in the 200-20353 64th Avenue apheresis product for subsequest stem cell MA: transplantation following myelosuppressive Langley, BC, V2Y IN5 or myeloablative chemotherapy
2' ,3' ,5'-trl-o-acetyluridlne DO: 1/13/2003 Treatment of mitochondrial disease Repligen Corporation 41 Seyon Street MA: Building 1, Suite 100 Waltham MA 02453 2-(3-diethylamlnopropyl)-8,8-dipro DO: 12/2/2003 Treatment of mulitple myeloma and Callisto Pharmaceuticals, Inc. pyl-2-azaspiro [4,5] decan associated bone resorption 2 Executive Drive dlmaleate Atiprimod MA: MA: Suite 450 Somerset NJ 08873
2-0-Butyryl-1-D-octyl-myo-Inositol DO: 8/15/2003 Treatment of cystic fibrosis Inologic, Inc. 3,4,5,6-tetrakisphosphate 101 Elliott Ave., West MA: Seattle WA 98119
4,5-dlbromorhodamine 123 DO: 4/10/2003 Treatment of chronic myelogenous leukemia Celmed BioSciences Inc. Theralux Irradiation Device 2310 boul Alfred-Nobel MA: Saint-Laurent, Quebec
5,5',5"-[Phosphlnothioylidyne-tris(1 DO: 8/20/2003 Treatment of pancreatic cancer Now Pharm AG mlno-2,1-ethanediyl)]tris[5-methylc 241, route d'Arlon helldoninlum]trihydroide hexahydrochloride
MA: L-1150
a-(3-aminophthalimldo) DO: 1/15/2003 Treatment of multiple myeloma Celgene Corporation Actimid MA: MA: 7 Powder Horn Drive Warren NJ 07059 4-2
Orphan Products Designations and Approvals List December 2003 a-Galactosidase A DO: 1/21/2003 Treatment of Fabry's disease Large Scale Biology Corporation Plant-Produced Human a-Glactosidase 3333 Vacaville Parkway MA: Suite 1000 Vacaville CA 95688
ACA125 DO: Treatment of epithelial ovarian cancer Cell Control Biomedical Laboratories AG Am Klopferspitz 19 MA: 0-82152
alendronate DO: 3/31/2003 Treatment of osteogenesis imperfecta In Merck & Co., Inc. pediatric patients 4 years of age and older 126 East Lincoln Ave. Fosamax 126 East Lincoln Ave. MA: Rahway NJ 07065-0900 alteplase DO: 1/27/2003 Treatment of intraventricular hemmorage Daniel F. Hanley, MD associated with intracerebral hemmorrhage Johns Hopkins University Activase Johns Hopkins University MA: 600 N. Wolfe St., Jefferson 1-109 Baltimore MD 21287
AMG531 DO: 3/27/2003 Treatment of Immune thrombocytopenic Amgen, Inc. purpura. One Amgen Center Drive MA: Thousand Oaks CA 91320-1799
anti-CD23 IgG1, kappa monoclonal DO: 211212003 Treatment of chronic lymphocytic leukemia IDEC Pharmaceuticals, Inc. antibody
MA: 3030 Callan Road San Diego CA 92121
Antl-CEA Sheep-human chimeric DO: 5/21/2003 Treatment of pancreatic cancer KS Biomedix Ltd monoclonal antibody labeled Ground Floor, 1 Occam Court w/lodine-131 (KAb201)
MA: Surrey Research Park
antl-Interteron-gamma Fab from DO: For the treatment of immunologic corneal Advanced Biotherapy, Inc. . goats allograft rejection 6355 Topanga Canyon Blvd. MA: Suite 510 WOOdland Hills CA 91367 antisense 20-mer DO: 3112/2003 Treatment for renal cell carcinoma Lorus Therapeutics, Inc phosphorothioate oligonucleotide 2 Meridan Road [complementary to the coding region of A2 component of the human ribonucleotide reductase mANA] GTI-2040 MA: MA: Toronto, Ontario 4-3
Orphan Products Designations and Approvals List December 2003
arsenic trioxide DD: 5/13/2003 Treatment of chronic lymphocytic leukemia Cell Therapeutics, Inc. Trisenox 501 Elliott avenue West MA: Suite 400 Seattle WA 98119 arsenic trioxide DD: 6/13/2003 Treatment of liver cancer Cell Therapeutics, Inc. Trisenox 501 Elliott Avenue West MA: Suite 400 Seattle WA 98119
Atomoxetlne hydrochloride DD: 8/26/2003 Treatment of Tourette's Syndrome ELI LILLY & Company STRATTERA Lilly Corporate Center MA: Indianapolis IN 46285
baclofen DD: 121212003 Treatment of dystonia Medtronic Neurological 710 Medtronlc Parkway NE MA: Minneapolis MN 55432- 5604
blfldobacterlum longum infantis DD: 1/16/2003 Treatment of pediatric Crohn's disease Alimentary Health Limited 35624. Guardwell, Kinsale MA:
bortezomlb DD: 1/15/2003 To treat multiple myeloma Millennium Pharmaceuticals, Inc. VELCADE 75 Sidney Street MA: Cambridge MA 02139
Capsaicin DD: 5/212003 Treatment of painful HIV-associated NeurogesX, Inc. neuropathy San Carlos Business Park MA: 981 F Industrial Road . San Carols CA 94070- 4117
Carboxypeptidase G2 DD: 8/19/2003 Treatment of patients at risk of methotrexate Protherics, Inc. toxicity 5214 Maryland Way, Suite 405 MA: Brentwood TN 37027
chollc acid (3 alpha, 7 alpha, 12 DD: 7/18/2003 Treatment of inborn errors of cholesterol and Dr. Falk Pharma GmbH alpha trihydroxy 5-beta cholanollc bile acid synthesis and metabolism Leinenweberstrasse 5 acid) Falkochol MA: MA: Postfach 6529
clnacalcet DD: 5/1212003 Treatment of hypercalcemia in patients with Amgen,lnc. parathyroid carcinoma MA: One Amgen Center Drive Thousand Oaks CA 91320-1799 4-4
Orphan Products Designations and Approvals List December 2003
Combretastatin A4 Phosphate DO: 7/23/2003 Treatment of anaplastic thyroid cancer, OXiGENE, Inc medullary thyroid cancer, and stage IV 321 Arsenal Street MA: Watertown MA 02472 MA: papillary or follicular thyroid cancer
conjugated bile acids DO: 7/18/2003 Treatment of steatorrhea in patients with Jarrow Formulas, Inc. short bowel syndrome 1824 S. Robertson Blvd. COBARTin 1824 S. Robertson Blvd. MA: Los Angeles CA 90035- 4317 cultured, partially T-Cell depleted, DO: 8/15/2003 As a therapy for primary immune deficiency Duke University Medical Center allogenic thymic tissue for resulting from athymia associated with Division of Pediatric Allergy & transplantation complete DiGeorge Syndrome. Immunology MA: Erwin Road Durham NC 27710 tyclosporln DO: Prophylaxis of acute rejection in patients Chi ron Corporation requiring allogenic lung transplant 4560 Horton Street MA: Emeryville CA 94608 cyclosporlne DO: For the treatment of refractory acute Chiron Corporation rejection in patients requiring allogenic lung 4560 Horton Street MA: Emeryville GA 94608 MA: transplants. debrase DO: 8/20/2003 Debridement of acute, deep dermal burns in MediWound, Ltd. hospitalized patients 3, Azrieli Center Debridase 3, Azrieli Center MA: Triangular Tower 45th Floor
Defibrotide DO: 5/21/2003 For the treatment of hepatiC veno-occlusive Gentium SpA disease Piazza XX Settembre, 2 MA: 22079 Villa Guardia (CO)
Dehydroeplandrosterone (DHEA) DO: 8/19/2003 Replacement therapy in individuals with Paladin Labs, Inc. adrenal insufficiency 6111 Royalmount Avenue Suite Fidelin 6111 Royalmount Avenue Suite MA: Montreal, Quebec
dextran 1 DO: 3/21/2003 Treatment of cystic fibrosis BCY LifeSciences Inc. 160 Eglinton Ave. East MA: Suite 600
DHA-paclltaxel DO: 5/1/2003 Treatment of adenocarcinoll1a of the Protarga, Inc. stomach or lower esophagus 2200 Renaissance Boulevard· Taxoprexin 2200 Renaissance Boulevard MA: Suite 450 King of Prussia PA 19406 4-5
Orphan Products Designations and Approvals List December 2003 diferuloylmethane DO: 6/13/2003 Treatment of cystic fibrosis Seer Pharniarceuticals, LLC P. O. Box 138 MA: Southport CT 06890
dlpheriylcyclopenone DO: 6/13/2003 Treatment of chronic severe forms of Lloyd E. King, Jr. alopecia areata (Alopecia Totalis 1900 Patterson Street MA: Suite 104 MA: [ATj/Alopecia Universalis [AU]) Nashville TN 37203 ecullzumab DO: 8/20/2003 Treatment of paroxysmal nocturnal Alexion Pharmaceuticals, Inc. hemoglobinuria 352 Knotter Drive MA: Cheshire CT 06410
Erlotinib Hydrochloride DO: 7/18/2003 Treatment of malignant gliomas Genentech, Inc Tarceva 1 ONAWay MA: South San Francisco CA 94080-4990 Factor xm [A2] homodlmer, DO: 5/21/2003 Treatment of congenital FXIII deficiency ZymoGenetics, Inc. recombinant DNA origin 1201 Eastlake Avenue East MA: Seattle WA 98102
Factor xm [A2} homodlmer, DO: 11/6/2003 For the prophylaxis of bleeding associated ZymoGenetics, Inc. recombinant DNA origin with congential FXIII deficiency 1201 Eastlake Avenue East MA: Seattle WA 98102 ferric hexacyanoferrate (II) DO: 6/26/2003 Treatment of patients with known or DegussaAG "Prusslan Blue" suspected Internal contamination with Weissfrauenstr.9 radioactive or non-radioactive cesium or MA: thallium 0-60287 Frankfurt
HepeX-B DO: 7/15/2003 For the prevention of hepatitis B virus (HBV) XTL Biopharmaceuticals, Ltd. reinfection in patients who have received a Kiryat Weizmann MA: Science Park Bldg 3 MA: liver transplantation
Human Anti-tumor Necrosis factor DO: 1/16/2003 Treatment of uveitis of the posterior Centocor, Inc. alpha monoclonal antibody segment of non-infectious etiology, and 200 Great Valley Parkway uveitis of the anterior segment of· MA: non-infectious etiology and refractory to Malvern PA 19355-1307 conventional therapy human gammaglobulin DO: Treatment of idiopathic inflammatory Protein Therapeutics, Inc. myopathies 2761 N. Country Club Road MA: Suite 202 Tucson AZ 85716 4-6
Orphan Products Designations and Approvals List De'cember 2003
hydroxocobalamin DD: Treatment of acute cyanide poisoning EMD Pharmaceuticals, Inc. Cyanokit P. O. Box 13319 MA: 2311 Shannon Road, Suite 500 Durham NC 27707
Icatbant DD: Treatment of angioedema JerlnlAG Invalidenstr. 130 MA: 10115 Berlin
IDN 6556 DD: 8/19/2003 Treatment of patients undergoing solid organ Idun Pharmaceuticals, Inc. transplantation. MA: 9380 Judicial drive San Diego CA 92121
Imexon DD: 11/1/2003 Treatment of pancreatic adenocarcinoma AmpliMed, CorporationAmpliMed, Corporation 2321 Camino La Zorrela MA: Tucson AZ 85718
Infllxlmab DD: 5/6/2003 Treatment of giant cell arteritis Centocor, Inc. Remicade 200 Great Valley .Parkway MA: Malvern PA 19355-1307
Infllxlmab DD: 5/21/2003 Treatment of chronic sarcoidosis Centocor, Inc. Remicade 200 Great Valley Parkway MA: Malvern PA 19355-1307
Inflixlmab DD: Treatment of pediatric (0 to 16 years of age) Centocor, Inc. Crohn's Disease 200 Great Valley Parkway REMICADE 200 Great Valley Parkway MA: Malvern PA 19355-1307
infliximab DD: Treatment of pediatric (0 to 16 years of age) Centobor, Inc. ulcerative colitis 200 Great Valley Parkway REMICADE 200 Great Valley Parkway MA: Malvern PA 19355-1307
INGN 201 DD: 1/27/2003 Treatment of head and neck cancer Introgen Therapeutics, Inc. ADVEXIN MA: MA: 2250 Holcombe Blvd Houston TX 77030
Iron(III)-hexacyanoferrate(ll) DD: 5/1/2003 Treatment of patients with known or Heyl Chemlsch- Pharmzeutische susupected internal contamination with Fabrik GMBH & Co, KG radioactive or non-radioactive cesium or Goerzallee 253 Radiogardase MA: thallium Goerzallee 253 MA: D-14167 Berlin, Federal Republic of Germany 4-7
Orphan Products Designations and Approvals List December 2003
Lactoferrin alpha DD: 8/20/2003 For the treatment of graft versus host Agennix, Inc. disease Greenway Plaza MA: Suite 910 Houston TX n046
Lactoferrin alpha DO: 8/20/2003 For the prevention of graft-versus-host Agennix, Inc. disease 8 Greenway Plaza MA: Suite 910 Houston TX n046 liposomal p-ethoxy growth DO: 12/5/2003 Treatment of chronic myelogenous leukemia Interpath Pharmaceuticals, INc. receptor bound proteln-2 20651 Prince Creek Dr. MA: KatyTX n450
Mafosfamlde DO: 1/21/2003 Treatment of neoplastic meningitis Baxter Oncology GmbH (formerly ASTA Medica Oncology) Daimlerstrasse 40 MA: 60314 franfurtlMain
MaxAdFVIII DO: 3/312003 Treatment of Hemophilia A GenStar Therapeutics Corporation 10865 Altman Row MA: Suite 200 San Diego CA 92121- 1113 monarsen DO: Treatment of Myasthenia Gravis Medica Venture Partners Ackersteln Towers, Bldg B, 10th Floor MA: ISRAEL
motexafin gadolinium DO: 1/27/2003 For use in conjunction with whole brain Pharmacyclics, Inc. radiation for the treatment of brain 999 East Arques Avenue Xcytrin MA: metastases arising from solid tumors 999 East Arques Avenue MA: Sunnyvale CA 94085- 4521
Mx-dnG1 or Rexin-G retrovlral DO: 8/15/2003 Treatment of pancreatic cancer Epeius Biotechnologies Corporation REXIN-G 345 Pioneer Drive, 1803W MA: Glendale CA 91203 myristoylated recombinant SCR1-3 DO: 5/21/2003 Prevention of delayed graft function in solid Adprotech, Ltd. of human complement reseptor organ transplant Chesterford Research Pk, type I APT070 MA: MA: Little Chesterford, Saffron Walden,
N-acetyl-sarcosyl,glycyJ-L-valyl-D-a DO: 12/9/2003 For the treatment of soft tissue sarcoma Abbott Laboratories Iloisoleucyl-L-threonyl-L-norvalyl- Pharmaceutical Products Division L-lsoleucyl-L-arglnyl_L-prolylethyl amlnde acetate .
MA: 200 Abbott Park Road 4-8
Orphan Products Designations and Approvals List December 2003
Abbott Park IL 60064
nlprlsan DO: 8/15/2003 Treatment of sickle cell disease Xechem International, Inc. Hemoxin New Brunswick Technology Center MA: 100 Jersey~venue, Building B, Suite 310 New Brunswick NJ 08901
polyinoslnlc-polycytldillc acid DO: 3/312003 Treatment of flavivirus infections including Oncovir . those due to West Nile, Japanese 3203 Cleveland Ave., NW Poly-ICLC MA: encephalitiS, dengue, St. Louis encephalitis, 3203 Cleveland Ave., NW MA: yellow fever, Murray valley, and Banzai Washington DC 20008- 3450 viruses
Protaxel DO: 5/21/2003 Treatment of ovarian cancer Biophysica, Inc. 3333 North Torrey Pines Court MA: Suite 100 La Jolla CA 92037
recombinant adeno-associated DO: 1/27/2003 Treatment of alpha1-antitrypsin deficiency Applied Genetic Technologies Corp. virus alpha 1-antitrypsin vector 12085 Research Drive rAAV-AAT MA: MA: Suite 110 Alachua FL 32615
recombinant human neutrophil DO: 1219/2003 Treatment of cystic fibrosis Dyax Corporation inhibitor (hNE) 300 Technology Square MA: Cambridge MA 02139
recombinant inhibitor of human DO: 2/4/2003 Treatment of angioedema Dyax Corp plasma kallikrein 300 Technology Square MA: Cambridge MA 02139
Recombinant T-ceJl receptor DO: 5/212003 Treatment of multiple sclerosis patients who Virogenomics, Inc. are both HLA-DR2 positive and autoreactive 9020 SW Washington Square Road MA: residues 35-55 Suite 380 MA: to myelin Oligodendrocyte glycoprotein Tigard, OR 97223-4332
repertaxin DO: 1/27/2003 Prevention of delayed graft function in solid Dompe s.p.a. organ transplant Via Campo di Pile MA: 67100 - L'Aquila
repository corticotropin or DO: 5/21/2003 Treatment of infantile spasms Questcor Pharmaceuticals, Inc. adrenocorticotropic hormone 3260 Whipple Road HP. Acthar Gel MA: MA: Union City CA 94587- 1217 4-9
Orphan Products Designations and Approvals List December 2003 reslrilferatoxln DO: 5/13/2003 Treatment of intractable pain at end-stage Andrew J. Mannes, Md disease Bldg 10/Rm 2N236 - MA: DASS/PPCS/NIDCRINIH 10 Convent Drive Bethesda MD 20892 rhIGF-VrhIGFBP-3 DO: 1219/2003 Treatment of extreme insulin resistance Insmed Inc. syndromes (type A, Rabson-Mendenhall 4851 Lake Brooke Drive SomatoKine MA: syndrome, Leprechaunism, Type B 4851 Lake Brooke Drive MA: syndrome) Glen Allen VA 23060 rhuMAb VEGF[bevacizumab]) DO: 11/6/2003 treatment of renal cell carcinoma Genentech, Inc. Avastln 1 ONAWay MA: South San Francisco CA 94080-4990
rlbavlrln DO: 4/4/2003 Treatment of chronic hepatitis C in pediatric Schering Corporation patients 2000 Galloping Hill Road REBETOL 2000 Galloping Hill Road MA: Kenilworth NJ 07033
SC-1 monoclonal antibody DO: Treatment of patients with CD55 (sc-1) H3 Pharma, Inc. positive gastric tumors 666 Sherbrooke Street West, Suite MA: 1400 Montreal, Quebec
SGN-30 (antl-C030 mAb) DO: 7/18/2003 Treatment of Hodgkin's disease Seattle Genetics, Inc 21823 30th Drive, Southeast MA: Bothell WA 98021 slpllzumab DO: 7/15/2003 Treatment of T-cell lymphomas Medlmmune Oncology, Inc. 35 W. Watkins Mill Road MA: Gaithersburg Md 20878
sodium dlchloroacetate DO: 7/3/2003 Use as an antidote in the management of EBD Group systemic monochloroacetic acid poisoning 6120 Paseo del Norte MA: SuiteJ2 Carlsbad CA 92009
Sodi,um pyruvate DO: 3/31/2003 Treatment of cystic fibrosis Cellular Sciences, Inc. 84 Park Avenue MA: P. O. Box 968 Flemington NJ 08822 suberoylanllide hydroxamic acid DO: 6/1212003 Treatment of multiple myeloma Aton Pharma, Inc. 777 Old Saw Mill River Road MA: Tarrytown NY 10591- 6717
Tezacltabine DO: 1/27/2003 Treatment of adenocarcinoma of the Chiron Corporation esophagus and stomach 4560 Horton Street MA: Emeryville CA 94608- 2916 4-10
Orphan Products Designations and Approvals List December 2003
Tlnldazole DO: 8/20/2003 For the treatment of amebiasis Presutti Laboratories, Inc. 1607 N. Douglas Avenue MA: Arlington Heights IL 60004
Tranllast DO: 121212003 For the treatment of maligant glioma Angiogen Pharmaceuticals, Pty. Ltd. Rizaben Level 31, ABN AMRO Tower MA: 88 Phillip Street Sydney, N.S.W. 2000
Tretinoin DO: 4/11/2003 Treatment of T-cell non-Hodgkin's Anligenlcs, Inc. lymphoma 34 Commerce Way ATRA-/V 34 Commerce Way MA: Woburn MA 01801
vapreotlde pamoate DO: 11/4/2003 For the treatment of acromegaly H3 Pharma, Inc. Sanvar 666 Sherbrooke Street West, Suite MA: 1400 Montreal, Quebec 5-1
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION
NO DECEMBER 2003 ADDITIONS
A-I PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020977 001 ABACAVIR SULFATE;ZIAGEN 5034394 DEC 18, 2011 5034394*PED JUN 18, 2012 020978 001 ABACAVIR SULFATE;ZIAGEN 5034394 DEC 18, 2011 5034394*PED JUN 18, 2012 >ADD> 021320 001 ABARELIX;PLENAXIS NCE NOV 25, 2008 020213 001 ACETYLCHOLINE CHLORIDE;MIOCHOL-E 6261546 APR 29, 2019 U506 021478 001" ACYCLOVIR;ZOVIRAX 4963555 OCT 16, 2007 020338 001 ADAPALENE;DIFFERIN RE34440 MAY 31, 2010 U275 020899 001 ALBUMIN HUMAN;OPTISON 5573751 APR 25, 2012 5529766 JUN 25, 2013 U505 5558094 FEB 28, 2012 U505 020950 001 ALBUTEROL SULFATE;DUONEB 6632842 DEC 28, 2021 U532 020560 001 ALENDRONATE SODIUM;FOSAMAX 5358941 DEC 02, 2012 I-309 SEP 29, 2003 4621077 AUG 06, 2007 Ul14 PED MAR 29, 2004 5681590 DEC 02, 2012 5849726 JUN 06, 2015 6008207 JUN 06, 2015 U303 6090410 DEC 02, 2012 6194004 DEC 02, 2012 4621077*PED FEB 06, 2008 U114 5358941*PED JUN 02, 2013 5681590*PED JUN 02, 2013 5849726*PED DEC 06, 2015 6008207*PED DEC 06, 2015 U303 6090410*PED JUN 02, 2013 6194004*PED JUN 02, 2013 020560 002 ALENDRONATE SODIUM;FOSAMAX 5358941 DEC 02, 2012 4621077 AUG 06, 2007 U114 5681590 DEC 02, 2012 5849726 JUN 06, 2015 6008207 JUN 06, 2015 U303 6090410 DEC 02, 2012 4621077*PED FEB 06, 2008 U114 5358941*PED JUN 02, 2013 5681590*PED JUN 02, 2013 5849726*PED DEC 06, 2015 6008207*PED JUN 06, 2015 U303 6090410*PED JUN 02, 2013 020560 003 ALENDRONATE SODIUM;FOSAMAX 5358941 DEC 02, 2012 4621077 AUG 06, 2007 U114 5681590 DEC 02, 2012 5849726 JUN 06, 2015 6008207 JUN 06, 2015 U303 6090410 DEC 02, 2012 4621077*PED FEB 06, 2008 U114 5358941*PED JUN 02, 2013 5681590*PED JUN 02, 2013 5849726*PED DEC 06, 2015 6008207*PED DEC 06, 2015 U303 6090410*PED JUN 02, 2013 A-2 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020560 004 ALENDRONATE SODIUM;FOSAMAX 6015801 JUL 17, 2018 U353 NS OCT 20, 2003 4621077 AUG 06, 2007 U114 D-61 OCT 20, 2003 5358941 DEC 02, 2012 D-62 OCT 20, 2003 5681590 DEC 02, 2012 PED APR 20, 2004 5849726 JUN 06, 2015 PED APR 20, 2004 6008207 JUN 06, 2015 PED APR 20, 2004 6090410 DEC 02, 2012 5994329 JUL 17, 2018 6225294 JUL 17, 2018 4621077*PED FEB 06, 2008 U114 5358941*PED JUN 02, 2013 5681590*PED JUN 02, 2013 5849726*PED DEC 16, 2015 5994329*PED JAN 17, 2019 6008207*PED DEC 06, 2015 6015801*PED JAN 17, 2019 U353 6090410*PED JUN 02, 2013 6225294*PED JAN 17, 2019 020560 005 ALENDRONATE SODIUM;FOSAMAX 6015801 JUL 17, 2018 U353 NS OCT 20, 2003 . 4621077 AUG 06, 2007 Ul14 D-61 OCT 20, 2003 5358941 DEC 02, 2012 D-62 OCT 20, 2003 5681590 DEC 02, 2012 PED APR 20, 2004 5849726 JUN 06, 2015 PED APR 20, 2004 5994329 JUL 17, 2018 PED APR 20, 2004 6008207 JUN 06, 2015 6090410 DEC 02, 2012 6225294 JUL 17, 2018 4621077*PED FEB 06, 2008 U114 5358941*PED JUN 02, 2013 5681590*PED JUN 02, 2013 5849726*PED DEC 06, 2015 5994329*PED JAN 17, 2019 6008207*PED DEC 06, 2015 6015801*PED JAN 17, 2019 U353 6090410*PED JUN 02, 2013 6225294*PED JAN 17, 2019 021575 001 ALENDRONATE SODIUM;FOSAMAX 4621077 AUG 06, 2007 1-309 SEP 29, 2003 4621077*PED FEB 06, 2008 PED MAR 29, 2004 5462932 MAY 17, 2014 D-61 OCT 20, 2003 5994329 JUL 17, 2018 PED APR 20, 2004 5994329*PED JAN 17, 2019 6015801 JUL 17, 2018 6015801*PED JAN 17, 2019 6225294 JUL 17, 2018 6225294*PED JAN 17, 2019 021287 001 ALFUZOSIN HYDROCHLORIDE;UROXATRAL 4661491 MAY 27, 2006 NCE JUN 12, 2008 6149940 AUG 22, 2017 021001 001 ALMOTRIPTAN MALATE;AXERT 5565447 MAY 07, 2015 021001 002 ALMOTRIPTAN MALATE;AXERT 5565447 MAY 07, 2015 >ADD> 021107 001 ALOSETRON HYDROCHLORIDE;LOTRONEX 5360800 JAN 13, 2013 DS DP U405 ~ 6284770 OCT 05, 2018 U405 A-3 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
>ADD> 021107 002 ALOSETRON HYDROCHLORIDE;LOTRONEX 5360800 JAN 13, 2013 DS DP U405 NCE FEB 09, 2005 >ADD> 6284770 OCT OS, 2018 U405 021434 001 ALPRAZOLAM;XANAX XR NDF JAN 17, 2006 021434 002 ALPRAZOLAM;XANAX XR NDF JAN 17, 2006 021434 003 ALPRAZOLAM;XANAX XR NDF JAN 17, 2006 021434 004 ALPRAZOLAM; XANAX XR NDF JAN 17, 2006 020221 002 AMIFOSTINE;ETHYOL 5424471 JUL 31, 2012 020965 001 AMINOLEVULINIC ACID HYDROCHLORIDE;LEVULAN 5954703 OCT 31, 2017 U289 020364 002 AMLODIPINE BESYLATE;LOTREL 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020364 003 AMLODIPINE BESYLATE;LOTREL 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020364 004 AMLODIPINE BESYLATE;LOTREL 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020364 005 AMLODIPINE BESYLATE;LOTREL 4410520 AUG 11, 2003 NS JUN 20, 2005 4410520*PED FEB 11, 2004 PED DEC 20, 2005 >ADD> 019787 001 AMLODIPINE BESYLATE;NORVASC NPP JAN 08, 2007 >ADD> PED JUL 08, 2007 >ADD> 019787 002 AMLODIPINE BESYLATE;NORVASC NPP JAN 08, 2007 >ADD> PED JUL 08, 2007 >ADD> 019787 003 AMLODIPINE BESy-LATE;NORVASC NPP JAN 08, 2007 >ADD> PED JUL 08, 2007 021303 001 AMPHETAMINE ASPARTATE;ADDERALL XR 10 6322819 OCT 21, 2018 66053.00 OCT 21, 2018 021303 006 AMPHETAMINE ASPARTATE;ADDERALL XR 15 6322819 OCT 21, 2018 6605300 OCT 21, 2018 021303 002 AMPHETAMINE ASPARTATE;ADDERALL XR 20 6322819 OCT 21, 2018 6605300 OCT 21, 2018 021303 004 AMPHETAMINE ASPARTATE; ADDERALL XR 25 6322819 OCT 21, 2018 6605300 OCT 21, 2018 021303 003 AMPHETAMINE ASPARTATE;ADDERALL XR 30 6322819 OCT 21, 2018 6605300 OCT 21, 2018 021303 005 AMPHETAMINE ASPARTATE;ADDERALL XR 5 6322819 OCT 21, 2018 6605300 OCT 21, 2018 040422 005 AMPHETAMINE ASPARTATE DEXTROAMP SACCHARATE PC SEP 15, 2003 040422 006 AMPHETAMINE ASPARTATE DEXTROAMP SACCHARATE PC SEP 15, 2003 040422 007 AMPHETAMINE ASPARTATE DEXTROAMP SACCHARATE PC SEP 15, 2003 021007 001 AMPRENAVIR;AGENERASE 5723490 MAR 03, 2015 U257 021549 001 APREPITANT;EMEND 5719147 JUN 29, 2012 NCE MAR 26, 2008 5538982 JUL 23, 2013 6048859 JUN 29, 2012 6096742 JUL 01, 2018 6235735 JUN 29, 2012 021549 002 APREPITANT;EMEND 5719147 JUN 29, 2012 NCE MAR 26, 2008 5538982 JUL 23, 2013 6048859 JUN 29, 2012 6096742 JUL 01, 2018 6235735 JUN 29, 2012 021436 001 ARIPIPRAZOLE;ABILIFY 4734416 MAR 29, 2005 I-401 AUG 28, 2006 5006528 OCT 20, 2009 A-4 PRESCRIPTION AND OTC DRUG PRODUCT Pl',TENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODErS) CODE EXPIRES
021436 002 ARIPIPRAZOLE;ABILIFY 4734416 MAR 29, 2005 1-401 AUG 28, 2006 5006528 OCT 20, 2009 021436 003 ARIPIPRAZOLE;ABILIFY 4734416 MAR 29, 2005 1-401 AUG 28, 2006 5006528 OCT 20, 2009 021436004 ARIPIPRAZOLE;ABILIFY 4734416 MAR 29, 2005 1-401 AUG 28, 2006 5006528 OCT 20, 2009 021436 005 ARIPIPRAZOLE;ABILIFY 4734416 MAR 29, 2005 1-401 AUG 28, 2006 5006528 OCT 20, 2009 021436 006 ARI PIPRAZOLE,; ABILIFY 4734416 MAR 29, 2005 1-401 AUG 28" 2006 5006528 OCT 20, 2009 021387 001 ASPIRIN;PRAVIGARD PAC (COPAC 4346227 OCT 20, 2005 4346227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5180589 JUL 09, 2208 5180589*PED JAN 09, 2009 5622985 APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 021387 002 ASPIRIN;PRAVIGARD PAC (COPAC 4346227 OCT 20, 2005 4346227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5622985 APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 5180589 JUL 09, 2008 5180589*PED JAN 09, 2009 021387 003 ASPIRIN;PRAVIGiRn PAC (COPAC 4346227 OCT 20, 2005 4346227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5180589 JUL 09, 2008 5180589*PED JAN 09, 2009 5622985 APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 021387 004 ASPIRIN;PRAVIGARD PAC (COPAC 4346227 OCT 20, 2005 4346227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5180589 JUL 09, 2008 5180589*PED JAN 09, 2009 5622985 APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 021387 005 ASPIRIN;PRAVIGARDPAC (COPAC 4346227 OCT 20, 2005 43'46227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5180589 JUL 09, '2008 5180589*PED JAN 09, 2009 5622985 APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 ,;":: A-5 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S} CODE EXPIRES
021387 006 ASPIRIN;PRAVIGARD PAC (COPAC 4346227" OCT 20, 2005 4346227*PED APR 20, 2006 5030447 JUL 09, 2008 5030447*PED JAN 09, 2009 5180589 JUL 09, 2008 5180589*PED JAN 09, 2009 5622985 " APR 22, 2014 U335 5622985*PED OCT 22, 2014 U335 021567 001 ATAZANAVIR SULFATE;REYATAZ 5849911 APR 09, 2017 NCE JUN 20, 2008 6087383 DEC 21, 2018 021567 002 ATAZANAVIR SULFATE;REYATAZ 5849911 APR 09, 2017 NCE JUN 20, 2008 6087383 DEC 21, 2018 021567 003 ATAZANAVIR SULFATE;REYATAZ 5849911 APR 09, 2017 NCE JUN 20, 2008 6087383 DEC 21, 2018 021411 001 ATOMOXETINE HYDROCHLORIDE;STRATTERA 5658590 JAN 11, 2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 021411 002 ATOMOXETINE HYDROCHLORIDE;STRATTERA 5658590 JAN 11, 2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 021411 003 ATOMOXETINE HYDROCHLORIDE;STRATTERA 5658590 JAN 11, "2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 021411 004 ATOMOXETINE HYDROCHLORIDE;STRATTERA 5658590 JAN 11, 2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 021411 005 ATOMOXETINE HYDROCHLORIDE;STRATTERA 5658590 JAN 11, 2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 021411 006 ATOMOXETINE" HYDROCHLORIDE;STRATTERA 5658590 JAN 11, 2015 U494 NCE NOV 26, 2007 5658590*PED JUL 11, 2015 U494 PED MAY 26, 2008 020702 002 ATORVASTATIN CALCIUM;LIPITOR 5969156*PED JAN 08, 2017 021078 001 ATOVAQUONE;MALARONE 6166046 NOV 25, 2013 U406 NC JUL 14, 2003 5053432 OCT 01, 2008 PED JAN 14, 2004 6291488 NOV 25, 2013 5053432*PED APR 01, 2009 6166046*PED MAY 25, 2014 6291488*PED MAY 25, 2014 021078 002 ATOVAQUONE;MALARONE PEDIATRIC 6166046 NOV 25, 2013 NC JUL 14, 2003 5053432 OCT 01, 2008 PED J~ 14, 2004 >ADD> 6291488 NOV 25, 2013 U406 NPp DEC 02, 2006 >ADD> 5053432*PED APR 01, 2009 PED JUN 02, 2007 6166046*PED MAY 25, 2014 6291488*PED MAY 25, 2014 020259 001 ATOVAQUONE;MEPRON 4981874 AUG 15, 2009 U69 5053432 OCT 01, 2008 5053432*PED APR 01, 2009 4981874*PED FEB 15, 2010 U69 >ADD> 020500 001 ATOVAQUONE;MEPRON 6649659 JUL 10, 2016 DS DP U69 ODE JAN 05, 2006 >ADD> 6649659*PED JAN 10,2017 PED JUL 05, 2006 4981874 AUG 15, 2009 U69 5053432 OCT 01", 2008 5053432*PED APR 01, 2009 4981874*PED FEB 15, 2010 U69 021470 001 AZELAIC ACID;FINACEA 6534070 NOV 18, 2018 A-6 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
>ADD> 020114 001 AZELASTINE HYDROCHLORIDE;ASTELIN 5164194 NOV 01, 2011 U207 >ADD> 5164194*PED MAY 01, 2012 021589 001 BACLOFEN;KEMSTRO 6024981 APR 09, 2018 DP 6221392 APR 09, 2018 DP 021589 002 BACLOFEN;KEMSTRO 6024981 APR 09, 2018 DP 6221392 APR 09, 2018 DP 019851 001 BENAZEPRIL HYDROCHLORIDEiLOTENSIN 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 019851 002 BENAZEPRIL HYDROCHLORIDE;LOTENSIN 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 019851 003 BENAZEPRIL HYDROCHLORIDE;LOTENSIN 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 019851 004 BENAZEPRIL HYDROCHLORIDE;LOTENSIN 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020033 001 BENAZEPRIL HYDROCHLORIDE;LOTENSIN HCT 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020033 002 BENAZEPRIL HYDROCHLORIDE;LOTENSIN HCT 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020033 003 BENAZEPRIL HYDROCHLORIDE;LOTENSIN HCT 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 020033 004 BENAZEPRIL HYDROCHLORIDE;LOTENSIN HCT 4410520 AUG 11, 2003 4410520*PED FEB 11, 2004 021055 001 BEXAROTENE TARGRETIN 5780676 JUL 14, 2015 U509 021056 001 BEXAROTENE TARGRETIN 5780676 JUL 14, 2015 U510 021602 001 BORTEZOMIB VELCADE 5780454 OCT 28, 2014 NCE MAY 13, 2008 6083903 OCT 28, 2014 U515 ODE MAY 13, 2010 6297217 OCT 28, 2014. U515 6617317 OCT 28, 2014 DS DP 021290 001 BOSENTAN;TRACLEER 5292740 NOV 20, 2015 021290 002 BOSENTAN;TRACLEER 5292740 NOV 20, 2015 >ADD> 021262 001 BRIMONIDINE TARTRATE;ALPHAGAN P 6673337 JUL 26, 2021 DP >ADD:; 6673337*PED JAN 26, 2022 6562873 JUL 10, 2021 6562873*PED JAN 10, 2022 6627210 JUL 18, 2021 DP 6627210*PED JAN 18, 2022 6641834 JUL 28, 2021 DP 6641834*PED JAN 28, 2022 076260 001 BRIMONIDINE TARTRATE;BRIMONIDINE TARTRATE PC SEP 16, 2003 020929 001 BUDESONIDE;PULMICORT RESPULES 6598603 DEC 23, 2018 U529 6598603*PED JUN 23, 2019 020929 002 BUDESONIDE;PULMICORT RESPULES 6598603 DEC 23, 2018 U529 6598603*PED JUN 23, 2019 020929 003 BUDESONIDE;PULMICORT RESPULES 6598603 DEC 23, 2018 U529 6598603*PED JUN 23, 2019 021515 001 BUPROPION HYDROCHLORIDE;WELLBUTRIN XL 60963.41 OCT 30, 2018 M-10 JUN 11, 2004 6143327 OCT 30, 2018 021515 002 BUPROPION HYDROCHLORIDE;WELLBUTRIN XL. 6096341 OCT 30, 2018 M-10 JUN 11, 2004 6143327 OCT 30, 2018 075766 001 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 A-:-7 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
075766 002 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 075823 001 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 075823 002 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 075836 001 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 075836 002 CALCITRIOL;CALCITRIOL PC SEP 17, 2003 021160 002 CALCIUM ACETATE;PHOSLO 6576665 APR 03, 2021 021160 003 CALCIUM ACETATE;PHOSLO GELCAPS 6576665 APR 03, 2021 021485 002 CARBIDOPA;STALEVO 100 5446194 AUG 29, 2012 NCE OCT 19, 2004 5135950 OCT 31, 2010 4963590 NOV 27, 2007 6500867 JUN 29, 2020 5112861 MAY 12, 2009 021485 003 CARBIDOPA;STALEVO 150 5446194 AUG 29, 2012 NCE OCT 19, 2004 5135950 OCT 31, 2010 4963590 NOV 27, 2007 6500867 JUN 29, 2020 5112861 MAY 12, 2009 021485 001 CARBIDOPA;STALE~O 50 5446194 AUG 29, 2012 NCE OCT 19, 2004 5135950 OCT 31, 2010 4963590 NOV 27, 2007 6500867 JUN 29, 2020 5112861 MAY 12, 2009 020452 001 CARBOPLATIN;PARAPLATIN 4657927 APR 14, 2004 U175 020452 002 CARBOPLATIN;PARAPLATIN 4657927 APR 14, 2004 U175 020452 003 CARBOPLATIN;PARAPLATIN 4657927 APR 14, 2004 U175 020637 001 CARMUSTINE;GLIADEL 4789724 AUG 01, 2006 1-382 FEB 25, 2006 4757128 AUG 01, 2006 020297 001 CARVEDILOL;COREG 1-388 MAR 27, 2006 020297 002 CARVEDILOL;COREG 1-388 MAR 27, 2006 020297 003 CARVEDILOL;COREG 1-388 MAR 27, 2006 020297 004 CARVEDILOL;COREG 1-388 MAR 27, 2006 021227 001 CASPOFUNGIN ACETATE;CANCIDAS 1-399 JAN 07, 2006 021227 002 CASPOFUNGIN ACETATE;CANCIDAS 1-399 JAN 07, 2006 021150 001 CETIRIZINE HYDROCHLORIDE;ZYRTEC-D 12 HOUR 4525358 JUN 25, 2007 U295 4525358*PED DEC 25, 2007 U295 6469009 JUL 13, 2019 U295 6489329 APR 08, 2016 020774 001 CHLORHEXIDINE GLUCONATE;PERIOCHIP 5002769 MAR 16, 2006 5023082 MAR 30, 2005 021159 001 CICLOPIROX;LOPROX NDF FEB 28, 2006 >ADD> 019537 001 CIPROFLOXACIN HYDROCHLORIDE;CIPRO 4670444*PED JUN 09, 2004 >ADD> 5286754*PED AUG 15, 2011 >ADD> 52136754 FEB 15, 2011 >ADD> 4670444 DEC 09, 2003 U36 >ADD> 019537 002 CIPROFLOXACIN HYDROCHLORIDE;CIPRO 4670444*PED JUN 09, 2004 >ADD> 5286754*PED AUG 15, 2011 >ADD> 4670444 DEC 09, 2003 U36 >ADD> 5286754 FEB 15, 2011 >ADD> 019537 003 CIPROFLOXACIN HYDROCHLORIDE;CIPRO 4670444*PED JUN 09, 2004 >ADD> 5286754*PED AUG 15, 2011 >ADD> 4670444 DEC 09, 2003 U36 ~ 5286754 FEB 15, 2011 A-8 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT /PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
>ADD> 019537 004 CIPROFLOXACIN HYDROCHLORIDE;CIPRO 4670444*PED JUN 09, 2004 >ADD> 5286754*PED AUG 15, 2011 >ADD> 4670444 DEC 09, 2003 U36 >ADD> 5286754 FEB 15, 2011 >ADD> 019847 001 CIPROFLOXACIN;CIPRO 4670444*PED JoN 09, 2004 >ADD> 4705789*PED MAY 10, 2005 >ADD> 4808583*PED AUG 28, 2006 >ADD> 4670444 DEC 09, 2003 >ADD> 4705789 NOV 10, 2004 >ADD> 4808583 FEB 28, 2006 >ADD> 020780 001 CIPROFLOXACIN;CIPRO 5695784 DEC 09, 2014 >ADD> 4670444 DEC 09, 2003 >ADD> 613634"7 JAN 06, 2013 U362 >ADD> 4670444*PED 0JUN 09, 2004 >ADD> 5695784*PED JUN 09, 2015 >ADD> 6136347*PED JUL 06, 2013 >ADD> 020780 002 CIPROFLOXACIN;CIPRO 5695784 DEC 09, 2014 >ADD> 4670444 DEC 09, 2003 >ADD> 6136347 JAN 06, 2013 U362 >ADD> 4670444*PED JUN 09, 2004 ~ 5695784*PED JUN 09, 2015 >ADD> 6136347*PED JUL 06, 2013 ;ADD; 019857 001 CIPROFLOXACIN;CIPRO IN DEXTROSE 5% 4670444*PED JUN 09, 2004 >ADD> 4705789*PED MAY 10, 2005 >ADD> 4957922*PED MAR 18, 2008 >ADD> 4808583*PED AUG 28, 2006 >ADD> 4670444 DEC 09, 2003 >ADD> 4705789 NOV 10, 2004 >ADD> 4957922 SEP 18, 2007 >ADD> 4808583 FEB 28, 2006 >ADD> 021473 001 CIPROFLOXACIN;CIPRO XR 4670444*PED oJ1JN 09, 2004 NDF DEC 13, 2005 >ADD> 4670444 DEC 09, 2003 PED JUN 13, 2006 021473 002 CIPROFLOXACIN;CIPRO XR NDF DEC 13, 2005 >ADD> PED JUN 13, 2006 >ADD> 1-416 AUG 28, 2006 >ADD> PED FEB 28, 2007 021537 001 CIPROFLOXACIN;CIPRODEX 4844902 FEB 11, 2008 NC JUL 18, 2006 6284804 AUG 10, 2020 6359016 AUG 10, 2020 020822 004 CITALOPRAM HYDROBROMIDE;CELEXA NCE JUL 17, 2003 PED Jl'>N 17, 2004 021535 001 CLOBETASOL PROPIONATE;CLOBEX 6106848 SEP 22, 2017 NDF JUL 24., 2006 >ADD> 021142 001 CLOBETASOL PROPIONATE;OLUX FOAM 6126920 OCT 03, 2017 U484 020839 001 CLOPIDOGREL BISULFATE;PLAVIX 6504030 JUN 10, 2019 019758 001 CLOZAPINE;CLOZARIL 1-380 DEC 18, 2005 019758 002 CLOZAPINE;CLOZARIL 1-380 DEC 18, 2005 021141 001 COLESEVELAM HYDROCHLORIDE;WELCHOL 6066678 JUN 10, 2014 U323 021176 001 COLESEVELAM HYDROCHLORIDE;WELCHOL 6066678 JUN 10, 2014 U323 017821 001 CYCLOBENZAPRINE HYDROCHLORIDE;FLEXERIL D-78 FEB 03, 2006 ~ 020287 001 DALTEPARIN SODIUM;FRAGMIN 1-414 DEC 10, 2006 A-9 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
>ADD> 020287 002 DALTEPARIN SODIUM;FRAGMIN I-414 DEC 10, 2006 >ADD> 020287 003 DALTEPARIN SODIUM; FRAGMIN I-414 DJ.;:C 10, 2006 >ADD> 020287 004 DALTEPARINSODIUM;FRAGMIN I-414 DEC 10, 2006 021572 001 DAPTOMYCIN;CUBICIN 5912226 JON 15, 2016 NCE SEP 12, 2008 6468967 SEP 24, 2019 021572 002 DAPTOMYCIN;CUBICIN 5912226 JON 15, 2016 NCE SEP 12, 2008 6468967 SEP 24, 2019 020705 002 DELAVIRDINE MESYLATE;RESCRIPTOR 5563142 OCT 08, 2013 6177101 JON 11, 2018 021271 001 DESIRUDIN;IPRIVASK 4745177 MAY 17, 2005 4801576 JAN 31, 2006 5733874 MAR 31, 2015 021165 001 DESLORATADINE;CLARINEX 4659716 APR 21, 2004 U427 NCE DEC 21, 2006 4863931 SEP 15, 2008 PED JON 21, 2007 480,4666 FEB 14, 2006 U428 5595997 DEC 30, 2014 U429 610-0274 JUL 07, 2019' 4659716*PED OCT 21, 2004 U427 4804666*PED AUG 14, 2006 U428 4863931*PED MAR 15, 2009 5595997*PED JON 30, 2015 U429 6100274*PED JAN 07, 2020 021312 001 DESLORATADINE;CLARINEX 4659716 APR 21, 2004 U427 NCE DEC 21, 2006 4659716*PED OCT 21, 2004 U427 PED JON 21, 2007 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 4804666 FEB 14, 2006 U428 4804666*PED AUG 14, 2006 U428 5595997 DEC 30, 2014 U429 559,5997*PED JON 30, 2015 U429 6100274 JUt 07, 2019 61002·74*PED JAN 07, 2020 020648 001 DIAZEPAM;DIASTAT 5462740 SEP 17, 2013 020648 002 DIAZEPAM;DIASTAT 5462740 SEP 17, 2013 02064,8 003 ,DIAZEPAM; DIASTAT 5462740 SEP 17, 2013 020648 004 DIAZEPAM;DIASTAT 5462740 SEP 17, 2013 020648 005 DIAZEPAM ;,DIASTAT 5462740 SEP 17, 2013 021392 001 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 20i3 021392 002 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 2013 021392 003 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 2013 021392 004 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 2013 021392 005 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 2013 021392 006 DILTIAZEM HYDROCHLORIDE;CARDIZEM LA 5288505 JON 26, 2011 NDF FEB 06, 2006 5529791 JON 25, 2013 020401 006 DILTIAZEM HYDROCHLORIDE;TIAZAC 5529791 JON 25, 2013 A-10 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY. DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021168 001 DIVALPROEX SODIUM;DEPAKOTE ER 6511678 DEC 18, 2018 021168 002 DIVALPROEX SODIUM;DEPAKOTE ER 6511678 DEC 18, 2018 020941 001 DOCOSANOL;ABREVA 4874794 APR 28, 2014 020624 002 DOLASETRON MESYLATE MONOHYDRATE;ANZEMET 4906755 JUL 02, 2011 020624 003 DOLASETRON MESYLATE MONOHYDRATE;ANZEMET 4906755 JUL 02, 2011 >ADD> 020869 001 DORZOLAMIDE HYDROCHLORIDE;COSOPT 4797413 APR 28, 2008 U103 >ADD> 4619939 OCT 28, 2003 U104 >ADD> 4619939*PED APR 28, 2004 >ADD> 4797413*PED OCT 28, 2008 >ADD> 020408 001 DORZOLAMIDE HYDROCHLORIDE;TRUSOPT 4797413 APR 28, 2008 U103 >ADD> 4619939 OCT 28, 2003 U104 >ADD> 4619939*PED APR 28, 2004 >ADD> 4797413*PED OCT 28, 2008 020972 001 EFAVIRENZ;SUSTIVA 6555133 APR 06, 2019 U248 6639071 FEB 14, 2018 DS 020972 002 EFAVIRENZ;SUSTIVA 6555133 APR 06, 2019 U248 6639071 FEB 14, 2018 DS 020972 003 EFAVIRENZ;SUSTIVA 6555133 APR 06, 2019 U248 6639071 FEB 14, 2018 DS 021360 001 EFAVIRENZ;SUSTIVA 5663169 SEP 02, 2014 6639071 FEB 14, 2018 DS 021360 002 EFAVIRENZ;SUSTIVA 6639071 FEB 14, 2018 DS >ADD> 021500 001 EMTRICITABINE;EMTRIVA 6642245 NOV 04, 2020 U541 NCE JUL 02, 2008 5210085 MAY 11, 2010 581463·9 SEP 29, 2015 5914331 SEP 29, 2015 021481 001 ENFUVIRTIDE;FUZEON 5464933 JUN 07, 2013 NCE MAR 13, 2008 6i33418 JUN 07, 2013 64754.91 JUN 07, 2015 U248 >ADD> 020164 001 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 002 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 003 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 004 ENOXAPARIN SODIUMiLOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 005 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 006 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 >ADD> 020164 007 ENOXAPAR-IN SODIUM; LOVENOX 5389618 FEB 14, 2012 DS DP U545 I-315 NOV 17, 2003 >ADD> 020164 008 ENOXAPARIN SODIUM;LOVENOX 5389618 FEB 14, 2012 DS DP U545 I-315 NOV 17, 2003 >ADD> 020164 009 ENOXAPARIN SODIUM;LOVENOX 4692435 DEC 24, 2004 DS DP U123 I-315 NOV 17, 2003 >ADD> 5389618 FEB 14, 2012 DS DP U545 020796 001 ENTACAPONE;COMTAN 6599530 SEP 14, 2018 DP 021565 001 EPINASTINE HYDROCHLORIDE;ELESTAT NCE OCT 15, 2008 021437 001 EPLERENONE;INSPRA 4559332 APR 09, 2004 U537 I-407 OCT 07, 2006 6558707 DEC 08, 2009 DP U537 6534093 DEC 08, 2019 U537 6495165 DEC 08, 2019 U537 6534093 DEC 08, 2019 U3 6410054· DEC 08, 2019 U537 021437 002 EPLERENONE;INSPRA 4559332 APR 09, 2004 U537 I-407 OCT 07, 2006 6534093 DEC 08, 2019 U3 6558707 DEC 08, 2009 DP U537 6495165 DEC 08, 2019 U537 6534093 DEC 08, 2019 U537 6410054 DEC 08, 2019 U537 A-11 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021437 003 EPLERENONE;INSPRA 4559332 APR 09, 2004 U537 I-407 OCT 07, 2006 6558707 DEC 08, 2009 DP U537 6410054 DEC 08, 2019 U537 6495165 DEC 08, 2019 U537 6534093 DEC 08, 2019 U3 6534093 DEC 08, 2019 U537 >ADD> 021323 001 ESCITALOPRAM OXALATE;LEXAPRO I-251 DEC 18, 2006 ;AI5D> 021323 002 ESCITALOPRAM OXALATE;LEXAPRO I-251 DEC 18, 2006 >ADD> 021323 003 ESCITALOPRAM OXALATE;LEXAPRO I-251 DEC 18, 2006 >ADD> 021365 001 ESCITALOPRAM OXALATE;LEXAPRO RE34712 JUN 08, 2009 I-251 DEC 18, 2006 RE34712*PED DEC 08, 2009 019386 002 ESMOLOL HYDROCHLORIDE;BREVIBLOC 4593119 JUN 03, 2003 5017609 MAY 21, 2008 5017609*PED NOV 21, 2008 4593119*PED DEC 03, 2003 019386 003 ESMOLOL HYDROCHLORIDE;BREVIBLOC 5017609 MAY 21, 2008 4593119 JUN 03, 2003 5017609*PED NOV 21, 2008 4593119*PED DEC 03, 2003 019386 004 ESMOLOL HYDROCHLORIDE;BREVIBLOC 6528540 JAN 12, 2021 4593119 JUN 03, 2003 6310094 JAN 12, 2021 6528540*PED JUL 12, 2021 6310094*PED JUL 12, 2021 4593119*PED DEC 03, 2003 019386 006 ESMOLOL HYDROCHLORIDE;BREVIBLOC 6528540 JAN 12, 2021 4593119 JUN 03, 2003 6310094 JAN 12, 2021 6528540*PED JUL 12, 2021 6310094*PED JUL 12, 2021 4593119*PED DEC 03, 2003 019386 007 ESMOLOL HYDROCHLORIDE;BREVIBLOC 4593119 JUN 03, 2003 6310094 JAN 12, 2021 6528540 JAN 12, 2021 6528540*PED JUL 12, 2021 6310094*PED JUL 12, 2021 4593119*PED DEC 03, 2003 019386 005 ESMOLOL HYDROCHLORIDE;BREVIBLOC DOUBLE STR 6528540 JAN 12, 2021 4593119 JUN 03, 2003 6310094 JAN 12, 2021 6528540*PED JUL 12, 2021 6310094*PED JUL 12, 2021 4593119*PED DEC 03, 2003 021367 001 ESTRADIOL ACETATE;FEMRING 5855906 DEC 19, 2015 U508 NP MAR 20, 2006 021367 002 ESTRADIOL ACETATE;FEMRING 5855906 DEC 19, 2015 U508 NP MAR 20, 2006 020375 005 ESTRADIOL CLIMARA 5223261 JUN 29, 2010 020375 006 ESTRADIOL CLIMARA 5223261 JUN 29, 2010 >ADD> 021258 001 ESTRADIOL CLIMARA PRO 5252334 OCT 12, 2010 DP NC NOV 21, 2006 5770219 OCT 12, 2010 DP 5393529 FEB 28, 2012 DP 5676968 OCT 14, 2014 DP A-12 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE .NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
004782 003 ESTROGENS, CONJUGATED;PREMARIN D-82 JUL 16, 2006 004782 006 ESTROGENS, CONJUGATED;PREMARIN D-82 JUL 16, 2006 020527 002 ESTROGENS, CONJUGATED;PREMPHASE 14/14 RE36247 MAY 02, 2006 020527 001 ESTROGENS, CONJUGATED;PREMPRO D-79 MAR 12, 2006 020527 003 ESTROGENS, CONJUGATED;PREMPRO D-79 MAR 12, 2006 020527 004 ESTROGENS, CONJUGATED;PREMPRO RE36247 MAY 02, 2006 NP MAR 12, 2006 5547948 JAN 17, 2015 D-79 MAR 12, 2006 5210081 FEB 26, 2012 D-81 JUN 04, 2006 020527 005 ESTROGENS, CONJUGATED;PREMPRO 5210081 FEB 26, 2012 NS JUN 04, 2006 RE36247 MAY 02, 2006 D-81 JUN 04, 2006 5547948 JAN 17, 2015 021180 001 ETHINYL ESTRADIOL;ORTHO EVRA 5876746 JUN 07, 2015 U514 5972377 JUN 07, 2015 U514 >ADD> 019697 001 ETHINYL ESTRADIOL;ORTHO TRI-CYCLEN 4544554 SEP 26, 2003 U66 >ADD> 4616006 SEP 26, 2003 U66 >ADD> 4628051 SEP 26, 20'03 U66 >ADD> 4530839 SEP 26, 2003 U112 >ADD> 4530839*PED MAR 26, 2004 >ADD> 4544554*PED MAR 26, 2004 >ADD> 4616006*PED MAR 26, 2004 >ADD> 4628051*PED MAR 26, 2004 >ADD> 021241 001' ETHINYL ESTRADIOL;ORTHO TRI-CYCLEN LO 4616006 SEP 26, 2003 U112 NP AUG 22, 2005 >ADD> 6214815 JUN 09, 2019 .U112 PED FEB 22, 2006 >ADD> 4530839 SEP 26, 2003 U112 >ADD> 4544554 SEP 26, 2003 U112 ~ 4628051 SEP 26, 2003 U112 >ADD> 4530839*PED MAR 26, 2004 >ADD> 4544554*PED MAR 26, 2004 >ADD> 4616006*PED MAR 26, 2004 >ADD> 4628051*PED MAR 26, 2004 >ADD> 6214815*PED DEC 09, 2019 >ADD> 021490 001 ETHINYL ESTRADIOL;OVCON-35 NDF NOV 14, 2006 021544 001 ETHINYL ESTRADIOL;SEASONALE 5898032 JUN 23, 2017 U1 NP SEP OS, 2006 020325 002 FAMOTIDINE;PEPCID AC NP SEP 23, 2006 021203 001 FENOFIBRATE ;'TRICOR 6589552 JAN 09, 2018 6652881 JAN 09, 2oi8 DP 021203 003 FENOF'IBRATE; TRICOR 6589552 JAN 09, 2018 6652881 JAN 09, 2018 DP 020747 001 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 020747 002 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 020747 003 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 020747 004 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 020747 005 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 020747 006 FENTANYL CITRATE;ACTIQ 4863737 SEP OS, 2006 5785989 SEP OS, 2006 A-13 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME ··PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
019813 001 FENTANYL;DURAGESIC 4588580 JUL 23, 2004 U43 NPP MAY 20, 2006 4588580*PED JAN 23, 2005 U43 PED NOV 20, 2006 019813 002 F~TANYL;DURAGESIC 4588580 JUL 23, 2004 U43 NPP MAY 20, 2006 4588580*PED JAN 23, 2005 U43 PED NOV 20, 2006 019813 003 FENTANYL;DURAGESIC 4588580 JUL 23, 2004 U43 NPP MAY 20, 2006 4588580*PED JAN 23, 2005 U43 PED NOV 20, 2006 019813 004 FENTANYL;DURAGESIC 4588580 JUL 23, 2004 U43 NPP MAY 20, 2006 4588580*PED JAN 23, 2005 U43 PED NOV 20, 2006 021626 001 FERRIC HEXACYANOFERRATE(II) ;RADIOGARDASE (PRUSSI ODE OCT 02, 2010 NCE OCT 02, 2008 020625 001 FEXOFENADINE HYDROCHLORIDE; ALLEGRA 5578610 NOV 26, 2013 U192 M-25 MAY 12, 2006 5855912 FEB 28, 2015 PED NOV 12, 2006 5738872 FEB 28, 2015 5932247 FEB 28, 2015 6037353 MAR 14, 2017 U138 6113942 FEB 28, 2015 618779i MAY 11, 2012 U138 6399632 MAY 11, 2012 U468 5578610*PED MAY 26, 2014 U192 5738872*PED AUG 28, 2015 5855912*PED AUG 28, 2015 5932247*PED AUG 28, 2015 60.37353*PED SEP 14, 2017 U138 6113942*PED AUG 28, 2015 6187791*PED· NOV 11, 2012 U138 6399632*PED NOV 11, 2012 U468 020872 001 FEXOFENADINE HYDROCHLORIDE;ALLEGRA 5578610 NOV 26, 2013 U139 NDF . FEB 25, 2003 5932247 FEB 28, 2015 PED AUG 25, 2003 5855912 FEB 28, 2015 M-25 MAY 12, 2006 6037353 MAR 14, 201.7 U138 PED NOV 12, 2006 6113942 FEB 28, 2015 618779i MAY i1, 2.012 U138 6399632 MAY 11, 2012 U468 5578610*PED MAY 26, 2014 U139 5855912*PED AUG 28, 2015 5932247*PED AUG 28, 2015 6037353*PED SEP 14, .2017 U138 6113942*PED AUG 28, 2015 6187791*PED NOV 11, 2012 U138 6399632*PED NOV 11, 2012 U468 020872 002 FEXOFENADINE HYDROCHLORIDE;ALLEGRA 5578610 NOV 26, 2013 U139 NDF FEB 25, 2003 5932247 FEB 28, 2015 PED AUG 2"5., 2003 5855912 FEB 28, 2015 M-25 MAY 12, 2006 6037353 MAR 14, 2017 U138 PED NOV 12, 2006 6113942 FEB 28, 2015 6187791 MAY 11, 2012 U138 6399632 MAY 11, 2012 U468 5578610*PED MAY 26, 2014 U139 5855912*PED .AUG 28, 2015 5932247*PED AUG 2·8, 2015 6037353*PED SEP 14, 2017 U138 6113942*PED AUG 28, 2015 6187791*PED NOV 11, 2012 U138 6399632*PED NOV 11, 2012 U468 A-14 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020872 004 FEXOFENADINE HYDROCHLORIDE;ALLEGRA 5578610 NOV 26, 2013 U139 NDF FEB 25, 2003 5932247 FEB 28, 2015 PED AUG 25, 2003 5855912 FEB 28, 2015 M-25 MAY 12, 2006 6037353 MAR 14, 2017 U138 PED NOV 12, 2006 6113942 FEB 28, 2015 6187791 MAY 11, 2012 U138 6399632 MAY 11, 2012 U468 5578610*PED MAY 26, 2014 U139 5855912*PED AUG 28, 2015 5932247*PED AUG 28, 2015 6037353*PED SEP 14, 2017 U138 611.3·942·*PED AUG 28, 2015 6187791*PED NOV 11, 2012 U138 6399632*PED NOV 11, 2012 U468 020786 001 FEXOFENADINE HYDROCHLORIDE;ALLEGRA-D 5578610 NOV 26, 2013 M-25 MAY 12, 2006 5855912 FEB 28, 2015 PED NOV 12, 2006 6037353 MAR 14, 2017 U138 60399'74 JUL 31, 2018 6113942 FEB 28, 2015 6187791 MAY 11, 2012 U138 6399632 MAY 11, 2012 U468 5578610*PED MAY 26, 2014 5855912*PED AUG 28, 2015 6037353*PED SEP 14, 2017 U138 6113942*PED AUG 28, 2015 6187791*PED NOV 11, 2012 U138 6399632*PED NOV 11, 2012 U468 020180 001 FINASTERIDE;PROSCAR 6046183 MAR 20, 2011 020038 001 FLUDARABINE PHOSPHATE;FLUDARA 4357324 FEB 24, 2003 4'357324*PED AUG 24, 2003 020101 001 FLUOXETINE HYDROCHLORIDE;PROZAC NPP JAN 03, 2006 PED JUL 03, 2006 020974 001 FLUOXETINE HYDROCHLORIDE;PROZAC NPP JAN 03, 2006 PED JUL 03, 2006 020974 002 FLUOXETINE HYDROCHLORIDE;PROZAC NPP JAN 03, 2006 PED JUL 03, 2006 >ADD> . 021520 002 FLUOXETINE HYDROCHLORIDE;SYMBYAX 522982 APR 23, 2011 DS DP NC DEC 24, 2006 >ADD> 5945416 MAR 24, 2017 DS DP >ADD> 021520 003 FLUOXETINE HYDROCHLORIDE;SYMBYAX 5229382 APR 23, 2011 DS DP NC DEC 24, 2006 >ADD> 5945416 MAR 24, 2017 DS DP >ADD> 021520 004 FLUOXETINE HYDROCHLORIDE;SYMBYAX 5229382 APR 23, 2011 DS DP NC DEC 24, 2006 >ADD> 5945416 MAR 24, 2017 DS DP >ADD> 021520 005 FLUOXETINE HYDROCHLORIDE;SYMBYAX 5229382 APR 23, 2011 DS DP NC DEC 24, 2006 >ADD> 5945416 MAR 24, 2017 DS DP 021077 001 FLUTICASONE PROPIONATE;ADVAIR DISKUS 100/50 4335121 NOV 14, 2003 NC AUG 24, 2003 5270305 SEP 07,"2010 U387 4992474 FEB 12~ 2·008 U211 5225445 FEB 12, 2008 U211 5126375 FEB 12, 2008 5290815' MAR 01, 2011 U386 4335121*PED MAY 14, 2004 A-15 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021077 002 FLUTICASONE PROPIONATE;ADVAIR DISKUS 250/50 4335121 NOV 14, 2003 NC AUG 24, 2003, 5270305 SEP 07, 2010 U387 I-410 NOV 17, 2006 4992474 FEB 12, 2008 U211 5225445 FEB 12; 2008 U211 5126375 FEB 12, 2008 5290815 MAR 01, 2011 U386 4335121*PED MAY 14, 2004 021077 003 FLUTICASONE PROPIONATE;ADVAIR DISKUS 500/50 4335121 NOV 14, 2003 NC AUG 24, 2003 5270305 SEP 07, 2010 U387 4992474 FEB 12, 2008 U211 5225445 FEB 12, 2008 U211 5126375 FEB 12, 2008 5290815 MAR 01, 2011 U386 4335121*PED MAY 14, 2004 019,957 001 FLUTICASONE PROPIONATE;CUTIVATE 4335121 NOV 14, 2003 4335121*PED MAY 14, 2004 019958 001 FLUTICASONE PROPIONATE;CUTIVATE 4335121 NOV 14, 2003 4335121*PED MAY 14, 2004 020121 001 FLUTICASONE PROPIONATE;FLONASE 4335121 NOV 14, 2003 D-76 MAY 23, 2005 4335121*PED MAY 14, 2004 PED NOV 23, 2005 M-24 MAY 01, 2006 PED NOV 01, 2006 020548 001 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 4335121*PED MAY 14, 2004 020548 002 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 4335121*PED MAY 14, 2004 020548 003 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 4335121*PED MAY 14, 2004 020549001 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020549 002 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020549 003 FLUTICASONE PROPIONATE;FLOVENT 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020833 001 FLUTTCASONE PROPIONATE;FLOVENT DISKUS 50 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020833 002 FLUTICASONE PROPIONATE;FLOVENT DISKUS 100 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020833 003 FLUTICASONE PROPIONATE;FLOVENT DISKUS 250 4335121 NOV 14, 2003 U409 4335121*PED MAY 14, 2004 U409 020261 001 FLUVASTATIN SODIUM;LESCOL 5354772 OCT 11, 2011 U109 I-394 MAY 27, 2006 5354772 OCT 11, 2011 U413 020261 002 FLUVASTATIN SODIUM;LESCOL 5354772 OCT 11, 2011 U109 I-394 MAY 27, 2006 5354772 OCT 11, 2011 U413 021192 001 FLUVASTAT'IN SODIUM; LESCOL XL 5354772 OCT 11, 2011 U413 I-394 MAY 27, 2006 5354772 OCT 11, 2011 U109 020961 001 FOMIVIRSEN SODIUM;VITRAVENE PRESERVATI 5442049 AUG 15, 2012 5595978 AUG 15, 2012 U522 4689320 OCT 15, 2004 U522 5264423 NOV 23, 2010 U522 5276019 JAN 04, 2011 U522 A-16 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regar\iing report content
APPL/PROD INGREDIENT NAME; . TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021345 OO~ FONDAPARINUX SODIUM;ARIXTRA I-397 JUN 17, 2006 020831 001 FORMOTEROL FUMARATE;FORADIL 6488027 MAR 08, 2019 I-342 SEP 25, 2004 NPP JUN 27, 2006 021548 001 FOSAMPRENAVIR CALCIUM;LEXIVA 6436989 DEC 24, 2017 U257 NE OCT 20, 2006 6514953 JUL 15, 2019 U257 >ADD> 076139 001 FOSINOPRIL SODIUM;FOSINOPRIL SODIUM PC APR 23, 2004 >ADD> 076139 002 FOSINOPRIL SODIUM;FOSINOPRIL SODIUM PC APR 23, 2004 >ADD> 076139 003 FOSINOPRIL SODIUM;FOSINOPRIL SODIUM PC APR 23, 2004 019915 002 FOSINOPRIL SODIUM;MONOPRIL 4337201 DEC 04.- 2002 NPP MAY 27, 2006 5006344 JUL 10, 2009 PED NOV 27, 2006 5006344*PED J]W 10, 2010, 4337201*PED JUN 04, 2003 0199.15 003 FOSINOPRIL SODIUM';MONOPRIL 4337201 DEC 04, 2002 NPP MAY 27, 2006 5006344 JUL 10, 2009 PED NOV 27, 2006 5006344*PED JAN 10, 2010 4337201*PED JUN 04, 2003 019915 004 FOSINOPRIL SODIUM;MONOPRIL 4337201 DEC 04, 2002 NPP MAY 27, 2006 5006344 JUL 10, 2009 PED NOV 27, 2006 5006344*PED JAN 10, 2010 4337201*PED JUN 04, 2003 020286 001 FOSINOPRIL SODIUM;MONOPRIL-HCT 4337201 DEC 04, 2002 5006344 JUL 10, 2009 5006344*PED JAN 10, 2010 4337201*PED JUN 04, 2003 020286 002 FOSINOPRIL SODIUM;MONOPRIL-HCT 4337201 DEC 04, 2002 50.06344 JUL 10, 2009 5006344*PED JAN 10, 2010 4337201*PED JUN 04, 2003 021489 001 GADOTERIDOL;PROHANCE MULTIPACK 5474756 DEC 12, 2012 U536 6143274 DEC 12, 2012 U536 4885363 DEC 05, 2006 5846519 DEG 08, 2015 076457 001 GANCICLOVIR;GANCICLOVIR PC FEB 16, 2004 07645,7 002 GANCICLOVIR;GANCICLOVIR PC FEB 16, 2004 021061 001 GATIFLOXACIN;TEQUIN I-329 OCT 17, 2005 021061 002 GATIFLOXACIN;TEQUIN I-329 OCT 17, 2005 021062 001 GATIFLOXACIN;TEQUIN 1-329 OCT 17, 2005 021062 002 GATIFLOXACIN;TEQUIN I-329 OCT 17, 2005 021062 003 GATIFLOXACIN;TEQUIN I-329 OCT 17, 2005 021062 004 GATIFLOXACIN;TEQUIN I-329 OCT 17, 2005 021493 001 GATIFLOXACIN;ZYMAR 5880283 DEC 05, 2015 NDF MAR 28, 2006 4980470 DEC 15, 2009 NCE DEC 17, 2004 021399 00.1 GEFITINIB;IRESSA 5457105 .:rAN 19, 2013 NCE MAY 05, 2008 5616582 JAN 19, 2013 5770599 APR 26, 2016 021158 001 GEMIFLOXACIN MESYLATE;FACTIVE 6262071 SEP 21, 2019 U513 NCE APR 04, 2008 6331550 SEP 21, 2019 U511 6340689 SEP 14, 2019 U512 6455540 SEP 21, 2019 U511 5633262 JUN 15, 2015 5776944 JUN 15, 2015 5962468 JUN 15, 2015 U282 A-17 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020622 001 GLATIRAMER ACETATE;COPAXONE 6620847 MAY 24, 2014 DS 020622 002 GLATIRAMER ACETATE;COPAXONE 5981589 MAY 24, 2014 ODE DEC 20, 2003 6054430 MAY 24, 2014 6342476 MAY 24, 2014 U441 6362161 MAY 24, 2014 U441 6620847 MAY 24, 2014 DS 076467 001 GLIPIZIDE;GLIPIZIDE PC OCT 19, 2003 020329 001 GLIPIZIDE;GLUCOTROL XL 5091190 SEP OS, 2009 U111 5545413 JUL 21, 2008 U111 020329 002 GLIPIZIDE;GLUCOTROL XL 5091190 SEP OS, 2009 U111 5545413 JUL 21, 2008 U111 020329 003 GLIPIZIDE;GLUCOTROL XL 4612008 SEP 16, 2003 5024843 SEP OS, 2009 5082668 SEP 16, 2003 5091190 SEP OS, 2009 U111 5545413 JUL 21, 2008 U111 5591454 JAN 07, 2014 U111 021178 001 GLYBURIDE;GLUCOVANCE 6303146 JUL 14, 2019 U412 NC JUL 31, 2003 6303146*PED JAN 14, 2020 U412 1-368 SEP 30, 2005 PED JAN 31, 2004 PED MAR 30, 2006 021178 002 GLYBURIDE;GLUCOVANCE 6303146 JUL 14, 2019 U412 NC JUL 31, 2003 6303146*PED JAN 14, 2020 U412 1-368 SEP 30, 2005 PED JAN 31, 2004 PED MAR 30, 2006 021178 003 GLYBURIDE;GLUCOVANCE 6303146 JUL 14, 2019 U412 NC JUL 31, 2003 6303146*PED JAN 14, 2020 U412 1-368 SEP 30, 2005 PED JAN 31, 2004 PED MAR 30, 2006 020239 001 GRANISETRON HYDROCHLORIDE;KYTRIL 5952340 SEP 14, 2016 U519 02023,9 002 GRANISETRON HYDROCHLORIDE;KYTRIL 5952340 SEP 14, 201,6 U519 021282 002 GUAIFENESIN;MUCINEX 6372252 APR 28, 2020 U489 ~ 019967 001 HALOBETASOL PROPIONATE;ULTRAVATE 4619921 DEC 16, 2004 019968 001 HALOBETASOL PROPIONATE;ULTRAVATE 4619921 DEC 16, 2004 021532 002 HYDROCHLOROTHIAZIDE;BENICAR HCT 5616599 APR 01, 2014 U500 NC JUN OS, 2006 NCE APR 25, 2007 021532 003 HYDROCHLOROTHIAZIDE;BENICAR HCT 5616599 APR 01, 2014 U500 NC JUN OS, 2006 NCE APR 25, 2007 021532 005 HYDROCHLOROTHIAZIDE;BENICAR HCT 5616599 APR 01, 2014 U500 NC JUN OS, 2006 NCE APR 25, 2007 020818 003 HYDROCHLOROTHIAZIDE;DIOVAN HCT 5399578 MAR 21, 2012 U3 6294197 JUN 18, 2{)17 U3 ~ 020387 001 HYDROCHLOROTHIAZIDE; HYZAAR 5153197 OCT 06, 2009 U538 1-415 SEP 30, 2006 5153197*PED APR 06, 2010 U538 >ADD> 020387 002 HYDROCHLOROTHIAZIDE; HYZAAR 5153197 OCT 06, 2009 U538 1-415 SEP 30, 2006 5153197*PED APR 06, 2010 U538 021162 001 HYDROCHLOROTHIAZIDE;MICARDIS HCT 6358986 JAN 10, 2020 021162 002 HYDROCHLOROTHIAZIDE;MICARDIS HCT 6358986 JAN 10, 2020 020716 001 HYDROCODONE BITARTRATE;VICOPROFEN 6599531 JUN 10, 2017 020453 001 HYDROCORTISONE PROBUTATE;PANDEL 4794106 AUG 28, 2006 A-18 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021455 001 IBANDRONATE SODIUM;BONIVA 4927814 JUL 09, 2007 U520 NCE MAY 16, 2008 6143326 APR 21, 2017 U520 6294196 OCT 07, 2019 021472 001 IBUPROFEN; IBUPROFEN 6251426 JUN 25, 2018 021321 001 ICODEXTRIN;EXTRANEAL 6248726 JUN 19, 2018 U495 ODE DEC 20, 2009 4761237 AUG 02, 2005 U495 4886789 DEC 12, 2006 U495 6077836 JUN 20, 2017 U495 021335 001 IMATINIB MESYLATE;GLEEVEC 1-392 MAY 20, 2006 021335 002 IMATINIB MESYLATE;GLEEVEC 1-392 MAY 20, 2006 021588 001 IMATINIB MESYLATE;GLEEVEC 5521184 MAY 28, 2013 NCE MAY 10, 2006 1'-376 DEC 20, 2005 ODE FEB 01, 2009 ODE MAY 10, 2008 1-392 MAY 20, 2006 021588 002 IMATINIB MESYLATE;GLEEVEC 5521184 MAY 28, 2013 NCE MAY 10, 2006 1-376 DEC 20, 2005 ODE FEB 01, 2009 ODE MAY 10, 2008 1-392 MAY 20, 2006 020367 002 IMIGLUCERASE;CEREZYME . 5549982 AUG 27, 2013 U252 020685 001 INDINAVIR SULFATE;CRIXIVAN 6645961 MAR 04, 2018 DP 020685 003 INDINAVIR SULFATE;CRIXIVAN 6645961 MAR 04, 2018 DP 020685 005 INDINAVIR SULFATE;CRIXIVAN 6645961 MAR 04, 2018 DP 020685 006 INDINAVIR SULFATE;CRIXIVAN 6645961 MAR 04, 2018 DP 021081 001 INSULIN GLARGINE;LANTUS D-80 MAY 01, 2006 020563 001 INSULIN LISPRO;HUMALOG 5474978 JUN 16, 2014 U534 5514646 MAY 07, 2013 U534 020563 002 INSULIN LISPRO;HUMALOG PEN 5474978 JUN 16, 2014 U534 5514646 MAY 07, 2013 U534 021425 001 IOPROMIDE;ULTRAVIST (PHARMACY 4364921 MAR 06, 2005 U498 021425 002 IOPROMIDE;ULTRAV1ST (PHARMACY 4364921 MAR 06, 2005 U498 021528 001 KETOROLAC TROMETHAMINE;ACULAR LS 5110493 .MAY 05, 2009 NP MAY 30, 2006 5110493*PED NOV 05, 2009 020857 001 LAMIVUDINE;COMBIV1R 5047407*PED MAY 17, 2010 5047407 NOV 17, 2009 021003 001 LAMIVUDINE;EP1VIR-HBV 5047407 NOV 17, 2009 5047407*PED MAY 17, 2010 021004 001 LAMIVUDINE;EP1V1R-HBV 5047407 NOV 17, 2009 5047407*PED MAY 17, 2010 020241 001 LAMOTRIGINE;LAMICTAL 1-387 JAN 17, 2006 1-404 JUN 20, 2006 020241 002 LAMOTRIGINE;LAMICTAL 1-387 JAN 17, 2006 1-404 JUN 20, 2006 020241 003 LAMOTR1G1NE;LAMICTAL 1-387 JAN 17, 2006 1-404 JUN 20, 2006 020241 004 LAMOTRIG1NE;LAMICTAL 1-387 JAN 17, 2006 1-404 JUN 20, 2006 020241 005 LAMOTRIGINE;LAMICTAL 1-387 JAN 17, 2006 1-404 JUN 20, 2006 A-19 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020241 006 LAMOTRIGINE;LAMICTAL I-387 JAN 17, 2006 I-404 JUN 20, 2006 020764 001 LAMOTRIGINE;LAMICTAL CD I-387 JAN 17, 2006 I-404 JUN 20, 2006 020764 002 LAMOTRIGINE;LAMICTAL CD I-387 JAN 17, 2006 I-404 JUN 20, 2006 020764 003 LAMOTR1G.INE ; LAM1CTAL CD I-387 JAN 17, 2006 I-404 .JUN 20, 2006 >ADD> 020764 004 LAMOTRIGINE;LAMICTAL CD 5698226 JAN 29, 2012 I-387 JAN 17, 2006 ;rum; 4602017 JUL 22, 2008 U106 I-404 JUN 10, 2006 >ADD> ODE AUG 24, 2005 021281 001 LANSOPRAZOLE;PREVACID 4628098 MAY 10, 2009 4689333 JUL 29, 2005 U126 5013743 FEB 12, 2010 U452 5026560 JUN 25, 2008 504532i SEP 03, 2008 5093132 SEP 03, 2008 5433959 SEP 03, 2008 021281 002 LANSOPRAZOLE;PREVACID 4628098 MAY 10, 2009 4689333 JUL 29, 2005 U126 5013743 FEB 12, 2010 U452 5026560 JUN 25, 2008 5045321 SEP 03, 2008 5093132 SEP 03, 2008 5433959 SEP 03, 2008 020905 001 LEFLUNOMIDE;ARAVA NCE SEP 10, 2003 I-395 JUN 13, 2006 PED MAR 10, 2004 PED DEC 13, 2006 020905 OQ2 LEFLUNOMIDE;ARAVA NCE SEP 10, 2003 I-395 JUN 13, 2006 PED MAR 10, 2004 PED DEC 13, 2006 020905 003 LEFLUNOMIDE;ARAVA NCE SEP 10, ,:2003 I-395 JUN 13, 2006 PED MAR 10, 2004 PED DEC 13, 2006 021488 001 LEUPROLIDE ACETATE;ELIGARD 4938763 OCT 03, 2008 NP FEB 13, 2006 5278201 JAN 11, 2011 5324519 OCT 20, 2011. 5599552 FEB 04, 2014 5733950 OCT 03, 2008 5739176 OCT 03, 2008 020837 001 LEVALBUTEROL HYDROCHLORIDE;XOPENEX 5362755 NOV 08, 2011 U332 >ADD> 021035 001 LEVETIRACETAM KEPPRA 4943639 AUG 06, 2009 >ADD> 021035 002 LEVETIRACETAM KEPPRA 4943639 AUG 06, 2009 >ADD> 021035 003 LEVETIRACETAM KEPPRA 4943639 AUG 06, 2009 ~ 021505 001 LEVETIRACETAM KEPPRA 4943639 AUG 06, 2009 NCE NOV 30, 2004 4837223 JUN 06, 2006 020219'001 LEVOCABASTINE HYDROCHLORIDE;LIVOSTIN 4369184 DEC 07, 2004 A-20 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding ,report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020634 001 LEVOFLOXACIN;LEVAQUIN 1-393 MAY 23, 2006 D-83 OCT 23, 2006 020634 002 LEVOFLOXACIN;LEVAQUIN 1-393 MAY 23, 2006 D-83 OCT 23, 2006 020634 003 LEVOFLOXACIN;LEVAQUIN 1-393 MAY 23, 2006 D-83 OCT 23, 2006 020635 001 LEVOFLOXACIN;LEVAQUIN 1-393 MAY 23, 2006 D-83 OCT 23, 2006 020635 004 LEVOFLOXACIN;LEVAQUIN 5053407 DEC 20, 2010 1-393 MAY 23, 2006 1-372 OCT 30, 2005 >ADD> D-83 OCT 23, 2006 020635. 002 LEVOFLOXACIN;LEVAQUIN IN DEXTROSE I~393 MAY 23, 2006 D-83 OCT 23, 2006 02Q635· 003 LEVOFLOXACIN;LEVAQUIN IN DEXTROSE 1-393 MAY 23, 2006 D-83 OCT 23, 2006 020635 005 LEVOFLOXACIN;LEVAQUIN IN DEXTROSE 5053407 DEC 20, 2010 1-393 MAY 23, 2006 1-372 OCT 30, 2005 >ADD> D-83 OCT 23, 2006 021199 001 LEVOFLOXACIN;QUIXIN 5053407 DEC 20, 2010 021301 001 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 002 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 003 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 004 LEVOTHYROXINE.SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 005 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 006 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 007 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 02130.1 008 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 009 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 010 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 011 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 021301 012 LEVOTHYROXINE SODIUM;LEVOXYL 6555581 FEB 15, 2022 020612 001 LIDOCAINE;LIDODERM 5589180 MAR 17, 2009 U485 5411738 MAY 02, 2012 5827529 OCT 27, 2015 U486 5709869 MAR 17, 2009 U485 5601838 MAY 02, 2012 U488 ~ 021451 001 LIDOCAINE.; ORAQIX NDF DEC 19, 20·06 021130 001 LINEZOLID;ZYVOX 6559305 JAN 29, 2021 NPP DEC 19, 2005 6514529 MAR 15, 2021 DP 1-402 JUL 22, 2006 021130 002 LINEZOLID;ZYVOX 6559305 JAN 29, 2021 NPP DEC 19, 2005 6514529 MAR 15, 2021 DP 1-402 JUL .22, 2006 021.131 001 LINEZOLID;ZYVOX 6559305 JAN 29, 2021 NPP DEC 19, 2005 1-402 JUL 22, 2006 021132 001 LINEZOLID;ZYVOX 6559305 JAN 29, 2021 NPP DEC 19, 2005 1-402 JUL 22, 2006 019558 001 LISINOPRIL;PRINIVIL NPP MAY 29, 2006 PED NOV 29, 2006 019558 002 LISINOPRIL;PRINIVIL NPP MAY 29, 2006 PED NOV 29, 2006 019558 003 LISINOPRIL;PRINIVIL NPP MAY 29, 2006 PED NOV 29, 2006 A-21 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD ING~EDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
019558 004 LISINOPRIL;PRINIVIL NPP MAY 29, 2006 PED NOV 29, 2006 019558 006 LISINOPRIL;PRINIVIL NPP MAY 29, 2006 PED NOV 29, 2006 019777 001 LISINOPRIL;ZESTRIL PED NOV 29, 2006 NPP MAY 29, 2006 019777 002 LISINOPRIL;ZESTRIL PED. NOV 29, 2.006 NPP MAY 29, 2006 019777 003 LISINOPRIL;ZESTRIL PED NOV 29, 2006 NPP MAY 29, 2006 019777 004 LISINOPRIL;ZESTRIL PED NOV 29, 2006 NPP MAY 29, 2006 019777 005 LISINOPRIL;ZESTRIL PED NOV 29, 2006 NPP MAY 29, 2006 019777 006 LISINOPRIL;ZESTRIL PED NOV 29, 2003 NPP MAY 29, 2006 021226 001 LOPINAVIR;KALETRA 6521651 NOV 01, 2017 019658 002 LORATADINE;CLARITIN 4659716 APR 21, 2004 U142 4659716*PED OCT 21, 2004 U142 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 020641 002 LORATADINE;CLARITIN 4659716 APR 21, 2004 U142 4659716*PED OCT 21, 2004 U142 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 6132758 JUN 01, 2018 020704 002 LORATADINE;CLARITIN REDITABS 4659716 APR 21, 2004 U142 4659716*PED OCT 21, 2004 U142 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 019670 002 LORATADINE;CLARITIN-D 4659716 APR 21, 2004 U142 4659716*PED OCT 21, 2004 U142 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 020470 002 LORATADINE;CLARITIN-D 24 HOUR 4659716 APR 21, 2004 U142 4659716*PED OCT 21, 2004 U142 4863931 SEP 15, 2008 4863931*PED MAR 15, 2009 5314697 OCT 23, 2012 5314697*PED APR 23, 2013 075209 001 LORATADINE;LORATADINE PC JUL 21, 2003 075822 001 LORATADINE;LORATADINE PC AUG 09, 2003 075706 001 LORATADINE;LORATADINE AND PSEUD PC NOV 29, 2003 076050 001 LORATADINE;LORATADINE AND PSEUD PC JUL 30, 2003 020386 001 LOSARTAN POTASSIUM;COZAAR 5210079 MAY 11, 2010 U496 I-383 SEP 17, 2005 5210079*PED NOV 11, 2010 U496 020386 002 LOSARTAN POTASSIUM;COZAAR 5210079 MAY 11,2010 U496 I-383 SEP 17; 2005 5210079*PED NOV 11, 2010 U496 020386 003 LOSARTAN POTASSIUM;COZAAR 5210079 MAY 11, 2010 U496 I-383 SEP 17, 2005 5210079*PED NOV 11, 2010 U496 A-22 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021487 001 MEMANTINE HYDROCHLORIDE;NAMENDA 5061703 APR 11, 2010 U539 NCE OCT 16, 2008 5614560 MAR 25, 2014 U539 021487 002 MEMANTINE HYDROCHLORIDE;NAMENDA 5061703 APR 11, 2010 U539 NCE OCT 16, 2008 5614560 MAR 25, 2014 U539 021487 003 MEMANTINE HYDROCHLORIDE;NAMENDA 5061703 APR 11, 2010 U539 NCE OCT 16, 2008 5614560 MAR 25, 2014 U539 0214B7 004 MEMANTINE HYDROCHLORIDE;NAMENDA 5061703 APR 11, 2010 U539 NCE OCT 16, 200B 5614560 MAR 25, 2014 U539 021410 001 METFORMIN HYDROCHLORIDE;AVANDAMET NCE MAY 25, 2004 021410 002 MET FORM IN HYDROCHLORIDE;AVANDAMET NCE MAY 25, 2004 021410 003 METFORMIN HYDROCHLORIDE;AVANDAMET NCE MAY 25, 2004 021410 004 METFORMIN HYDROCHLORIDE;AVANDAMET NCE MAY 25, 2004 021410 005 METFORMIN HYDROCHLORIDE;AVANDAMET NCE MAY 25, 2004 ~ 021202 001 METFORMIN HYDROCHLORIDE;GLUCOPHAGE XR 6660300 MAR 19, 2018 U542 >ADD> 021202 004 METFORMIN HYDROCHLORIDE;GLUCOPHAGE XR 6660300 MAR 19, 2018 U542 NDF OCT 13, 2003 6475521 MAR 19, 2018 021121 001 METHYLPHENIDATE HYDROCHLORIDE;CONCERTA 5082668 SEP 16, 2003 4783337 SEP 16, 2003 U372 4612008 SEP 16, 2003 50B2668*PED MAR 16, 2004 4612008*PED MAR 16, 2004 4783337*PED MAR 16, 2004 021121 002 METHYLPHENIDATE HYDROCHLORIDE;CONCERTA 5082668 SEP 16, 2003 47"83337 SEP 16, 2003 U372 4612008 SEP 16, 2003 5082668*PED MAR 16, 2004 4612008*PED MAR 16, 2004 4783337*PED MAR 16, 2004 021121 003 METHYLPHENIDATE HYDROCHLORIDE;CONCERTA 5082668 SEP 16, 2003 4783337 SEP 16, 2003 U372 4612008 SEP 16, 2003 50B2668*PED MAR 16, 2004 4612008*PED MAR 16, 2004 4783337*PED MAR 16, 2004 021121 004 METHYLPHENIDATE HYDROCHLORIDE;CONCERTA 461200B SEP 16, 2003 4783337 SEP 16, 2003 U372 5082668 SEP 16, 2003 5082668*PED MAR 16, 2004 4612008*PED MAR 16, 2004 4783337*PED MAR 16, 2004 021259 002 METHYLPHENIDATE HYDROCHLORIDE;METADATE CD 6344215 OCT 27, 2020 NDF APR 03, 2004 021259 003 METHYLPHENIDATE HYDROCHLORIDE;METADATE CD 6344215 OCT 27, 2020 NDF APR 03, 2004 019962 001 METOPROLOL SUCCINATE;TOPROL-XL 5081154 MAR 19, 200B 019962 002 METOPROLOL SUCCINATE;TOPROL-XL 5081154 MAR 19, 200B 019962 003 METOPROLOL SUCCINATE;TOPROL-XL 5081154 MAR 19, 2008 4927640 MAY 22, 2007 01996.2 004 METOPROLOL SUCCINATE;TOPROL-XL 5081154 MAR 19, 2008 U107 021348 001 MIGLUSTAT;ZAVESCA 5472969 MAY 13, 2013 NCE JUL 31, 2008 5525616 JON 11, 2013 ODE JUL 31, 2010 076119 001 MIRTAZAPINE;MIRTAZAPINE PC JON 16, 2003 A-23 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
076119 002 MIRTAZAPINE;MIRTAZAPINE PC JUN 16, 2003 076204 001 MOEXIPRIL HYDROCHLORIDE;MOEXIPRIL HCL PC SEP 21, 2003 076204 002 MOEXIPRIL HYDROCHLORIDE;MOEXIPRIL HCL PC SEP 21, 2003 021085 001 MOXIFLOXACIN HYDROCHLOR1DE;AVELOX I-385 FEB 28, 2006 021277 001 MOXIFLOXACIN HYDROCHLORIDE;AVELOX IN SODIUM CHL 4990517 JUN 30, 2009 U298 1-385 FEB 28, 2006 5607942 MAR 04, 2014 U298 5849752 DEC 05, 2016 U298 021598 001 MOXIFLOXACIN HYDROCHLORIDE;VIGAMOX 4990517 JUN 30, 2009 NDF APR 15, 2006 5607942 MAR 04, 2014 PED OCT 15, 2006 >ADD> 5849752 DEC 05, 20·16 NCE DEC 10, 2004 >ADD> 4990517*PED DEC 30, 2009 PED JUN 10, 2004 5607942*PED SEP 04, 2014 5849752*PED JUN 05, 2017 >ADD> 021204 001 NATEGLINIDE;STARLIX 6641841 NOV 14, 2017 DP U214 I-411 OCT 20, 2006 6559188 SEP 17, 2019 >ADD> 021204 002 NATEGLINIDE;STARLIX 6641841 liIov 14, 2017 DP U214 I-411 OCT 20, 2006 6559188 SEP 17, 2019 020778 001 NELFINAVIR MESYLATE;VIRACEPT 5484926 OCT 07, 2013 5952343 OCT 07, 2013 U257 6162812 OCT 07, 2013 U248 5952343*PED APR 07, 2014 U257 5484926*PED APR 07, 2014 6162812*PED APR 07, 2014 U248 020779 001 NELFINAV1R MESYLATE;VIRACEPT 5484926 OCT 07, 2013 5952343 OCT 07, 2013 U257 6162812 OCT 07, 2013 U248 5484926*PED APR 07, 2014 5952343*PED APR 07, 2014 U257 6162812*PED APR 07, 2014 U248 021503 001 NELFINAVIR MESYLATE;VIRACEPT 5484926 OCT 07, 2013 5484926*PED APR 07, 2014 5952343 OCT 07, 2013 U257 5952343*PED APR 07, 2014 U257 6162812 OCT 07, 2013 U248 6162812*PED APR 07, 2014 U248 020636 001 NEVIRAPINE;VIRAMUNE 5366972 NOV 22, 2011 U167 5366972*PED MAY 22, 2012 020933 001 NEVIRAPINE;VIRAMUNE 5366972 NOV 22, 2011 5366972*PED MAY 22, 2012 021330 001 NICOTINE POLACRILEX;COMMIT 5110605 AUG 21, 2010 021330 002 NICO+INE POLACRILEX;COMMIT 5110605 AUG 21, 2010 020076 004 NICOTINE;HABITROL 4597961 JAN 23, 2005 U56 5016652 MAY 21, 2008 020076 ·005 NICOTINE;HABITROL 4597961 JAN 23, 2005 U56 5016652 MAY 21, 2008 020076 006 NICOTINE;HABITROL 4597961 JAN 23, 2005 U56 5016652 MAY 21, 2008 019983 003 NICOTINE;PROSTEP 4946853 AUG 07, 2007 U56 019983 004 NICOTINE;PROSTEP 4946853 AUG 07, 2007 U56 021498 001 NITAZOXANIDE;ALINIA 5387598 FEB 07, 2012 U524 5578621 SEP 08, 2014 U525 5965590 JUL 03, 2017 U523 5968961 MAY 07, 2017 6020353 SEP 08, 2014 6117894 MAY 07, 2017 A-24 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021232 001 NITIsINONE;ORFADIN 5006158 APR 09, 2008 5550165 AUG 27, 2013 021232 002 NITISINONE;ORFADIN 5006158 APR 09, 2008 5550165 AUG 27, 2013 021232 003 NITISINONE;ORFADIN 5006158 APR 09, 2008 5550165 AUG 27, 2013 020845 002 NITRIC OXIDE;INOMAX 5873359 JAN 23, 2013 U297 020845 003 NITRIC OXIDE;INOMAX 5873359 JAN 23, 2013 U297 020799 001 OFLOXACIN;FLOXIN D-84 SEP 30, 2006 019921 001 OFLOXACIN;OCUFLOX 4382892 SEP 02, 2003 ODE MAY 22, 2003 4551456 NOV 14, 2003 U80 PED NOV 22, 2003 4382892.*PED MAR 02, 2004 4551456*PED MAY 14, 20'04 U80 020592 001 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 020592 002 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 020592 003 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 020592 004 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 020592 005 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 020592 006 OLANZAPINE;ZYPREXA I-400 JUL 10, 2006 021286 002 OLMESARTAN MEDOXOMIL BENEVAS 5616599 APR 01, 2014 U500 021286 001 OLMESARTAN MEDOXOMIL BENICAR 5616599 APR 01, 2014 U500 021286 003 OLMESARTAN MEDOXOMIL BENICAR 5616599 APR 01, 2014 U500 021229 001 OMEPRAZOLE MAGNESIUM PRILOSEC OTC 4738974 APR 19, 2005 RTO JUN 20, 2006 5900424 MAY 04, 2016 4786505 APR 20, 2007 4853230 APR 20, 2007 5690960 NOV 25, 2014 5817338 OCT 06, 2015 5753265 JUN 07, 2015 6403616 NOV 15, 2019 6428810 NOV 03, 2019 4786505*PED OCT 20, 2007 4853230*PED OCT 20, 2007 020007 003 ONDANSETRON HYDROCHLORIDE;ZOFRAN PRESERVATIVE 4695578 JAN 25, 2005 4753789 JUN 24, 2006 U44 020766 001 ORLISTAT;XENICAL 4598089 JUN 18, 2009 NCE APR 23, 2004 6004996 JAN 06, 2018 PED OCT 23, 2004 >ADD> 4598089*PED DEC 18, 2009 M-29 DEC 12, 2006 ~ 6004996*PED JUL 06, 2018 PED JUN 12, 2007 020776 001 OXAPROZIN POTASSIUM;DAYPRO ALTA 6030643 MAY 16, 2017 U497 >ADD> 017577 001 OXYBUTYNIN CHLORIDE;DITROPAN M-28 APR 15, 2006 PED OCT 15, 2006 >ADD> 018211 001 OXYBUTYNIN CHLORIDE;DITROPAN M-28 APR 15, 2006 PED OCT 15, 2006 020897 001 OXYBUTYNIN CHLORIDE;DITROPAN XL NPP APR 15, 2006 PED OCT 15, 2006 020897 002 OXYBUTYNIN CHLORIDE;DITROPAN XL NPP APR 15,. 2006 PED OCT 15, 2006 020897 003 OXYBUTYNIN CHLORIDE;DITROPAN XL NPP APR 15, 2006 PED OCT 15, 2006 A-25 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021351 002 OXYBUTYNIN;OXYTROL 5164190 DEC 11, 2010 NDF FEB 26, 2006 5601839 APR 26, 2015 5834010 APR 26, 2015 021372 001 PALONOSETRON HYDROCHLORIDE;ALOXI 5202333 APR 13, 2010 U528 NCE JUL 25, 2008 020987 001 PANTOPRAZOLE SODIUM;PROTONIX 4758579 JUL 19, 2010 020987 002 PANTOPRAZOLE SODIUM;PROTONIX 4758579 JUL 19, 2010 020988 001 PANTOPRAZOLE SODIUM;PROTONIX IV 4758579 JUL 19, 2010 020819 001 PARICALCITOL;ZEMPLAR 5246925 APR 17, 2012 U314 5587497 DEC 24, 2013 6136799 APR 08, 2018 6361758 APR 08, 2018 DP 5246925*PED OCT 17, 2012 5587497*PED JUN 24, 2014 6136799*PED OCT 08, 2019 6361758*PED OCT 08, 2018 075356 001 PAROXETINE HYDROCHLORIDE;PAROXETINE HCL PC MAR 06, 2004 075356 002 PAROXETINE HYDROCHLORIDE;PAROXETINE HCL PC MAR 06, 2004 075356 003 PAROXETINE HYDROCHLORIDE;PAROXETINE HCL PC MAR 06, 2004 075356 004 PAROXETINE HYDROCHLORIDE;PAROXETINE HCL PC MAR 06, 2004 020936 001 PAROXETINE HYDROCHLORIDE;PAXIL CR 6548084 JUL 19, 2016 1-405 AUG 28, 2006 6548084*PED JAN 19, 2017 020936 002 PAROXETINE HYDROCHLORIDE;PAXIL CR 6548084 JUL 19, 2016 1-405 AUG 28, 2006 6548084*PED JAN 19, 2017 020936 003 PAROXETINE HYDROCHLORIDE;PAXIL CR 6548084 JUL 19, 2016 1-405 AUG 28, 2006 6548084*PED JAN 19, 2017 021299 001 PAROXETINE MESYLATE;PAROXETINE MESYLATE 5874447 JUN 10, 2017 U286 5874447 JUN 10, 2017 U518 5874447 JUN 10, 2017 U46 021299 002 PAROXETINE MESYLATE;PAROXETINE MESYLATE 5874447 JUN 10, 2017 U286 5874447 JUN 10, 2017 U518 587444.7 JUN 10, 2017 U46 021299 003 PAROXETINE MESYLATE;PAROXETINE MESYLATE 5874447 JUN 10, 2017 U286 5874447 JUN 10, 2017 U518 5874447 JUN 10, 2017 U46 021299 004 PAROXETINE MESYLATE;PAROXETINE MESYLATE 5874447 JUN 10, 2017 U286 5874447 JUN 10, 2017 U518 5874447 JUN 10, 2017 U46 021106 001 PEGVISOMANT;SOMAVERT 6057292 SEP 21, 2015 U507 NCE MAR 25, 2008 5849535 SEP 21, 2015 ODE MAR 25, 2010 5958879 SEP 27, 2011 U507 5350836 SEP 27, 2011 U507 5681809 SEP 27, 2011 U507 6583115 SEP 27, 2011 U507 021106 002 PEGVISOMANT;SOMAVERT 6057292 SEP 21, 2015 U507 NCE MAR 25, 2008 5849535 SEP 21, 2015 ODE MAR 25, 2010 5958879 SEP 27, 2011 U507 5350836 SEP 27, 2011 U507 5681809 SEP 27, 2011 U507 6583115 SEP 27, 2011 U507 021106 003 PEGVISOMANT;SOMAVERT 6057292 SEP 21, 2015 U507 NCE MAR 25, 2008 5849535 SEP 21, 2015 ODE MAR 25, 2010 5958879 SEP 27, 2011 U507 5350836 SEP 27, 2011 U507 5681809 SEP 27, 2011 U507 6583115 SEP 27, 2011 U507 A-26 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
020629 001 PENCICLOVIR SODIUM;DENAVIR 6469015 OCT 22, 2019 U501 NPP OCT 10, 2006 6573378 SEP 24, 2010 6579981 JUN 17, 2020 U501 076061 001 PERGOLIDE MESYLATE;PERGOLIDE MESYLATE PC MAY 31, 2003 076061 002 PERGOLIDE MESYLATE;PERGOLIDE MESYLATE PC MAY 31, 2003 076061 003 PERGOLIDE MESYLATE;PERGOLIDE MESYLATE PC MAY 31, 2003 020184 001 PERINDOPRIL ERBUMINE;ACEON 5162362 NOV 10, 2009 DS DP U531 020184 002 PERINDOPRIL ERBUMINE;ACEON 5162362 NOV 10, 2009 DS DP U531 020184 003 PERINDOPRIL ERBUMINE;ACEON 5162362 NOV 10, 2009 DS DP U531 021073 001 PIOGLITAZONE HYDROCHLORIDE;ACTOS 4687777 JAN 17, 2011 021073 002 PIOGLITAZONE HYDROCHLORIDE;ACTOS 4687777 JAN 17, 2011 021073 003 PIOGLITAZONE HYDROCHLORIDE;ACTOS 4687777 JAN 17, 2011 6150384 JUN 19, 2016 U419 020451 001 PORFIMER SODIUM;PHOTOFRIN I-391 AUG 01, 2006 ODE AUG 01, 2010 074726 003 POTASSIUM CHLORIDE;KLOR-CON M15 PC DEC 24, 2003 021416 001 PROPAFENONE HYDROCHLORIDE;RYTHMOL SR 5681588 OCT 28, 2014 NDF SEP 04, 2006 021416 002 PROPAFENONE HYDROCHLORIDE;RYTHMOL SR 5681588 OCT 28, 2014 NDF SEP 04, 2006 021416 003 PROPAFENONE HYDROCHLORIDE;RYTHMOL SR 5681588 OCT 28, 2014 NDF SEP 04, 2006 021438 001 PROPRANOLOL HYDROCHLORIDE;INNOPRAN XL 6500454 DEC 31, 2022 NP MAR 12, 2006 021438 002 PROPRANOLOL HYDROCHLORIDE;INNOPRAN XL 6500454 DEC 31, 2022 NP MAR 12, 2006 020973 001 RABEPRAZOLE SODIUM;ACIPHEX 5045552 MAY 08, 2013 U385 020973 002 RABEPRAZOLE SODIUM;ACIPHEX 5045552 MAY 08, 2013 U385 019901 001 RAMIPRIL;ALTACE 5403856 APR 04, 2012 U7l 019901 002 RAMIPRIL;ALTACE 5403856 APR 04, 2012 U7l 019901 003 RAMIPRIL;ALTACE 5403856 APR 04, 2012 U7l 019901 004 RAMIPRIL;ALTACE 5403856 APR 04, 2012 U7l 020903 001 RIBAVIRIN;REBETOL 6524570 NOV 01, 2016 U499 M-26 MAR 06, 2005 6524570*PED MAY 01, 2017 U499 ODE JUL 29, 2010 PED JAN 29, 2011 020903 002 RIBAVIRIN;REBETOL M-26 MAR 06, 2005 ODE JUL 29, 2010 PED JAN 29, 2011 021546 001 RIBAVIRIN;REBETOL 6472373 SEP 21, 2017 U521 NDF JUL 29, 2006 6472373*PED MAR 21, 2018 U521 PED JAN 29, 2007 6461605 NOV 01, 2016 U521 ODE JUL 29, 2010 6461605*PED MAY 01, 2017 U521 PED JAN 29, 2011 6172046 SEP 21, 2017 U521 6172046*PED MAR 21, 2018 U521 6063772 JAN 23, 2016 U521 6063772*PED JUL 23, 2016 U521 5767097 JAN 23, 2016 U521 5767097*PED JUL 23, 2016 U521 020835 001 RISEDRONATE SODIUM ACTONEL 6096342 NOV 22, 2011 020835 002 RISEDRONATE SODIUM ACTONEL 6096342 NOV 22, 2011 020835 003 RISEDRONATE SODIUM ACTONEL 5583122 DEC 10, 2013 U222 6096342 NOV 22, 2011 6165513 JUN 10, 2018 >ADD> 020272 001 RISPERIDONE;RISPERDAL I-412 DEC 04, 2006 >ADD> I-413 DEC 04, 2006 A-27 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
>ADD> 020272 002 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 >ADD> 020272 003 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 >Ai5D'> 020272 004 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 >ADD> 020272 005 RISPERIDONE;RISPERDAL 1-412 DEC 04. 2006 >ADD> 1-413 DEC 04, 2006 >ADD> 020272 007 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 >ADD> 020272 008 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 >ADD> 020588 001 RISPERIDONE;RISPERDAL 1-412 DEC 04, 2006 >ADD> 1-413 DEC 04, 2006 02144..4 001 RISPERIDONE;RISPERDAL 4804663 DEC 29, 2007 U516 M-15 MAR 03, 2005 >ADD> 5648093 JUL 15. 2014 1-412 DEC 04, 2006 >ADD> 6224905 JUN 10, 2017 U516 1-413 DEC 04, 2006 021444 002 RISPERIDONE;RISPERDAL 4804663 DEC 29, 2007 U516 M-15 MAR 03, 2005 >ADD> 5648093 JUL 15, 2014 1-412 DEC 04, 2006 >ADD> 6224905 JUN 10, 2017 U516 1-413 DEC 04, 2006 021444 003 RISPERIDONE;RISPERDAL 4804663 DEC 29, 2007 M-15 MAR 03, 2005 >ADD> 5648093 JUL 15, 2014 1-412 DEC 04, 2006 >ADD> 6224905 JUN 10, 2017 U516 1-413 DEC 04, 2006 U516 >ADD> 021346 001 RISPERIDONE;RISPERDAL CONSTA 6544559 NOV 19, 2013 NDF OCT 29, 2006 >ADD> 6368632 NOV 19, 2013 U543 >ADD> 6403114 MAY 02, 2017 4804663 DEC 29, 2007 5688801 NOV 18, 2014 5770231 NOV 19, 2013 5965168 NOV 19, 2013 6110921 NOV 19, 2013 5792477 MAY 02, 2017 5916598 MAY 02, 2017 6110503 MAY 02, 2017 6194006 DEC 30, 2018 6264987 MAY 19, 2020 6596316 DEC 30, 2008 DP 6379703 DEC 30, 2018 DP 6379704 MAY 19, 2020 DP 6534092 MAY 19, 2020 DP >ADD> 021346 002 RISPERIDONE;RISPERDAL CONSTA 6544559 NOV 19, 2013 NDF OCT 29, 2006 >ADD> 6368632 NOV 19, 2013 U543 >ADD> 6403114 MAY 02, 2017 4804663 DEC 29, 2007 5688801 NOV 18, 2014 5770231 NOV 19, 2013 5965168 NOV 19, 2013 6110921 NOV 19, 2013 5792477 MAY 02, 2017 5916598 MAY 02, 2017 6110503 MAY 02, 2017 6194006 DEC 30, 2018 6264987 MAY 19, 2020 6596316 DEC 30, 2008 DP 63797(}3 DEC 30, 2018 DP A-28 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
6379704 MAY 19, 2020 DP 6534092 MAY 19, 2020 DP >ADD> 021346 003 RISPERIDONE;RISPERDAL CONSTA 6544559 NOV 19, 2013 NDF OCT 29, 2006 >ADD> 6368632 NOV 19, 2013 U543 >ADD> 6403114 MAY 02, 2017 4804663 DEC 29, 2007 5688801 NOV 18, 2014 5770231 NOV 19, 2013 5965168 NOV 19, 2013 6110921 NOV 19, 2013 5792477 MAY 02, 2017 5916598 MAY 02, 2017 6110503 MAY 02, 2017 6194006 DEC 30, 2018 6264987 MAY 19, 2020 6596316 DEC 30, 2008 DP 6379703 DEC 30, 2018 DP 6379704 MAY 19, 2020 DP 6534092 MAY 19, 2020 DP 021042 001 ROFECOXIB;VIOXX M-27 AUG 06, 2006 021042 002 ROFECOXIB;VIOXX M-27 AUG 06, 2006 021042 003 ROFECOXIB;VIOXX M-27 AUG 06, 2006 021052 001 ROFECOXIB.; VIOXX M-27 AUG 06, 2006 021,052 002 ROFECOXIB;VIOXX M-27 AUG 06, 2006 020658 006 ROPINIROLE HYDROCHLORIDE;REQUIP 4824860 MAY 19, 2008 020658 007 ROPINIROLEHYDROCHLORIDE;REQUIP 4824860 MAY 19, 2008 >ADD> 020533 001 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NAROPIN 4870086 SEP 24, 2010 >ADD> 020533 003 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NAROPIN 4870086 SEP 24, 2010 >ADD> 020533 004 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NAROPIN 4870086 SEP 24, 2010 >ADD> 020533 005 ROPIVACAINE HYDROCHLORIDE MONOHYDRATE NAROPIN 4870086 SEP 24, 2010 021071 002 ROSIGLITAZONE MALE1:\TE;AVANDIA 1-384 FEB 27, 2006 021071 003 ROSIGLITAZONE MALEATE;AVANDIA 1-384 FEB 27, 2006 021071 004 ROSIGLITAZONE MALEATE;AVANDIA 1-384 FEB 27, 2006 021366 002 ROSUVASTATIN CALCIUM;CRESTOR RE37314 JUN 12, 2012 NCE AUG 12, 2008 6589959 DEC 23, 2019 6316460 AUG 04, 2020 021366 003 ROSUVASTATIN CALCIUM;CRESTOR RE37314 JUN 12, 2012 NCE AUG 12, 2008 6589959 DEC 23, 2019 6316460 AUG 04, 2020 021366 004 ROSUVASTATIN CALCIUM;CRESTOR RE37314 JUN 12, 2012 NCE AUG 12, 2008 6589959 DEC 23, 2019 6316460 AUG 04, 2020 021366 005 ROSUVASTATIN CALCIUM;CRESTOR RE37314 JUN 12, 2012 NCE AUG 12, 2008 6589959 DEC 23, 2019 6316460 AUG 04, 2020 019414 001 RUBIDIUM CHLORIDE RB-82;CARDIOGEN-82 4562829 MAY 01, 2004 U503 02.1136 001 SECRETIN;SECREFLO NP APR 04, 2005 ODE APR 04, 2009 1-408 NOV 01, 2005 >ADD> 021385 001 SERTACONAZOLE NITRATE;ERTACZO NCE DEC 10, 2008 A-29 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
0.19839 001 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 019839 002 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 019839 003 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 019839 004 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 019839 005 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 020990 001 SERTRALINE HYDROCHLORIDE;ZOLOFT 1-261 FEB 07, 2006 020926 001 .SEVELAMER HYDROCHLORIDE RENAGEL 6509013 AUG 13, 2013 021179 001 SEVE LAMER HYDROCHLORIDE RENAGEL 6509013. AUG 13, 2013 021179 002 SEVE LAMER HYDROCHLORIDE RENAGEL 6509013 AUG 13, 2013 019766 001 SIMVASTATIN;ZOCOR 1-390 APR 16, 2006 019766 002 SIMVASTATIN;ZOCOR 1":390 APR 16, 2006 019766 003 SIMVASTATIN;ZOCOR 1-390 APR 16, 2006 019766 004 SIMVASTATIN;ZOCOR 1-390 APR 16, 2006 019766 005 SIMVASTATIN;ZOCOR 1-390 APR 16, 2006 02108.3 001 SIROLIMUS;RAPAMUNE 1-386 APR 11, 2006 021110 001 SIROLIMUS;RAPAMUNE 1-386 APR 11, 2006 021110 002 SIROLIMUS;RAPAMUNE 5100899 JUN 06, 2009 U290 NCE SEP 15, 2004 5212155 MAY 18, 2010 U291 1-386 APR 11, 2006 5308847 MAY 03, 2011 U292 5403833 APR 04, 2012 U293 5989591 MAR 11, 2018 >ADD> 020231 001 SODIUM FLUORIDE;COLGATE TOTAL 4894220 JAN 16, 2007 DP ;ADo;" 5037635 JAN 16, 2007 DP >ADD> 5156835 OCT 20, 2009 DP >ADD> 5538715 JAN 16, 2007 DP >ADD> 5776435 JAN 16, 2007 DP >ADD> 5344641 MAR 09, 2010 DP 5288480 JUL 16, 2008 020280 007 SOMATROPIN RECOMBINANT;GENOTROPIN ODE OCT 31, 2004 020280 001 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 002 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 003 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 005 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 008 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 009 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 010 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 011 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 0202-80 012 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 020280 013 SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT ODE OCT 31, 2004 019640 001 SOMATROPIN RECOMBINANT;HUMATROPE 1-398 JUL 25, 2006 019640 004 SOMATROPIN RECOMBINANT;HUMATROPE 1-398 JUL 25, 2006 019640 005 SOMATROPIN RECOMBINANT;HUMATROPE 1-398 JUL 25, 2006 019640 006 SOMATROPIN RECOMBINANT;HUMATROPE 1-398 JUL 25, 2006 019640 007 SOMATROPIN RECOMBINANT;HUMATROPE 1-398 JUL 25, 2006 021148 001 SOMATROPIN RECOMBINANT;NORDITROPIN 5633352 MAY 27, 2014 5849700 DEC 15, 2015 U340 5849704 DEC 15, 2015 021148 002 SOMATROPIN RECOMBINANT;NORDITROPIN 5633352 MAY 27, 2014 5849700 DEC 15, 2015 U340 5849704 DEC 15, 2015 A-30 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021148 003 SOMATROPIN RECOMBINANT;NORDITROPIN 5633352 MAY 27, 2014 5849700 DEC 15, 2015 U340 5849704 DEC 15, 2015 >ADD> 021597 001 SOMATROPIN;ZORBTIVE NP DEC 01, 2006 >ADD> ODE DEC 01, 2010 >ADD> 021597 002 SOMATROPIN;ZORBTIVE NP DEC 01, 2006 >ADD> ODE DEC 01, 2010 >ADD> 021597 003 SOMATROPIN;ZORBTIVE NP DEC 01, 2006 >ADD> ODE DEC 01, 2010 >ADD> 021597 004 SOMATROPIN;ZORBTIVE NP DEC 01, 2006 >ADD> ODE DEC 01, 2010 021151 005 SOTALOL HYDROCHLORIDE;BETAPACE AF NP FEB 22, 2003 PED AUG 22, 2003 021151 006 SOTALOL HYDROCHLORIDE;BETAPACE AF NP FEB 22, 2003 PED AUG 22, 2003 021151 007 SOTALOL HYDROCHLORIDE;BETAPACEAF NP FEB 22, 2003 PED AUG 22, 2003 020413 001 STAVUDINE;ZERIT 4978655 JUN 24, 2008 4978655*PED DEC 24, 2008 021453 001 STAVUDINE;ZERIT XR 4978655 JUN 24, 2008 U248 NDF DEC 31, 2005 4978655*PED DEC 24, 2008 U248 PED JUL 01, 2006 021453 002 STAVUDINE;ZERIT XR 4978655 JUN 24, 2008 U248 NDF DEC 31, 2005 4978€i55*PED DEC 24, 2008 U248 PED JUL 01, 2006 021453 003 STAVUDINE;ZERIT XR 4978655 JUN 24, 2008 U248 NDF DEC 31, 2005 4978655*PED DEC 24, 2008 U248 PED JUL 01, 2006 021453 004 STAVUDINE;ZERIT XR 4978655 JUN 24, 2008 U248 NDF DEC 31, 2005 4978655*PED DEC 24, 2008 U248 PED JUL 01, 2006 >ADD> 021368 001 TADALAFIL;CIALIS NCE NOV 21, 2008 >ADD> 021368 002 TADALAFIL;CIALIS NCE NOV 21, 2008 >ADD> 021368 003 TADALAFIL; CIALIS NCE NOV 21, 2008 020600 001 TAZAROTENE;TAZORAC 5914334 JUN 07, 2014 U517 6258830 JUN 07, 2014 U517 020600 002 TAZAROTENE;TAZORAC 5914334 JUN 07, 2014 U517 6258830 JUN 07, 2014 U517 020372 001 TECHNETIUM TC-99M TETROFOSMIN KIT;MYOVIEW I-396 FEB 28, 2006 020850 001 TELMISARTAN;MICARDIS 6358986 JAN 10, 2020 020850 002 TELMISARTAN;MICARDIS 6358986 JAN 10, 2020 020850 003 TELMISARTAN;MICARDIS 5591762· JAN 07, 2014 U3 NCE NOV 10, 2003 6358986 JAN 10, 2020 021356 001 TENOFOVIR DISOPROXIL FUMARATE;VIREAD NPP AUG 15, 2006 020749 001 TERBINAFINE HYDROCHLORIDE;LAMISIL 6121314 MAY 18, 2012 U502 021124 001 TERBINAFINEHYDROCHLORIDE;LAMISIL AT 6121314 MAY 18, 2012 U504 020489 001 TESTOSTERONE;ANDRODERM 4863970 NOV 14, 2006 4983395 NOV 12, 2007 5152997 DEC 11, 2010 U490 5164190 DEC 11, 2010 4849224 NOV 12, 2007 4855294 SEP 06, 2008 020489 Q02 TESTOSTERONE;ANDRODERM 4849224 NOV 12, 2007 4855294 SEP 06, 2008 4863970 NOV 14,2006 498339·5 NOV 12, 2007 5152997 DEC 11, 2010 U490 5164190 DEC 11, 2010 A-31 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021543 001 TESTOSTERONE;STRIANT 46'15697 OCT 07, 2003 NP JON 19, 2006 6248358 AUG 23, 2019 U527 021454 001 TESTOSTERONE;TESTIM NP OCT 31, 2005 020785 001 THALIDOMIDE;THALOMID 6561977 OCT 23, 2020 U371 6561976 AUG 28, 2018 U371 020785 0·02 THALIDOMIDE;THALOMID 6045501 AUG 28, 2018 U371 ODE JUL 16, 2005 6315720 OCT 23, 2020 U442 NCE JUL 16, 2003 6561977 OCT 23, 2020 U371 6561976 AUG 28, 2018 U371 020785 003 THALIDOMIDE;THALOMID 6045501 AUG 28, 2018 U371 ODE JUL 16, 2005 6315720 OCT 23, 2020 U442 NCE JUL 16, 2003 6561977 OCT 23, 2020 U371 6561976 AUG 28, 2018 U371 >ADD> 020771 001 TOLTERODINE TARTRATE;DETROL 5382600 MAR 25, 2012 >ADD> 5559269 NOV 05, 2013 U318 ;ADri"; 5382600*PED SEP 25, 2012 >ADD> 5559269*PED MAY 05, 2014 >ADD> 020771 002 TOLTERODINE TARTRATE;DETROL 5382600 MAR 25, 2012 >ADD> 5559269 NOV 05, i013 U318 >ADD> 5382600*PED SEP 25, 2012 ;ADri"; 5550269*PED MAY 05, 2014 >ADD> 021228 001 TOLTERODINE TARTRATE;DETROL LA 5382600 MAR 25, 2012 NDF DEC 22, 2003 >ADD> 5559269 NOV 05, 2013 U318 PED JON 22, 2004 >ADD> 5382600*PED SEP 25, 2012 >ADD> 5559269*PED MAY 05, 2014 >ADD> 6630162 NOV 11, 2019 DP U544 >ADD> 6630162*PED MAY 11, 2020 >ADD> 021228 002 TOLTERODINE TARTRATE;DETROL LA 5382600 MAR 25, 2012 NDF DEC 22, 2003 >ADD> 5559269 NOV 05,'2013 U318 PED JON 22, 2004 >ADD> 5382600*PED SEP 25, 2012 >ADD> 5559269*PED MAY 05, 2014 ;ADri"; 6630162 NOV 11, 2019 DP U544 >ADD> 6630162*PED MAY 11, 2020 020505 001 TOPIRAMATE;TOPAMAX 4513006 SEP 26,' 2004 020505 002 TOP I RAMATE'i TOPAMAX 4513006 SEP 26, 2004 020505 003 TOPIRAMATE;TOPAMAX 4513006 SEP 26, 2004 020505 004 TOPIRAMATEiTOPAMAX 4513006 SEP 26, 2004 020505 005 TOPIRAMATE;TOPAMAX 4513006 SEP 26, 2004 020505 006 TOPIRAMATE;TOPAMAX 4513006 SEP 26, 2004 020844 001 TOPIRAMATEiTOPAMAX SPRINKLE 4513006 SEP 26, 2004 020844 002 TOPIRAMATEiTOPAMAX SPRINKLE 4513006 SEP 26, 2004 020844 003 TOPIRAMATEiTOPAMAX SPRINKLE 4513006 SEP 26, 2004 021257 001 TRAVOPROSTi~RAVATAN M-23 FEB 13, 2006 021108 001 TRETINOINiRENOVA 6531141 MAR 07, 2020 >ADD> 020487 001 VALACYCLOVIR HYDROCHLORI-DE;VALTREX 4957924 JON 23, 2009 U530 D-67 JON 25, 2004 ;ADri"; 5879706 JAN 19, 2016 U530 1-381 SEP 09, 2005 ;ADri"; 61.07302 JAN 19, 2016 U530 1-403 AUG 29, 2006 >ADD> 1-389 APR 01, 2006 >ADD> 020487 002 VALACYCLOVIR HYDROCHLORIDEiVALTREX 5879706 JAN 19, 2016 U530 D-67 JON 25, 2004 >ADD> 6107302 JAN 19, 2016 U530 1-381 SEP 09, 2005 >ADD> 4957924 JON 23, 2009 U530 1-403 AUG 29, 2006 >ADD> 1-389 APR 01, 2006 A-32 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021304 001 VALGANCICLOVIR HYDROCHLORIDE;VALCYTE 1-406 SEP 12, 2006 021400 001 VARDENAFIL HYDROCHLORIDE;LEVITRA 6362178 OCT 31, 2018 DS DP U533 NCE AUG 19, 2008 021400 002 VARDENAFIL HYDROCHLORIDE;LEVITRA 6362178 OCT 31, 2018 DS DP U533 NCE AUG 19, 2008 021400 003 VARDENAFIL HYDROCHLORIDE;LEVITRA 6362178 OCT 31, 20i8 DS DP U533 NCE AUG '19, 2008 021400 004 VARDENAFIL HYDROCHLORIDE;LEVITRA 6362178 OCT 31, 2018 DS DP U533 NCE AUG 19, 2008 020699 001 VENLAFAXINE HYDRbCHLORIDE;EFFEXOR XR 6444708 JUN 28, 2013 U398 1-261 FEB 11, 2006 64'44708*PED DEC 28, 2013 U398 6419958 MAR 20, 2017' U535 6419958*PED SEP 20, 2017 U535 6403120 MAR 20, 2017 U535 6403120*PED SEP 20, 2017 U535 020699 002 VENLAFAXINE HYDROCHLORIDE;EFFEXOR XR 6444708 JON 28, 2013 U398 1-261 FEB 11, 2006 6444708*PED DEC 28, 2013 U398 64i9958 MAR 20, 2017 U535 6419958*PED SEP 20, 2017 U535 6403120 MAR 20, 2017 U535 6403120*PED SEP 20, 2017 U535 020699 003 VENLAFAXINE HYDROCHLORIDE;EFFEXOR XR 6444708 JON 28, 2013 U398 1-261 FEB 11, 2006 6444708*PED DEC 28, 2013 U398 6419958 MAR 20, 2017 U535 6419958*PED SEP 20, 2017 U535 6403120 MAR 20, 2017 U535 6403120*PED SEP 20, 2017 U535 020699 004 VENLAFAXINE HYDROCHLORIDE;EFFEXORXR 6444708 JON 28, 2013 U398 1-261 FEB 11, 2006 6444708*PED DEC 28, 2013 U398 6419958 MAR 20, 2017 U535 6419958*PED SEP 20, 2017 U535 6403120 MAR 20, 2017 U535 6403120*PED SEP 20, 20i7 U535 020552 001 VERAPAMIL,HYDROCHLORIDE;COVERA-HS 4612008 SEP 16, 2003 6146662 AUG 14, 2007 U366 020552 002 VERAPAMIL, HYDROCHLORIDE;COVERA-HS 4612008 SEP 16, 2003 6146662 AUG 14, 2007 U366 021266 001 VORICONAZOLE;VFEND 5116844 AUG 11, 2009 DP U540 1-409 NOV 14, 2006 5364938 NOV 15, 2011 DS 5567817- OCT 22, 2013 DS DP U540 5773443 JAN 25, 2011 DS DP U540 021266 002 VORICONAZOLE;VFEND 5116844 AUG 11, 2009 DP U540 1-409 NOV 14, 2006 5364938 NOV 15, 2011 DS 5567817 OCT 22, 2013 DS DP U540 5773443 JAN 25, 2011 DS DP U540 021267 001 VORICONAZOLE;VFEND 5773443 JAN 25, 2011 DS DP U540 1-409 NOV 14, 2006 5116844 AUG 11, 2009 DP U540 5364938 NOV 15, 2011 DS 5567817 OCT 22, 2013 DS DP U540 6632803 JON 02, 2018 DP , 5376645 JAN 23, 2010 DP 5134127 JAN 23, 2010 DP 020859 001 ZALEPLON;SONATA 4626538 JON 06, 2008 020859 002 ZALEPLON;SONATA 4626538 JON 06, 2008 A-33 PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY DATA See report footnotes for information regarding report content
APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT/PED EXCL PATENT EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE(S) CODE EXPIRES
021223 002 ZOLEDRONIC ACID;ZOMETA 4777163 JUL 24, 2007 NCE AUG 20, 2006 4939130 NOV 13, 2007 U53 I-361 FEB 22, 2005 ODE AUG 20, 2008 >ADD> 020768 001 ZOLMITRIPTAN;ZOMIG 5466699*PED MAY 14, 2013 >ADD> 5863935*PED MAY 14, 2013 >ADD> 5466699 NOV 14, 2012 ~ 5863935 NOV 14, 2012 >ADD> 020768 002 ZOLMITRIPTAN;ZOMIG 5466699*PED MAY 14, 2013 >ADD> 5863935*PED MAY 14, 2013 >ADD> 5466699 NOV 14, 2012 >ADD> 5863935 NOV 14, 2012 >ADD> 021450 004 ZOLMITRIPTAN; ZOM.IG 5466699*PED MAY 14, 2013 NDF SEP 26, 2006 >ADD> 5466699 NOV 14, 2012 U436 PED MAR 26, 2007 >ADD> 021231 001 ZOLMITRI PTAN ; .ZOMIG- ZMT 5466699*PED MAY 14, 2013 NDF FEB 13, 2004 >ADD> 5466699 NOV 14, 2012 PED AUG 13, 2004 >ADD> 021231 002 ZOLMITRIPTAN;ZOMIG-ZMT 5466699*PED MAY 14, 2013 NDF FEB 13, 2004 >ADD> 5466699 NOV 14, 2012 PED AUG 13, 2004 020789 002 ZONISAMIDE;ZONEGRAN NCE MAR 27, 2005 020789 003 ZONISAMIDE;ZONEGRAN NCE MAR 27, 2005
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(c) (3) (5).
2. Patents submitted on FDA Form 3542 and listed after August 18, 2003 will have one to three patent codes indicating specific patent claims as submitted by the sponsor: DS = Drug Substance claim DP = Drug Product claim U and number = Method of Use claim (may be multiple). Specific Method of use claims are listed at http://www.fda.gov/cder/orange/patex.htm
3. 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.
4. *PED and PED represent pediatric exclusivity. Patents with pediatric exclusivity granted after August 18, 2003 will be indicated with *PED as was done prior to August 18, 2003. Patents with *PED added after August 18, 2003 will not contain any information relative to the patent itself other than the *PED extension. Information·related specifically to the patent will be conveyed on the original patent only.
B-1
PATENT AND EXCLUSIVITY TERMS
DUE TO SPACE LIMITATIONS IN THE PATENT AND EXCLUSIVITY COLUMNS, ABBREVIATIONS AND REFERENCES HAVE BEEN DEVELOPED. PLEASE REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 23RD EDITION FOR A FULL LISTING OF PATENT AND EXCLUSIVITY TERMS (ABBREVIATIONS, NEW DOSING SCHEDULE, NEW INDICATIONS AND PATENT USE CODES). THE CUMULATIVE SUPPLEMENT WILL LIST NEW CODES ADDED SINCE THE LAST ANNUAL EDITION.
PATENT & EXCLUSIVITY ABBREVIATIONS
RTO RX TO OTC SWITCH OR OTC USE
EXCLUSIVITY DOSING SCHEDULE
D-78 USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL, MUSCULOSKELETAL CONDITIONS D-79 NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ANDIOR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WI THE MENOPAUSE D-80 CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY DOSING D-81 NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS D-82 USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS D-83 750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP) D-84 ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS(AGES 6 MO & OLDER) WI OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF E.COLl, P.AERUGINOSA AND S.AUREUS
EXCLUSIVITY INDICATION
1-380 TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR EMERGENT SUICIDAL BEHAVIOR 1-381 TREATMENT OF COLD SORES (HERPES LABIALlS) IN ADULT AND ADOLESCENT PATIENTS 12 YEARS OF AGE AND OLDE:R . 1-382 FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY AND RADIATION 1-383 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY 1-384 USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES 1-385 MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD "INCLUDING PENICILLIN-RESISTANT STRAINS, MIC PENICILLlN>=2MCG/ML" TO STREPTOCOCCUS PNEUMONIAE 1-386 RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION 1-387 ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL TO 2 YEARS OF AGE 1-388 TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION 1-389 SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS 1-390 USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART DISEASE, DIABETES, PERIPHERAL VESSEL DISEASE, STROKE HISTORY, OTHER CV DISEASE TO REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH, REDUCE NONFATAL MI & STROKE. .... 1-391 INTENTIONALLY LEFT BLANK 1-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLTOR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL 1-393 CHRONIC BACTERIAL PROSTATITIS B-2 1-394 USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING CORONARY REVASCULARIZATION PROCEDURES 1-395 TO IMPROVE PHYSICAL FUNCTION
1-396 EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS BEING EVALUATED FOR HEART DISEASE ANDIOR VENTRICULAR FUNCTION 1-397 EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY 1-398 IDIOPATHIC SHORT STATURE 1-399 TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS 1-400 USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER 1-401 LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA 1-402 DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS 1-403 USE OF VAL TREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE RISK OF TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE PARTNER IN A HETEROSEXUAL COUPLE 1-404 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY 1-405 TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING REGIMEN 1-406 PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY,HEART, AND KIDNEY-PANCREAS TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE) 1-407 IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (EJECTION FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER AN ACUTE MYOCARDIAL INFARCTION 1-408 STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE AMPULLA OF VATER AND ACCESSORY PAPILL.A DURING ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP) 1-409 ESOPHAGEAL CANDIDIASIS . 1-410 USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COP D) ASSOCIATED WITH CHRONIC BRONCHITIS 1-411 EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE THIAZOLIDINEDIONE CLASS 1-412 MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER 1-413 ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER 1-414 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM (PE) IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS 1-415 SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDSTHE RISK OF INITIATING COMBINATION THERAPY . 1-416 THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED PYELONEPHRITIS
EXCLUSIVITY MISCELLANEOUS
M-23 INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT . M-24 INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY INFORMATION .. M-25 ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE ADDED TO PKG INSERT M-26 INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE REBETOL PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION WITH REBETOL FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01 M-27 INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY M-28 INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL CONDITION M-29 LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN ADOLESCENTS AGED 12 TO 16 YEARS B-3
PATENT USE
U-494 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER U-49S PERITONEAL DIALYSIS SOLUTION U-496 METHOD FOR TREATING CHRONIC RENAL FAILURE U-497 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS U-498 INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST . ' ; . U-499 METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-INTRON POWDER FOR INJECTION . U-SOO USE AS AN ANTIHYPERTENSIVE AGENT U-S01 TREATMENT OF RECURRENT HERPES LABIALlS(COLD SORES) IN ADUl-is ' U-S02 PITYRIASIS VERSICOLOR U-S03 GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH GENERATOR U-S04 TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS U-SOS ULTRASOUND CONTRAST AGENT . U-S06 PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER PHARM ACTIVE AGENT COMPRISING ACETYLCHOLINE, BUFFER IN 1ST CHAM IS SUFFICIENT TO BUFFER PH OF MIXED SOL RESULTING MixTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE .. U-S07 ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY AND/OR MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE U-S08 METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN FOR AT LEASTTHREE WEEKS U-S09 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEIOUS T-CELL LYMPHOMAIN PATIENTS WHO ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY U-S10 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES OR WHO HAVE NOT TOLERATED OTHER THERAPIES U-S11 USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC, BACTERIA U-S12 USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA U-S13 METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA U-S14 PREVENTION OF OVULATION IN A WOMAN U-S1S TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY U-S16 METHOD OF TREATING A PSYCHOTIC DISEASE U-S17 STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS U-S18 OBSESSIVE COMPULSIVE DISORDER U-S19 POSTOPERATIVE NAUSEA AND VOMITING U-S20 PREMENOPAUSAL OSTEOPOROSIS U-S21 METHOD OF USING ,RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C U-S22 TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE OLIGONUCLEOTIDE OAPABLE OF HYBRIDIZING WITH CMV MRNA U-S23 METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED U-S24 METHOD OF TREATING DIARRHEA U-S2S METHOD OF TREATING PARASITIC INFECTIONS U-S26 METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED RELEASE COMPOSITION U-S27 METHOD, OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE U-S28 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING U-S29 ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE U-S30 TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES, SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES U-S31 TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN WITH OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES U-S32 TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE BRONCHO DILATOR U-S33 ERECTILE DYSFUNCTION U-S34 HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA U-S3S TREATMENT OF SOCIAL ANXIETY DISORDER U-S36 CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING, U-S37 TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND B-4 CARDIAC INSUFFICIENCY, WITH EPLER EN ONE U-538 FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE ENOUGH THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY IN THESE PATIENTS U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE U-540 TREATMENT OF FUNGAL INFECTIONS U-541 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1 U-542 METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION U-543 TREATMENT OF SCHIZOPHRENIA U-544 TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE U-545 METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS MYOCARDIAL INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS THROMBOSIS IN A POSTOPERATIVE HUMAN PATIENT