m CUMULATIVE SUPPLEMENT i 2 JAH~ 88·DEC~ 88

APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

8TH EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF MANAGEMENT SUBSCRIBE NOW! Available in March 1989 New 9th Edition

APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

9 TH EDITION i989

CONTENTS

• Prescription Drug Product List • OTe Drug Product List • List of Drug Products Approved Under Section 505 of the Act by the Division of Blood and Blood Products • Discontinued Drug Product List • Orphan Drug Products with Exclusive Approval • Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution • Biopharmaceutic Guidance Availability • ANDA Suitability Petitions • Patent and Exclusivity Information

See Subscription Form Inside Back Cover APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 8TH EDITION

CUMULATIVE SUPPLEMENT 12 DECEMBER 1988

CONTENTS

PAGE

1.0 INTRODUCTION iii 1.1 How to Use the Cumulative Supplement iii 1.2 Products Requiring Revised Labeling for Full Approval v 1.3 Applicant (Name) Changes v -1-o4·---l:f"ra-z-odofle~·Hyd-roetr"'o-rtde· "... "...... -"-~~-~.-..y.i-..-~_ 1.5 Report of Counts for the Prescription Orug Product List vii

2.0 DRUG PRODUCT LISTS 2.1 Prescription Drug Product List 1 2.2 OTC Drug Product List 64 2.3 _U,t ~ nrug Products in the Division of B1ooe! and Blood Products Approved Under Section 505 of the Act).,. d.--t:;" 66 2.4 Orphan Oru~ Products with Exclusive Approval (:'7 2.5 Drug Products Which Must Demonstrate in vivo 9ioavai1ability Only if Product Fails to Achieve Ac1equate nissolution 72 2.6 Biopharmaceutic Guidance Availability 73 2.7 ANnA Suitability Petitions 7~

PATENT AND EXCLlJS I V lTV I NFOR~1.1\ TI ON AonE~ourl A. Exclusivity Terlils 8. Patent and Exclusivity Lists

APPROVED DRUG PRODUCTS with

THERAPEUTIC EQUIVALENCE EVALUATIONS

8th EDITION

CUMULATIVE SUPPLEMENT 12

DECEMBER 1988

1.0 INTRODUCTION

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT This Cumulative Supplement is one of a series of monthly updates to the AaProved Dlu g Products with Therapeutic Equivalence Evaluations, 8th E ition (t e List). The""""'Llst is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations, over-the-counter (OTC) drug products that require approved appl ications as a condition of marketing, drug products in the Division of Blood and Blood Products approved under Section 505 of the Act, anrl products discontinued from marketing or products which have had their approval 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 con­ tains appropriate drug patent and exclusivity information required of the Agency by the IIDrug Price Competition and Patent Term Restoration Act of 1984 11 for the Prescription, OTC, and Drug Products in the Division of Blood and Blood Products Approved Under Section 505 of the Act lists. The Patent and Exclusivity Lists are arranged in alphahetica1 order by active ingredient name. For those products with multiple active ingre­ dients, 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, along with the application number and product number (FDA's internal file number). All patents with their expiration dates are displayed for each application number. lise patents are indicated with the symbol IIU II followed by a number representing a specific use. Exclusivity information for a specific drug is indicaterl by an abbreviation followed by the date upon which the exclusivity expires. Refer to the Exclusivity Terms section in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations.

iii 1 Because all parts of the publ ication are subject to changes, additions, or del etions, the List must be used in conjunction with the most current Cumulative Supplement. Users may wish to place an asterisk (*) 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. [Strength(s) which already exist in the List will not be repeated for context.] The effective date for the approved drug product (the earl iest date a product may be marketed) appears, when appropriate, to the left of the approval date. 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.) Additions new to the Prescription Drug Product list, aTC Drug Product 1 List, List of Drug Products in the Division of Blood and Blood Products Approved Under Section 505 of the Act and the Patent and Exclusivity Data are indicated by the symbol >...ARJL> to the left of the line on which new information. exists. The >~> symbol is then dropped in subsequent Cumu1 ative Suppl ements for that item. A newly approved product is a1 so identified by a lozenge ( .. ) to the right of its strength which remains throughout all Cumulative Supplements for this edition. Deletions new to the Prescription Drug Product list, OTC Drug Product List, List of Drug Products in the Division of Blood and Blood Products Approved Under Section 505 of the Act and the Patent and Exclusivity Data are indicated by the symbol >.JtI.L.> (DELETE) to the 1 eft of the 1 ine containing overstruck print. The >.JlLL> symbol is dropped in subsequent Cumulati v9/Supp1 ements for that item. The overstruck pri nt wi 11 remain in the Prescription Drug product List and aTC Drug Product lists in all Cumulative Supplements for this edition. However, the overstruck print in F the 1:1,t cPorug Products in the Division of Blood and Blood Products Approved Under Section 505 of the Act and the Patent and Exclusivity Data will be dropped in subsequent Cumulative Supplements. A A Products discontinued from marketing or products which have had their approval withdrawn for other than safety or effectiveness reasons, will be flagged in this Cumulative Supplement with the II a II symbol to designate their non-marketed status. All products having a II" II symbol in the 12th Cumulative Supplement of the 8th Edition List will then be added to the IIDiscontinued Drug Product listll appearing in the 9th Edition. ~ C

iv 1.2 PRODUCTS REQUIRING REVISED LABELING FOR FULL APPROVAL , t Drug products in this category (1) initially received approval only on the basis of safety before effectiveness studies were required, or (2) were conditionally approved under the temporary exemption that allowed these products to be marketed while effectiveness studies were being conducted. Listed below are those drugs which are now required to revise their label ing and provide additional information necessary for full approval on the basis of requirements listed in the Federal Register. As approval is granted by the Agency for a specific product, based on additional information submitted by the app1 icant, the product will be inc1 uded in the appropriate Drug Product List. Products Federal Register Reference Nitroglycerin (capsule, controlled release;oral) SEP 7, 1984 (49 FR 35428) Nitroglycerin (tablet, controlled release;oral) SEP 7, 1984 (49 FR 35428) Nitroglycerin (tablet, controlled re1ease;bucca1) JUL 5, 1985 (50 FR 27688) Tranylcypromine Sulfate MAR 22, 1984 (49 FR 10708) 1.3 APPLICANT (NAME) CHANGES Because 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, the cumulation of these transfers and name changes will be identified in this section only. '~here only partial approved product lines are transferred between applicants, each approved product involved will appear as an applicant name change in the Cumulative Supplement.

APPLICANT (NAME) CHANGES

FORMER APPLI CANT (NAt,1E) NEW APPLICANT (NAME) NEW ABBREVIATED NAME

: AYERST LABORA.TORIES INC OIV ~/YETH AYERST LABORATORIES INC lllYETH AYERST LARS : AHERICAN HOME PRODUCTS CORP , HOECHST CELANESE HOECHST ROUSSEL HOECHST PHARMACEUTICAL INC

~'MY K LABORATORIES INC PHARMACEUTICAL BASICS INC PBI

~ NnVOCOL CHEMICAL MANUFACTURING NnVOCOL PHARMAC~UTICAL INC NOVOCOL PHARr1 ,\ COf1PANY INC

v APPLICANT (NAME) CHANGES

FORt·1ER APPL I CANT (NAf'1E) NEVI APPLICANT (NAME) NEW ABBREVIATED NAME

SEARLE PHARMACEUTICALS INC GD SEARLE CO SEARLE TRAVENOL LABORATORIES INC BAXTER HEALTHCARE CORP BAXTER WYETH INC WYETH AYERST LABORATORIES INC WYETH AYERST LABS WYETH LABORATORIES INC WYETH AYERST LABORATORIES INC WYETH AYERST LABS 1.4 TRAZODONE HYDROCHLORIDE

Generic Trazodone HC1 l50mg tablet entries, marked with a (t), are rated as therapeutically equivalent (AB) to Mead Johnson's Desyrel (Trazodone HC1) Dividose l50mg tablets. The therapeutic equivalence determination, among other things, was made on the basis of an acceptable bioequ;valence study and acceptable in vitro dissolution testing. A patent that exists on the Desyre1 l50mg tablet scoring design, which enables the patient to break Desyrel into three 50mg segments, prevents a generic firm from copying this feature. Therefore, a patient will not be able to obtain three 50mg segments from the generi c tabl et. Prescri bers and di spensers should be aware of this difference and take it into account when writing a prescription or practicing drug product selection.

l I I I [ vi I l \ "..JoJ o::J c.n c.n

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1.5 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 sections 505 and 507 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 1987) refers to the products in the Prescription Drug Product List. For each three-month period, a column of quarterly data is added which incorporates counts of product activity from the previous quarter(s) with those in the baseline count. DEFINITIONS Drug Product For this report, a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts, esters and derivatives) either as a single ingredient or as a combination product, provided in a specific dosage form and strength for a given route of admin­ istration 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.

vii • ... ..:~.... ,,~ __ .~ ___ ~W<....-. .... ~....:::._

COUNTS CUMULATIVE BY QUARTER1

CATEGORIES COUNTED DEC 1987 JUN 1988 JUN 1988 DEC 1988 DRIIG PRODLICTS LISTED 9709 9769 9993 10091 * SI NGLE SOURCE 2096 (21.6%) 1975 (20.2%) 1973 (19.7%) 1983 (19.7%) t1UL TISOURCE 7613 (78.4%) 7794 (79.8%) 8020 (80.3%) 8108 (80.3%) THERAPEUTICALLY EQUIVALENT 6691 (68.9%) 6937 (71. 0%) 71 61 (71. 7%) 7242 (71.8%) NOT THER/\PEUTICALLY EOIIIVALHIT 848 ( 8.7%) 757 ( 7.8%) 749 ( 7.5%) 748 ( 7.4%) EXCEPTIONS2 74 ( 0.8%) 100 ( 1.0%) 110 ( 1.1%) 118 ( 1.1%) NEI4 t10LECULAR ENTITIES APPROVED 2 3 17 NU;1RER OF APPLICANTS 349 378 387 374

*T~is number is inclusive of products discontinued since December 1987, and any products approved or discontinued through December 1988. lCumulative counts are calculated from January 1, 1988 to, and including, the month indicated. 2Ani1o acid-containing products of varying composition (see Introduction, page 1-8 of the List).

vi;; t. •

PRESCRIPTION DRU8 PRODUCT LIST 1 8TH EDITION CUHULATIVE SUPPLEMENT NUMBER 12 / JAN'88 - DEc'ee ACETAMINOPHEN; BUTALBITAL ACETAMINOPHEN. CODEINE PHOSPHATE TABLET; ORAL TABLET; ORAL DUTALmAL AMP ACIIAHIHOPHIH AI HALSEY DRUG lnt!!ijSt§ll N89568 001 1tt6~j~('/~~U OCT OS, 1988 'w,a:.=-lIN ~7 . ItW~(..4/~~U ACETAMINOPHEN; BUTALBITAL; CAFFEINE ~~ IJM:flttitAJ,mt' ~I~r 1tt6~:U/.d.d~1 TABLET; ORAL ~~:d~~l~~ BUIALBITAL, ACETAMINOPHEN AND CAFFEINE ~~ ~ f 1tf6~.dU/.d.d('1 MIKART 500HGj5OHGj40~ N89451 001 M MCNEIL PHARM ~j1....litS N85056 001 HAY 23, 1988 M nm!jlmi N85056 002 IUIALmAL t APAP t AMP CAFFEINI M lUH!! jEtS N85056 003 AI HALSEY DRUG ll2!!!jS!!ij~ N89536 001 M nmij!mi N85056 004 FEB 16, 1988 ~ I&m lINtWJ 7f ().d mmtl HO. 7 ftaW ItW.d~~/~.dU >~> AI FOREST PHARHS ~j2m!ij~ N89660 001 M MCNEIL PHARM }QQ!§J1....R!!! N85055 001 >-AJHL> DEC 23, 1988 IW':'_m~mtIHO'L ~ 7 miIt(iiidl 1tt6~.d~~1 ~#I M MCNEIL PHARM 122!!Hl.6 N85055 002 ACETAMINOPHEN; CODEINE PHOSPHATE _ tv CO,UHI HO. ~ I W UtJK 7 (.HIidI ItW~~~/~.d~1 ELIXIR; ORAL M MCNEIL PHARM ~j~ N85055 003 MAPAP AND CODmtl _ nmgHl HO. llitii M MY K LABS l?OHG/SHLjl?HG/5Ml N87006 001 Iw~t f..b 7 (~ 1tt6~~~~/~~('1 ItHU~ M MCNEIL PHARM l!mt§ji.QH!i N85055 004 lIN -'M7~T~~r- -- li~(ttt4!VB4.:1 1tt6.1.d.dM ~~JI ~EHOl tv CODmtl IIN~t t7lA6~7 lilltidlB4.:Jitt4dlM:I ItW~~j/~#1 ACETAMINOPHEN; HYDROCOOONE BITARTRATE M MCNEIL PHARtt 1?QHG/SHLj12MSISHL N85057 001 CAPSULE; ORAL TABLET; ORAL AC!ETAI1DtDPHDf AMP H'rPROCODOHE IJIABTRATI ACITNmIOPHEH AMP COPElNE !IHOSI'HATI M GRAHAM LABS i22!:!!! j~ N87336 001 BARR LABS l.!U!!Sj.!Q!S. N85794 001 JUL 08, 1982 1221 I~~/~~~I 1WttS.(lMI oo-amo I~'~U~~~~~~ M CENTRAL PHARMS H!!!S ; liit§III N89360 001 M CHARLOTTE PHARtt 30OHG; lSH!!II N89990 001 MAR 02, 1988 SEP 30, 1988 M 300t1G;30MGIII N89805 001 Iwl'B'~1 I~MIJMtI SEP 30, 1988 1.J6~A~~~~:~~ M 300HGj!QHGII N898?8 001 SEP 30, 1988 TABLET; ORAL M HALSEY DRUG llQt!! j!.Qt§ N86549 001 >-AmL> trrCOPAP M KJTUAL PHARM }22!§;~ N89671 001 >...AJUL> M CHARLOTTE PHARM .5.Q.Q!:§ j~ N89971 001 FEB 10, 1988 >-AmL> DEC 02, 1988 M ~;30~ N89672 001 trrPROCOQOHE mAltT!ATE AHD ACIIAHIHOPHDI FEB 10, 1988 M BEECHAM LABS ~;LB N89725 001 M ~j!mP N89673 001 SEP 30, 1987 FEB 10, 1988 M CHARLOTTE PHARM Sm:!!i;~ N89831 001 M PHARHAFAIR EQtSjEH!i N8776? 001 SEP 07, 1988 DEC 10, 1982 It)( DRUQ PRODUCT LIST / CUlJLATIYE SUPPLEMENT N.JeER 12 / JAN'88 - DEC'88 2

A'EIAHIHQeHEHi HXg~ODONE IIIABIBAIE ~EIQHXE!BmsAH1' ~Ig

TABLET; ORAL TABLET; ORAL HIDROOORmfI mARTRATI Mm YIIAKDtO!H1H LITHOSTAT M LUCHEH PHARMS ~;~ N89696 001 HISSION PHARHA 250HS N18749 001 APR 21, 1988 HAY 31, 1983 M HIKART ~;L..HP N89689 001 #~~r+f.' ~ 29, 1988 'l¥~'~t~' ,r&~~~~1'~~~~ >...AWL> M MATSON LABS i2m§;~ N89883 001 >..AJHL> DEC 01, 1988 >...AWL> YICODIN ES ALBUTEBQL ~L[AIE >-AIHL> KNOLL PHARM 750HS;7.5HSII N89736 001 >-AIHL> DEC 09, 1988 CAPSULE; INHALATION YENTOLIN ROnCAPS GLAXO EQ 0.2HS BASE. Nl9489 001 A~ETAHIHQPH~Hi ~RQP~PHE~ HAeSXLAIE HAY Oft, 1988

TABLET; ORAL !lmJlOXYftjEHI -mwi A!m ACIIAKDtO!H1H ALSE ROX't LON AI HALSEY DRUG ~;~ N72105 001 HAY 13, 1988 TABLET; ORAL D 650HS ;.l2.Qt:!2II N72106 001 HAY 13, 1988 '~~;'~~~~~~11~~~1 #r+f.1 I~~~#~/~~U AI HYLAN PHARMS ~j.l2mP N72195 001 a DORSEY L~S 2HS N09215 001 FEB 16, 1988 '~~11~1~~~~~~1 Itr+f.1 I~~UM'~~U RAlttILOID ACEIAZOLAHIDE RIKER LABS 2HS N08867 001

TABLET; ORAL ACnAZOLAKEDI AMANTADINE HYDROCHLORIDE AI KffiJAL PHARM l?5HGII N89752 001 ~ 22, 1988 CAPSULE; ORAL AI ~ N89753 001 ~ 22, 1988 Iw'1mE' I~ ~ 1~'~~~1%~~ 61 LEDERLE LABS ~ N08943 001 S'l'HAD%H1 AI REID ROHELL 100HS N71000 001 SEP 04, 1986 A~~IAZOLAHI~~ §2DI~

INJECTABLE; INJECTION AHCINONIDE ACnAZOLAKEDI I!2DlU1 AI! QUAD PHARMS SOOHGIVIA~ N89619 001 LOTION; TOPICAL JAN 13, 1988 CYCLOCORT ~ LEDERLE LABS 0.1X. N19729 001 AI! LEDERLE LABS SOOHGIVIAL N09388 001 .AJo4 13. 1988

'. • •

RX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEHENT tUoeER 12 / JAN'88 - DEC'88 3 AHILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE !HINO ACIDS; CALCI\I1 CHLORIDE; DEXTROSE; HAGtfESI\I1 CHLORIDE; POTASSIlJ1 CHLORIDE; POTASSI!JH PHOSPHATE. DIBASIC; SODIlJ1 TABLET; ORAL CHLORIDE "LORIDI HCL AHD !1YPROCI1L.OROnqAZ'%DI All BARR LABS ~;SOHGII N71111 001 INJECTABLE i INJECTION HAY 10, 1988 AHINOSYN II 4.25% H/ ELECTROLYTES IN DEXTROSE 20% H/ CALCIUM IN PLASTIC CONTAINER ABBOTT LABS 4.2S%i36.8HG/100HL;20GH/100HLi AMINO ACIDS SlHG/10OHLi22.4HG/10OHL;261HG/100HL 20SHG/100HU. N19683 002 INJECTABLEi INJECTION NOV 07, 1988 AHINOSYN 3.S% IN PLASTIC CONTAINER 4.2S%;36.8HG/100HLi20GH/100HL; l~ff/~~1 1~;~t.1 SlHG/100HLi22.4HG/100HLi261HG/100HL I 20SHG/100HU. N19714 002 a ABBOTT LABS 3.5% ~~~~:~'iU~~Nl887S 001 SEP 12, 1988 AUG 08, 1984 AHINOSYN II 4. 2S% H/ ELECTROLYTES IN DEXTROSE 2S% H/ CALCIUM IN PLASTIC CONTAINER 1~~~r~~~Y 1~:r+t.1 ABBOTT LABS 4.2S%;36.8HG/10OHLi2SGK1100HLi I J~~11~~i~:~~ SlHG/100HLiZZ.4HG/100HLiZ61HG/100HL a KABIVITRUM 6.4% N1879Z 001 20SHG/10OHU. N19683 003 JAN 17, 1984 NOV 07, 1988 TRAVASOL 10% IN PLASTIC CONTAINER 4.2S%i36.8HG/10OHLi2SGK1100HLi BAXTER 10~ N18931 004 SlHG/100HLiZ2.4HG/10OHLi261HG/10OHL APR 27, 1988 20SHG/10OHU. N19714 004 TROPHAHINE 10% SEP 1Z, 1988 KENDALL HCGAH 10%11 N19018 003 AHINOSYN II 5% H/ ELECTROLYTES IN DEXTROSE 2S% H/ CALCIUM SEP 07, 1988 IN PLASTIC CONTAINER ABBOTT LABS S%i36.8HGV100HLiZSGH/100HLi SlHG/100HL;2Z.4HG/100HL;261HG/10OHL !HlNO ACIDS; CALCIlJ1 CHLORIDE; DEXTROSE; HAGNESI\I1 CHLORIDE; 20SHG/100HU. N19683 004 POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE. DIBASIC i SODIU!1 NOV 07, 1988 CHLORIDE S%i36.8HG/100HLi2SGK1100HLi SlHG/100HLi2Z.4HG/100HLi261HG/100HL INJECTABLE; INJECTION ZOSHG/100HU. N19714 003 AHINOSYN II 3.5% H/ ELECTROLYTES IN DEXTROSE 2S% H/ SEP 12, 1988 CALCIUM IN PLASTIC CONTAINER ABBOTT LABS 3.S%i36.8HG/100HLi2SGK110OHLi SlHG/10OHLiZZ.4HG/10OHLiZ61HG/100HL AMINO ACIDS; DEXTROSE ZOSHG/100HU. N19683 001 NOV 07, 1988 INJECTABLE i INJECTION 3.5%i36.8HG/10OHLiZSGKI100HLi AHINOSYN II 3.5% IN DEXTROSE Z5% IN PLASTIC CONTAINER SlHG/100HLiZZ.4HG/100HLiZ61HG/10OHL ABBOTT LABS 3.S%iZSGKI100HU. N19681 001 20SHG/100HU. N19714 001 NOV 01, 1988 SEP 12, 1988 3.5%;ZSGKI100HU. N19713 006 SEP 09, 1988 AHINOSYN II 3.5% IN DEXTROSE S% IN PLASTIC CONTAINER ABBOTT LABS 3.5%iSGKI100HU. N19681 002 NOV 01, 1988 3.S%iSGKI100HU. N19713 OOZ SEP 09. 1988 AX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUMBER 12 / JAN'88 - DEC'88 4

AMINO ACIDS; DEXTROSE AHINO ACIDS; DEXTROSE; HAGNESIUH CHLORIDE; POTASSIUH CHLORIDE; SQDIUH CHLORIDE; SODIUH PHOSPHATE. DIBASIC INJECTABLE; INJECTION AHINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER INJECTABLE; INJECTION ABBOTT LABS 4. 25%;10GH/IOOHL. N19681 004 AHINOSYN II 3.5% H IN DEXTROSE 5% IN PLASTIC CONTAINER NOV 01, 1988 ABBOTT LABS 3.5%;5GHI100ML;30HG/100HL; 4.25%;10GH/IOOH~ N19713 001 97HG/100ML;120HG/100HL; SEP 09, 1988 49. 3HG/IOOH~ N19682 001 AHINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER NOV 01, 1988 ABBOTT LABS 4.25%;20GH/100H~ N19681 005 3.5%;5GHIIOOHL;30HG/100HL; NOV 01, 1988 97HG/IOOHL;lZOHG/100ML; 4.25%;20GH/IOOH~ N19713 004 49.3HG/100H~ N19712 001 SEP 09, 1988 SEP 08, 1988 AHINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AHINOSYN II 4.25% H IN DEXTROSE 10% IN PLASTIC CONTAINER ABBOTT LABS 4.25%;25GH1100H~ N19681 003 ABBOTT LABS 4. 25%;10GH/IOOHL;30HG/100HL; NOV 01, 1988 97HG/IOOHL;120HG/100HL; 4.25%;25GH1100H~ N19713 005 49.3HG/100M~ N19682 002 SEP 09, 1988 NOV 01, 1988 AHlNOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER ABBOTT LABS 5X;25GH1100H~ N19681 006 NOV 01, 1988 AMINO ACIDS; HAGNESIUM ACETATEj PHOSPHORIC ACID; POTASSIUM 5%;25GH1I00H~ N19713 003 ACETATE; POTASSIUM CHLORIDE; SODIUH ACETATE SEP 09, 1988 INJECTABLE; INJECTION FREAHINE III 8.5% HI ELECTROLYTES AHINQ ACIDS; DEXTROSEj HAGNESIUH CHLORIDE; POTASSIUH ACETATEj KENDALL HCGAH 8.5%;110HG/100HL;230HG/IOOHL; POTASSIUM CHLORIDEj POTASSIUH PHOSPHATE. DIBASICj SODIUM lOHG/100HL;440HG/100ML; CHLORIDE 69OHG/IOOM~ N16822 007 JUL 01, 1988 INJECTABLE; INJECTION AHINOSYN II 4.25% HI ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER AHINO ACIDSj MAGNESIUM ACETATE; PHOSPHORIC ACIDj POTASSIUH ABBOTT LABS 4. 25%;10GHIIOOHL;51HG/100ML; ACETATE; SODIUM CHLORIDE 176.5HG/100ML;22.4MG/100ML; 104.5HG/100HL; INJECTABLE; INJECTION 205HG/100H~ N19682 003 llorl/~~~·~/!.·~~t.llrVttV~.4<~~~~(~~~~J~t~}~'4d~/-Idd.J "I NOV 01, 1988 f'W)I:t1 I I-I'P~ I.:> .... 1.., ~ .... p¢/t.d~~j...•.. ."...... pj.. .• 4. 25%;10GHIIOOHL;51HG/100ML; 176.5HG/100HL;22.4HG/IOOHL; ~~~~~~~~~~;I l~t~j~/~~~1 104.5HG/IOOHL; 1~~/~~.:lt.4p(./ 205HG/10OH~ N19712 002 a ABBOTT LABS 3.5%;21HG/IOOMl;40HG/IOOHL; SEP 08, 1988 128HG/IOOHL; 234HG/IOOHL Nl8875 002 AUG 08, 1984

AHINQCAPROIC ACID INJECTABLE; INJECTION ~ >-AruL> !e. LEDERlE LABS jnH N15229 002 >-2LI->I6t/ Itt~t~tt/~~~ft~1 I I l~t$#~/~~U

• ... '- • RX DRUG PRODUCT LIST / CUMULATIYE SUPPLEMENT NUMBER It / JlN'ee - DEc'ee I AMINQCAPROIC ACID AMITRIPTYLINE HYDROCHLORIDE INJECTABLE; INJECTION TABLET; ORAL AKIHOCAPROIQ ACID !f lBBOTT LABS 25ottG/J1l11 N70888 001 ~ 16, 1988 ~ ~~~J~I .~~i~~~~:~~ ~ ~ I~~~~'~~~~~ AHINOHIPPURATE SODIUM ~I ~tV.~~4~/ddJl ~ / ~ ltfU/J~/~~U INJECTABLE; INJECTION AI HARNER CHILCOTT .l2!!i N83939 001 AKDtOHIPPURATE IODM AI ~ N83937 001 !f ~&D ~ N05619 001 AI ~ N83938 002 !f QUAD PHA~ ~ N89821 001 AI ~ N84957. 001 JUL 14, 1988 AI l2.Qt!!i N85093 001 AI llm!i N86295 001 AMINOPHYLLINE /=~~~:~~~ TABLET; ORAL ~I~L AMINOPHYLLINE ~ ~ ~~l~~~~~~~ /~/ /~~~/~~/ /J.~~~/ I I ItW.1MI ~.dU u~~~·1~~~~~~ a LEDERLE LABS I10HG N86744 001 /~/ #~.d~1 ItW~·4M~dU a 25t1G N86746 001 / ~f$/1.~::/J.~~~1 a 50HG N86743 001 a BARR LABS 100HG N88297 001 a 75t1G N86745 001 AUG 19, 1983 a 100HG N86747 001 a 200HG N88298 001 AUG 19, 1983 BD HALSEY DRUG 100HG N84674 001 AMITRIPTYLINE HYDRocHLORIDE; CHLORDIAZEPOXIDE /~/ /J.~~~/ 1~~.1(./.6#/ BD a RICHLYN LABS 100HG N84574 001 TABLET; ORAL BD a 200HG N84576 001 a1LORD:rAZEPmaDI AHDAHI'J"R%PTYYHI HCL >....!mL> AI DANBURY PHARHl EQ 12.5HG BASE;~ N72052 001 ~~~ ~~~~~~ ~~~~~~:~,~~ >-AJm...> DEC 16, 1988 BD YALE CHEH 100HG N84533 001 >-AJm...> AI Eq 25MG BASE;l~ N72053 001 /~/ /J.~~~/ /~('~~~/~#I >-AJm...> DEC 16, 1988 AI PAR PHARM Eq 12.5HG BASE;~ N72277 001 HAY 09, 1988 AHINOSALICYLATE SODIUM AI E9 25HG BASE;10~ N72278 001 HAY 09, 1988 TABLET; ORAL AI PHARM BASICS E9 12.5HG BASE;~ N70477 001 JAN 12, 1988 1~~.d~1 1t1~j~~~/~~U AI E9 ?5MG BASE;~ N70478 001 1~~t'~~~~~~~d~1a CNSOL MIDLAND 500HG N07320 002 JAN 12, 1988 RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUMBER 12 / JAN'88 - DEC'88 6

AMITRIPTYLINE HYDROCHLORIDE i PERPHEHAZIHE AMPICILLIN SODIUM TABLET; ORAL INJECTABLE; INJECTION PERPHJHADHI AMP AI1UR:I:mL%HE HCL N1P':tC1LL%H IODM AI t1YLAN PHARHS l!!1:!H~ N70336 001 AI! HARSAH PHARHS E§I 125MG BASE/yIAlJI N62816 001 NOV 10. 1988 OCT 24, 1988 g lm!!;~ N71442 001 AI! EQ 2SOHG BASE/VIAlJI N62816 002 NOV 10, 1988 OCT 24, 1988 ~ 25HG;~ N70337 001 AI! EQ SOOHG BASt;/yIAlJI N62816 003 NOV 10, 1988 OCT 24, 1988 g .m:§;~ N70338 001 AI! EQ 1GH BASE/yIAu. N62816 004 NOV 10. 1988 OCT 24, 1988 M ~;~ N71443 001 !f. t;§I 2GH 8ASE/VIAlJI N62816 005 NOV 10. 1988 OCT 24, 1988 !f t;g 10eM BASE/vIALJI N62994 001 SEP 15, 1988 AHOXICIlLIN CAPSULE; ORAL AHPICIlLIN SODILtli SULBACTAH SooIl.., AMOXmtLL%H AI CUH1EL CHEHS 2S0HGa N62884 001 INJECTABLE; INJECTION FEB 25. 1988 ~SYN AI S2!P N62881 001 PfIZER LABS EQ 1GH BASE/vIAL; FEB 25, 1988 EQ SOOHG BASE/vIALJI N62901 001 NOV 23, 1988 POHDER FOR RECONSTITUTION; ORAL AHC»aC:ELL%H AI CLOtf1EL CHEHS 125HG/SHLJI N62927 001 AMPICILLIN/AMPICILLIN TRIHYDRATE NOV 25. 1988 g 2S0HG/SHLJI N62927 002 CAPSULE; ORAL NOV 25. 1988 AHP':EC%LL%H AI NOVOPHARM 12SHG/SHLJI N62946 001 ~ CUH1EL CHEHS E§I g50HG BASE .. N62883 001 NOV 01, 1988 FEB 25, 1988 POLYHOJ( AB E§I 500HG BASE .. N62882 001 AI BRSTL t1YRS IHO 12SHG/SHL" N6288S 001 FEB 25, 1988 HAR 08, 1988 Itt~tF1ttl~~1 M 2S0HG/SHLJI N6288S 002 ~~ ~991~ ~~~~~~~~~~~ HAR 08, 1988 a LEDERLE LABS EQ 2S0HG BASE N62208 001 a EQ SOOMG BASE N62208 002 POLYC%LL%H ~ BRSTL HYRS INO t;§I 250HG BAS~" N62888 001 HAR 04, 1988 ~ E§I SOOHG BASE" N62888 002 HAR 04, 1988

POHDER FOR RECONSTITUTION; ORAL II/~# I~~:~~~~U I ~~~~j~~~~~ ~ a AYERST LABS ~lfn.EQ 125HG BASE/SHL NS0019 002 a EQ 2SOHG BASE/SHL NS0019 003 a EQ 100HG BASE/HL NS0019 001

.. " •

AX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / JAN'88 - DEC'88 7 AHILERIDINE HYDROCHLORIDE ASPIRIN; MEPROBAMATE TABLET; ORAL

'f~,M~~~1~' ItN~/~I.~tI /~~d~~/d~U /W/~~ /UMl!illtMI a ttS&D Eq 25HG BASE NI0585 002 . /~~~~~~~

ANILERIDINE PHOSPHATE ASPIRIN; HETHOCARBAHOL

fjtUt~fl.d~Jf~)t¢f;t~/ TABLET; ORAL HmtOCARBAHOL AHD AlPD%H /t'~~l~lJ /t.N~~/~I.~t./r4t./ /~~d~~d/dd"J/ AI PAR PHARH ~;~ N89657 001 a ttS&D EQ 25HG BASEIHt NI0520 003 NOV 04, 1988

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE > ADD > AmmZOLE

TABLET; ORAL >....!mL> TABLET; ORAL ORPHEHADRDfE CCHPCUHD >...AQlL> HISHANAL AI VITARINE 38.5HG;3OHS;2SHGa N71564 001 >--AQIL> JANSSEN PHARHA 10~ Nl9402 001 JUN 23. 1988 >...!IUL> DEC 29. 1988 ORPHEHADR%HE CCHPC!UfD DOUBLE STREHrm1 ~ VITARINE 770HG;~;50~ N71565 001 JUN 23. 1988 ATENOLOL TABLET; ORAL ASPIRIN; CAFFEINE; PROPOXYPHENE IfYDROCHLORIDE AIEHOLOL AI ICI PHARHS imP N72303 001 CAPSULE; ORAL JUL15,1988 AI .l.2Q!P N72304 001 /W/~~~~/ /~{~{UtW JUL IS, 1988 /1.(tt1~~'~~~~~ TIENCIAHDI a BAN1AX PHARHS 389HG;32.4HG;65HG N84553 002 AI STUART PHARHS im!i N18240 001 AUG 17, 1983 AI ~ N18240 002

ASPIRIN; HYDROCOOONE BITARTRATE ATRopINE SUlFATE; DIFENOXIN IfYDROCHLORIDE TABLET; ORAL TABLET; ORAL AZDONE CENTRAL PHARHS 50OHS;5HGII N89420 001 m~~$:1&/U6~/ /~;~~~~J~f¢/ /~~j'JMt/ ~~~/ JAN 25, 1988 HOTOFEN CARNRICK LABS O. OZSHG;1HG Nl7744 002 ASPIRIN; MEPROBAMATE AZATHIOPRINE SODIlI1 TABLET; ORAL HEPRO-AlPD%H INJECTABLE; INJECTION AI VITARINE ll6;12.2t!!i N89127 001 AZAnaopgttl HAR 02, 1987 AP QUAD PHARHS Eg 10QHG BA$EtyIAu. N71056 001 JUN 08, 1988 AX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEMENT tueER 12 / JAN' 88 - DEC' 88 8

AZATHIOPRI~DIUH IE~BOPINE HESYLATE INJECTABLE; INJECTION TABLET; ORAL ~ I~P%HE HmLAII Ae BURROUGHS HELLC ~~OOHG BASEIYIAl Nl7391 001 M PAR PHARH O.SHG N88877 001 APR 11. 1985 M !!§ N88894 001 BAClOFEN APR 11. 1985 !A .m! N88895 001 TABLET; ORAL APR 11. 1985 BACLOFEH /~n /~.:~/ M PHARH BASICS ImP N71260 001 nmn1~1i~~~ HAY 06. 1988 /~n fj.t4¢/ /tf6U.44/ddU AI 20HGII N71261 001 / ~f'f1.nJ.:H~~1 HAY 06. 1988 /~n #~I ~ VITARlNE ~ N71901 001 n~1~~~~~ APR 13. 1988 !A PHARH BASICS 0.5HGII N89211 001 ~ ~ N71902 001 ~ 14. 1988 APR 13. 1988 !A .ll!§II N89212 001 M ZENITH LABS ImP N72234 001 JUN 14. 1988 JUl 21, 1988 M 2HG11 N89213 001 AI ImP N72235 001 ~ 14, 1988 JUL 21, 1988 M "'-'ANTUH PHARHCS ~ N88514 001 U'9RESAL JAN 31, 1984 ~ GEIGY PHARHS nH!i N17851 001 AA IHG N88510 001 U'9RESAL PI JAN 31, 1984 AI GEIGY PHARHS nt!! N17851 003 M 2HG N88511 001 JAN 20. 1982 JAN 31. 1984 I~n I~.:~~I ItW~H/~.dU BLNlTHIAZIDE I~n fj.~1 ')~F~~~I~ TABLET; ORAL I~n #~I I )~~~~i'}~~l~ f)~lJJ.:h.46(.f 1~~1'~'~~~'~~1~, 1f,~~1 1t¥"#~('l.d#1 AA SIDHAK LABS 9..:..stP N89058 001 a PRIVATE FHLTNS 50HG N83206 001 AUG 10. 1988 M 1HG11 N89059 001 AUG 10, 1988 M nP N89060 001 AUG 10, 1988 COGENTDt !! HS&D ~ N09193 004 AA !!§ N09193 003 N09193 002 ~~~ ~m~1 ~~~~~~~~~~;~ I~~/ #~I 1~~.4J~"J/~#1 • • •

AX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUHBER 12 / ~AN'88 - DEC'88 9 HTAHETHASQNE DIPRQPIQNAU IBOHPHEHIRAHlNE HALJATE LOTION; TOPICAL TABLET; ORAL IEIAl1mtASOHE DJPROPI'OHATI All COPLEY PHARM EQ 0.05% BASE_ N71882 001 /iIJ TIiliiBff"E mLIA"'~/ /t16~~/~~u ~ 06, 1988 a BARR LABS 4MG N84468 001 M THAHES PHARMA Ea 0.05% BASE_ N72276 001 AUG 24, 1988 DIPROLENE BROHPHENIRAMINE MALEATE i DEXTROHETHORPHAH HYDROBRDHIDE. IX SCHERING EQ 0.05% BASE_ N19716 001 PSEUDOEPHEDRINE HYDROCHLORIDE AUG 01, 1988 SYRUP; ORAL >~> IROI1FED-AT BETAHETHASQNE VALERATE >...AJ2!L> M tfJRO PHARM 2MG/SML;1OHG/SHL; >-A!m..> 3011G/SH~ N89681 001 CREAM; TOPICAL >-AIUL> DEC 22, 1988 D!ERHABEI AI TARO PHARMS Ea 0.1% BASE_ N72041 001 ~AN 06, 1988 BUPIVACAINE HYDRocHLORIDE

LOTION; TOPICAL I~ECTABLE; I~ECTION BEIAl1ElliYOHE VALERATE >.JH.L.> AI COPLEY PHARM Ea 0.1% BASE_ N71883 001 >....2!.I...> "J~m~~7t\(tJ' /~;j~t./ APR 22, 1988 >....lI.L.> IENIOR'!J'T"E /~'~~~1~'i~~~ >~>/~ I~~~~/~~~/~~~I /~ BETAZOLE HYDROCHLORIDE >.JU,L> /A~~~m~~~

I~ECTABLE; I~ECTION >....!ruL> I~ECTABLE; SPINAL /tU/~fA,t6tjJ/ >-A!m..> 1UP%VACA%HE tj.~tf/ /~.6~/r4t1 /~~.4"J(tt+l.6~U >-A!m..> !f ABBOTT LABS ~ N71810 001 a LILLY 5OMG/ML N09344 001 >....!ruL> DEC 11, 1987 >-A!m..> HARCADfI >....!ruL> Af! STERLING DRUG ~ N18692 001 BETHANECHOL CHLORIDE > ADD > MAY 04, 1984 >-A!m..> IEHIORCA%HE I~ECTABLE; I~ECTION >-.!R.!L > !f ASTRA PHARM PRODS L.m N71202 001 BEnlAHECHOL D1LOR%DE >....!ruL> APR !!i. 1987 AP QUAD PHARMS ~ N89815 001 APR 12, 1988 URECHOUHE >~> AP MS&D 5MG/ML N06536 001 >~> /'J~,Jt¢fA~:ifn~~¢fj.s'tt/ >....lU..I.-> BRETYLIUH TOSYLATE >....lU..I.-> Wt~J~~tj~~~~~~ /A;j~t.J~;~~t.1 /~1.U4U~~U /tfJ.. J/M.;/J~~tt/ I~ECTABLE; I~ECTION BRETYI..%U1 TO!lYLATE !f LUITPOLD PHARMS 50MG/M~ N70891 001 .JUL 26, 1988 H QUAD PHARMS 50MG/M~ N71181 001 FEB 16, 1988 RX DRUG PRODUCT LIST / CUHULATIVE SUPPLEHENT NUHBER 12 / JAN'88 - DEC'88 10 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CAlCIUM CHLORIDE i DEXTROSE; MAGNESIUM CHLORIDE; SOOIW CHLORIDE; SODIUM LACTATE INJECTABLE i INJECTION BUPIVACAINE HCL AND EPINEPHRINE SOLUTIONi INTRAPERITONEAL ABBOTT LABS 0.25%iO.005HG/HlJI N71165 001 IHPERIOL-U1 IV DEXTROSE I,Jg IH 'LAme COHIAlHIR .x... 16, 1988 AI lBBOTT LABS 2S.7HG/100HLi3.SGH!100MLj 0.25ljO.005HG/HlJI N71166 001 5.08HG/100MLj538MG/100HLj Ju. 16, 1988 448HG/10OHlJI N18379 008 0.25%'0.005HG/HlJI N71167 001 .x... 2ft, 1988 ~ 16, 1988 O.5%'O.OOSMG/HlJI N71168 001 ~ 16, 1988 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM O.5%iO.OO5HG/HlJI N71169 001 CHLORIDE; SODIUM LACTATE ~ 16, 1988 O.5%jO.OO5HG/HlJI N71170 001 INJECTABLE j INJECTION ~ 16, 1988 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN 0.75%'0.00SMG/HlJI N71171 001 PLASTIC CONTAINER ~ 16, 1988 KENDALL HCGAH 10HG/100HL,2.SGHI10OHLilSMG/100HL, 300MG/100HL, l60MG/100HlJI N1963ft 001 CALCIUM; HEGLUMINE; HETRIZOIC ACID FEB 24, 1988 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC >.JaL> CONTAINER >...JU.L> /~~~~~~~~;~~~~¢f~~/ KENDALL HCGAH 4HG/100HL,4GHI100HL,6MG/100ML, >...m.L.> l~ft~t.Jj!i¢/~~jj¢/ 1~;~~~~t..~~~~.:~r4¢~t.J / 120MG/100HL,62MG/10OHLa N19634 002 >.JlJ.L> f.4.;.I> •• pp?~~1 /~u~~~/~#/ FEB 2ft, 1988 >...AmL> iI STERLING DRUG o . 35HG/HL j 140 • 1MG/HL j DEXTROSE I? IH LACTATED UHGER "' IH PLAI'T%C COHI'AlHER >...AIUL> 461.8ttG/HL N17506 001 Af KENDALL HCGAH 20MG/100HL,5GH/10OHL,30MG/100HLj 600MG/100HL, 3l0MG/100HlJI N1963ft 003 CALCIUH CHLORIDE; DEXTROSE; HAGNESIlI1 CHLORIDE; SODIUH FEB 24, 1988 CHLORIDE; SODIUM LACTATE POTASSlUH OtLOR%DE 1C1HEQ IH DEXTROSE 57. AHD LACTATED RDtGER "' IH PLAIT%C COHTA%HER SOLUTION; INTRAPERITONEAL !f lBBOTT LABS 20MG/I00HL,SGHII00HL,104HG/I0OHLj D%AHEAL 'D-1 IV DEXTROSE 1,57. Itt 'LAI'nC COHI'ADfER 600HG/I00HL, AI BAXTER ?5·ZHG/IOOHL,3.SGHII00HL, 310HG/I00Hu. N19685 005 15.2MG/I00HL,56ZHG/I00HL, OCT 17, 1988 392MG/IOOML N17512 010 !f 20HG/I00HLi5GH!100HL,179HG/I00HL, NOV 18, 1985 600HG/I00HL, D%AHEAL 'D-I IV DEXTROSE 1,57. :EN 'LAme COHTADfER 310HG/I00HlJI N1968S 006 AI BAXTER ?5.!HG/IOOHL;3.5GH!100HL, OCT 17, 1988 5.08HG/I00HL,538HG/I00HL, POTASSlUH OtLOR%DE 1!it1EQ IH DEXTROSE Jg AMD LACTATED 448HG/IOOHL N17512 011 R%H!OER "' IH PLAI'nC COHTA%HER NOV 18, 1985 Af lBBOTT LABS 20HG/I00HLiSGHII00HLi2S4HG/I00ML, ltt'EBSOL IV DEXTROSE 1,57. IH 'LAme COHI'ADfEB 6001'l;/10OHL, AI ABBOTT LABS ?5.7MG/100MLj3.SGH/100HL, 310HG/I00Hu. N19685 007 l5.2MG/100HL,56lHG/100HLj OCT 17, 1988 392HG/I00Hu. N18379 007 ~ 2ft, 1988 ·' • • RX DRUG PRODUCT LIST / CUHULATIVE SUPPLEHENT N.lBER 12 / JAN'88 - DEC'88 11 CAlCIlM CHLORIDE i DEXTROSE i PQTASSIlJ1 CHLORIDE i SODIlJ1 CARIsopRODOL CHLORIDE i SOOIlM LACTATE TABLET; ORAL INJECTABLEj INJECTION CARPOPRODOL PClTASmI1 CHLORXPE 'OHE; Dt DEXTROSE sg AHD LACTATED M PIONEER PHARHS ~ N89390 001 RDCER"S Dt 'L.ASl%C cotrrAZHER OCT 13. 1988 Af lB80TT LABS ?OHG/I00HLiSGHlI00HLiI79HG/10QHLJ M YITARINE nmP N89S66 001 600HG/I00HLj AUG 30. 1988 31OHG/I00HU. N1968S OO? OCT 17. 1988 Af 20HG/I00HLiSGH/I00HLi328HG/I00HLi ~ARPH~NA~He HAb~A~ 600HG/l00HLi 310HG/IOOHu. N1968S 008 OCT 17. 1988 If'~j~~~1'1 IJOTASSJUot CHLOR%DE JOHEQ DI DEXTROSE sg AHD lACTATED jt~/~.t~~f/~~~1 ~~~~ RZH!iER"S DI PLAST%C COHTAZHER ~~~~~~~~~~~ Af ABBOTT LABS ZOHG/I00HL;SGHII00HLi?S4HG/I00HLj a HYETH AYERST LABS ?SHG NU768 002 600HG/l00HLj a SOHG Nl2768 004 310HG/I00HU. N1968S 003 OCT 17. 1988 IJOTASSJUot CHLOR:EDE ~OHEQ DI DEXTROSE 5Z AHD LACTATED CARPRQFEN RDCEH"S DI 'LAme COHTAZHER !f ABBOTT LABS 20MG/I00HLjSGH/lOQHL;328HG/100HL; 600HG/I00HLj 310HG/I00Hu. N1968S 004 'f"~rf' n~~~1 l~~~f,f,)/~~# OCT 17. 1988 IJOTASSJUot CHLOR%DE 5t1EQ DI DEXT'ROSE sg AMD LACTATED nf,~1 I~~~~~~~~~~~ R2:HGER"S DI PLA5T%C COHTAZHER l~t~lJf..:n1f.ll !f lB80TT LABS ?OHG/I00HL;SGHIlOOHL;104HG/100HL; a ROCHE 100HG NI8SS0 002 600HG/100HL; DEC 31, 1987 31OHG/IOOHU. N1968S 001 a lSOHG N18SS0 003 OCT 17. 1988 DEC 31, 1987

CALCIlM CHLORIDE i POTASSIUI1 CHLORIDE i SOOIUI1 CHLORIDE i SQDIlJ1 >-AJHL> CARIEOLOL HYDROCHLORIDE LACTATE >...!mL> TABLET; ORAL INJECTABLE; INJECTION >-AJHL> CARTROL LACTATED RZHIiEB"' PI 'LASTJa COHTAZHEB >-AJHL> ABBOTT LABS 2 • .!iI1GIII N19204 001 Af KENDALL HCGAH ?OMG/IOOHLj3OHG/I0QHLj600MG/I0QHL; >-AmL> DEC 28, 1988 310HG/100Hu. N1963? 001 >...,!WL> SHGII N19204 002 FEB ?9. 1988 >...,!WL> DEC 28, 1988 >...,!WL> 10HGll N19204 003 >..AmL> DEC 28, 1988 CARBAHAZEPIrE TABLET. CHEHABLE; ORAL CARBAHAZEPDfI AI HARNER CHILCOTT ~ N71940 001 FEB 01. 1988 TPmL AI GEIGY PHARHS l22!!!i N18?81 001 RX DRUG PRODUCT LIST / ClHJLlTIVE SUPPLEHENT tu4BER 12 / JAN'88 - DEC'88 12 CEill.I.QB >...MHL> tEfOIIMLttYDROClilORIDE POHDER FOR RECONSTITUTION; ORAL > ADD > INJECTABLE; INJECTION CECLOR > ADD > CERADON LILLY Eq 187HG BASE/SHU. N6ZZ06 003 >--AruL> TAKEDA CHEH Eq IGH BASEIVIAU. NSD601 001 APR ZO, 1988 > ADD > DEC 30, 1988 Eq 375HG BASE/SHLX N6ZZ06 004 APR ZO, 1988 CEPHALEXIN

CEFAZObIN ~DIYH CAPSULE; ORAL CEPHALE)(Dt INJECTABLE; INJECTION M JEROME STEVENS E~ 250HG ~ASE_ N62870 001 ~ HAR17,1988 Ae SK&F LABS ~§! ~ ~AS~ffiAL NS0461 004 !Ii E~ 500HG BASE_ N6Z869 001 ;EEAZO~ .,DDI1 HAR 17, 1988 AP BEN VE~E LABS ~§! Z50HG BASEIVI!~ N6Z894 001 AI LABROS URAL E~ Z50HG BASE_ N6Z713 001 JUL Zl, 1988 JUL 15, 1988 Af. ~§! 500~ ~ASEIVIA~ N6Z894 OOZ !Ii E~ 500HG ~ASE_ N6Z713 OOZ .AIL Zl, 1988 JUL 15, 1988 AI! ~§! ASH BAS~IVIAU. N6Z894 003 !Ii SquIBS HARK j;~ Z50HG BASE_ N6Z973 001 .AIL Zl, 1988 NOV 08, 1988 Af ~§! 5GH BAS~IVIA~ N6Z894 004 !Ii E~ ~OOHG BASE_ N6Z974 001 JUL Zl. 1988 NOV Z3. 1988 AP E§! 10GH BASEIVIA~ N6Z894 DOS AI TAG PIiARHS ~~ 250HG BASE_ N6Z8Zl 001 JULZl.1988 FEB OS, 1988 AI! ELKINS SINN ~§1 ZsOHG ~ASE~IA~ N6Z807 001 AI E§! 500HG BASE_ N6Z8Z3 001 JAN 12, 1988 FEB OS, 1988 Af. E§! i20~ BAS~IVIA~ N62807 OOZ AI YOSliITOHI PIiARH ~§I Z50HG BASE_ N6Z872 001 JAN 12. 1988 JUN 20, 1988 !f! E§! 1~ BAS~IVIAI.,JI N62807 003 !Ii ~§I !!OQ!§ BASE_ N6Z871 001 JAN 12. 1988 JUL OS, 1988 AP ~§I ~ BA~EIVIAU. N6Z807 004 JAN lZ, 1988 POWDER FOR RECONSTITUTION; ORAL Af. E§! 10SH BASEIVIA~ N62807 DOS CEPHALpaif JAN 12. 1988 AI TAG PIiARHS E§! 125HG B~SE/SHI.,JI N62873 001 AI! E§! 20~ IAS~IVIAI.,JI N6Z807 006 HAYB,1988 JAN 12, 1988 AI E§! ~sOHG ~ASE/5H1.,JI N62867 001 > ADD> ZOL%CEF APR 15, 1988 >-AQJL> Af. BRISTOL HYERS E§I !!OO~ ~AS~lY1!1.,JI N6Z831 001 >...MHL> DEC 09, 1988 TABLET; ORAL > ADD> AI! E§! l~ ~A~E~IAI.JI N6Z831 OOZ CEPHALDaH >...MHL> DEC 09. 1988 AI YITARINE E§! ~50HG BASE_ N6Z863 001 AUG 11. 1988 AI E§! !!00t!l ~ASE_ N62863 OOZ CEFOTETAN DISODIUH AUG 11, 1988 All E§! IGH BASE_ N6Z863 003 INJECTABLE; INJECTION AUG 11, 1988 CEFOTAN m.uI STUART PIiARHS Eq 10GH BASEIVUU. NS0588 003 All LILLY EQ IGHBASf NS0440 002 APR Z5, 1988

." • •

RX DRUG PRODUCT LIST / ClH./LATIVE SUPPLEHENT N.tBER 1£ / JAN'88 - DEC'88 15 tEPHALEXXN HYPROCHLORIDE CHLORPIAZEPOXIDE HYDRQCHLORIDE TABLET; ORAL CAPSULE; ORAL KEFTlB D1LDRUAZIPOJaDI HCL LILLY EEl 3331'1; BASE_ NS0614 003 AD PIONEER PHARHS lQHGII N89533 001 HAY 16, 1988 JUI.. 15, 1988 All ~ N89558 001 JUL IS, 1988 CEPHAPIRIN SODIUM l~t~ItIft1~tV ~m~~~~~~:~~ INJECTABLE; INJECTION ! ~fi It¥t4r/n~U CEFADYL a PUREPAC PHARM 5HG N85155 001 AI! BRSTL HYRS IND EQ 500NG BASE!YIAu. N62961 001 a 101'1; N84939 002 SEP 20, 1988 a 25HG N85144 001 AI! EQ ISH BASEIVIAlJI N62961 002 SEP 20, 1988 IBtItWJ4:II AI! EQ 2SH BASEIVIAu. N62961 003 ! ~=~~:~~A1~ SEP 20, 1988 AI! EQ 4GH BASEIYIAu. N62961 004 a BAt-IWC PHARMS ~I~51'1; f~~~16f~'UN85107 002 SEP 20, 1988 a 101'1; N85009 001 a 25HG N85108 001 CEPHRADINE CHLORMERODRIN. HG-197 CAPSULE; ORAL CEPHRAD%HI AS BARR LABS ~ N62850 001 IJ~~~~~~J6~~'~J~~{1 APR 22, 1988 ~4JJ~' It. . 1~;~ft.:(.ftJ~f-I l~t#~~/66tl M 500HGa N62851 001 a SQUIBB 0.6-1.4HtI/HL N17269 001 APR 22, 1988 AB YITARINE g50HGa N62813 001 FEB 25, 1988 CHLOROQUINE HYDROCHLORIDE All ~ N62813 002 FEB 25, 1988 IJ?J~~f~?7{IJ~t¢fJ~1 PCHDER FOR RECONSTITUTION; ORAL l$f~~tJ~/~~1 It4l~~~/~~t~tl 1~~~~#/66U CEPHRAD%HI a STERLING DRUG EQ 401'1; BASE/HL N06002 002 AI BARR LABS U5HG/SHlJI N62858 001 HAY 19, 1988 AI 250f01;/SHlJI N62859 001 CHLOROQUINE PHOSPHATE HAY 19, 1988 TABLET; ORAL MAYH CHLORDIAZEPOXIDE HYDROCHLORIDE AA STERLING DRUG E9 300!!; BASE N06002 001 atbOROGUEHE PHDSPHATI CAPSULE; ORAL AA DANBURY PHARMl E9 30QHG BASE N88030 001 OfLORD%AZEPOXEDE HCl DEC 21, 1982 IW ItA 'U4t¥ 'U/tIJ ~~ Iltd~lt/~~1 ItW~~UddU 1~'m~1~~~~ a LEDERLE LABS ~Ii5HG ~1~.4~~~~1~N86892 001 a 101'1; N86876 001 a 25HG N86893 001 AX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEMENT tuBER 12 / JAN' 88 - DEC' 88 8 AZATHIOPRI~II.lf D~~BOPI~ HESYLAT~

INJECTABLE; INJECTION TABLET; ORAL ~ BEHZTROPDfE HmLAII AI! BURROUGHS HELlC Ea lOOMS BASE/vIAl Nl7391 001 M PAR PHARH 0.5HG N88877 001 APR 11. 1985 BACLOFEN M !!:§ N88894 001 APR 11. 1985 AA TABLET; ORAL ~ N88895 001 BACLOFEH APR 11. 1985 /p(J/ /~.:~/ AI PHARH BASICS 10HGIII N71260 001 /,(~1·!·1i~:~~ HAY 06. 1988 /~~/ n~/ AI 20HGIII N71261 001 /~'4~/~d 1 HAY 06. 1988 /~(J/ n~/ AB VITARINE ~ N71901 001 '~r~~~~~~i~ APR 13. 1988 /,(Pt1 li.J..: Ii. !I~~ / M PHARH BASICS ~ N89211 001 Aft 20HGIII N71902 001 ~ 14. 1988 APR 13. 1988 AA ~ N89212 001 Aft ZENITH LABS .l.!U:P N72234 001 ~ 14. 1988 JUL 21. 1988 .M 2HG111 N89213 001 AD 20HGIII N72235 001 ~ 14, 1988 JUl 21, 1988 M ~ANTU1 PHARHCS 0.5HG LJORESAL N88S14 001 GEIGY PHARHS JAN 31. 1984 AI .lmS N17851 001 M Y§ U'9RE!lAL DS N88S10 001 JAN 31, 1984 AI GEIGY PHARHS N178S1 003 zm!! M ~ N88S11 001 JAN 20, 1982 JAN 31. 1984 /~(J/ /~.:~~/ //W.~1.(.l.d#1 IiENZTHIAZIDE /~(J/ n~/ / J~/~~.;~~~~(.~ TABLET; ORAL / J~~ll1..4~~1 /~n n~/ /~~//~'~~~~~~1~/ /~.d~/ /tI/.~t.d~l.d~1./ AA SIOHAK LABS o.5HGIII /J~~~~i~:~~ a PRIVATE FHLTNS SOMS N89058 001 N83206 001 AUG 10. 1988 M 1HG111 N890S9 001 AUG 10. 1988 M l.tP N89060 001 AUG 10. 1988 COGEHIDt M HSID L3 N09193 004 M !I:§ N09193 003 N09193 002 ~~~ /~~/ 1~.d!l1.!I~/d~('/ I~n ~~~~ ~~~::~~~~~~~~

" '. • • • •

RX DRUG PRODUCT LIST / ClHJUTIYE SUPPLEHENT tu1BER 12 / JAH'88 - DEC '88 IS CHQlESTYRAHlNE CLIHDA!1'fClH PHOSPHATE POHDER. ORAL INJECTABLE. INJECTION >-DL> fP;STRAH LIGHT CLJ:HJWI'tCZH PHOSPHATI >...AmL> BRISTOL MYERS Eq 4GH RESIH/PACKE~ N19669 001 AI! LEJottON E9 15QMG BASEtHu. N62900 001 > ADD > DEC 05. 1988 J .... 08, 1988 >..AJZIL> Eq 4GH RESIH/SCOOPFUU. N19669 003 AI! LOCH PHARMS E9 150HG BASEIMu. N62905 001 >..A!UL> DEC OS, 1988 HAY 09, 1988 AE LYPHOHED E9 150MG BASEtHU. N62747 001 JUiI 03, 1988 CIClOPIROX OlAHINE AE HARSAH PHARMS E9 150m BASEIHu. H62913 001 OCT 20, 1988 >..A!UL> lOTION; TOPICAL AI! ~AD PHARMS E9 lSQHG BASEtHU. N62877 001 >..AJZIL> LOPROX HAR 15, 1988 >..AJ2!L> HOECHST v.. N19824 001 AI! SOLOPAK LABS E9 150HG BASE/MU. N62819 001 >..AIl.!L> DEC 30, 1988 HAR 15, 1988 AI! E9 150m BASEIMu. N62852 001 HAR 17, 1988 CISPlATIN SOLUTION. TOPICAL INJECTABLE; INJECTION IblDCltI I PlATINOl-Aq AI UP.JOHH E9 1% BASE N50537 001 BRISTOL MYERS IHGIHU. N18057 004 AI E9 1% BASE H62363 001 NOV 08, 1988 FEB 08, 1982 CLlHDtHtCIH IltIOSPHATI AI BARRE MATL E9 1% BASE. N62811 001 ClIHDAHYCIN HYDROCHLORIDE SEP 01, 1988 CAPSULE; ORAL CbEOCpt CLOFIBRATE AI UPJOHN HFG ~9 Z6 BA~E N61809 001 61 Eli! 150HG 8ASE N61809 002 CAPSULE j ORAL CLEOCIN HCl CLOfPRAII UP.JOHN Eq 300HS BASE. N50162 003 AI CORD 'LABS SmP N72191 001 APR 14, 1988 HAY 02, 1988 ~LDfDAHY'CIH tm!. AI VITARINE E9 75t1G IAS~. N62910 001 JUL 05. 1988 CLOMIPHENE CITRATE AI E9 152!§ l!:A~. N62910 002 JUL os, 1988 TABLET; ORAL IW I~~~t~"~ttl-1f'f..AA11. IMI ~~I~AHYCIH fHOSPH~ 1~7~r:7i~~~~ >...AJlIL> HELP,,"1ff1 INJECTABLE; INJECTION >...AJlIL> M HlLEX PRODS SiP H72196 001 g!.;H~ C%H PttI)S~I1 >....AmL> DEC 20, 1988 AI! ABBOTT LABS E9 1~!2!!! l!:§E!Hu. N62943 001 IEROmlttE SEP 29, 1988 61 SERONO LABS 52Hi N18361 001 AI! ELKINS SI,.. E9 l~ot§ IAKtHi.'C N62953 001 MAR 22, 1982 APR 21. 1988 AI! LEDERlE PARNTLS Ei lSOHG 1~~IHu. N62889 001 APR 25, 1988 4:'",

RX DRUG PRODUCT LIST / ClHJLAnYE SUPPLEMENT tutBER 12 / .JAN' 16

CLONIDINE

FILM, CONTROLLED RELEASE; PERCUTANEOUS CATAPRES-TTS-l H7i878 001 BOEHR INGEL 0.lHG/24HR Hl8891 001 M CHELSEA LABS " , .J1z5tp OCT 10, 1984 ; .,,,~. . HAR lS, 1988 U.:~I AI L.IJ!iII N71879 001 1~~~~1%~~ ~ ..-:; HAR lS, 1988 CATAPRES-TTS-2 AI ..Bt:P N71860 001 BOEHR INGEL 0.2HG/24HR Nl8891 002 HAR lS, 1988 OCT 10, 1984 61 CORD LABS .. LZi!P N7ZZ19 001 I~I AUG 26, 1988 !Ii .L.J!!!II N72220 001 1~~~1~1~i~:~~ AUG 26, 1988 CATAPRES-TTS-3 ?- BOEHR INGEL 0.3HG/24HR Nl8891 003 AI U!P N7Z112 001 OCT 10, 1984 AUG 26, 1988 fj;~1 !Ii PUREPAC PHARtt L.m!§!II N71924 001 1~~~1~:1~i~~ APR 2S, 1988 61 LJi!P N7192S 001 APR 2S, 1988 N71926 001 CLQNIDINE HYDROCHLORIDE AI ~ APR 2S, 1988 TABLET; ORAL 61 qtJANTU1 PHARMeS L..Z5!P N71S49 001 CLOHEPDfE HCL SEP 12, 1988 N7lSS0 001 AI CORD LABS ~ N70887 001 61 L..5tP AUG 31, 1988 SEP 12, 1988 61 0.2HG11 N70886 001 AI UtP N71S22 001 AUG 31, 1988 SEP 12, 1988 AI Jl.JH§II N71294 001 AI HARNER CHILCOTT ~ N71774 001 AUG 31, 1988 HAR 01, 1988 ·AI LEDERLE LABS .!L.l!P N71783 001 M 1.:.I!P N7177S 001 APR OS, 1988 HAR 01, 1988 N71776 001 AI ~ N71784 001 61 ~ APR OS, 1988 HAR 01, 1988 61 ~ N7178S 001 APR OS, 1988 TABLET; ORAL AI HARNER CHILCOTT N72138 001 ~LORAZEP~TI DlmASS1U'l ~ N72330 001 .JlJII 13, 1988 AI PlJREPAC PHARtt ~ AUG 08, 1988 AI ~ N72139 001 .A.tI 13, 1988 AI z...2!iII N7Z331 001 61 JL.lH!iII N72140 001 AUG 08, 1988 .JlJII 13, 1988 61 ll!§II N7Z332 001 AUG 08, 1988 AI HARNER CHILCOTT Llmi1I N71828 001 HAR 03, 1988 AI ~ N71829 001 HAR 03, 1988 AI lltP N71830 001 HAR 03, 1988 RX DRUG PRODUCT LIST / C\HJLATIVE SUPPLEHENT tueER 12 / JAN'88 - DEC'88 17

CLQRAZEPATE DIPOTASSIUM ~ TABLET; ORAL INTRAUTERINE DEVICE; INTRAUTERINE CLOBAZEPATI UpoTAISJU1 INTRAUTERINE COPPER CONTRACEPTIVE AI MATSON LABS ~ N718S2 001 POP COUNCIL CBR APPROX 176HG COPPE~ N18680 002 FEB 09, 1988 APR 29, 1988 .AI L..5!1!,!IC N718S3 001 FEB 09, 1988 AI l5!P N718S4 001 CORTISONE ACETATE FEB 09, 1988 GEH...lCEHI TABLET; ORAL AI ALRA LABS l....Z2§II N71787 001 CORTISONE ACETATE APR 26, 1988 8P RICHLYN LABS 25HG N094S8 001 AI ~ N71788 001 I~I /t~~1 Itl~~('u/~#1 APR 26, 1988 AI lm:iII N71789 001 APR 26, 1988 CYCLACIlLIN TABLET; ORAL CLQXACILLIN SODIUM mi.AClLLDt !I BlOC RAFT LABS 2S0HGIII N6289S 001 POHDER FOR RECONSTITUTION; ORAL AUG 04, 1988 CLOXACELLDt !IODlUt AI ~ N6289S 002 BIOCRAFT LABS UUS~ N62268 001 AUG 04, 1988 liil I ~ I~#"I>/~#I mLAPlH.. TmoPEH AI MYETH AYERST LABS 1m5 NSOS09 001 !! BRISTOL LABS NS0192 001 .AI ~ NSOS09 002 N614S3 001 ~~ ~~1~~~~~~~ CYCLQ8ENZAPRINE HYDROCHLORIDE· TABLET; ORAL CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE mLOlHAI'RPIE HOL M DANBURY PHARHA ImP N71611 001 SYRUP; ORAL HAY 03, 1989 FEB 29, 1988 >...!!2.IL> PHERAZ%NE NI OODElHE FLlXER%L >...AJ2!L> M HALSEY DRUG IOMG/SHLj6.Z5HG/SHU. N88739 001 .AI HS&D 12m N17821 002 >-AmL> DEC 23, 1988 >...AJ2!L> PAOHmtA2%HE HCL AND OODElHE PHOSPHATE >..A2!L> M PHARMS ASSOC 10HG/SHL;6.Z5MG/SMU. N89647 001 CYCRIMINE HYDROCHLORIDE >...AJ2!L> DEC 22, 1988 fjn~H~a'i1Y COLCHICINE; PROBENECID ft.:Jt.(..ff ~f~1 ?tl~~~~~~~~ TABLET; ORAL a LILLY 1.25HG N089S1 001 PROBENECID AND COLCHICINE a 2.5HG N089S1 002 I~N l~tt¢~~/{..NS~1 I~.:~J~~~~I 1t¥(tJtf.1 ~#I a BEECHAM LABS D.5HGjSOOHG N84321 001 PROBENECID KI COLCHICINE I~N /t.tf5tt1t.tl{..NS~1 I~.:~J~~~~I ItW~~('/~~'J./ a LEDERLE LABS O.5HG;SOOHG N869S4 001 AX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEHENT tu'eER 12 / JAN'88 - DEC'88 18

CYIARABINE ~IDE INJECTABLE, INJECTION OINTMENT, TOPICAL CYIOSAR-U DPCMEH UPJOHN lGtVVUL N16793 003 AI CHEN LABS ~ N71425 001 DEC 21. 1987 JUN 15. 1988 2GHIVUL N16793 004 TJgDESrLOH DEC 21. 1987 AI HILES PHARH ~ N17426 001

DACARBAZINE RESOXY~QBIICOST~R~ AC~IAT~ INJECTABLE, INJECTION PELLET, IHPLANTATION DACARBAZINE QUAD PHARHS 500HGNUlJI N71563 001 IJ!'~~~~~~M l#~1 1t1~(it(iU~M'/ HAY 06. 1988 a CIBA PHARH 125HG N05151 001

R~SIPRAHI~ HYDR~HLQBIR~ DEXAMETHASONE TABLET; ORAL TABLET; ORAL DEDPRAMDtI J:tgl. DEXAMETHASONE AI CORD LABS 10tDI N72099 001 ItI6~~t~/~~U HAY 24. 1988 ~~~ I~~~/~~I AI n!P N72100 001 ~f~=~ ~~~~~:4~~~~~ HAY 24. 1988 ~~~~ ~l'~ AI ~ N72101 001 I~:J~~~ ~~~~~~~~H HAY 24. 1988 ~~~ AI ~ N72102 001 I~n ~~J~~ ~~~~,~~~ ~ 20. 1988 a BARR LABS 0.25HG N84013 001 All 100tDI N72103 001 a O.Z5HG N84764 001 JUN 20. 1988 a 0.5HG N84084 001 AI 15011Glll N72104 001 a 0.75HG N84081 001 JUN 20. 1988 a 0.75HG N84765 001 AI VITARINE 1011Glll N72167 001 a 1.5HG N84086 001 FEB 03. 1988 a 1.5t1G N84763 001 All ll2.P N72254 001 BP a RICHLYN LABS 0.75tG N85376 001 FEB 03. 1988 I~/ /~.:1~/ /~(i~j~/~~U NORPRAKDf AI HERRELL DOH .lQH!! N14399 007 FEB 11. 1982 DEXAMETHASONE; T08RlHYCIN AI 15011G N14399 006 OIHTHENT, OPHTHALHIC T08RADEX DESHOPRESSIN ACETATE ALCON LABS 0.1%,0.3%11 NS0616 001 SEP 28. 1988 INJECTABLE, INJECTION DDAVP SUSPENSION/DROPS; OPHTHALHIC >.JU.L> 1~~/ftt1~rV /~;~~~/r'.tI T08RADEX >.JU.L> I~~~:~~~~ ALCON LABS 0.1%,0.3%11 NS0592 001 >...AruL> RORER PHARH O.OO4HG/HL N18938 001 AUG 18. 1988 >...ARJL> HAR 30. 1984 RX DRt» PRODUCT LIST / CUMULATIVE SUPPLEMENT tuBER 12 / JAN'88 - DEC'88 19

DEXTRQHETHORPHAN HXDROBRQMIDEiPROMETHAlINE HYDROCHLORIDE DEXTROSE i POTASSIl!1 CHLORIDE i SODI\I1 CHLORIDE

SYRUP; ORAL _ INJECTABLU INJECTION "~~~~'~~~l~m~~~~~~~r~;#-f.·:/~f~~~~~/~t(Jft~~t' IUJ '~lf1am8mun~(':t$WW.1 I~~~~~~~~~~~ f I14f(Jff/~~l 1~~J~~~t.fIt~d~n~~rK(1

DEXTROSE Idt~~C.:t4j=;~~~l;~~J~I.NW '''4t~W''~V INJECTABLE; INJECTION DEXTBOSI 10? Df PLAS'IJC cotn'ADtEB !f KENDALL HCGAH 10GH1100Hu. Nl9626 004 FEB 02. 1988 DEXTROSE 2.5% IN PLASTIC CONTAINER I~ ~# ~.'ffi~1dt4d1"d"'(/ 1~~6U4/~~~1 KENDALL HCGAH 2.5GHII00HU. N19626 001 POTASSIUM CHLORIDE 0.037% IN OEXTROSE 10% AND SODIUH FEB OZ. 1988 CHLORIDE 0.2% IN PLASTIC CONTAINER /~t~~~~II~~~/f./~~/~~~f~~1,~1~~~~~/{1 KENDALL HCGAH 10GH1100HL;37HG/I00HL; 1f4PW .. 1-I'Pi> 1~.. ?'PtVJd. J"lJ. 200HG/I00HU. N19630 031 /~'~~1~~%~:~~ FEB 17. 1988 a ABBOTT LABS 38.5GtV10OHL N189Z3 001 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUH SEP 19. 1·984 CHLORIDE 0.45% IN PLASTIC CONTAINER D~E S? Df PLASnC COHTADtEB KENDALL HCGAH 10GH1100HL;37HG/10OHLi ~ ABBOTT LABS 50HGIHL N19Z22 001 450HG/I00HU. N19630 037 .AlL 13, 1984 FEB 17, 1988 I~I /~~~~J'J POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM /;G~1~1'i~:fJ CHLORIDE 0.9% IN PLASTIC CONTAINER !f KENDALL HCGAH SGHtl00H", Nl9626 002 KENDALL HCGAH 10GKI100HL;37HG/100HL; FEB OZ. 1988 900HG/I00HU. N19630 043 DEXTROSE 7.7% IN PLASTIC CONTAINER FEB 17, 1988 KENDALL HCGAH 7.7GHVI00HU. N19626 003 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUH FEB 02, 1988 CHLORIDE 0.11% IN PLASTIC CONTAINER KENDALL HCGAH 5GH1100HL;37HG/100HL; 110HG/100HU. N19630 001 DEXTROSE i POTASSIUM CHLORIDE i SODIlM CHLORIDE FEB 17. 1988 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUH INJECTABLE; INJECTION CHLORIDE 0.2% IN PLASTIC CONTAINER KENDALL HCGAH 5GHI100HL;37HG/10OHLi /~~~~~~~~?'~~~~~~~~~t~~;:t;/~/~f~~~~~/~t(Jft~~t/ 200HG/10OHU. N19630 007 FEB 17, 1988 I~ . /f.I:6M ~~frJ'1~/~~r~n~~t1J... ,I~Md~/~#1 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUH • • /,l~ 1J1:j.J,Wd CHLORIDE 0.33% IN PLASTIC CONTAINER KENDALL HCGAH 5GKI100HL;37HG/100HLi /d~~~~~~~~~~~~~~~~l~~~t/~~~f./~/~f~~~~ 1~J.~J~tl 330HG/10OHU. N19630 013 FEB 17, 1988 / 100.. 1f.k6~7 . ~~frJ'1~1~f7·~n~~t1t..f' /tS,JM.1J.IA.dU POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUH . .. IJkJ/Jl~n.4~1 CHLORIDE 0.45% IN PLASTIC CONTAINER KENDALL HrGAH 5GKI100HLi37HG/10OHLi 'd~~~~~~l'~~~~~~~~'dt/~~~f./~/~f~~~~~/~J.~J~t' 450HG/100HU. N19630 019 Il~fflf.k6~1 ~~~rJ'1~1~~f4t1¢/~~~t1t..f' 1tS,~MjJ.IAA~1 FEB 17, 1988 J. /J~/lj .• /l4UI RX DRUG PRODUCT LIST I CUMULATIVE SUPPLEHENT NUHBER 12 I JAN'88 - DEC'88 20

DEXTROSE i POTASSIl.!1 CHLORIDE i SODIl.!1 CHLORIDE DEXTROSE i POTASSII.J1 CHLORIDE i SOPII.J1 CHLORIPE INJECTABLE j INJECTION INJECTABLEj INJECTION POTASSIUH CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUH POTASSIUH CHLORIDE 0.11% IN DEXTROSE 10% AND SODII.J1 CHLORIDE 0.9% IN PLASTIC CONTAINER CHLORIDE 0.45% IN PLASTIC CONTAINER KENDALL HCGAH SGHIIOOHLj37HG/IOOHLj KENDALL HCGAH 10GHIIOOHLjllOHG/100HLj 900HG/IOOHU. N19630 025 450HG/IOOHU. Nl9630 039 FEB 17, 1988 FEB 17, 1988 POTASSIUH CHLORIDE 0.075% IN DEXTROSE 10% AND SODII.J1 POTASSIUH CHLORIDE 0.11% IN DEXTROSE 10% AND SODII.J1 CHLORIDE 0.2% IN PLASTIC CONTAINER CHLORIDE 0.9% IN PLASTIC CONTAINER KENDALL HCGA" 10GH/IOOHLj75HG/IOOHLj KENDALL HCGAH 10GHllOOHLjllOHG/100HLj 200HG/IOOHU. N19630 032 900HG/IOOHL. Nl9630 045 FEB 17, 1988 FEB 17, 1988 POTASSIUH CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUH POTASSIUH CHLORIDE 0.11% IN DEXTROSE 5% AND SODII.J1 CHLORIDE 0.45% IN PLASTIC CONTAINER CHLORIDE 0.11% IN PLASTIC CONTAINER KENDALL HCGA" 10GH/IOOHLj75HG/IOOHLj KENDALL HCGAH SGHllOOHLjllOHG/lOOHLj 450HG/IOOHU. N19630 03B 110HG/IOOHU. Nl9630 003 FEB 17, 1988 fEB 17, 1988 POTASSIUH CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUH POTASSIUH CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUH CHLORIDE 0.9% IN PLASTIC CONTAINER CHLORIDE 0.2% IN PLASTIC CONTAINER KENDALL HCGAH 10GH/IOOHLj75HG/IOOHLj KENDALL HCGAH SGH/lOOHLjllOHG/lOOHLj 900HG/IOOHU. N19630 044 20OHG/IOOH~ Nl9630 009 FEB 17, 1988 FEB 17, 1988 I'OTASmI1 CHLOR%DE D,D'!? Pi DEXTROSE!? AND .,OM POTASSIUH CHLORIDE 0.11% IN DEXTROSE 5% AND SODII.J1 CHLOBl:OE 0, Z? :Ill PLAmC COHTADtER CHLORIDE 0.33% IN PLASTIC CONTAINER Ae KENDALL HCGAH SGHtlOOHLj75HG/100HLj KENDALL HCGAH SGH/IOOHLjllOHG/lOOHLj 200HG/IOOHL_ N19630 OOB 330HG/IOOHL. Nl9630 015 FEB 17, 1988 FEB 17, 1988 POTASS1U1 CHLOUI)E 0, D'S'/, %It PEXTROSE !? AHD .,OM POTASSIUH CHLORIDE 0.11% IN DEXTROSE 5% AND SODII.J1 CHLOBl:DE 0, Ill?, :Ill PLAmC COHTADfER CHLORIDE 0.45% IN PLASTIC CONTAINER Ae KENDALL HCGAH 5GM/IOOHLj75HG/I00HLj KENDALL HCGAH SGH/lOOHLjllOHG/lOOHLj 330HG/IOOHL_ N19630 014 4S0HG/IOOH~ Nl9630 on FEB 17, 1988 FEB 17, 1988 POIAS!mI1 CHLOR%DI D,D'!? %It DEXTROSE 5? AND .,OM POTASSIUH CHLORIDE 0.11% IN DEXTROSE 5% AND SODII.J1 CHLORJ:DE O,'-!? Pi PLASnC COHTADfER CHLORIDE 0.9% IN PLASTIC CONTAINER Ae KENDALL HCGA" SGH/I00HLj75HG/IOOHLj KENDALL HCGA" SGH/lOOHLjllOHG/lOOHLj 450HG/IOOHU. N19630 020 900HG/IOOHL. Nl9630 027 FEB 17, 1988 FEB 17, 1988 POIAsmI1 CHLOUPE D,D'!? Pi DEXTROSE!? AND .,OM POTASSIUH CHLORIDE 0.15% IN DEXTROSE 10% AND SODII.J1 CHLOR%DE O,"/, Pi PLA5nC COHIADfER CHLORIDE 0.2% IN PLASTIC CONTAINER Ae KENDALL HCGA" 5GH1100HLj75MG/I00HLj KENDALL HCGAH 10GHIIOOHLj150HG/I00HLj 900HG/I00HL_ N19630 026 20OHG/100H~ Nl9630 034 FEB 17, 1988 FEB 17, 1988 POTASSIUH CHLORIDE 0.075% IN DEXTROSE 5% AND SODII.J1 POTASSIUH CHLORIDE 0.15% IN DEXTROSE 10% AND SODII.J1 CHLORIDE 0.11% IN PLASTIC CONTAINER CHLORIDE 0.45% IN PLASTIC CONTAINER KENDALL HCGAH SGHIIOOHLj75HG/IOOHL; KENDALL HCGAH 10GHllOOHLj150HG/lOOHLj 110HG/IOOHU. N19630 002 450HG/IOOH~ Nl9630 040 FEB 17, 1988 FEB 17, 1988 POTASSIUH CHLORIDE 0.11% IN DEXTROSE 10% AND SODII.J1 CHLORIDE 0.2% IN PLASTIC CONTAINER KENDALL HCGAH 10GH/IOOHLjl10HG/100HLj 200HG/IOOHU. N19630 033 FEB 17, 1988 AX DRI.» PRODUCT LIST / ClHJLATIYE SUPPLEMENT tueER 12 / JAN'88 - DEC'88 21

DEXTROSE i POTASSIU1 CHLORIDE i SODIlI1 CHLORIDE DEXTROSE' POTASSIU1 CHLORIDE i SOOIlI1 CHLORIDE INJECTABLE; INJECTION INJECTABLE} INJECTION POTASSIU'I CHLORIDE 0.1.5% IN DEXTROSE 10l AND SODIU'I POTASSIlJ1 CHLORIDE O.22l IN DEXTROSE .5% AND SODIlJ1 CHLORIDE 0.9l IN PLASTIC CONTAINER CHLORIDE 0.2l IN PLASTIC CONTAINER KENDALL HCGAH 10GH/IOOHLi150MG/I00HL; KENDALL HCGAH SGH/10OHLi22OMG/100HL; 900MG/IOOHLa N19630 0~6 200MG/100HLa N19630 011 FEB 17, 1988 FEB 17, 1988 PO"I'ASSDI1 CHI.OR%PI o,m %It DIXIBOIE 5?, Atm 101M POTASSIU'I CHLORIDE 0.22l IN DEXTROSE 5l AND SODIlJ1 CHLOUDE o. g %It 'LAmC cotn'APfER CHLORIDE 0.33l IN PLASTIC CONTAINER Af KENDALL HCGAH SGHtlOOHL;150MG/10QHLi KENDALL HCGAH SGH/100HLi22OMG/100HL; ZOOMG/IOOHu. N19630 010 33OMG/100HLa N19630 017 FEB 17, 1988 FEB p, 1988 POTASSDI1 CHI,.OR%DE 0,15% %It DEXTROSE ~ AHD IODM POTASSIU'I C•. ;'ORIDE O. 22l IN DEXTROSE .5% AND SODIU'I CHLOR%DE O,!~ %It 'LA!I'J%C cotn'A%HER CHLORIDE 0.45l IN PLASTIC CONTAINER Af KENDALL HCGAH SGHt100HLi150MG/100HL; KENDALL HCGAH SGH/100HL;220MG/100HLi 330MG/IOOHu. N19630 016 ~5OMG/100HLa N19630 023 FEB 17, 1988 FEB 17, 1988 POTASUU1 CHLOR%DE 0 , 15% %It DEXTROSE 57. AHD IODM POTASSIU'I CHLORIDE 0.22l IN DEXTROSE 5l AND SODIlJ1 CHLOR%DE 0,"'57. %It 'LAmC cotn'A%HEB CHLORIDE 0.9l IN PLASTIC CONTAINER Af KENDALL HCGAH SGHtlOOHLiI50MG/100HL; KENDALL HCGAH SGH/100HL;220MG/I00HL; 45OMG/100HLa N19630 02Z 900HG/100HLa N19630 029 FEB 17, 1988 FEB 17, 1988 fIOTA5SJU1 CHLOR%DE 0,15% DC DEXTROSE 57. AHD IODM POTASSIlJ1 CHLORIDE 0.3l IN DEXTROSE 10l AND SODIlJ1 CHlOR%DE O,"/' %It 'LAme COHTA%HER CHLORIDE 0.2l IN PLASTIC CONTAINER !p KENDALL HCGAH SGH!10OHL;150MG/10OHLi KENDALL HCGAH 10GH/100HL;300MG/100HL; 900MG/100Hu. N19630 028 200MG/100HLa N19630 036 FEB 17, 1988 FEB 17, 1988 POTASSIU'I CHLORIDE 0.1.5% IN DEXTROSE .5% AND SODIU'I POTASSIlJ1 CHLORIDE 0.3l IN DEXTROSE 10% AND SODIlJ1 CHLORIDE 0.11l IN PLASTIC CONTAINER CHLORIDE 0.4.5% IN PLASTIC CONTAINER KENDALL HCGAH SGH/100HL;150MG/100HL; KENDALL HCGAH 10GH/100HLi300MG/100HL; 11OMG/I00HLa N19630 004 45OMG/100HLa N19630 042 FEB 17, 1988 FEB 17, 1988 POTASSIU'I CHLORIDE o. 22Y. IN DEXTROSE 10% AND SODIU'I POTASSIlJ1 CHLORIDE o. 3l IN DEXTROSE 10l AND SODIlJ1 CHLORIDE 0.2l IN PLASTIC CONTAINER CHLORIDE 0.9l IN PLASTIC CONTAINER KENDALL HCGAH 10GH/10OHLi2Z0MG/100HL; KENDALL HCGAH 10GH/100HLi300MG/I00HL; ZOOMG/100HLa N19630 035 90OMG/100HLa N19630 048 FEB 17, 1988 FEB 17, 1988 POTASSIU'I CHLORIDE 0.22l IN DEXTROSE 10l AND SODIU'I I'OTASSlU1 CHLOUDI 0, ~ ;at DEXI'IIOSI 5?, AHD 1O!)JU1 CltLOR%DI CHLORIDE 0.4.5% IN PLASTIC CONTAINER 0, Z? ::tH 'LAme COHTA%HER KENDALL HCGAH 10GH/100HLi2ZOMG/100HL; !! KENDALL HCGAH 5GH(100HL;300MG/I00HL; 450MG/100HLa N19630 0~1 200HG/100Hu. N19630 012 FEB 17, 1988 FEB 17, 1988 POTASSIU'I CHLORIDE 0.22% IN DEXTROSE 10l AND SODIU'I POTASSN1 Ct!LOJm)E O,l? ::tH DIXIROSE 5? AHa 1ODJU1 ClfLOUPE CHLORIDE 0.9l IN PLASTIC CONTAINER O,!~ %If 'LAme COHTAIHER KENDALL HCGAH 10GH/100HL;ZZOMG/100HLi Af KENDALL HCGAH SGHt100HLi300MG/100HLi 900MG/100HLa N19630 047 330MG/IOOHu. N19630 018 FEB 17, 1988 FEB 17, 1988 POTASSIU'I CHLORIDE O. 22l IN DEXTROSE .5% AND SODIU'I I'O'1'ASPW CHLOR%DI O,l? %It DEXTROSE S AND "DJU1 CHLOR%QI CHLORIDE 0.11% IN PLASTIC CONTAINER 0,ft.S? Df 'LAme COHIAXHEB KENDALL HCG~ 5GH/100HL;ZZOMG/100HL; Af KENDALL HCGAH 5GH(100HL;300HG/10QHL; 110MG/10OHLa N19630 005 ~50MG/100Hu. N19630 024 FEB 17, 1988 FEB 17, 1988 RX DRUG PRODUCT LIST / CtHJLATIVE SUPPLEHENT tueER 12 / JAN'88 - DEC '88 22

DEXTROSE i POTASSIUtt CHLORIDE i SOOIUtt CHLORIDE DEXTROSE i POTASSIl.t1 CHLORIDE i SODIl.!1 CHLORIDE INJECTABLE i INJECTION INJECTABLE; INJECTION I'OTAnDM CHLORIDE 0,& Itt Dpmosl R AMD 1OUU1 ClfLORDI POTAPJU1 CHLORIPE lOHEQ Pi DIXTROIE I? AHD IODM o.n JH 'LAmP COtfTADtER atLORJ:DI o,n IH ,LAme cotn'AZHER !f KENDALL MeGAN 5GM/I0QMLi30QHG/I0QMLi !f TRAVENOL LABS 5GM/100ML;75MG/I00MLi 900HG/I00Mu. N19630 030 900HG/I0OMu. N19308 004 FEB 17, 1988 APR OS, 1985 POTASSIl.t1 CHLORIDE 0.3% IN DEXTROSE 5% AND SODIl.t1 CHLORIDE poTASs:EUt1 atLOR%DE UHEQ ZH PEXTROSE II? AND SODJUot 0.11% IN PLASTIC CONTAINER ptLORJ:DE 0,ft.5? IH ,LAme COHTAZHER KENDALL MeGAN 5GM/I00MLi300HG/I00ML; !f ABBOTT LABS 5GH!100MLi224HG/lOOMLi 110HG/I00MU. N19630 006 450MG/lOOMU. Nl8362 006 FEB 17, 1988 MAR 28, 1988 POTAUlU1 atL9R%DE lOHEQ ZH DEXTROSE 5? AHD SOD:tU1 PqTAISN1 atL9R%DE UHEq Pi DEXTROSE 5? AND !IO!IJ\I1 atLORJ:DE O.w. Pi 'LASJ'%C COHTAZHER atbOR%DE O.,./. IH ,I.A5T1:C COtn'AZHER !f ABBOTT LABS 5GHtl00MLi74.5HG/100ML; !f ABBOTT LABS 5GHII00MLi224HG/I00MLi 450HG/I00ML N18362 009 900MG/lOOMU. N19691 006 JUL OS, 1983 MAR 24, 1988 Ae SGM/I00MLi149HG/I00MLi POTASSIl.t1 CHLORIDE lSMEQ IN DEXTROSE 5% AND SODIUH 4SQHG/I00Mu. Nl8362 OOS CHLORIDE 0.22S% IN PLASTIC CONTAINER MAR 28, 1988 ABBOTT LABS SGHI100ML;224HG/I00ML; POTAUlU1 CHLORJ:DE lOHEq Pi DEKT1tOSE 5? AND !IOD:tU1 225HG/I00HU. N1836S 008 atLORJ:DE 0, n Pf 'LA5nC COHTAZHER MAR 28, 1988 !f ABBOTT LABS 5GM/IOOMLi74.5MG/I00ML; POTASSIUH CHLORIDE ISMEQ IN DEXTROSE S% AND SODIl.t1 900MG/100Mu. N19691 002 CHLORIDE 0.3% IN PLASTIC CONTAINER MAR 24, 1988 ABBOTT LABS SGHII00HLi224HG/IOOMLi !e SGHtl00MLi149MG/100MLi 300MG/I00MU. NI8876 007 900MG/lOOMU. N1969l 004 MAR 28, 1988 MAR 24, 1988 PO'TASm.!1 CHbORl:DE IOHEQ Pf DEKTROSE 5? AND !IO!IJ\I1 POTASSIl.t1 CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIl.t1 CHLOR%DE 0,ft.5? Pi 'LAme COHTA:tHER CHLORIDE 0.225% IN PLASTIC CONTAINER !f ABBOTT LABS SGHIIOOHLiI49HG/I00MLi ABBOTT LABS SGHIlOOMLi74.5HG/I00ML; 4S0HG/I00Hba Nl8362 010 225MG/I00ML N18365 002 JUL OS, 1983 JUL OS, 1983 !f 5GHII00ML;298HG/I00ML; SGHIlOOMLi149MG/I00MLi 4S0MG/IOOHL_ Nl8362 007 225HG/I00MU. N18365 006 MAR 28, 1988 MAR 28, 1988 POTAS!I%U1 CHI.OR%DE ZOHEQ Pi DEKTROSE 5? AHO !IODJUot POTASSIl.t1 CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIl.t1 CHL9R%OE D,n IH 'LA5nC COtn'AZHER CHLORIDE 0.3% IN PLASTIC CONTAINER Ae ABBOTT LABS 5GHIIOOMLjI49HG/I00MLj ABBOTT LABS SGHII0OMLi74.5HG/I00MLi 900MG/I00HL_ Nl9691 OOS 300MG/I00ML NI8876 001 MAR 24, 1988 JAN 17, 1986 !f SGHII00Mli298HG/I0OMLi SGHI100MLi149MG/100MLi 900MG/I00HU. Nl9691 008 300HG/I00MU. Nl8876 006 MAR 24, 1988 MAR 28, 1988 POTASSIl.t1 CHLORIDE 2QMEQ IN DEXTROSE S% AND SODIl.t1 CHLORIDE 0.225% IN PLASTIC CONTAINER ABBOTT LA3~ SGM/100MLiI49HG/I00ML; 225MG/I00ML Nl836S 001 SGM/100MLi298HG/I00MLi 225HG/I00MU. Nl836S 009 MAR 28, 1988 RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUHBER 12 / JAN'88 - DEC'88 23 DEXTROSE i POTASSIlM CHLORIDE i SODIUH CHLORIDE DEXTROSE i POTASSIlM CHLORIDE; SODIlM CHLORIDE INJECTABLE i INJECTION INJECTABLE i INJECTION POTASSIUH CHLORIDE 20HEQ IN DEXTROSE 5Y. AND SODIUH POTASSIUH CHLORIDE 40HEQ IN DEXTROSE 5Y. AND SODIUH CHLORIDE 0.3% IN PLASTIC CONTAINER CHLORIDE 0.3Y. IN PLASTIC CONTAINER ABBOTT LABS 5GHIIOOHLi298HG/IOOHLi ABBOTT LABS 5GHI100HL;298HG/IOOHLj 300HG/IOOHLa NI8876 008 300HG/100HLa NI8876 004 MAR 28, 1988 MAR 28, 1988 POTASSIUH CHLORIDE 20HEQ IN DEXTROSE 5Y. IN SODIUH CHLORIDE POTA!SD,I1 atLORPE RIO :EH DIDC'IllOSE 5? AND .,DJU1 CI1LGREDE 0.3% IN PLASTIC CONTAINER O,ftS :EH 'LAme COHTADtER ABBOTT LABS 5GH1100HLiI49HG/I00HLl 6f ABBOTT LABS 5GM/IOOHL j 14. SHGI100HL j 300HG/I00HL NI8876 002 4SQHG/10OMu. N18362 008 JAN 17, 1986 MAR 28, 1988 POTAsm.tt atLOR%DE IIIME; :Dt DEXTROSE 5? AND 1OIIJU1 Af 5GHI100HLj149MG/IOQHL; atLOR%DE D,U? :Dt PLASnC cotn'ADtER 45OHG/100Hu. N18362 004 6f ABBOTT LABS 5GH1100HL;224HG/lOOHLi MAR 28, 1988 45OHG/I00HL N18362 002 POTASS%U1 atlpR%DE IMEG lit DIXTROSE 52 AND IOD1lI1 atLOgDI POTAsm.tt atLOR%DE IlIMn :EH DEXTROSE 5? AND 1OIIJU1 'In :EH 'LAmC CONTADtER atLOR%DE D,n :EH PLAS1'%C COHIADtER !f ABBOTT LABS 5GM/100HL;14.$HG/IOOHl; 6f ABBOTT LABS SGH!100HLi224HG/lOOHLi 900MG/I00Hu. N19691 001 900HG/I00HLa N1969l 007 MAR 24, 1988 HAR 24, 1988 Ae 5GHt100HLj149HG/100HL; POTASSIUH CHLORIDE 30HEQ IN DEXTROSE 5Y. AND SODIUH 900MG/100Hba N19691 003 CHLORIDE 0.225Y. IN PLASTIC CONTAINER MAR 24, 1988 ABBOTT LABS SGHIlOOHL;224HG/lOOHL; POTASSIUH CHLORIDE SHEQ IN DEXTROSE 5Y. AND SODIUH CHLORIDE 225HG/lOOHL N18365 003 0.225Y. IN PLASTIC CONTAINER JUL 05, 1983 ABBOTT LABS 5GHI100HL; 74. 5HG/100HL; POTASSIUM CHLORIDE 30HEQ IN DEXTROSE 5% AND SODIUH 225HG/100HLa N18365 005 CHLORIDE 0.3Y. IN PLASTIC CONTAINER MAR 28, 1988 ABBOTT LABS 5GHII00HL;224HG/lOOHL; 5GHI100HL;149HG/10OHL; 300HG/I00HL NI8876 003 225HG/10OHLa N18365 007 JAN 17, 1986 MAR 28, 1988 POTASSD.!1 atLORPE IIIMO :Dt DEXTROSE 5? AHD "DJU1 POTASSIUH CHLORIDE SHEQ IN DEXTROSE 5% AND SODIUH CHLORIDE at\,OUDE 0 , 97. :Dt ,LAST%C COH'TADtER 0.3Y. IN PLASTIC CONTAINER 6f TRAVENOL LABS SGM/I00HL;224HG/lOOHL; ABBOTT LABS 5GHIlOOHL;74.5HG/100HL; 900HG/I00Hl Nl9308 006 300HG/100HLa NI8876 005 APR 05, 1985 MAR 28, 1988 POTA5mI1 CHlOREDE ..lIMn :Dt DEXTROSE I? AHD .,DJU1 5GHIIOOHL;149HG/IOOHL; atLOrgDE 0,"5? :Dt 'LAS1%C COHIADtER 30OHG/100HLa Nl8876 009 Af ABBOTT LABS SGM/I00HL;298MG/100HL; MAR 28, 1988 45OHG/IOOHl N18362 003 poTASS1U1 atL9R%DE "mEG :Dt DEXTROSE,$? AND "DJU1 QtL,OR%DE D,n :Dt 'LASnC COHrADtER 6f ABBOTT LABS 5GM/100Hl;298MG/100HL; 90OHG/100HLa N19691 009 MAR 24, 1988 POTASSIUH CHLORIDE 40HEQ IN DEXTROSE 5Y. AND SODIUH CHLORIDE 0.225Y. IN PLASTIC CONTAINER ABBOTT LABS 5GHI100HL;298HG/10OHLi 225HG/10OHL Nl8365 004 JUL 05, 1983 RX DRUG PRODUCT LIST / ClKJLATIVE SUPPLEHENT ~ER 12 / JAN'88 - DEC'88 24 DEXTROSE i SODIU1 CHLORIDE DEXTROSE i SOOIU1 CHLORIDE INJECTABLE; INJECTION INJEC-TABLE; INJECT:"ON DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC DEXTROSE 5?, AHP !IOPJU!1 CHLOaPE 0. I~ 1M 'LAS'T%C COHTAJHIR CONTAINER !f KENDALL HCGAN 5GH!100HL;330HG/I00HL- N19631 008 KENDALL MeGAN 10GHI100HL;110HG/100HU. N19631 011 FEB 24. 1988 FEB 24, 1988 DEXTROSE 5?, AND !IODJU1 CHLORDE 0.ft,S?, PI 'LAS'nC COHTADtIR DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER !f KENDALL MeGAN SGH/IOOHL;4S0HG/IOOHU. N19631 009 KENDALL MeGAN 10GHI100HL;200HG/100HU. N19631 012 FEB 24. 1988 FEB 24. 1988 DEXTROSE 5?, AHP !IOP:nt1 CHLOR:rDE 0.9".1. PI PLAS'nC COHTADtER DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC !f KENDALL MeGAN SGHlI00HL;900HG/100HU. N19631 010 CONTAINER FEB 24. 1988 KENDALL MeGAN 10GHI100HL;330HS/I00HU. N19631 013 FEB 24. 1988 DEXTROSE 10% AND SODIUM CHLORIDE 0.4S% IN PLASTIC DIATRIZOATE HEGLUMINEi DIATRIZQATE SODIU1 CONTAINER KENDALL HCGAN 10GHII00HL;4S0HG/100HU. N19631 014 INJECTABLE; INJECTION FEB 24. 1988 REHOCAL-76 DEXTROSE 1~ AND IOPM CHLOaPE 0.9".1. %H PLA5'I%C COHTADtER !f ~IBB DlAGS 66%;10X. N89347 001 Af KENDALL MeGAN 10GHI100HL;900MG/100HL- N19631 01S Jltl 01, 1988 FEB 24. 1988 DEXTROSE 2.S% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DIAZEPAM KENDALL MeGAN 2.SGH/100HL; 110HG/100HU. N19631 001 INJECTABLE; INJECTION FEB 24. 1988 DIAZEPAM DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC > ADD > AP STERLING DRUG ~ N72079 001 CONTAINER >....!!lJL> DEC 20. 1988 KENDALL MeGAN 2.SGH/I00HL; 200HG/100HU. N19631 002 TABLET; ORAL FEB 24. 1988 PIAZEPAM DEXTROSE 2.S% AND SODIUM CHLORIDE 0.33% IN PLASTIC ~ PIONEER PHARMS 2HG11 N70787 001 CONTAINER AUG 02, 1988 KENDALL MeGAN 2.SGH/100HL; ~ ~ N70788 001 330HG/I00HU. N19631 003 AUG 02, 1988 FEB 24. 1988 .Y 10HGII N70776 001 PIXI'ROSE I.'" AHD IOPM CHLOaPE 0."'''' PI 'LAme AUG 02, 1988 COtfT'ADtER !::!l!H Af KENDALL MeGAN 2.5GH!100HL; ~ ~ANTUH PHARMeS ~ N72431 001 4S0MG/I00Hu. N19631 004 APR 29, 1988 FEB 24. 1988 .Y ~ N72432 001 DEXTROSE 2.S% AND SODIUM CHLORIDE 0.9% IN PLASTIC APR 29, 1988 CONTAINER M lID:!!!II N72433 001 KENDALL MeGAN 2.SGH/100HL; APR 29. 1988 900HG/100HL_ N19631 OOS FEB 24. 1988 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DIAZOXIDE KENDALL MeGAN SGH/100HL;110HG/100HL- N19631 006 FEB 24. 1988 CAPSULE; ORAL DIKDIOIE IX AHP 1OPlU1 CHLOR%DI 0. '" Pf ,LAmP COHTAXHER PROGLYCEH Af KENDALL MeGAN SGM/IOOHL;200MG/I00HL- N19631 007 HED tt<.IG SPEC SOHG N1742S 001 FEB 24. 1988 a 100HS N1742S 002 1~/~tltf1-j.~1 I~~~I l~tj(.t~/~~U RX DROO PRODUCT LIST / CutJLATIVE SUPPLEHENT tLtBER 12 / JAN'88 - DEC '88 25 DIAZOXIDE DIPHENHYDRAMINE HYDROCHLORIDE INJECTABLE; INJECTION CAPSULE; ORAL II%AZO)C%DE Ae ~AD PHARHS 151S1HU. N7l908 001 ~~ JAN 26, 1988 D,f'l=". tieL ~. ~~~~~~~~ a LEDERLE LABS 25HG N86874 001 SUSPENSION; ORAL a 50HG N86875 001 PROGLVCEM AA RICHLVN LABS N80807 001 HED ttDOPAMINE HYDROCHLORIDE DICVCLDHIHE HYDROCHLORIDE INJECTABLE; INJECTION DO'AHlHE HOL JH DIXI'ROS' IX %H 'LAmP CONIADIER SVRUP; ORAL Ae BAXTER 80MG/I0QHL N19615 001 UP:D:Ib HAR 27, 1987 AA HERRELL DOH 10MG/5HL N07961 002 !e 160HG/I00ML N19615 002 OCT 15, 1984 HAR 27, 1987 D%Cl'CLCII'mfE ttCL Ae 3?OHG/100ML N19615 003 !A BARRE NATL 10HG/SML N84479 001 HAR 27, 1987 640HG/I00HL N19615 004 HAR 27, 1987 DIETHYLCARBAHAZINE CITRATE IW lfJ1J. .'J~t.lf.Rj~1 Id6tkVtd6t1" j~1. ~ 1.?~~dJl TABLET; ORAL IW IU4~ I'{~l~l~~~~ IrfJ.~/I..1.: I1.~MI I~'~~~~~~~I If.d~1 l~d~~f.1IddU IW "tdtJG)1d6t1(1 a LEDERLE LABS 50HG N06459 001 1'(~~~1%~~~ 1~~dr'¢nddf$.t.I 1~?~1%~~~ DIFLQRASONE DIACETATE CREAM; TOPICAL QQXEPIN HYDROCHLORIDE I~~~~~~rt/~j.~¢tt~tt.{~.d.:df.# CAPSULE; ORAL '/~~~~~~%~~~ MAmI a UPJOHN O.Dg, N19Z59 001 AI PEtHlALT EQ lSQHG BASE N16987 007 AUG 28, 1985 APR 13, 1987 RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUMBER 12 / JAN'88 - DEC'88 26

D~~PIH HY~B~HLOBIDE DOXYCYCLINE HVCLATE CAPSULE; ORAL INJECTABLE; INJECTION POXEPIH HCL IIO)(JCYCUHI AI BARR LABS E9 2.m! ~A~E_ N71502 001 Af BEN VEtfJE LABS E9 102H§ ~A~ElY1A~ N62569 001 FEB 18, 1988 HAR 09, 1988 M fig ~Qt!!! BA~E_ N71653 001 Af E9 ~QOH§ BASE/VIA~ N62569 002 FEB 18, 1988 HAR 09, 1988 AI ~g 7~ BASE- N71654 001 FEB 18, 1988 TABLET; ORAL Eg 10Qt§ I!A~~_ N71521 001 DO)('(CYCL%HE HY'CbaTI • FEB 18, 1988 All INTERPHARH ~g 100HG BASt;;_ N62764 001 CHELSEA LABS Eg 7~ BASE_ N71763 001 SEP 02, 1988 • FEB 09, 1988 AI E9 J,50HG ~AS~_ N71764 001 FEB 09, 1988 DROPERIDOL AI LEDERLE LABS fig 10t§ BASE_ N71685 001 JAN 05, 1988 INJECTABLE; INJECTION AI ~g g.m! lASE_ N71686 001 PROPEUDOL JAN 05, 1988 AI! ABBOTT LABS 2.5HG1t1~ N71981 001 AI E9 ~OHG BASE_ N71673 001 FEB 29, 1988 JAN 05, 1988 Af ASTRA PHARH PRODS 2·SHG/HL- N72018 001 (g 75HG ~AS!;_ N71674 001 OCT 20, 1988 • JAN 05, 1988 Af 2.5HG/H~ N72019 001 AI (g lOOt!!! BAS!;_ N71675 001 OCT 19, 1988 JAN 05, 1988 AI! 2.SHG/HL_ N72020 001 AI Eg 150HG ~AS~_ N71676 001 OCT 19, 1988 JAN 05, 1988 Af g.5HG/H~ N72021 001 AI PUREPAC PHARH E9 ZSHG BASE_ N72386 001 OCT 19, 1988 SEP 08, 1988 Ae DUPONT CRI CARE 2.5HG/H~ N71645 001 M Eg 100HG BASE_ N72110 001 APR 07, 1988 SEP 08, 1988 Af LUITPOLD PHARHS 2.5HG/H~ N72123 001 All Eg 150HG BASE_ N72387 001 OCT 24, 1988 SEP OS, 1988 Af 2.5HG/H~ N72335 001 OCT 24, 1988 CONCENTRATE; ORAL Af QUAD PHARHS 2.5HG/H~ N71941 001 !)o)cEPJH HCL AUG 17, 1988 M MY K LABS Eg 10HG ~ASE/H!.JI N71918 001 Af 2.5HG/H~ N71942 001 JUL 20, 1988 AUG 17, 1988 AP SOLOPAK LABS g.5HG/H~ N71750 001 SEP 06, 1988 DOXYCYCLINE HYCLATE Af 2.5HG/H~ N71754 001 SEP 06, 1988 CAPSULE; ORAL Af g.5HG/H~ N71755 001 DOX'ICY~L%HI HY'CbaII SEP 06, 1988 g INTERPHARH Eg 50HG BA§~- N62763 001 SEP 02, 1988 AI fig 100t§ ~AS!;_ N62763 002 SEP 02, 1988 AI YITARINE fig 50H§ IA~fi- N62780 001 APR 12, 1988 ..

RX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEMENT tueER 12 / JAN'88 - DEC'88 27

DROPERIOOL i FENIANYL CITRATE EHALAPRILAT

INJECT ABLE; INJECTION INJECTABLE; INJECTION FEHrAH'CL CJTRATI AND DRO'IR%D9L YASOTEC A! ABBOTT LABS 2. SHGIHL; HS&D RES LABS 1. 25HG1H1.II N19309 001 [g O. 05HG BASElHl.II N71982 001 FEB 09, 1988 HAY 04, 1988 pttOVAR A! JANSSEN PHARt1A 2.5HGIHL; EPINEPHRINE; LIDocAINE HYDROCHLORIDE Eli O. 05HG BASElHl.II NU049 001 INJECTABLE; INJECTION LlD9CAXH1 HCL AHD EPPlEIIH!gHI DYDROGESTERONE A! ABBOTT LABS O.OO5HGIHL;~ N89635 001 Jt.tI 21, 1988 I!!.dun I~!.t./ A! O.OOSHGlHl;~ N89649 001 1¢,J,.(Mt~t'l J\.tf 21, 1988 /fm~fFl~tttl A! O.OO5HGIHL;~ N89645 001 ~~I ~~gm~~~~~ J\.tf 21, 1988 a KALI DUPHAR 5HG N17388 001 A! O.OOSHGIHL;~ N89650 001 a 10HG N17388 002 Jt.tI 21, 1988 A! O.OOSHGIHL;~ N89651 001 Jt.tI 21, 1988 EDETAIE CALCIUH DISQDIUH A! O.OlMGIHL;~ N89644 001 Jt.tI 21, 1988 Iti04ttt'IMi'l A! O.OlHGIHL;~ N89646 001 ·?¢!.'¢~~ai~J~/~FI~t~!tJ/ J\.tf 21, 1988 I~J~tFl/t!.P~f . I$~/~/ 1~~6~#/~#1 ~I HCL Nt IPPlI7l!r~ IIJJ J.I '(W /t¥~(.I;f,/~~'J/ TABLET; ORAL a LEHHON O.OlHGIHLjlX N85463 001 CALCIUH DISODIUH VERSENATE JCYLOCgHI Nt IPPIEPHRDfE a RIKER LABS 500HG N08922 002 AI! ASTRA PHARH PRODS O.OO5HGIHL;~ N06488 013 AI! O.OOSHGIHL;~ N06488 018 NOV 13, 1986 EDROPHQNIUH CHLORIDE A! 0.005HG1HL;~ N06488 019 NOV 13, 1986 INJECTABLE; INJECTION REVERS9L A! ORGANON 10HG1H1.II N89624 001 ERGQLOID HESYLATES HAY 13, 1988 TABLEH ORAL EHlLAPRIL MALEAIE IW 1~~t~11"' /1JW /~~:~~~~~ TABLET; ORAL AI!II:D1AL VASOTEC AI ChELSEA LABS l!fi N88207 001 HS&D RES LABS 2.5HGII N18998 005 HAR 22, 1984 JUL 26, 1988 TABLET; SlBLINGUAl ~~/_~~/ ~fir ~~~~~1~ a RIKER LABS 0.5HG N84868 001 a lHG N85809 001 RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEHENT NUHBER 12 / JAN'88 - DEC'88 28

ERGQLOID MESVLAIES ERYTHRQHYCIN ETHYLSUCCIH.uE i SULFISOXAZOLE ACETYL TABLET; SUBLINGUAL GRANULE; ORAL IJm1RCIt1'I cn4 mt'tL!UCCEHATI AHD SlLfPQICAZOLi ACmL $/~1~~~a~~ AI BARR LABS EQ 200MS BASE/SMLi ~~~~~~~ EQ 600MS BASE/~ N62759 001 DER:D1AL HAY 20, 1988 !A CHELSEA LABS ~ Ha6189 001 ER)'ZOLI .M •1m Ha6188 001 AI ALRA LABS E9 200HG BASE/SHli EQ 600HG BASE/SHlII N62758 001 JlI.I 15, 1988 ERYTHROHYCJN PEDJAZOLI AI ROSS LABS e9 200HG BASE/5ML; E9 600HG BASE/SH~ NS0529 001 AI ga. N62957 001 JUL 21, 1988 ERYTHROHYCIN LACTOBIONATE ~ AI PADDOCK LABS 1-%M N62687 001 INJECTABLE; INJECTION FEB 05, 1988 PmtROCPt !!! ABBOTT LABS EQ 50 OMS BASEIVIAlII N62586 001 TABLET, ENTERIC COATED; ORAL JAN 04, 1988 I-BAII ~ EQ ISH BASE/vIAlII N62586 002 AI BARR LABS ~ N62999 001 JAN Olt, 1988 NOV 25, 1988 ERY-TAB ABBOTT LABS 500HG N62298 002 ERYTHROHYtIN STEARATE

ERYTHROH'tqN ESTOLATE i SUlFISOXAZOLE ACETYL SUSPENSION; ORAL ~IfHft ~~~~~~~~ ILOSONE SULFA EQ 250MG BASE N61301t 001 LILLY E~ 1Z5HG BASE/SHL; EQ 250HG BASE N61887 001 E~ 600HG BASE/SHlII NS0599 001 SEP 16, 1988 ~HtI~ ~~:~~~::l~ E~ 250MG BASE N62032 001 ERYTHROHYCIN ETHYLSUCCINATE EQ 500HG BASE N62032 002 TABLET; ORAL IW IH..:~~MUAU/ 1~~~~.4/~~U DtTHRCM) CJH mtrl.!tUCCEHATI EQ 125HG BASE N60359 002 AI HYLAN PHARHS E9 1t00HG BASE- N6281t7 001 SEP lit, 1988 ~~ ~~~,~~~~~~ TABLET, CHEHABLE; ORAL it LEDERLE LABS N62089 001 IBUU it N62089 002 AI ABBOTT LABS Eg 200HG BASE- NS0297 003 .JUL 05, 1988 /t!U.dmiOOO /~j.j~U~~U IW '~f~'''~~1a PFIZER LABS EQ 500HG BASE N61791 002 !DC DRUII PRODUCT LIST / ClK./LATlV! SUPPLEMENT tueER 12 / JAN'. - DEC'ea Z9 ESHQLOL HYDROCHLORIDE ETHltffL ESTRADIOL

INJECTABLE ~ INJECTION TABLET; ORAL BREVIBLOC DUPONT CRI CARE 10HG/t1lJ1 N19386 001 11S~/t?l~1 AUG 15. 1988 ~fJI~ a ORGANON O.OlHG ~J'~:~~~~~N05490 003 a O.OSHG N05490 002 ESTRADIOL FILM. CONTROLLED RELEASEl PERCUTANEOUS ETHltffL ESTRADIOL l NORETHINDRONE ESTRADERM CIBA PHARH 0.0SHQ/24HR N19081 002 TABLET; ORAL-21 SEP 10. 1986 ttDRma:H VUI-Il 0.lHG/24HR N19081 003 AI SEARLE PHARHS 0.035f1G;}!P N71480 001 SEP 10. 1986 APR 12. 1988 I~I HORma:tfllROtII AHP mmrtL ESTRADmL AI KATSON LABS 0.035HG~0.5HG AND 1~ N71043 001 I~I '~'~~i~1~~~~~ APR 01. 1988 1~,~~~r:~~M~ OR'IltO-HOVU1 llVl1-11 AI ORTHO PHARM 0.035HG~0.SHG AND IMG N18354 001 JAN 11. 1982 ESTRANUSTINE PHOSPHAIE SODIUM TABLET; ORAL-28 CAPSULE ~ ORAL HORITKDt VISE-II EHCYT AI SEARLE PHARHS 0.03SHG~lH!iIC N71481 001 >JIlIL> PHARHAClA LABS E~ 140HS PHOSPHATE N18045 001 APR 12, 1988 >...m.L> 1~~tI It~~~~~/~~ftl I~~~~~/~~U HDRmmtOROHI AND mmtyL IIIJtADmL AI KATSON LABS 0.035MG;0.5MG AND 1~ N71044 001 APR 01. 1988 ESTRONE ORDtCt-H!M.l1 llVl1-11 AI ORTHO PHARH 0.035MG;0.5MG AND 1HP N18354 002 INJECTABLE ~ INJECTION JAN 11, 1982 ESTRONE I~~I l~ft~t~/~~1 I~~t./ 1tV.~tJ~/~~U STERIS LABS SHGIHL N85239 001 ETHIODIZED OIL THEELIN ~~~~ 1~~~t/~A~t~1 ~~~~~ ~~l~U~~'~~ lJ.tUt~f~t.t.J/ttVt¢ft~1 a PARKE DAVIS IHGIHL N03977 001 . ft~~~~~1 1~~t.1 I~~~~~~/~~~I a SHGIHL N03977 003 OIL~ INTRALYHPHATIC. INTRAUTERINE ETHIODOL >-AJm... > ETHANOLAHINE OLEAIE SAVAGE LABS 991. N09190 001

>...Alm...> INJECTABLE ~ INJECTION >-AJm...> ETHAHDLlN ETHYLESIRENDL >...!mL> GLAXO 50HGIHlJI N19357 001 >...!!HL> DEC 22. 1988 >.JH.L> >.JH.L> If~"~J.ly~ >....lU.L> IJ~I 1~f.~~~~/~#1 >-AIUL> aI""~~ ORGANON 2HG N14005 002 AX DRUa PROOUCT LIST I ClHJLATlVI SUPPLEMENT N.JeER 12 I JAH'88 - DEC'" 30

FENOPROFEN CALCIUM F~QfEI'l CAlCW1 ( CAPSULE; ORAL TABLET; ORAL EIlm~EIH ~I all E_~E@t ~LCDM AI AM THERPTCS Eg ~!U!t!!2 DA~E- N72307 001 All PUREPAC PHARtt Eg i!!QtI!i t~E- N72274 001 AUG 22, 1988 . HAY 02, 1988 AI Eg ~!!Ots ~§E- N72308 001 AI QUANlUt PHARMeS Eli §o!!m lASE- N72194 001 AUG 22, 1988 APR 14, 1988 All CORD LABS Eg ~!!Ot!!Z DA~E- N72394 001 .AD MATSON LA~e; Eg 60QHG M~E- N7216S 001 OCT 17, 1988 .JUL 08, 1988 AI Eg ~OOt§ ~A~E- N72395 001 AI ZENITH LABS Eg §OQ!S ftASE- N72557 001 OCT 17, 1988 AUG 29, 1988 .AD HALSEY DRUG Eli gOOtS BASE- N72355 001 Ha.!.fmf .ruL OS, 1988 All DISTA PRODS Eli 6QOHG ~ASE N1n10 001 !Il Eg ~OOHG DASE_ N72356 001 .JUL OS, 1988 AD PAR PHARtt Eg ~!!Qt!!Z DA~Ii- N72437 001 fIiBRQY§ ~LFAIIi fQLI~ ACID AUG 22, 1988 AD Eg 300HG BASE_ N72438 001 /~!'(J~~~t)jl-tl AUG 22, 1988 If'" . ~ M . QUANlUt PHARHCS Eg gOOt!!Z BA~E_ N72214 001 ~tlStil.' tlt.l.6# n#~J4.:j,j,r"¢/ /~4('4"#/44j,/ APR 14, 1988 a LEDERLE LABS 182HG;0.33HG N06012 003 M Eg ~OOHG DA~E- N71738 001 APR 14, 1988 M HATSON LABS Eg 200HG lASE_ N72294 001 fLECAINIDE ACETATE .JUL 08, 1988 AD Eg ~go!:§ ~A~E- N72293 001 TABLET; ORAL .ruL 08, 1988 TAHBOCOR ~ RIKER LABS 50~ Nl8830 004 AI DISTA PRODS Eg ~OO!:§ BA~E N17604 002 AUG 23, 1988 HALFOH ZOO 15~ Nl8830 003 .AD DISTA PRODS Eg 200HG BASE N17604 003 ~ 03, 1988 TABLET; ORAL EENOPROFEH CALCDM fbUOCI~L~ ACIiTONIDE AI AM THERPTCS Eg §00t!,! BASE_ N72309 001 ~ 16, 1988 CREAM; TOPICAL AD CHELSEA LABS Eg §OOtS BAS!;;_ N72407 001 EW0C'D40LOHE ACET'OKEDI .JUN 13, 1988 AI GIN LABS 0,01%11 N89526 001 AI CORD LABS Eg §OOHG BA~E_ N72396 001 .JUL 26, 1988 OCT 17, 1988 AI 0.025%11 N89525 001 All DANBURY PHARHA Eg 600tS BASE_ N72602 001 .JUL 26, 1988 OCT 11, 1988 AI HALSEY DRUG Eli 600t!,! BA~!;;_ N72357 001 OIL; TOPICAL JUL OS, 1988 DERHA-SHOOTHE/FS AI LEDERLE LABS Eg §QQHG BASE_ N72326 001 HILL DERtt 0.01%11 Nl9452 001 APR 20, 1988 FEB 03, 1988 AD HYLAH PHARMS Eg §OOHG BASE- N72267 001 .JUN 08, 1988 OINTMENT; TOPICAL Aft PAR PHARtt Eg §OQt!,! j!ASE- N72429 001 EI..IJOCD4OLOHI ACETOHEIII .JUL 19, 1988 AI GIN LABS 0.025%11 N89524 001 .AD PHARM BASICS Eg 6001:§ BASE- N72362 001 JUL 26, 1988 .JUN 16, 1988 .. ~ .. .

It)( DRUG PRODUCT LIST I CUlJLATIVE SUPPLEMENT tU1BER 12 I JAN'88 - DEC'88 31

FLUOCItDqDE FLUPHEHAZINE HYDROCHLORIDE

CRE~; TOPICAL TABLET; ORAL Ft.UpC:lHDHDl PERHITIL AI CLAY PARK LABS ~ H71790 001 BP SCHERIHG 2.SI1G N12034 004 APR 25, 1988 BP SI1G N12034 005 BP 101C H12034 006 SOLUTION; TOPICAL >-AJHL> FWOCDtOHEDE ~~ ~~fIf' ~~~~~~~~~~;~ >...AIllL> AI BARRE NATL ~ H71535 001 I~I U~(tf;1 lt4~~l~(./~1(.1 >...AmL> DEC 02, 1988 ~ >..AIllL > AI SYHTEX LABS ~ Hl8849 001 FLVRAZEPAn HYDROCHLORIDE >...ADJL> APR 06, 1984 CAPSULE; ORAL FbURAZEPA!1 HCL FLUOROURACIL ~ HALSEY DRUG ~ H71808 001 JAN 07, 1988 INJECTABLE; INJECTION AI EtP H71809 001 FL.UORCURACJL JAN 07, 1988 !! BEH VENJE LABS 50HGIHLII H89508 001 AI SUPERPHARH ~ H71659 001 JAN 26, 1988 AUG 04, 1988 AI mP H71660 001 AUG IY+, 1988 FLupHENAZINE HYDROCHLQRIDE

INJECTABLE; INJECTION FLURBIPROfEN FW,"fNAlP'1 HCL !! QUAD PHARtIS 2. !jHG/HLJI H89800 001 TABLET; ORAL ~ 08, 1988 ANSAID UPJOHH SOHGII H18766 002 TABLET; ORAL .OCT 31, 1988 EWPHEHAZDtI !:!Rio 100HGlll H18766 003 I AI HYLAN PHARMS J.t!!iII H89801 001 OCT 31, 1988 AUG 12, 1988 ~ z.Jit!!iIC H89802 001 AUG 12, 1988 FOLIC ACID AI :zH!ZIl H89803 001 lUG 12, 1988 TABLET; ORAL .Y l!!!P H89804 001 AUG 12, 1988 IW '~7m~1 11M! AI PAR PHARM ltP H89740 001 IJ~~~~~~ lUG 25, 1988 a BARR LlBC 1MG H89177 001 AI ~ H897ft1 001 JAN 08, 1986 AUG 25, 1988 AI :zH!ZIl H897ft2 001 AUG 25, 1988 FUBOSEHIDE !It ImP H897ft3 001 lUG 25, 1988 INJECTABLEJ INJECTION IW '"imlmll/t~1 ItdtMb4!:1 If'~~'~~i~~~ RX DRUG PRODUCT LIST / ClHJLATIVE SUPPLEHENT tlJoBER 12 / JAN'88 - DEC '88 32

FUROSEHIDE GRAMICIDIN; HEOHYCIN SULFATE i POLYMYXIN B SULFATE

INJECTABLE; INJECTION SOLUTION/DROP$; OPHTHALHIC fUROSEKE!)I HEOH'I CDt AHD POL'I'tmCDf I "'LFATD AHD p!tAI1ICIIIDf .Af HARNER CHILCOTT IOMGIHL Nl8420 001 AI IPHARM 0.025HGIHLiEg 1.75HG BASEIHL; FEB 26, 1982 10.000 YNIISIHUI N62S1S 001 OCT 11. 1988 TABLET; ORAL fUROSEKEDI AI BARR LABS ~ N70100 001 GYANABENZ ACETATE JAN 26, 1988 !Ii DANBURY PHARHl §Q!!,!II N71594 001 TABLET; ORAL FEB 09, 1988 1~1~~~~~~jt~~j/~/ It~j~/~~tl /~'~~~~~i~~~ GADOpENIETATE DIHEGbUHINE a HYETH AYERST LABS EQ 16HG BASE N1SSS7 003 SEP 07, 1982 INJECTABLE; INJECTION ttAGNEVIST BERLEX LABS 469.01HG/HUI N19596 001 GUAHFACINE HYDRocHLORIDE JU\1 02, 1988 TABLET; ORAL TENEX GALLI"" CITRATE. GA-67 >....!mL> ROBINS 2HG11 N1903Z 002 >..!mL> NOV 07. 1988 INJECTABLE i INJECTION >--A!m..> 3HG11 Nl9032 003 GALLIUM CITRATE GA 67 >--A!m..> NOV 07. 1988 l~t~t/~j~t¢~1 Ij~t~1 /~jjj~~/~~U a HEDI PHYSICS IHCIIHL NIZ700 001 HALOPERIDOL

GENTAMICIN suLFATE TABLET; ORAL HALDOL SOLUTAB SOLUTION/DROPS; OPHTHALHIC /~/~~ttt./~M /j~/ I~H~j~/~~U PEHTAHICIH SULFATI a HCNEIL PHARH lHG N17079 001 AI PACO RES Eg 3HG BlSEtHUI N62932 001 HALOPm;DOL NOV 07, 1988 AI! BARR LABS ~ N71212 001 JAN 07, 1988 AI .l.2tP N71173 001 GENTAMICIN SULFATE i PREDNISOLONE ACETATE JAN 07. 1988 AD zmp N71177 001 SUSPENSION/DROPS i OPHTHALHIC JAN 07. 1988 PRED-G ALLERGAN PHARMS EQ 0.3% BASEiVOl N50SS6 001 JU\1 10. 1988

6LYCOPYRROLlTE

INJECTABLE i INJECTION PL'tROPDROLATI AI! ABBOTT LABS O.2HG/HUI N89393 001 JU\1 15. 1988 .,.

RX DRU9 PRODUCT LIST / ClKJLATIYE SUPPLEtI!NT IUtSEIt 12 / JAN'88 - DEC'88 :s:s

HALOPERIDOL HePARIN SOOIU1

TABLET; ORAL INJECTABLE; INJECTION HALOPIR'IDOL M BOLAR PHARH L.miII N71S71 001 lill "~LU!II IU' '\JtttHbtI:/ 1~~_~~{t/A1AI .JUiI 03, 1988 a ABBOTT LABS 100 UUTSIHL NOS264 010 AI It:P N71S72 001 >..J1J.L>IW 1~1t~~~/~1 ,,~ 1~1jA~!tIA~1.I .JUiI 03, 1988 >~> a STERIS LABS 100 IIfITSlHL N17064 001 M mill N71S73 001 "EPARDt LOCK FLUItt 1M PLASTJQ OOKIA1HR JlIf 03, 1988 Af ABBOTT LABS 10 UNIISIHL NOS264 01S AI ~ N71374 001 HAY 21, 1985 JlIf 03, 1988 Af 100 lMISIHL NOS264 016 AI .l.Q!P N7137S 001 HAY 21, 1985 .JUiI 03, 1988 AI .m:P N71376 001 IW ",_lJr"" I~~ 1~1j~j~/~A"J1 .JUiI 03, 1988 a LYPHOHED S,OOO IIfITSlHL N17979 003 AI CORD LABS ~ N71210 001 1~1t~~~/~1 l~t:I~~/A1_1 HAR 11, 1988 >..J1J.L>/>~>/~ AI 1!!tP N71211 001 >..J1J.L>/ ~H~~~~~~ HAR 11, 1988 >....AIHL> a STERIS LABS ~~2,SOO IIfITSlHL N17064 01S >-'!LL> 1"J.;AA~/~U~~t./ 1~j.j"!t/~1~1 >....M!L.> a 3,000 IIfITSlHL N17064 016 HALOPERIDOL LACTATE >..J1J.L> H+.:~A~/~~1~*1 I~j.j~~!t/~j.jf >...!ruL> a 4,000 IIfITSlHL N17064 017 CONCENTRATE; ORAL >..J1J.L> 1~.;~.dA/~~#~t/ 1~j.j~~!tIA161 ~ >....M!L.> a 6,000 ltfITSIHL N17064 018 I'" l~t~~/~~1 .~t4d '''4f.1rli.1 1~j:~~#/~~1.I >....M!L.> a 7,SOO mITSlHL N17064 019 M HCNEIl PHARH 1ft 2m BASEIHL N1S922 001 >AIL> a 40,000 mITSlHL N17064 006 ttALOP!R%DOL "!PARDI 100M lit ,LAme CON1'Apta >....M!L.> M COPLEY PHARM Ea 2m BA$ElHlJI N71617 001 Af LYPHOHED 1.000 VNITSIMl N17029 013 >....!!m...> DEC 01, 1988 DEC OS, 1985 ttALOPERIDOL IKTItIIOL Af S.OOO mITSlHL N17029 014 M ROXANE LABS Ea 2m BASElHlJI N7204S 001 DEC OS, 1985 APR 12, 1988 Af 10.000 YNITSlHL N17029 01S DEC OS, 1985 INJECTABLE; INJECTION Af 20.000 UNITSIHl N17029 016 ttALOPER%DOL DEC OS, 1985 Af LEI't1ON Ea 5HG BASElHlJI N70713 001 "EMRDf IODNt 10.000 UHETS PI DEXTROSI S? PI P!.ASUO HAY 17, 1988 !f Ea 5HG BASElHlJI N70714 001 lill /fIIMfl~1 1'6;666'ddtt$lt6~/ /~~~~~~/AAj/ HAY 17, 1988 1rfH1.1t1.:n~~/ Af Ea .5MG BASE/HlIl N70744 001 a ABBOTT LABS 10,000 IIfITS/100HL N19339 003 HAY 17, 1988 HAR 27, 1985 "!pARDi !IIODm1 1000 WED AND 1ODJU1 CI1LC1R1D1 o·n Dt ,LAmP COHTAZHEB HEPARIN SOOIl", Af BAXTER 200 mITS/10OHL N18609 001 APR 28, 1982 INJECTABLE; INJECTION IW 1~1.:Jt~t/~1 Itd"ddtt$I"6~1 HIP F!.U!H gr Pi PLAIID COHTAZHa 11.~m:~'i~~~ Af L YPHOH£D 10 IIfITStHL N17029 017 DEC OS, 1985 Af 100 YNITSlHL N17029 018 DEC OS, 1985 RX DRUG PRODUCT LIST I ClKJLATIVE SUPPLEHENT tu1BER 12 I JAN'88 - DEC '88 34

HEPARIN SODIlt1 HEXOCYCLIlJ1 METHYLsuLFJll INJECTABLE; INJECTION I~ 'tt;dd' ':'~JltJhHt 'It ';bI'#'1.tttd1 '1~~~~'fr~t' 'r~/~11/~~1 Uf.rV;1 I~J~~~~/~~JI I~ . . ~I 1j;d6, 'dtIffl)t.HmJ 1~'H~~.41~~tI 1rfJ.~/tJ.,/H~~1 TABLET; ORAL a ABBOTT LABS 5,000 UNITS/I00HL N19339 001 TRAL HAR 27, 1985 ABBOTT LABS 2SHG NI0599 001 HEPARDf !IOQ%U1 1000 UKrII AND !IOD2U1 CI1!.OREPI o.n ;pt PLAme potfIAptER Af BAXTER 200 UNITS/I00HL N18609 002 HYDRALAZINE HYDROCHLORIDE APR 28, 1982 1~~~I.~d 'dtIffl'NIIf '_6d~'dtftJ(t ,,:td 'W TABLET; ORAL I~ Jm%. ~ I~ u~}~:~1~~:~~ IW "i~1 1M! I~~~:~~~~~ H"ARDI !IOQ%U1 15.000 UHETS Pi OEX1"RO!lI IZ Pi PLASl'JC a PUREPAC PHARH SOHG N88178 001 AUG 15, 1983 I ~ /fIliaHi'f.J.6~1 1r&~}~~11~~~~ I~ HYDRALAZINE HYDRocHLORIDE; HYDROCHLOROTHIAZIDE a ABBOTT LABS 5,000 UNITS/I00HL '~7~~11f~:~~N19339 004 CAPSULE; ORAL HAR 27, 1985 ~ a 10,000 UNITS/I00HL N19339 002 M REID ROHELL ~;2SHG N87608 001 HAR 27, 1985 FEB 08, 1982 HIPARDI !IOD:lU1 BODO UHJ:TS AND !100M CI1LOR%DI 0.".1. ;pt ~ ~;5OHG N87213 001 PLAST.EC CCHTADfER FEB 08, 1982 !f BAXTER 500 UNITS/I00HL N18609 003 I~I 1~f.rV;}~~~1 APR 28, 1982 If'~~~1'i~~~ I~ 1~~~t~t/~~1 I~~ 1~~}~~1~~:~~ I~I 1~6t'¢J~~~1 If,~~~~,r~~~ 1~~ __6!fDJrt '#If"ti~~tW . lUI -I~~ I -11t.H~ 1~~'~~1~~~~~ HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE I~ 1~;ddd'~'1 1~.d~~~~/~JU TABLET; ORAL I~ IU~ I~~~~~~~r~~~ RESERPINE, HYDRALAZINE HCL AND HYDROCHLOROTHIAZIDE I ~(it;.IJJ.;h~~~1 IJ!n l~ttJj/~~Ut./ l~fJ:~'!~.:j.~1 ltlf>j#~/~~JI a ORGANON 1,000 UNITSlHL N00552 011 BP REID ROHE'_L 2SHG;1SHG;0.IHG N88376 001 APR 11, 1986 OCT 28, 1983 a 5,000 UNITSlHL N00552 012 a 2SHG;ISHG;O.IHG N87210 001 APR 11, 1986 a 10,000 UNITSIHL N00552 013 I~I Uf.rV;.!Jf.rV;J~;j.~1 l~m~~~~~:~~ APR 11, 1986 1~~/~,~~~e~~1j~~t~~~1~~~~~tAtt~tf~Jj~4/~~JI 'i~~iSr p r-r<~ ~I /J. . ~. IllYhJ:II.H>U 1~j.~~~~/~~U a LEDERLE LABS 2SHGjlSHGjO.lHG N87709 001 ~j~~~~~~~~ HAY 13, 1982 ~~ a LYPHOHED ~m1~5,000 UNITS/HL N17033 002 a 10,000 UNITSIHL N17033 003 a 20,000 UNITSlHL N17033 004 .,

RX DRUG PROOUCT LIST / CI.HJLATIVE SUPPLEHENl' tueER 12 / JAN'88 - DEC'88 35

HYDROCHLOROTHIAZIDE HYDRQCHLOROTHIAZIDE1HETHYLDOPA

SOLUTION; ORAL TABlEn ORAL ml!lIOCI1LOROTHrAZ1:DI HITH'I""ImPA MI tI'tDIlODI~1 AA 1ft K LABS 5O!1G/SHUI N89661 001 AI NDVOPHARH llH!i ;§lHfiII N71819 001 .JUN 20. 1988 APR 08. 1988 AA ROXANE LABS 5ot1G/5HL N88587001 AI .mfi;U2!P N71820 001 JUL 02. 1984 APR 08. 1988 AI EH!i;~ N71821 001 TABLET; ORAL APR 08, 1988 .AI ~;~ N71822 001 ~1IOCI1~1 APR 08. 1988 ~t~ ~~~~,~~ IW lM1t~#/~1 IWMJ~ it BANHAX PHARttS ~-2SHG N86369 001 1~~1~~1%W~ it 50tG N83554 001 it PURE PAC PHARM 50HG;50OHG N70689 001 !I HARNER CHILCOTT llH!i N87586 001 APR 2~. 1986 HAY 03, 1982 AI HATSON LABS 11!!1!;~ N71920 001 !I SH!i N87587 001 AUG 29, 1988 HAY 03, 1982 AI ~;~ N71921 001 AUG 29, 1988 IW/~:Jt~1 IUW AI ~;~ N71922 001 AUG 29, 1988 IW 1M! !I im!i;~ N71923 001 I1f~~ . 1~r:Ji~t~ AUG 29, 1988 AI ZENITH LABS .lmi;~ N71458 001 MAR 08, 1988 HYDROCHlOROTHUZIDELlABETALOL HYDROCHLORIDE AI 12I!i;~ N71459 001 MAR 08, 1988 TABLEn ORAL AI lJ!I::I!I ;smp N71460 001 NORHOZIDE HAR 08, 1988 l~t""t~1 I~Jt+~~1 AI 5OHG;~ N71461 001 I~~~~~~~:~~ MAR 08, 1988 it SCHERING 2SHG;40OHG N19046 004 APR 06, 1987 TRAHDATt; H!l[ HYIl~HLOROTHIAZII:!~ i eltmQLQL AI GLAXO n!1!i;lm!!!i N19174 001 APR 10, 1987 TABLEn ORAL AI .m!i;~ N19174 002 APR 10, 1987 N~~'~I I~J~I g ~;~ N19174 003 APR 10, 1987 1t~#~~1 IJ~:~~~Jl~ it 25HG;400HG N19174 004 APR 10. 1987 a SANDOZ PHARMS 2SHI;J5HG ,~~H~'~J~~Nl8872 001 JUl 22. 1987 /W IW.!ddt1 /UMfillJW I 25HG;101C Nl8872 002 JUL 22, 1987 /W / ~*JJtfllitIdI 'fWl~~Z .t1.~ ~tl IW IUM1lliW / ~.t~~~~l~ /~~l.t "~~~ IW 1t8'lft+~~/ ,~~M/r~~~ RX DRUG PRODUCT LIST / C\HJLATIVE SUPPLEHENT If..to8ER 12 / JAN'88 - DEC'88 36

HYDROCHLOROTHIAZIDE i PROPRANOLOL HYDROCHLORIDE HYDROCHLOROTHIAZIDE; TRIAHIEREHE TABLET; ORAL TABLET; ORAL PROPRAHOL9L HCL AMP trtPROCtf!...ORO'lHrAZl:DI IDAHTPDfI AND trtDROqfLORODqAZtDI .AI SIDHAK LABS ~j~ N72042 001 .AI DAteURY PHARHA 5ot1G;~ N71969 001 MAR 14. 1988 JAN 15. 1988 Aft ~jlmP N72043 001 M PAR PHARH 50HG;~ N72337 001 MAR 14. 1988 HAY 11. 1988 M HARNER CHILCOTT llmj~ N71771 001 AI QUANTlM PHARHCS 5ot1G;~ N71980 001 JAN 26. 1988 FEB 01. 1988 AI! !lit!!! j 80HGM N71772 001 .AI MATSON LABS ~;7SHG11 N71851 001 JAN 26. 1988 NOV 30. 1988 >-AJm...> .AI ZENITH LABS 25HG;40HGM N71552 001 >...AIlIL> DEC 01. 1988 >...AruL> AI nm;8011G11 N71553 001 HYDROCORTISONE >...!JlIL> DEC 01. 1988

HYDROCHLOROTHIAZIDE; RESERPINE AI .@I N89706 001 HAR 10. 1988 TABLET; ORAL AI ~ N89682 001 HYDROCHLOROTHIAZIDE NI RESERPINE HAR 10. 1988 l'J/~#lftl~F1~1 1~~J~.:j.~~1 1t¥~('#/~.6f.1 AI N'1C LABS ~ N87795 001 a PHARHAFAIR 25HG;0.125HG N85421 001 HAY 03, 1983 RESERPINE AND HYDROCHLOROTHIAZIDE mpROTEX AI SYOSSET LABS .01 N87427 001 ~~~~ 1~~F1It.J$# ~~=J'J~=~ ~~~,~~~~~~ APR 04. 1988 a BARR LABS 2SHGjO.125HG N84S80 001 a· 50HGiO.125HG N84579 001 IIi1I 1.t.J$~1 lUI I~~~lm~~~ HYDROCHLOROTHIAZIDE; SPIRONOLACTONE LOTION; TOPICAL BETA~C TABLET; ORAL AI BETA DERM 11)1 N89495 001 tV trt~1 JAN 25, 1988 IW ImmLACTOHJ~t.f.7tApr ~ I~j~j.j./~~j./ trtDROCORT%SOHE a LEDERLE LABS 25HG;25HG N87511 001 AI NASKA PHARHA 11)1 N89705 001 APR 25. 1988

HYDROCHLOROTHIAZIDE; TRIAMrERENE OINTHENT~ TOPICAL ~ (Hl'DAOOORlUOHl) CAPSULE; ORAL ~~/)IV~~/.IfMI TRrAHJ'ERItII AMI HrDBOCIfLOROIHrAZEDI ~1~rJ/ ~~~~:~~i~~:~~ AI VITARINE ~;~ N71737 001 AI CIM PHARHA 12: NaOlt81 ODZ FEB 12. 1988 HIDAOCORT"J:SOH' AI NASKA PHARHA li:M N897D4 001 TABLET; ORAL HAR 10, 1988 tw

IffDROCORTIS(M i NEOH'fCIN SULFATE i PO!.'fH'fXIN , SUlFm HYDBOFLUMEJHIazIDE

SUSPENSION/DROPS, OPHTHALHIC TABLET; ORAL H!p1)cmt AND POLnmaH , "'LEAla AHD tn'DROOOBipotfl AI STERIS LABS ~;Eg 3.H BASEIHL; /W "J~rl /wa/ 10.000 UHITSlHu. N6287. 001 1~~A~~~i~ HAY 11, 1988 a BOLAR PHARH 50HG N88031 001 APR 06, 1983

HYDROCORTISONE ACETATE HYDROxyPRQPYL CELLULOSE CREAM; TOPICAL INSERT; OPHTHALHIC IW "l_~rrATl/W LACRISERT Im1~~'~~~ HS&D RES LABS 5H9 N18771 001

IffDROCORTISONE ACETATE i PRAHOXINE HYDROCHLORIDE HYDROXYZINE HYDRocHLORIDE

AEROSOL; TOPICAL IPlfCW4 AI REED & CARNRICK ~j~ N86.57 001 IIJJ I'MWIJ 1tt61~1.~/AAtl AI ~j~ N89440 001 IIJJ I ddrlt4Jrlt(,l I~?~~~j~~~~~ HAY 17, 1988 Ufit1.IM:n§l,U a ALTAm 2HIHL N87273 001 APR 20, 1982 IffDROCORTISONE ACETATE i UREA a SOHGIHL N87273 002 APR 20, 1982

SYRUPj ORAL AI N80505 001 tn'DROXl'ZPfI HCL M NASKA PHARHA l°tlG/SHu. N88785 001 AI N89472 001 FEB 03, 1988 JlJ\I 13, 1988 TABLET; ORAL tn'RROX'tZ%NI HOL HYDROCORTISONE BUTYRATE AI HALSEY DRUG l2tP N89366 001 HAY 02, 1988 SOLUTIONj TOPICAL AI mP N89117 001 tf'tl'!f!OCORTDOHI IIUIlRAII HAY 02, 1988 AI GIST BROCADES ~ N19116 001 g 5mP N89396 001 FEB 25, 1987 HAY 02, 1988

1_~~~t~1 1~;tt.1 1f'~~1~~~~~:~~ ~ AI C»4EN LABS JL..L%M N19819 001 SEP 15, 1988 R)( DRU9 PRODUCT LIST I ClHJUTIVE SUPPLEMENT tueER 12 I JAN'sa - DEC'sa 38

IBUPROFEN IMIPRAMINE HYDROCHLORIDE TABLET; ORAL TABLET; ORAL D!U=TAI AI ALRA LABS !!ImP N710sa 001 AUG 1l. 1988 'I '~J'tI.CIW, ~~~~~~~ AI iJ!.2H!!II N71059 001 I ~I 1tff."J6tJ/~ ~I AUG 1l. 1988 a BAN1AX PHARHS ~I10K; N83827 001 AI ~ N71965 001 a 25t1G N83827 002 AUG 11. 1988 a 50HG N83827 003 PUI'ROFEIf AI HALSEY DRUG ~ N72137 001 FEB 05. 1988 I~IUH IN-III ~~NO~I~ AI INYAHED ~ N72064 001 JAN 14. 1988 AI i22!:!§II N72065 001 '~~~~~~~~i~~~~~~~t, JAN 14. 1988 l~t~~H~1 . ~~I AI I2QtP N71938 001 Ijj~~~~~11i~~~~ JAN 14. 1988 AI HEDICOPHARHA ~ N71644 001 INJECTABLE; INJECTION FEB 01. 1988 INDIUH IN-1l1 OXYQUINOLINE AI PRIVATE FMLINS 800MGll N7Z300 001 AMERSHAH IMCIIML N19044 001 JUL 01, 1988 DEC 23. 1985 AI PURE PAC PHARH §ll.QtP N71964 001 FEB 01. 1988 INDOCYANI~ GR~~H >....!Il.IL> IFOSFAHIDE INJECTABLE; INJECTION CARDIO-GREEN >-AJlL> INJECTABLE; INJECTION a B-D MICROBIOL SYS lOHGIYIAL Nl1525 003 >....!!m....> IFEX 2SHGIYIAL N11525 001 >..!Il!L> BRISTOL MYERS IGMIVIAlJI N19763 001 a 40HGIYIAL N11525 004 >...AruL> DEC 30. 1988 50HGIYIAL N11525 002 >..!!HL> 3GMIVIAlJI N19763 002 IH~/~t~/Jljj~1 > ADD> DEC 30. 1988 ~~=~~~~ ~~~~~~~~:~~

IHIPBAHI~ HY~~HbQBIDE INDOt!ETHACIN TABLET; ORAL CAPSULE; ORAL na:miml HC~ DtDOt1EniACDt AI NOYOPHARH 2511G11 N71342 001 I h'imdl APR 18. 1988 I~~~:~~~ ~ ~#I All SOHGII N71343 001 a LEDERLE LABS 10ttS N86269 001 APR 18. 1988 a 25t1G N86267 001 AI YITARINE 2511G11 N7171l 001 a •50HG N86268 001 JUL 05. 1988 AI i2tP N71712 001 JUL 05. 1988 ·''''

AX DRUG PRODUCT LIST I CI.KJUTIVE SUPPLEMENT ....ER lZ I JAN'88 - DEC'88 39

INSULIN PORK IRON DEXTRAN

INJECTABLE~ INJECTION INJECTABLE; INJECTION /J~t{t.~~1 ): ):):. 1$~~/~t~/r4t/ 1~j.I~~t/~~t/ lUi '~nUllf 1"'dd~'~1 . 1~j.1f.~1I~~t/ !lETIN I a fISONS Eq 50HG IRONIHL N17807 001 LILLY 500 ~TSIHL N17931 001

I~IH&BI~ HlDROCHLQBIQi IOHEXOL SOLUTION; INHALATION INJECTABLE ~ INJECTION mE111ARDf1 1:51. otflIPAQUE 140 AM DEY LABS L.lr& N87390 001 STERLING DRUG 30. v:. N18956 005 mmwtDll tmL IlE HOY 30, 1988 M DEY lABS ~ N89817 001 otflIPAQUE 180 HOY 22, 1988 1~/~ft~tt~/~~~1 rU;f.t./ M ~ N89818 001 I~'~~~:~~~~~ HOY 22, 1988 STERLING DRUG 38.8Y. N18956 001 !It O.lrl.Jl NS9819 001 DEC 26, 1985 HOY 22, 1988 M ~ N89820 001 HOY 22, 1988 IQ!HALAHAT~ ~GLUHIHE

SOLUTION; INTRAVESICAL ISONIAZID CYSTO-CONRAY II HALLINCKRODT 17.V. N17057 002 INJECTABLE; INJECTION T'9""A?TP SOLUTION~ INTRAVESICAL, URETERAL A! quAD PHARMS 100HGIHlJI N89816 001 CYSTO-CONRAY OCT 28, 1988 HALLINCKRODT 437. N17057 001 to'DRAZU A! squIBB 100HGIHL N0866Z 001 I~~~ TABLET; ORAL @(t ~((Jtl 1!t~f.1 1~j.1~$1I~~t/ lIN ~ IlliW I~~~~~/~~U 1¢/~~t~~~~}' 11.1;~t./ 1~j.I~$I/~~# a DOH PHARMS 300HG NS0330 OOZ LAHrAZD M LAmETT ~ N89776 001 >...AmL> IOVERSOL ~ 13, 1988

>...AP.IL> INJECTABLE; INJECTION >...!I!JL> OPTIRAY-160 IS0S0R8II:!~ I:!IHlmm >...AP.IL> HALLINCKROOT 34.". N19710 003 >-AI!.IL > DEC 30, 1988 CAPSULE. CONTROLLED RELEASE; ORAL >-AI!.IL > OPTIRAY-240 DILATRATE-SR >-AIHL> HALLINCKRODT 51:t.M N19710 002 BC REED & CARNRICK 40HG11 N19790 001 >...!I!JL> DEC 30. 1988 SEP OZ, 1988 >...!I!JL> OPTIRAY-3Z0 ISORDIl >...!I!JL> HALLINCKRODT 68:t.M N19710 001 Be HYETH AYERST lABS 4~ N12882 002 >...AP.IL> DEC 30. 1988 .AIL Z9. 1988 RX DRUG PRODUCT LIST" ClHJLATIVE SUPPLEHENT tueER 12 " JAN'88 - DEC'88 40

ISOSQRBIDE DINITRATE ISOSORBID~ ~INIIB!I~ TABLET; ORAL TABLET, CONTROLLED RELEASE; ORAL pPRDIL ISORDIL g HYETH AYERST LABS ~ N12093 007 HYETH AYERST LABS 40HGII N12882 001 JUL 29, 1988 JUL 29. 1988 All lm!!i'I N12093 002 JUL 29, 1988 All 20HGII N12093 006 KEIAHINE HYDROC"LORIDE JUL 29, 1988 AI 30HGII N12093 005 INJECTABLE; INJECTION JUL 29, 1988 KETALAR 40HG11 N12093 001 AI! PARKE DAVIS ~g 10HG ~ASEIHL N16812 001 JUL 29. 1988 AI! ~g ~OHG BA~IHI. N16812 002 mS)R8JDE DDIn1tAII AI! Eg 100HG ~ASEIH!. N16812 003 All BARR LABS }2t!§l N87564 001 KnAMEHE He!. SEP 18. 1986 !f QUAD PHARMS Eg 10HG BAS~lHlJI N71949 001 All CORD LABS ~ N86221 001 APR ll. 1988 JAN 07. 1988 !f ~g ~OHG BASElHlJI N71950 001 All lQtP N86223 001 APR ll. 1988 JAN 07, 1988 AI! ~g 100~ BA~~IH~ N71951 001 AI 20HGII N89367 001 APR ll. 1988 APR 07. 1988 All DAJeURY PHARHA ~ N86034 001 JAN 06. 1988 lACIULOSE AD 10HGII N86032 001 JAN 07, 1988 SYRUP; ORAL All PAR PHARH ~ N87946 001 JAN 12. 1988 I'" I.~I~tld~1 ItdW1.j,),(J I~j.j~~jfddt/ atRO~LAC TABLET; SUBLINGUAL M HERRELL DOH 1OGH/ISHL N17884 001 ISORDIL C!OHST%LAC All HYETH AYERST LABS ~ N12940 004 M ALRA LABS 10GtV15HlJI N71054 001 JUL 29. 1988 JUL 26. 1988 All ~ N12940 003 COHSJULOSE JUL 29. 1988 M BARRE NUL 10stVlSH!.JI N70288 001 AD 10HGII N12940 005 AUG 15. 1988 JUL 29. 1988 LACIULOSE mSORBllr; UHmtAII M HY K LABS 1000015HlJI N71841 001 All BARR LABS l.Q!:!!i N87545 001 SEP 22. 1988 SEP 18. 1986 I'" 1~~t.I~# 1161W!j,),(J 1~j.j.4~~/~~j.f AI CORD LABS ~ N86225 001 FEB 19, 1988 SYRUP; ORAL. RECTAL AI ~ N86222 001 CEPKlLAC FEB 19, 1988 M HERRELL DOH 10GtVl5HL N17657 DOl AI DANBURY PHARHA ~ N86033 001 HJ,M FEB 26, 1988 M ALRA LABS 1OGH/1SH!.JI N71331 001 AI .2!i N86031 001 JUL 26. 1988 SEP 29. 1987 EHULOSI M BARRE NUL 1OG!V15H!.JI N71548 001 AUG 15. 1988

,. ... ,..,

AX DIU; PRODUCT LIST I CUlJLATIVE SUPPLEHENT tuBER 12 I JAH'ea - DEC'ea ~1

LACMQSE LEyoNORDEFRINI tlEPIYACAItE HYDROCHLORIDe

SYRUP; ORAL, RECTAL INJECTABLE; INJECTION IIHPLAQ POLOCAptI W LIVOHC!!DlFmt M HY K LABS 10GtV15HLM N71842 001 A! ASTRA PHARH PRODS 0, 0st1G/ML;~ N89517 001 SEP 27, 1988 APR Itt, 1988 LACmJLOSI M KALI DUPHAR 10GH115HL N17906 001 LIDOCAINE HYDROCHLORIDE

LEUCOVORIN CALCIUM INJECTABLE; INJECTION L.DOCADtI HDL INJECTABLE; INJECTION Af ABBOTT LABS ~ N89362 001 LI1ICOWRDt CALCJU1 HAY 25, 1988 Af BEN VENUE LABS Ea 10QMG BASEtvIAu. N89717 001 HAR 28, 1988 ~~ /f.t~1 ~~ ~~~~~,~~~ Af INTL PHARH Ea 3t1G BASEIt!u. N89352 001 it LEHHON 1% N83627 001 ~ 01, 1988 it V. N83627 002 Af Ea 50MG BASEIYIlu. N89353 001 .,u.a 01, 1988 >~> Ij~Jt~t Af LEDERLE LABS Ea 3HG BASEIt!L N08107 001 ~ ~tT ~/W la----,- ~ Af Ea 100HG BASEIYIALM N08107 004 1~"J.4J.!t/~~tI HAY 23, 1988 >-D,bL> I' ." , Af QUAD PHARHS EQ 100MG BASE/yIAL N89636 001 >-D1I->IW - I l~t~~~jf~~tI DEC 2tt, 1987 >-D,bL> I • >....D.I.L>IIJI A¥i~~ >.JlI.L> 1~}~~1%U~~ LEVOCARNITINE >-AmL> INJECTABLE; SPINAL SOLUTION; ORAL >..!DJL> UDQCADfE HCL W DEXTROSI CARHETOR >-MlJL> Af ABBOTT LABS g N8391tt 001 A! SIGMA TAU IGHtlOMu. N18948 002 >....!\HL> XYLOCAINE HI DEXTROSE 7.5% APR 27, 1988 >..!lIL> ASTRA PHARH PRODS 1.5% N16297 001 mACARH >-AmL> XYLOCADfI 5? W fiwcosl 7tB M KENDALL MeGAN IGH11ot1L N19257 001 >...M!lL> Af ASTRA PHARH PRODS S N10tt96 002 APR 10, 1986 >-A!m...> JUL 07, 1982

LEVOOOPA LINCOMYCIN HYDRocHLORIDE

CAPSULE; ORAL INJECTABLE; INJECTION LPfCOCDt Iddll~'~~~~1 AI!. UPJOHN EQ 30QMG BA$E/Hl NS0317 001 ~~~=~ ~~~~~~~~~ J.PICC!H'l CElt teL ~~~ I_M~1 l~t~.~l.d. tl AI!. QUAD PHARHS Ea 300MS BASEIHu. N62784 001 it ICN PHARHS 100HG N16948 003 HAR Itt, 1988 it 2S0HG N16948 001 it 500HG N16948 002 RX DRUG PRODUCT LIST / ClHJLlTIYE SUPPLEMENT tuBER 12 / JAN'88 - DEC'88 4Z

LISIHOpRIL L~Ael~ ~~IHAIl

TABLET; ORAL CAPSULE; ORAl.. PImClYJ:L LOXAmfl ~I1 AI HS&D RES LABS B N19SS8 001 AD HATSON LABS ~g lZ!!i IA~~_ N7ZZ04 001 DEC Z9. 1987 ~ 15. 1988 AI l!!!i N19SS8 OOZ AI ~g 11m!! las~- N7ZZ0S 001 DEC Z9. 1987 JlIf 15. 1988 AI 1m!i N19SS8 003 AI ~g 2:!!:§ IA~_ N7ZZ06 001 DEC Z9. 1987 JlIf 15. 1988 >...AmL> 40HG11 N19SS8 004 AI ~g SOHG lAg- N7Z06Z 001 >..AmL> OCT ZS. 1988 ~ 15. 1988 ZqTR%L LOXlTAHI AI IHPERIAL CHEM ~ N19777 001 AI! LEDERLE LABS ~g ~ BA~~ N17SZS 001 HAY 19. 1988 AI ~g 10m IA~~ N17SZS OOZ AI ~ N1977700Z AI ~g 2M I§~ N17SZS 003 HAY 19. 1988 AI Elil SOHG BASE N17SZS 004 AI zmp N19777 003 HAY 19. 1988 MAPROIlLINE HYDROCHLORIDE

LOP~BA~I~E HYQR~HLQBIO~ TABLET; ORAL HAPRCm:!,,;IHE t:!!:1L AD AM THERPTCS mP N7Z129 001 I~~~~~~~tl JAN 14. 1988 IJ~~~~/~~I /'J.~/~tI AI! SOHGII N7Z130 001 l~j11M~~~ JAN 14. 1988 a JANSSEN PHARHA IHG/SHL N19037 001 AI ~ N7Zl31 001 JUL 31. 1984 JAN 14. 1988 AI! HYLAN PHARHS ~ N7ZZ84 901 OCT 03. 1988 LORAZEPAH AI iQH!!II N7ZZ8S 001 OCT 03. 1988 TABLET; ORAL AI ~ N7ZZ86 001 LPRAZEP,," OCT 03. 1988 AI! CORD LABS ~ N71193 001 .AI! HATSON LABS ~ N7Zl6Z 001 APR 15. 1988 ~ 01. 1988 AI! l!P N71194 001 AI ~ N7Zl63 001 APR 15. 1988 ~ 01. 1988 AI m!Il N7119S 001 AI mP N7Zl64 001 APR 15. 1988 ~ 01. 1988 AD HARNER CHILCOTT 1P N71038 001 JAN lZ. 1988 AI zma N71039 001 HECLIZINE HYDROCHLORIDE JAN lZ. 1988 TABLET; ORAL AHT%YERT LOVASTATIN M ROERIS iQH!i NI07Zl 001 JAN ZOo 198Z TABLET; ORAL H~u:z:tH1 lSI. HEVACOR M PAR PHARM SOHGII N89674 001 >..AJm....> tts&D RES LABS 40t1G111 N19643 004 HAR 31. 1988 >..AmL> DEC 14. 1988 ">

RX DRUG PRODUCT LIST I ClHJLlTIYE SUPPLEMENT tueER 12 I JAN'88 - DEC'88 43

MECLOfENAHATE SODIUM tlEPBOBAHATE

CAPSULE; ORAL TABLET; ORAL It~LOEEIW1AII I!!IIDI"I AI CORD LABS E!i ~Q!!i IAliE- N72262 001 lIN ltiD~' lillltdI It'j$~j#~~# NOV 29. 1988 a MALLARD 400HG N15072 002 AI! E!i l0!!l:!!i IA~_ N72263 001 lIN Int~/~J$t~~1 IlliiIJI NOV 29. 1988 AI PAR PHARM E!i !!2!!i IAS!;;- N72077 001 lIN I~ MAR 10. 1988 'pJ I t.".:n~11 g E!i Ion IAS~ N72078 001 a PHARM BASICS 200HG N87825 001 MAR 10. 1988 MAR US •. 1982 g PHARM BASICS E!i ~Q!!i I§!;;- N71007 001 a 400HG N87826 001 MAR 25. 1988 MAR 18. 1982 AI E!i lOO!!i lASE- N71008 001 lIN l~f~~~/~1 lillltdI It't(.(.jf+l~~!+1 MAR 25. 1988 a STANlABS PHARM 400HG Nl4474 004 g YITARINE E!i !!Q!§ I§!;;- N71710 001 ~ 15. 1988 AI E!i l0!:!!!i lAg_ N716M 001 >..AJm..> ~ ~ 15. 1988 >..!IHL> INJECTABLE; INJECTION >-AIUL> HESNEX MEfENAHI!;; ACID >...AD.!L> BRISTOL tfYERS 10OHGIH~ N198M 001 >...AJHL> DEC 30. 1988 CAPSULE; ORAL ItIFEHAHEC g, AI VITARINE U2!:§II N72179 001 MESTRANOL; NORETHINDRONE APR 21. 1988 flOHSTEL TABLET; ORAL-21 AI PARKE DAVIS PR ~ Nl503lt 003 gETHIH IlICIH-n AI SEARLE PHARMS L.Qmi;lIP N71539 001 APR 12. 1988 HE~::!TROL A!;;EIAn tgmmtDRtI aim HIESTRANOI. AI HATSON LABS ~;lt!iII N70758 001 TABLET; ORAL JUL 01. 1988 ItIGESIROb ~mII AI PAR PHARM 1m:P N72422 001 >-UJ.L>IW ~~n~ 1~{1iJ4I It't(.jt''I~~tI AUG OS. 1988 >-AruL> a ORTHO PHARM O.08HG;lHG N16715 001 AI !mP N72423 001 ORTHO-NOYUH 2-21 AUG OS. 1988 >-UJ.L> l(Ij1.ffflj/ntlJrV 1~:t~J~1 It't#I.~I~~'''1 >...AJHL> a ORTHO PHARM O.lHG;2HG N12728 005

HEP!;;~LAn IROHIDE TABLET; ORAL-28 tmBETHIH lalit-II AI SEARLE PHARMS ~;JtP N71SltO 001 1~~~~~~(Ij1.~1 APR 12. 1988 t~~~t.t./~1 11$N1M4t1 It'tUj~I~~f+I gmtDfDRtI _ HI!IT1tANOI. a HERRElL DOH 25HG1SHL Nl0679 00lt AI HATSON LABS JWl5Ifi;ltP N70759 001 JUL 01. 1988

>-UJ.L>IW~~~!lll 1~{1iJ4I It't(.jt'''I~~# >-AIUL> a ORTHO PHARtt O.08HG;lHG N16715 002 RX DRU9 PRODUCT LIST / ClMJLATIYE SUPPLEMENT tu18ER 12 / JAN'88 - DEC'88 44

tIi~BAHQli HQR~mH!mBIiI. ~IAPBQT~R~NOL ~LEAI~

TABLET; ORAL-20 TABLET; ORAL AWPE!fT IAiI 71mttl 1j;j1$!JljJMJI 1~j.~.4.1('1 ~~(./ AI BOEHR INGEL l2!:!i NlS87~ 002 a SEARLE 0.075HG;5t1G NI0976 004 AI ~ NlS874 001 HnAPROTEREHO!.. !lUI-fAIl Iw/~~iW 1t:.1iiGJUW 1~j..d.4j('1 ~~(,/ AI! AM THERPTCS 10HG11 N72054 001 a SEARLE 0.lHG;2.5tG NI0976 006 ~ 23, 1988 AI ~ N720S5 001 Jl.toI 23, 1988 HETAPROTERENOL SULFATE AI PAR PHARM ~ N7202~ 001 ~ 28, 1988 SOLUTION; INHALATION AI 20HGa N7202S 001 AWPEHI JLtI 28, 1988 m BOEHR INGEL 0.4;'; N18761 002 AI! PHARM BASICS 10HGa N71013 001 OCT 10, 1986 JAN ZS, 1988 DEY-DOSI AI 20HGII N7l014 001 m DEY LABS 2 N70805 001 JAN ZS, 1988 AUG 17, 1987 DEY-LUII m DEY LABS 0.4%)11 N7l786 001 HEIBADONE HYDROCHLORIDE AUG OS, 1988 !t:I 0.6% N70804 001 CONCENTRATE; ORAL AUG 17, 1987 HmtADOHE 0.33%11 N7l806 001 A! MALLINtKRODT lOHGIHL N17116 OOZ AUG OS, 1988 t!mtA!!m!E ~L Dn'EH!IO!. 0.5%aI N7l805 001 M ROXANE LABS 10MGIHlJI N89897 001 AUG OS, 1988 SEP 06, 1988 . t!IIAPROTlBamL IY!.EAII !t:I ARMOUR PHARM O.~ N71275 001 JUL 27, 1988 t1E~ZOLAt1IDE m 0.6%11 N7l018 001 JUL 27, 1988 TABLET; ORAL lIN I~t"~# It:.W ~.1d6d('l.ddj./ NEPTAZANE >-.!!HL> LEDERLE LABS Z5HGII N1l7Zl OOZ lIN Irdl 1~1~~~l~'~~~l~ >....AmL> MAR 04, 1988 1~/j..1.:fj..46j/ m MY K LABS ~ N7Zl90 001 JU\I 07, 1988 tliD:!l~tIE HYI!BQ!;HLQBII!~ !t:I PACO RES ~ N7l855 001 JUL 1~, 1988 1f!#t1~~¢f1~ AM 2...@1 N7l726 001 .AIL 1~, 1988 I~~~'j/~# fj.r+fil I~H('#/~~j./ a DORSEY LABS lHG N13~ZO 001 SYRUP; ORAL IWI_At~I4/ It6W""1 HEIHOCARBAHOL l;t'~~~~'i:m~ PRCIHIIA TABLET; ORAL .Y tlJRO PHARM 10HGl5HL N72023 001 ~L SEP 15, 1988 lIN I~mw 1t¥~/~~j.1 a BARR LABS 500HG N84488 001 ~

RX DRUQ PRODUCT LIST / ClHJLAnYE SUPPLEHENT tueER 12 / .JAN'as - DEC'88 ~5

METHOTREXATE METHYLDOPA /:f~tt:fJ/'~~tI TABLEn ORAL "IllfY'LDO'A /~'~~tt/~/ /~;~/ /tt~/J~fJ/~~U AI SIDHAK LABS 1mfiII N72126 001 .JUL 07, 1988 AI .&EtP N72127 001 METHOTREXATE SOOIlJ1 .JUL 07, 1988 AI ~ N72128 001 INJECTABLE; INJECTION .JUL 07, 1988 HETHOTREXATE LEDERLE LABS EIO! IGH BASE.lYIAl.II Nl1719 009 APR 07, 1988 METHYLPHENIDATE HYDROCHLORIDE HmtOIREXATE "DDI1 Af PHARHACHEHIE Eg 2SMG BASEIt1u. N89158 001 TABLET, CONTROLLED RELEASE; ORAL .JUL 08, 1988 HmtYLPHEKEDATI HOL AI HI) PHARM 12tP N89601 001 TABLET; ORAL .JUf 01, 1988 HETHOTREXATE mALDf-SR BP LEDERLE LABS EIO! 2.5tG BASE. N08085 002 AI CIBA PHARM 1!!IS N18029 001 MAR 30, 1982

HETHOXSALEN METHYLPREDNISOLONE CAPSULE; ORAL TABLEn ORAL /~I//~~~~~'~~1 fj..~/ Itt~!I~!rf,/~#1 t1IIHmI. 8-HOP AI UP.JOHN t!Hli Nl1153 005 ELDER PHARMS IOHG N09048 001 AI lm.l N11153 006 HDlf'(Ll'RlDtqSOLOHI M HEATHER DRUG N85650 001 HETHYCLOTHIAZJDE 1~11 /~/ 1tt6U~~/~~t1 AI PAR PHARM ~ N89207 001 TABLET; ORAL APR 25, 1988 HmrrCL01HJAZDI g ~ N89208 001 AI CORD LABS ~ N89835 001 APR 25, 1988 AUG 18, 1988 AI lltP N89209 001 AI 2P N89837 001 APR 25. 1988 AUG 18, 1988

HETOCLOPRAHIDE HYDROCHLORIDE METHYLDOPA INJECTABLE; INJECnON TABLET; ORAL HUOCLOPRl!KEDE HCL Mmt"I"LDO'A Af DUPONT CRI CARE Eg lQHQ BASE/2Hu. N70847 001 AI CORD LABS l.mP N71700 001 NOV 07, 1988 HAR 02, 1988 !f HAURRY BIOL Eg 10HG BASE/ZMl.II N70892 001 AI HALSEY DRUG ~ N71751 001 AUG 26, 1988 MAR 28, 1988 AI ~ N71752 001 SYRUP; ORAL HAR 28, 1988 HfJOCL9'BAHEDI HCL All 500HGll N71753 001 !A BARRE NATL Eg 5HG BASElSHl.II N71340 001 MAR 28, 1988 AUG 18, 1988 RX DRUQ PROOUCT LIST / CtKJLATIVE SUPPLEHENT toeER 12 / JAN'88 - DEC'88 46

HETOCLQPRAHIDE HYDROCHLORIDE METRONIDAZOLE

SYRUP5 ORAL GEL; TOPICAL HUOCWPRAHPI HDL HETROGEL >...AU...> AA PACO RES E9 SH9 BASE/5HlJC N71665 001 CURATEK PHARHS 0.751.11 N19737 001 >-AI!JL> DEC OS, 1988 t«N 22. 1988 >...AU...> M ROXANE LABS E9 !iHG BASE/5HlJC N72038 001 >..Al!JL> DEC OS, 1988 t1EZLQCILLIN SODIUM MONOHYDRATE TABLET; ORAL ~ INJECTABLE; INJECTION .AI QUANTUH PHARHCS E9 SH9 BASE_ N72384 001 MEZLIN ~ 02, 1988 HILES PHARM Eq 20GH BASE/VIAlJC NS05ft9 005 HEIOCLOPRAHEDI HCL MAR 02, 1988 .AI SIDHAK LABS E9 1!»1G BASE_ N71250 001 Eq 20GH BASENIAlJC N62372 004 FEB 03, 1988 MAR 02, 1988 ~ All ROBINS E9 !iHG BAse N1785ft 002 MAY OS, 1987 HINOXIDIL

SOLUTION; TOPICAL HETOCUBINE IODIDE ROGAINE UPJOHN 2:t.ai N19501 001 INJECTABLE; INJECTION AUG 17, 1988 Hn'OCUIaHE mDDI !! QUAD PHARMS ~ N89443 001 TABLET; ORAL ~ 01, 1988 HZHODTL MEJVUNI mDDI AI QUANTlJ1 PHARHCS .z....miII N72153 001 AI! LILLY .6LHL N06632 003 JUL 13, 1988 tmtOMDIL AI PAR PHARM 2.5HGII N71826 001 METOLAZQNE NOV 14, 1988 AI 10HG11 N71839 001 TABLET; ORAL NOV 14, 1988 >~> AD PHARM B~:CS ~ N71537 001 I~~~~:tl I~;~I >-AmL> DEC 16, 1988 I~~~r~~~~ HYKROX FISONS 0.5H9 N19532 001 >-AIm.. > HISOPRQSTOL OCT 30, 1987 >-A!HL> TABLET; ORAL >...!Q!L> CYTOTEC t1ETRIZAHIDE >-A!l!L> SEARLE 0.2JOI N19268 001 >-A!l!L> DEC 27, 1988 INJECTABLE; INJECTION AHIPAQUE >...Jl.I.L> 1~:tt~tj~/~~1 It~;~~j~ MITOMYCIN >....IlLI..> 1~'~H~1~i~~~ >JIUL> a STERLING DRUG 13.5GHIVIAL N17982 004 INJECTABLE; INJECTION >....!IlJL> SEP 12, 1983 MJTAHYCIN BRISTOL HYERS 4ot1GNIAlJC N62336 003 MAR 10, 1988 R)C DRUQ PRODUCT LIST / C\HA.Anve SUPPLEMENT .....ER 12 / JAN'M - DEC'M 47

t10RPHINE SULFATE HlLOXONE HYDROCHLORIDE

INJECTABLE; INJECnON INJECTABLE; INJECnON tIORPtaHI IULFATI HALmCOHI tieL AI! ABBOTT LABS O.5HSIHLJC N71849 001 A! DUPONT CRI CARE O.4tfGItILJC N71083 001 HAYll,1988 JUL 28. 1988 A! l!!ilI1\.II N718S0 001 A! lH!UH1JI N71084 001 HAY 11, 1988 JUL 28. 1988 A! .lm!HI.II N71311 001 TABLET, CONTROLLED RELEASE; ORAL JUL 28. 1988 t1S CONTIN A! ELKINS SI... g. g~HGItlu. N71272 001 PURDUE FRDAK 60HGII N19S16 002 HAY 24. 1988 APR 08, 1988 A! 1ml!1I.JI N71273 001 HAY 24. 1988 A! ~ N71274 001 NlFCILLIN SODIUM HAY 24, 1988 A! lH!!lHI.JI N71287 001 INJECTABLE; INJECnON HAY 24, 1988 HAFC:I:LLDf SODD.!t A! INTL HEDTN SVS ~ N72076 001 A! HARSAH PHARt1S E9 SOONG BASE/YIAu. N62844 001 HAR 24. 1988 OCT 26, 1988 AI! ~ N7211S 001 A! Ea ISM BASE/YIALJC N62844 002 APR 27. 1988 OCT 26, 1988 >...AIHL> A! LVPHQHED ~ N71604 001 A! Ea 2SM BASEIYIAu. N62844 DOlt >-AJHL> DEC 16, 1988 OCT 26, 1988 A! HARSAM PHARt1S g.4HGII1u. N71811 001 AI! Ea 4Gt1 BASE/YIA!.II N62844 ODS JUL 19. 1988 OCT 26, 1988 A! Ea lOGH BASEIYIAIJI N63008 001 SEP29.1988 >-AJHL> NICARDIPI~DROC~LORID£ Eft 1. SGM BASEIYIAIJI N62844 003 OCT 26, 1988 CAPSULE; ORAL >...AlHL> CARDENE >-AJHL> SVNTEX LABS 20t1G11 Nl9488 001 HAFTIFIHE HYDROCHLORIDE >...AmL> DEC 21, 1988 >...!ruL> 3011G11 Nl9488 002 CREAM; TOPICAL >...AlHL> DEC 21, 1988 NAFnN HERBERT LABS 1;1)1 N19S" 001 FEB 29. 1988 >,.AU...> NIHOQIPItIE >-AJHL> CAPSULE; ORAL NALIDIXIC ACID >-AJHL> NIHOTOP >-A!lJL> HI LES PHARtt 30HG11 Nl8869 001 TABLET; ORAL >...AI!IL> DEC 28. 1988 HA!.%DpaO Am AI DNeURY PHARHA imP N71936 001 .... 28, 1988 AI ~ N7206l 001 .... 28. 1988 AI l§HJI N71919 001 .... 28. 1988 RX DRUG PRODUCT LIST / CUHULATIVE SUPPLEMENT NUMBER 12/ JlN'88"- DEC'88 48 NITROFURANTOIN NIZATIDINE

I¢A~!1t.tJ/~At.1 CAPSULE; ORAL lXID 1~'~w~m~~1 I_~~I 1~(t#~/~~tI LILLY 150HG11 N19508 001 a BOLAR PHARH 50HG N84326 001 APR n, 1988 lJ.~~~1 1~(t~I~/~#1 300HGII N19508 002 a 100HG N84326 002 APR n, 1988 TABLET; ORAL NORTRIPTYLINE HYDROCHLORIDE IW'm~ lilliIJI 1~4¥.t1l~#1 a BOLAR PHARH 100HG N80447 002 CAPSULE; ORAL AVENTYL HCL BD LILLY EQ lOHG BASE N14684 001 NITROFURANTOIN SODIUM BD EQ 25HG BASE N14684 002 ~~~~~~~~~~ n~~:tAJi§~JI,1f)t~:tt~1 ~~~ PlHELOR ~~~~=~~~~~~ I 1~~¢~;tA~1 It~~6~~/~~t/~tAtI 1~~M~U~~tI BD SANDOZ PHARHS EQ 10HG BASE H18013 001 a NORHICH EATON EQ 180HG BASE/VIAL N12402 001 BD EQ 25HG BASE H18013 002 ~~~ ~~~~~n~~~~ NITROFURANTOIN, MACROCRYST ALLINE ~~~=~~~~~~ CAPSULE; ORAL NYSTATIN HACBODAtfTJH All NORWICH EATON 50HG Nl6620 001 CREAM; TOPICAL All l2.ID:!i Nl6620 002 IftSIAnH NmIOFURAtfi'Cmf MACROCR' STALLPII AI NlSKA PHARHA 100,000 UNIISI~ N62949 001 All BOLAR PHARH ~ N70248 001 JUN 13, 1988 JUN 24, 1988 AI ~ N70249 001 SUSPENSION; ORAL JUN 24, 1988 trtSTAnH !! THAMES PHARHA 100,000 UNITSlHU- N62876 001 FEB 29, 1988 NITROGLYCERIN TABLET; ORAL INJECTABLE; INJECTION trtSTAnH ta:I'ROQLYCEJmt >....!QIL> M tuTUAL PHARH 500,000 UNITSII N62838 001 AI! LUITPOLD PHARHS ~ N71492 001 >..!lllL> DEC 22, 1988 HAY 24, 1988 AI! ~ N72034 001 HAY 24, 1988 NYSTATIN; TRIlHCINOLONE ACETONIDE OINTMENT; TOPICAL CREAM; TOPICAL NITROGLYCERIN tn'UAnH AHD JUAHC:Dl)LOHI ACITOKEDI lLTANA 2X11 N87355 001 >~> AI NlSKA PHARHl 100,000 UNITSIGH;~ N63010 001 JUL 08, 1988 >~> DEC 20, 1988 AX DRU9 PRODUCT LIST I CtH.ILATIYE SUPPLEMENT NHSER 12 I "AN'88 - DEC'88 ~9 otTREOTlDE ACETATE OXAZEPAM INJECTABLE; INJECTION CAPSULEl ORAL SANDOSTATIN CWtZIPN'J SANDOZ PHARMS Eq O. OSHG BASEIHlJI N19667 001 !It BARR LABS lm!i N70957 001 otT 21, 1988 ·AUG 10. 1987 Eq 0 .1HG 8ASEIHlJI N19667 002 !It la N71025 001 OCT 21. 1988 AUG 10, 1987 Eq 0.5HG BASEIHlJI N19667 003 AI }2H!i N71026 001 OCT 21. 1988 1'6(11 AUG 10. 1987 1t~~1 1~~:I~~~~~~tI ~~ILLItt SODI ..... 1'6(1/ I~I /~nA~:t/~~~~ INJECTABLE; INJECTION I~(I/ I$~~I 1 ~1~~~~h~f BACTOCl:LL 1~~/t~.:n.4/Jj~ !f BEECHAM LABS ~g 12§H ft~SE!Y1AL N6133~ 010 AI CHELSEA LABS ImP N71661 001 OKAC%lLDt SOIllUt HAil D2. 1988 !f HARSAM PHARMS Eg ~~ ~ASEIVIA~ N62856 001 AI llrP N71662 001 OCT 26. 1988 HAR 02. 1988 !f Eg 50~ ~ASEIVIA~ N62856 002 AI }2!P N71663 001 OCT 26. 1988 HAR 02. 1988 !f Eg IGH BASElVlAlJI H62856 003 M CORD LABS ImP N71813 001 OCT 26. 1988 APR 19. 1988 !f Eg ~!iH ftASEIVIA~ H62856 OO~ M l3rP N71756 001 OCT 26. 1988 APR 19. 1988 !f Eg ~ BASEIVIA~ N62856 005 AI 1QP N71814 001 OCT 26. 1988 APR 19. 1988 AP Eg l~ BA~E~AlJI N62984 001 I~(li 1r4j(.JNnt~r4~1 1t~~1 SEP 29. 1988 1~~~~1~~~~11 PROITAPHLDt I~(li It~1 1. ~ .. !f BRISTOL LABS Eg 2~QHi ftA~EIVIAL NS0195 001 ,J'~/n:AUf !f Eg 250MG BASEIVIAL N61490 001 I~(li I$~I a HYLAN PHARMS 10MS IJ~J~~17r~:J~N71713 001 OXAZEPAM OCT 20. 1987 a lSHG N7171~ 001 CAPSULE; ORAL OCT 20. 1987 OXAZEPAM a 30HG N71715 001 A§ AM THERPTCS l2!:§II N71955 001 OCT 20. 1987 MAR 03. 1988 AI PURE PAC PHARM !.m:P N72251 001 ~ 1SHG11 N71956 001 APR 14. 1988 MAR 03. 1988 M !SIP N72252 001 M }.!ltP N71957 001 APR 14, 1988 MAR 03. 1988 AI ~ N72253 001 APR 14. 1988 IX DRUa PIODUCT LIST I CUHULATIVE SUPPLEHENT NUMBER 12 I JAN'" - DEC'" 50

~~H~~Y'LIHI~ HY~BQkHLQBI~~

CAPSULE; ORAL TABLET; ORAL OMZIPAt1 DARICON AI ZENITH LABS lm!i N70943 001 /~tt(.}t~/~~/ /IHrI>/ /ttll~/U~~1.I AUG 03, 1987 PFIZER LABS lOts Nll6lZ 001 g ,U!!i N70944 001 AUG 03, 1987 g Em N70945 001 ~PI:!~NONI!.!!:I DROHIOE AUG 03, 1987 /~'N /I~r+t-/ >J.LL> n~~~~1~~~~~ >-IZJ.L> ':t?~~i~r1V /~'N 11._~/ >J.LL> /¢J~M~~IV /~/ /tt~6MU~dU ,~~~~~~i~~~ >....!Im....> iii CI8A PHARtt 5HG N0849Z OOZ /~f'1 I'J~~I I~~~n:~~~~~ I.IBM mrullRAC'fCLINEHYDROCHLORIDE g HYETH lm!i NI5539 OOZ M lH NlS539 004 CAPSULE; ORAL N15539 006 IW~~L 1~~·tUt4d·U&tl l~d~'Jf+I~#1 ~~_'J~~~~ iii PURE PAC PHARM Eq Z5ot1G BASE N60634 001 I~~~~'" ~~I'J~ I ?tI~~~~~/~~~~ WCOPAH M qlJANTUt PHARHCS ~ N70650 001 P!NCURONI~ BROHIDE MAR 01, 1988 g ~ N70640 001 INJECTABLE; INJECTION MAR 01, 1988 PAHCUROtmI1 AI mP N70641 001 Af ELKINS SI~ IM;/HlJI N7Z058 001 MAR 01, 1988 MARZ3,1988 Af ~ N7ZD59 001 HAR Z3, 1988 >....!Im....> ~CONAZOb~ HlIRAI~ Af ~ N7Z060 001 HAR Z3, 1988 >...AJ!!L> CREAM; TOPICAL PA~ 8RCKI:DI >...AmL> OXISTAT Af ASTRA PHARtt PRODS IM;/HlJI N7ZZl0 001 >...MlL> GLAXO Eq 1% 8ASE. N198Z8 001 HAR 31, 1988 >...MlL> DEC 30, 1988 Af .mia1!.II N7ZZll 001 HAR 31, 1988 Af ZM;/HlJI N7ZZ1Z 001 ~BUTVNIN Cl:!bQBI~~ HAR 31, 1988 AI! ~ N72213 001 TABLET; ORAL HAR 31, 1988 DrIROPAH Af !¥.lAD PHARtIS ~ N7Z209 001 g HARION LABS 5t!!! N17577 001 ~ 03, 1988 0X'l'8Un'KDI GHLORZRI Af ~ N72208 001 g PHARM 8ASICS ~ N70746 001 JlJ'I 03, 1988 HAR 10, 1988 PAVULOH >..AmL> g qlJANTUt PHARHCS ~ N72296 001 Af ORGANON ~ Nl701S OOZ >..AmL> DEC 08. 1988 Af ~ N17015 001 g SIDHAK LABS B:!\!II N71655 001 NOV 14, 1988 RX DRUG PRODUCT LIST / CtHJllTIYE SUPPLEMENT tUBER 12 / JAN'88 - DEC'88 51 PARAMETHADIONE PENICILLIN G SODIVH INJECTABLE; INJECTION 1~,.y~uI PENICILLIN 9 SODIUH IWI . ~I Iff'rIf4hII(l I~~~~~~/~~# HARSAI1 PHARMS 5.000.000 UNITSIVIAU. N63014 001 SeP 13. 1988 SOLUTION; ORAL 1~~t~/~~1./ 1f•. :~.6~.:~~#~j.:f~/'JtUI 1~j..4'J_/~~j./ PARADmHE a ~I88 SPA 5.000.000 UNITSIVIAL N61935 001 M ABBOTT LABS 300HSIHL N06800 002 PENICILLIN V pOTASSIUM PENICILLAMINE POHDER FOR RECONSTITUTION; ORAL CAPSULE; ORAL p.L%H V WADlUt CUPRIHINE IW~¢nttMl I~ 1~j.jU/~~~1 ttSlD 125HG N19853 002 a PUREPAC PHARH EQ 250HG BASE/SHL N61758 002 /1.~~1 1~~~j~/~~# 250HG N19853 001 TABLET; ORAL II$~~I 1~~'Jj~/~~j.1 'EHEC:I:LL%H V !lOTASUU1 AI CLON1EL CHEttS Eli 250HG BASE- N62936 001 TABLET; ORAL NOV 25. 1988 DEPEN 250 AD Eli 500NG BASE_ N62935 001 HALLACE LABS 250HG N19854 001 NOV 23. 1988 #_~~I I~~('~j./~~j./ ~~ IfVift~~~/ftt~1 ~n:JfII:~ ~~~~H~~~~ a PUREPAC PHARM EQ 250HG BASE N61571 002 PENICILLIN G POTASSIUM a EQ 500HG BASE NU571 003 INJECTABLE; INJECTION PIEHECELL%H 9 POJA"" .. >~> PERGQlIDE MESYLATE !f HARS~ PHARttS 1.000.000 UNITSlVIAu. N62991 001 SEP 13. 1988 >....!Im...> TABLET; ORAL !f 5.000.000 YNITSlVIlu. N62991 002 >..!JHL> PERHAX SEP 13. 1988 >...AmL> LILLY EQ O. 05HG BASe. N19385 001 !f 10,000.000 YNITS/YIAu. N62991 003 >.-A!!lL> DEC 30. 1988 SEP 13. 1988 >-AruL> EQ 0.25HG BASE_ N19385 002 !f 20,000.000 UNIIStYIAu. N62991 004 >--A!lL> DEC 30. 1988 SEP 13. 1988 >--A!lL> EQ IHG BASE_ N19385 003 !f ~I88 10.000.000 WITS/VIAL N60362 004 >....!Im...> DEC 30. 1988 POWDER FOR RECONSTITUTION; ORAL PEHmILL%HA't ~ADIUt PERPHENAZINE IW 7Mft.#.¢/1t I~ddd 'dtJffl)M;1 1~j.j('~/~~# a PUREPAC PHARH 400.000 UNITS/SHL N61740 002 I~m~"r&i~ TABLET; ORAL l~tMJV;1 1~/*,f.1 1t1j.j.~~(./~~# a SCHERING 2t1G/SHL N11294 002 ~~ 'iIOOm'iA't,WlAHDl1~HI:Uf. ~~m~~~~ a PUREPAC PHARH 250.000 UNITS N61588 002 a 400.000 UNITS N61588 003 RX DRUG PRODUCT LIST / ClKJUTIVE SUPPLEMENT tu1BER lZ / JAN'88 - DEC '88 5Z PERPHENAZINE PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE TABLET; ORAL SYRUPj ORAL PERPHEHAUHE >-A!HL> ~ CORD LABS ~ N89683 001 lIN 1~~:f/~~1 IMVM:f':i$IAJR4a >-A!llL> DEC 08. 1988 I~~~~:~~~~:~~ >-A!HL> A§ ~ N89684 001 >-AruL> DEC 08. 1988 >-AruL> A§ §!:§II N89685 001 PIPERACETAZINE >-AmL> DEC 08. 1988 >-AruL> AI! ~ N89686 001 1:f~~~~1~~#1 >-AruL> DEC 08. 1988 I.I~~/~~I ~~~~~~~~~~ PHENQIMETRAZINE TARTRATE a DOH PHARHS ~~=~lOt«; N13615 001 a ZSHG N13615 OOZ

PIRBUTERQL ACETATE ~. ~~~~~~~~ AEROSOL. METERED; INHALATION ~~~~~~M~ >-1H.L,> 1f.1.iREL/ } ~. ftfl,(.J,'Jf.1.6. f./ >.JtI.I..> IP.F.i.t~~I.~#~/ ItM~.:I.rv./~lJtlt~1 ~I >....ru.L> I ItI6~~!V/~~UI 1~'~~j~1'i~~ ~ I I ItI6~;>~ ~.6f. > ADD> HAXAIR a BARR LABS 3SMG N83644 001 >-AruL> RIKER LABS EQ O. ZHG BASE/INK N19009 001 a 3SMG N83684 001 >-AruL> DEC 30, 1986 a 35HG N83686 001 a 3SMG N83687 001 iI 35HG N84831 001 POLYETHYLENE GLYCOL 3350 i POT ASSIlI1 CHLORIDE i SQDIlI1 a 3SMG N84834 001 BICARBONATE; SOOIlI1 CHLORIDE i sooIU1 SULFATE a 35HG N84835 001 POHDER FOR RECONSTITUTION; ORAL >.JtI.I..> It=i.~t~ "ffll PHENMETRAZINE HYDROCHLORIDE >..m.L>IW ItltlttV >.JU.L> ~~_i1at~_fj.(~~j.' 1:f~~~~~~12' >....ru.L> I 'oj. U.,If..~1 Ildttt~lJ.~tt.l u~rt¢1 1~f.~('('~/~~~1 >....ru.L>IW ~~i~tt/~~1 a BOEHR INGEL ZSMG NI0460 005 >....ru.L> ~1~i1il!~~~j.' >....ru.L> I t.lj.'J.:lJ/~(t1 >-AruL> BRAINTRE E LABS Z36GH1BOTjZ.97GH1BOTj6.74GHIBOTj PHENIERHINE RESIN CQHPLEX >..AIHL> 5.86GH1BOT;ZZ.74GH/BOT· Nl9011 001 >..AruL> JUL 13, 1984 CAPSULE. CONTROLLED RELEASE; ORAL :p:!tW1Dt-10 AD PENNHALT EQ 30MG BASE Nll613 OOZ PHEHI'PMEHI Ra;tH '0 AD QUANTU1 PHARHCS EQ 30m BASE_ N891Z0 001 FEB 04. 1988 IV< DRUG PRODUCT LIST / CUHULATIVE SUPPLEttENT IU'8ER lZ / JAN'aa - DEC'aa 53 poLYETHYLENE GLYCOL 3 POTAS§IU1 AMINOSALICYLATE BICARBONATE i sooIU1 ~~lAsm~SSIU1• sooIU1 CHLORIDE SUlFATE i SOOIU1 SOLUTION j ORAL 1~/Mr~"H~.s.,.tA~",·t¢f'·"1'" OCL l~tUlti~t(T No o'lut./ 1t¥~~~/~~U 1~/~fflt.J6# ~~,J'1~~~~~n~~J~~/~~~r4tJl a HEXCEL CHEM 100X NS0098 001 Il. ~o~~od~f..1 1~~~~6.0/~t~~~1 I/"fiffl i>~.' J.oYflPI POTAssIU1 CHLORIDE ABBOTT LABS 6GH1100HLj75HG110OHLj168HG110OHLj 146HG/I0OHLj CAPSUlE. CONTROLLED RELEASEj ORAL 1.Z9GH/100HL N19284 001 tIECRO-It 10 APR 30. 1986 .AI ROBINS ~ N18238 002 MAY 14. 1984 1"6¢1 lt~tM POLYETtffLENE SL YCOL 3350; POIAssIIM CHLORIDE i SOOIlJ1 I~~~~~i~:~~ BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE. ANHYDROUS poTASIW1 CI1L01t1DI .AI KV PHARH l2HH N70980 001 POHDER FOR RECONSTITUTIONj ORAL fEB 17. 1987 1"6¢1 lt~tM IW/~_r41 If'~~1r:'i~J~ ~rnMffi~j~H' d/dd GRAMJLE FOR RECONSTITUTION. CRj ORAL I ~/"fiff/~~1/~~~~ HICRO-K LS POLOVAGI ROBINS 20HEQ/PACKETM N19561 003 AA DYNAPHARH 227.1GH1PACKET;2.82GHfPACKET; AUG 26. 1988 6. 36GM/PACKETj5.53GM/PACKETj 21.5GH!pACKETM N71320 001 INJECTABLE j INJECTION APR 20. 1988 poTASPI1 atLOlgDI ~ Af STERIS LABS ZHElVHlJI N89163 001 !A REED & CARNRICK 227,1GH/PACKETj2,82GM/PACKET; MAR 10. 1988 6, 36GM/PACKET;5.53GHIPACKETj 21.5GHIPAqKE NI8983 004 TABLET. CONTROLLED RELEASEj ORAL OCT 26. 1964 POTASSIlJ1 CHLORIDE >...!JHL> 1-1-111 PREP LYTI Be ABBOTT LABS SHEQII N18279 002 >...!JHL> M E Z EH 236GH1BOT;2,97GHI8QTj6,74GH/BOTj AUG 01. 1988 >...!JHL> 5,86GH180Tj22.74~ N71278 001 >..!lllL> NOV 21. 1988 >~> GLYCOPltlp POTASSIl.!t CHLORIDE; SOOIlJ1 CHLORIDE >..!lllL> !A TOGA HED PRODS 236GH/BOI;2,97GH/BOTj6,74GHIBQT; >-.!PIL> 5,86GH1BOTj22.7~ N72319 001 INJECTABLE j INJECTION >...!JHL> DEC 23. 1988 POTASmI1 atLORlDI ICI1n %H p!DI1 atLORUI 0,,,, PI PLAme COtffADIER Af ABBOTT LABS l'9MG/100HLj POL YHYXXN B SULFATE; IRIHETHOpRIH SULFATE 9OOHG/100Hu. N19686 001 OCT 17. 1988 SOLUTION/DROPS j OPHTHAlHIC poTA!l1JU1 CI1LOR:EDI 40CIHn Df s)DM atLORlDI o,n Df POLYTRIM PLAme COHTAIHER BURROUGHS HELLC 10.000 UNITS/HLj Af ABBOTT LABS Z28HG/10OHL j EQ IHG BASE/HlJI NS0567 001 900HG/100Hu. N19686 002 OCT 20. 1988 OCT 17. 1988 RX DRUG PRODUCT LIST / ClH.ILATIVE SUPPLEMENT tueER 12 / .JAN'as - DEC'88 54 POTAssIUM CITRATE PREDNISOLONE SOOIUH PHOSPHATE; SULFACETAMIDE SODIUM POHDER FOR RECONSTITUTION; ORAL SOLUTION/DROPS; OPHTHALMIC POTASSIUH CITRATE VASOCIDIN UNIV TEXAS 10HEQ/PACKEr. N19647 002 IOLAB PHARHS EQ 0.23% PHOSPHATEilO%a N18988 001 OCT 13. 1988 AOO 26. 1988 20HEQ/PACKEr. N19647 001 OCT 13. 1988 PREDNISONE TABLET. CONTROLLED RELEASE; ORAL POTASSIUH CITRATE SOLUTION i ORAL UNIV TEXAS SHEQ N19071 001 PRIDNPOtCI AOO 30. 1985 M MY K LABS H/SHlJI N89726 001 AUG 02. 1988 1~~~1:&~~1 l~tM M ROXANE LABS 5MGISHL N88703 001 1~~71~~i~~~ NOV 08. 1984 TABLET; ORAL PRALIDQXIHE CHLORIDE HETICORTEN >....!mL> BX SCHERING lHG N09766 002 IN.JECTABLE; IN.JECTION >.Jl.LL> I~I tJrt/.! l~d.4.1~~/~d# PBA!.:EQO)CR!E CHLORIDE PREDKPOHI !E QUAD PHARHS IGtVyJAlJI N72224 001 >-.!!m....> All CHELSEA LABS SOHG N87772 001 NOV n. 1988 >....!mL> .JUL 13. 1982 PROTOPAH CHLOR%PE >-1!.!.L > I~~I /!>~rt/./ Af HYETH AYERST lABS IGHtyIAL N14134 001 >.Jl.I.L> 1~~n~~iU~~ D SUPERPHARH H N8886S 001 OCT 25. 1984 PRAZOSIN HYDROCHLORIDE D lOHG N88866 001 OCT 25. 1984 CAPSULE; ORAL AI ZOHG N88867 001 HDqPRESS OCT 25. 1984 AD PFIZER LABS 1m N17442 002 I~U /!>rt/./ ItW-U~/~~f.I All zm N17442 003 1~~/J.4MI All H N17442 001 I~U tJdrt/./ I'RAZOmf HCL All ZENITH LABS l!P N71994 001 I~U /Jdrt/./ ,J~i~~ HAY 16. 1989 SEP 12. 1988 /Jf/J~.:M~:?j All ~ N71995 001 HAY 16. 1989 SEP 12. 1988 AD ~ N71745 001 PROBUCDL HAY 16. 1989 SEP 12. 1988 TABLET; ORAL LDRElCD PREDNISOLONE HERRELL DOH 500HGII N17535 OOZ JUL 06. 1988 TABLET; ORAL PREDNISOLONE I~~I I~A#~/~~I I~I 1t¥~#/~~# a BARR LABS 5HG N84426 002 1~~t'~~'~~~~t¢~1 I~I 1t~~~~~/~~tI a PFIZER LABS 5HG N09996 001

.' RX DRUQ PRODUCT LIST / ClHJLATIYE SUPPLEMENT N.HSER 12 / JAN'88 - DEC'" 55

PRQCAINAHIDE HYDROCHLORIDE PROPIOLACJQNE

CAPSULE; ORAL SOLUTION; IRRIGATION BETAPRONE I~Mr ~~~,~~ FOREST LABS N/A N11657 001 1iW.4. ~rlM.1 a LEDERLE LABS 250HG NS6942 001 pROPOXYP~HE HYgROCHIJmID~ a 375HG NS69S2 001 a •500HG NS6943 001 CAPSUlE; ORAL INJECTABLE; INJECTION IW '1J_~~) IWIII 1t¥$~~/~~U PROCIADWqDI HCL a BAtf1AX PHARMS 65HG N83184 001 Ae HARNER CHILCOTT 100HGlHlJI N89S28 001 IW I~~/~# ItlMI 1t¥"J~U/~~U HAY 03. 1988 a BARR LABS 6" NS3186 001 Ae 50~ NS9S29 001 HAY 03. 1988 PBQfRANOLQL HYDROCHLORlg~

PROCHLORPERAZINE EDISYLAIE TABLET; ORAL mPRAHOYU, IS&. INJECTABLE; INJECTION AI INVAHED ImP N71658 001 PBOCHLORPERAZPtI EDD'ILATI JUl as, 1988 Ae ELKINS SItill Eli 5H9 BASEI!1lJI NS9523 001 AI 1l!!P N71687 001 HAY 03. 1988 JUL as, 1988 >-AmL> Ae HARSAJ1 PHARMS E9 5HG BASEI!1lJI NS967S 001 AI !Mill N71688 001 >...!mL> DEC os. 1988 JUL as, 1988 Ae QUAD PHARMS E9 " BlSElHlJI NS9637 001 AI imP N72197 001 FEB 01. 1988 JUL as, 1988 Ae E9 .!iHG BASEtHlJI NS9638 001 !I utI!iI' N71689 001 FEB 01. 1988 JUl 05. 1988 A! STERLING DRU6 E9 5HG BASElHlJI N89703 001 AI .mP N72198 001 APR 07. 1988 JUl as. 1988 AI LEDERLE LABS ImP N72117 001 JUoI 23, 1988 PROMETHAZINE HYDROCHLORIDE AI ImP N72118 001 JUoI 23. 1988 INJECTABLE; INJECTION AI !m§II N72119 001 f'lP!nMA7JN1 HCL JUoI 23. 1988 Ae HARSAH PHARMS 25HG!Hl11 NS9463 001 AI ImP N72120 001 HAY 02. 1988 JUoI 23. 1988 Ae 5OHG/HlJI NS9477 001 IW 1t~1 IUtW HAY 02. 1988 1~~~~1'~U~~ a LEtI10N lotG N70232 001 TABLET; ORAL OCT 07. 1987 PROHETHAZINE HCL IW 1~/.H.tI~l.oJ~~1 IUtW ~~~ I~~/~~I ~~~I ~~~fA~~ 1~'~m"i~1 I~~I ~~ It¥~_j/'fjil a BARR LABS 12." N84SSS 001 a 25!S N84554 001 a 50HG N84SS7 001 AX DRUG PRODUCT LIST I CUMULATIVE SUPPLEHENT NUHBER 12 I JAN'88 - DEC'88 S6 2~BAHQI.QL HXD~Hl.2BIgli !iUINESTROL TABLET; ORAL !B2PRANObRL tlRL 11?ltf{~l.yt. " ~I M SIDHAK LABS lm!!iII N71972 001 'I~~/~I.:JJ~I APR 06, 1988 ~f~~~ ~~~~~~~~~~ AI lQt!!!II N71973 001 a PARKE DAVIS O.lHG N16768 002 APR 06, 1988 a 0.2HG N16768 003 AI !IDP N71974 001 APR 06, 1988 M 60HGII N7197S 001 §y1~lolNE GLUCONATIi APR 06, 1988 AI 80HG11 N71976 001 TABLET, CONTROLLED RELEASE; ORAL APR 06, 1988 cama:DDlI gWCOHo!lTI AI ~ N71977 001 > ADD> AI CORD LABS 3Z4tQI N89894 001 APR 06, 1988 >..A!HL> DEC lS, 1988 M SUPERPHARH 10HGII N71SlS 001 ..JtM 08, 1988 AI 20HGII N71S16 001 iYlNIOINE SULFATE Jlt.l 08, 1988 AI 40HGa N71S17 001 TABLET; ORAL ..JtM 08, 1988 cama:DDfI ~LFAII AI §mp N71S18 001 AI CORD LABS 300HGll N89839 001 Jlt.l 08, 1988 SEP 29, 1988 AI HARNER CHILCOTT lm!!i N70438 001 SEP IS, 1986 AI ZENITH LABS 10HGII N72063 001 BANITIDINE HYQB~HbQBIQIi JUL 29, 1988 AI 20HGII N72066 001 >..A!HL> SYRUP; ORAL JUL 29, 1988 >..A!HL> ZANTAC AI 40HG11 N72067 001 >-..!IUL> GLAXO EQ l!iHG BASElHlJI NI967S 001 JUL 29, 1988 >..A!HL> DEC 30, 1988 AI 60HGII N72068 001 JUL 29, 1988 AI §mp N72069 001 BAUHOLFIA S~R21iH!IHA JUL 29, 1988 TABLET; ORAL RAUVAL PROTAHItL$ULFATE BP VALE CHEH SOHG N09108 002 BP 100HG Non08 004 INJECTABLE; INJECTION ~~, SULFATI ~~~ ~~~~I ~~~~~~~~~~~ ~~ ~~, ,j~lP:,~i~~ RESERPINE a UPJOHN SOHG/VIAL N07413 001 a 2S0HGIVIAL N07413 002 TABLET; ORAL AUG 02, 1984 RESERPINE 1~f'1 1~N1~/(.J.fJ~1 Id.:~~1 1~d1#lddU a BARR LABS 0.2!iHG N80721 002 AX DRUIiI PRODUCT LIST / CltlJUnYE SUPPLEMENT ....EIt 12 I JAN'II - DEC'U 57

RESERPINE i TRICHLORtIETHIAZIDE SODI", IODIDE. I-In

If~,:,tfJI.(Jj$.fft.1 I CAPSULE; ORAL SODIlI1 IODIDE I 131 1~~II"~~~~~~~~t/~/'~~~~1~~ 1t¥~~(.I.I~~U 1rW.t.~~fl 1~;~~t~~~1 /~t~_U/~~U a BOLAR PHARH O.lHGj4HG N8S248 001 a HALLINCKRODT 0.8-100HCI . N165Ui 002

SECOBARBITAL SODIUH SOOII.I1 NITROPRUSSIDE

CAPSULE; ORAL INJECTABLE; INJECnON NITROPRESS IW "9~AL7~ lilltW /t¥(+#_/~~U ABBOTT LABS 25HGlHlJI N71961 001 a BARR LABS 100HG N84225 001 Aug 01, 1988

SODIlI1 BICARBONATE i TARTARIC ACID SOPIUH SUCCINATE

GRANULE, EFFERVESCENT; ORAL BAROS '~~~1~~~~~~~{~~' >~> LAFAYETTE 460HGIGH;420HGIGH N18509 001 It~1~/~~~/· 1~~f,1 1t¥~_t~/~~U >...!DJL> AUG 07, 1985 a ELKINS SINN 30% N80516 001 >.J!..bL> 1rW.t.~~r>Jfl /~~~If,ttJ!+~~/(;fV >.JlLL> I~~~':~%m~ spIRONOLACTONE

SODIlI1 CHLORIDE TABLEn ORAL

INJECTABLE; INJECnON IW '.ai.fml IUM! /t¥"~!tI~~U .,DM CHLODJ:DI O. n IN 'LASm COHTAPtER a LEDERLE LABS 25HG N87634 001 !e KENDALL HCGA" 9QOHG/100Hu. N19635 002 HAR 09, 1988 "DM CI1L.C!B%DI O.Y? De 'LASTJO OOHIADfEB SULFACETAMIDE SODIUM AI! ABBOTT LABS 45Qt1S/10OHu. N19759 001 ~ 08, 1988 SOLUTION/DROPS; OPHTHALHIC !f KENDALL HCGAH 450HG/10OHlJI Nl9635 001 IULFAQITAHPI IODlUt HAR 09, 1988 AI STERIS LABS ~ N89560 001 .,DIUt CHLOUDI 9."" JjH 'LASDC cot!TAPtEB OCT 18, 1988 !e ABBOTT LABS 9HGIHL N19217 001 JUL13,1984 /~I /.~*/ 1J6~~l~~J~~~ suLFAHETtfOXAZOLE .,DM CI1LOUDI PIN 'LASm COHTAPtI! TABLET; ORAL !e KENDALL HCGAH 3GH110OHu. Nl9635 003 HAR 09, 1988 IW 7~m~LI I~ A! TRAYENOL LABS 3GH110OHL N19022 001 /~~A~~%~~~ NOV 01, 1983 a BARR LABS 500HG N87189 001 1OP1U1 CI1LORJ:11I ,g IN 'LAmP COtfIADfEB JUL 25, 1983 !e KENDALL HCGAH 5GM/100Hu. Nl9635 004 HAR 09, 1988 A! TRAYENOL LABS 5GHt10OHL Nl9022 002 NOV 01, 1983 RX DRUG PRODUCT LIST / ClKJLAIIYE SUPPLEMENT tU1BER 12 / .JAN'sa - DEC'sa 5&

SULFAMETHOXAZOLE i TRIMETHQPRIM TECHNETIUM TC-99H ETIDRQHATE KIT

SUSPENSION; ORAL INJECTABLE; INJECTION TIm1IDV1ULFA AI NlSKl PHARHl 200MG(5HL;!0MGI5Hu. N72Z89 001 11.Y1~t1~ 1~j.j('('lIddj.f MAY 23. 1988 a MEDI PHYSICS NlA N17667 001 AI 200MGlSML ;!OMGISMu. N7Z398 001 MAY 23, 1988 IMI I~~ Ji661i IHaI /Ni.7454 106 i / AI 200MG/SML;4QHG/5Mu. N7Z399 001 OSTEOSOAU MAY 23. 1988 MALLINCKRODT NlA N17454 001

TABLET; ORAL IULFAHmgcAZOLi AND 1'f!RIE'IHOPRRI >-AruL> TECHNEII!.Jf TC-99H EXAHETAZIME KIT >~> AI MARTEC PHARMS ~;~ N72408 001 >~> DEC 07, 1988 >~> INJECTABLE; INJECTION IULFAHmtep(AZOLI AND l1tP1mtOPRJI1 !!C!UaLi ITRIHmt >~> CERETEC >....!mL> AI MARTEC PHARMS mll!.H!!;~ N72417 001 >...!!m...> AHERSHAM NIAll Nl98Z9 001 >~> DEC 07, 1988 >~> DEC 30. 1988

SULfISOXAZOLE tECHNETIUM TC-99H PENIETATE KIT

TABLET; ORAL INJECTABLE; INJECTION IUL~LE >-'U.L> 16tl>4/ IAdI n 7 I~mw 1t¥(td"Jl./ddl./ >~>II.Y II1Ul~/f'ttt~~~1 ItJlIJ I~t'#(.(tld#1 a BARR LABS 500HG N84031 001 >...!!UL> TECl!fnlUf TC-,," P"ElATI ICZT IW /t.tJ5t~t.UtJt,~1 1~m!Jj1 It¥j(.(t~ld#1 >...!IlJL> !f MEDI PHYSICS Ha N17264 002 a LEDERLE LABS 500HG N87649 001

TEHAZEPAM SULINDAC CAPSULE; ORAL TABLET; ORAL TEHAZEPAH CI..%HOR%L AD CORD LABS llt§II N71427 001 AI MS&D 150MG N17911 001 .JAN 12. 1988 AI ~ N17911 OOZ AI 30HG11 N7l428 001 IULDfDAC .JAN 12. 1988 AD AM THERPTCS 150HGII N72171 001 AI DURAMED PHARMS ll!P N7l708 001 APR 03, 1990 MAY 23, 1988 SEP 29, 1988 All 200HGII N72172 001 AI 30f1G11 N7l709 001 APR 03, 1990 MAY 23, 1988 SEP 29, 1988 150HGII N7l891 001 AI DANBURY PHARHA APR 03, 1990 MAR 03, 1988 IEBAZOSIN HYDROCHLORIDE l2.!2tP N7l795 001 APR 03, 1990 MAR 03, 1988 TABLET; ORAL HYTRIN >...!ruL> SlIPROFEN 1~/~ffl(.H.~1 fj.d~1 1~~7rIJi~t >-AJ!IL> SOLUIIONIDROPS; OPHTHALMIC ABBOTT LABS lOHG Nl9057 004 >...!ruL> PROFENAL AUG 07. 1987 >...!IlIL> ALCON LABS 1Y.11 N19387 001 >..AJm..> DEC 23, 1988 AX DR\» PRODUCT LIST I C\.tIJUTIVE SUPPLEMENT NJt1BER 12 I JAN'sa - DEC'88 59

TERCONAZQLE THEOPIffLLINE

SUPPOSITORY; VAGINAL TABLET, CONTROLLED RELEASE; ORAL TERlZOL 3 >.JlI.L> 1~1JJJliJI ORTHO PHARM 8~ N19641 001 >-RLI->/~ -1'~~~jJ~~1 IlliW HAY 24, 1988 >.JH.L> I~~~~~~~~ >.In.L> Iftl U~~I ItW __ .f).Zd~U >.JlI.L> TESTOSTERONE CYPIQNAIE >-DJ.L> Iftl #~~~I 1~~~~lJ~~~ >.JlI.L> Illtmt.:lJ.fl~1 INJECTABLE; INJECTION >...!ruL> a FOREST LABS 100tG N88S03 001 TES!OSTEROtfI QYP2DHATI >-AmL> APR 03, 1985 A2 QUAD PHARHS 10Qt!;/MlJI N89326 001 >...!ruL> a 20rm; N88504 001 OCT 28, 1988 >...!!llL> APR 03, 1985 AQ 200MGIMlJI N89327 001 >-AmL> a 300ttG N88505 001 OCT 28, 1988 >....!llJL> APR 03, 1985 THEOLAIR-SR BC RIKER LABS 250tG N86363 002 tETRACYCLINE HYDROCHLORIDE JUL 16, 1987 #-~~I CAPSULE; ORAL l.s6mrJ~~~~ TEIRAC'l'CLDtI HOL AI LABROS ATRAL 25~ N62752 001 lUG 12, 1988 THIORIDAZINE HYDROCHLORIDE All ~ N62752 002 lU9 12, 1988 TABLET; ORAL All VITARINE ~ NUtt71 001 IHI:DR%DAZPII HOL g KlTUAL PHARM ~ N89953 001 OCT 07, 1988 THEopHYLLINE M PAR PHARM .ImP N89764 001 FEB 09, 1988 ELIXIR; ORAL AI 12QH!iII N89765 001 lHEOPH'rLLDtI FEB 09, 1988 M MASKA PHARHl 80tG/15HlJI N89223 001 g ROXANE LABS m:s N88664 001 HAY 27, 1988 HAR 15, 1984 M THAMES PHARHl 80!1G/15HlJI N89626 001 OCT 2S, 1988 IHIOIHIXENE HYDROCHLORIDE INJECTABLE; INJECTION lHEOPH'rLLDtI! AND D!!XTROSI I? IN PI.ASDO COtf[AJHIB CONCENTRATE; ORAL 6f TRAVENOL LABS 320tGI100ML N1S649 006 lKlOTKIXEltI HOL NOV 13, 1985 >-AmL> M PACO RES E9 " BASEIHU. N71939 001 lH!OPH'rLLDtI PI PEXllIOII R Df PLAS'IDl CC!HIAlHIB >-AmL> DEC 16, 1988 6f l880TT LABS 320MG/10OMu. N19211 006 JAN 20, 1988 TIOCONAZQLE

'6n;UJi~~rmt' 1~;f.f,1

a ROERIS 6.Sl IJj'~f1r.~~N19355 001 DEC 30. 1986 AX DRUG PRODUCT LIST I CUHULATIVE SUPPLEMENT NUHBER 12 I JAN'88 - DEC'88 60 TIOPRONIN TRETINQIN TABLET; ORAL CREAH; TOPICAL TIOPRONIN RETIN-A ~IV TEXAS 100HGll N19569 001 ORTHO·PHARtt 0.02~ N19049 001 AUG 11, 1988 SEP 16, 1988

roLlZAHIDE TRIlHCINOLONE TABLET; ORAL TABLET; ORAL JOJ.AZAKEDI TRIlHCINOLONE AI PHARH BASICS .l.Q2tP N71355 001 JAN 11, 1988 ~~~~ I~~~/~~I ~E~ ;j~~~~~~~ I~N ~~~'rddll TOLBUTAHIDE ~=~~ ~~~ /~~;U~~~d!~ I~n ~~~d/~:h TABLET; ORAL a BARR LABS ~=/2HG N84286 001 a 2HG N84318 001 1641 7_7MMI~1 I~I ItW!f+!ldd!l a 4HG N84267 001 a BA~ PHARHS 500HG N86141 001 a 4HG N84319 001 a 8HG N84268 001 a 8HG N84320 001 TRAZOD~ HYDROCHLQBID~

TABLET; ORAL IBIA~INOL~ AC~IQHID~ DqyREL AI MEAD JOHNSON ~ N18207 003 CREAH; TOPICAL MAR 25, 1985 lYl:mI TRAZODONI 1::1;1. .AI SYOSSET LABS ~ N87430 001 AI PURE PAC PHARH ~ N71636 001 NOV 01, 1988 APR 18, 1988 .AI ~ N87429 001 AI lQ2tp N71514 001 NOV 01, 1988 APR 18, 1988 .AI ~ N87428 001 g SIDHAK LABS ~ N71523 001 NOV 01, 1988 DEC 11, 1987 AI l2mS N71524 001 It1I _tl~# /j;JzI DEC 11, 1987 /~~1'~~:~~ Iw'11ff_~1 a SAVAGE LABS 0 . .5% N88198 001 IIMMI 1~'~~~~~1iU~~ MAR 25, 1983 TRAZOtt-150 OINTHENT; TOPICAL ll2tP AI SIDHAK LABS t N71525 001 ~ MAR 09, 1988 AI SYOSSET LABS ~ N87375 001 NOV 01, 1988 Iw'11.'f~# IWIM AI ~ N87377 001 1~'~~~~1'iU~~ NOV 01, 1988 AI ~ N87376 001 NOV 01, 1988

t SEE SECTION 1." OF INTRODUCTION •

IX DRUG PRODUCT LIST I C\KJLATIVE SUPPLEMENT N.lBER 12 I JAN'88 - DEC'88 61

TRIAMCINOLONE ACETONIDE IRIfLUOPERAZINE HYDROCHLORIDE

OINTHENT; TOPICAL TABLETJ ORAL TRIAt1CDtOLOHI AQII'OHQI mFLUOPIRA?J"1 HCL >...AmL> AI GIN LABS ~ N89795 001 AI BOLAR PHARM Ea 1HG BASEJI N85975 001 >-Aml..> DEC 23, 1988 .~ 23, 1988 >...!mL> AI ~ N89796 001 AI Ea 2", BASEJI N85976 001 >..AQL> DEC 23, 1988 ~ 23, 1988 >-Aml..> AI NASKA PHARMA ~ N89913 001 All Ea 5HG BASE. N85973 001 >-AJHL> DEC 23, 1988 JUN 23, 1988 AI Ea 1" BASE. N88710 001 JUN 23, 1988 TRIAZOLAt1

TABLET; ORAL TRIMEPRAZlNE TARTRATE HALCION /JJ~)~/ /_.:~/ CAPSULE, CONTROLLED RELEASEJ ORAL /~~1~1~~~:~~ TEHARIL a UPJOHN 0.5HG N17892 002 HERBERT LABS EQ 5HG BASE NUll6 004 NOV 15, 1982 /~~f/~~/ /t~~/~~t/ 1~j.j."Jj.~/~~('/ SYRUP; ORAL TRICLOfQS SODIUM rpwg:L HERBERT LABS NUll6 003 /~~:tt~JI,~~t/ /221 /~~f/~# 1~j.j."Jj.~/~~"J1 I. /~~~~~tf/~~/ n.:~j.~/ /~j.~6"J~/~~j./ TABLETJ ORAL a MERRelL DOH 1.SGtVl5HL N16830 001 TEHARIl HERBERT LABS EQ 2.5HG BASE NUll6 001 /:t~Jt1J I(JffMJ /~#/~~/ It~~.:~/~~tI 1~j.j."Jj.~/~~f.I . /~~~~~1~/~~/ /j$~r+/#/ /~j.~6~j/~~U a HERRELL DOH 750HG N16809 002 TRIHETHQPRIH

TABLET; ORAL TRIDIHEXETHYL CHLORIDE TJgHrntOPRRI D BARR LABS 1Q2HS N70494 001 /t~~¢1Ad.tt}lt~t¢:tt~/ JAN 22, 1986 /w lilltW /~~~~t~~~/ /j.~r+/#~t/ /~.dj#j/ ~~j./ ,~1~i~0W~ a LEDERLE LABS lOHGIHL N09729 001 /~/ n~~r+/#I ,1~I~~~~~ a 200HG N70495 001 TRIfLUOPERAZINE HYDROCHLORIDE HAR 14, 1986

INJECTABLE; INJECTION STELAZDlI TRIPELENNAMINE HYDROCHLORIDE !f SKlf CO Eli 2m BASEIML NU552 005 mFLUOPERADHI HCL TABLETJ ORAL A! QUAD PHARMS Eli 2MS BASEIHUl N89893 001 ~IHCL OCT 17, 1988 lIN I'MMI 1~~jM+/~~f.I a BARR LABS 50HG N80744 001 RX DRUG PRODUCT LIST / ClHJLATIYE SUPPLEMENT MftER 12 / JAN'88 - DEC'88 62

IBI2BQLlgl~ ~gBQkHLQBlg~ YA!:&mr£~IH ~g~HI..Q!IDE

SYRUP; ORAL INJECTABLE; INJECTIQt" YAHPOUD /W/_~;J/ /s.;J.1JIiIl1/JJ Af LEDERLE LABS ~g l!!!:l IA~~caAI.II N62682 002 /)~~r:,~~§~ HAR 30. 1988 a MY K LABS 1. 25HS1'!iHL N87963 001 Af tig 5H t~ffiAL N62682 004 JAN 18. 1983 HAY 11. 1988 AI! ~g l~ tAS~/VIAI.II N62682 005 HAY 11. 1988 lUBOCURARINE ~HLORIDE EQ 2GH 8ASE/vUlJI N62682 003 HAY 11. 1988 INJECTABLE; INJECTION YAHCOH"I CDt tmb 1'UIIOClURAR%H1 gtLOR%RI Af ABBOTT lABS ~g SO~ 1~~caAI.II N62911 001 Af QUAD PHARHS ~ N89442 001 AUG Oft. 1988 AUG 12. 1988 Af ~g l!!!:l tAS~ffiAI.II N62912 001 AUG Oft. 1988 AI! ELKINS SINN ~g 500HG IASEffiAI.II N62879 001 URSODIOl AUG 02, 1988 Af ~g IGH IASliffiAlJI N62879 002 CAPSULE; ORAL AUG 02. 1988 ACTIGALL Af QUAD PHARHS ~g ~OOHG BASE/VIAI.II N62845 001 a CIBA PHARH ISOHG NI9S94 001 JUL IS, 1988 DEC 31. 1987 Af ~g l!!!:l IAStiffiAI.II N6284S 002 300HG N19S94 002 JUl 15. 1988 DEC 31. 1987 YAHCOR !f ADRIA LABS ~g SOOHG IAS~/VIAlJI N629S6 001 /"~~~~t# U~Jr+¢/ AUG 01. 1988 /,,~~~~·~UJ~ Af ~g lGH BA~Ii/VUI.II N629S6 002 lJJJr+¢/ /"t~~~~::/f~6~~ AUG 01. 1988 ~RAP~L H~DROCHLDRID!i Y~QHX~IN HlDBOCHLORIDIi TABLET; ORAL INJECTABLE; INJECTION LYpttDCDt 7m.tU/ n~6r+¢/ l~mt,,~J6~/ Af lYPHOHED ~g I!!!:I 1~~ffiAL N62663 002 /ft~ ~J.. J1U/ JUl 31. 1987 ~ SEARLE PHARHS 40HG11 Nl8817 003 AI! ~g ~ BAS~!YlAlJI N62663 003 FEB 23. 1988 JUN 03. 1988 a 160HG Nl8817 004 yAHCOCDf tml. FEB 23. 1988 AI! LIllY ~g l~ ~S~ffiAL N60180 002 pol'mf HAR 21. 1986 AD KNOLL PHARH !Q!:!!i N18S93 003 Af ~g I!!!:I BAS~/VIAL N62476 002 NOV 23, 1987 HAR 21. 1986 VERAPtlHEL He!. Af ~g IGH IASliffiAL N62716 002 Aft CORD LABS §2!:P N71423 001 HAR 13. 1987 HAY 24. 1988 Af ~g lfiH IASliffiAL N62812 002 g ll.Qt!!!II N71424 001 NOV 17. 1987 HAY 25. 1988 Af ~g lQiH l~lYIAL N62812 003 NOV 17. 1987 It)( DRUIil PRODUCT LIST / C\HJLATIVE SUPPLEHENT tueER 12 / JAN'sa - DEC'sa 63

VERAPAHIL HYDROCHLORIDE PUTER fOR IN.lECTICli. STERILE

TABLET; ORAL LIQUIDJ Nl'A YERAPAHEL HCL UIRZLI NATa FOR JHJmpN Dt PLAIIJP CQNUJHII M LEDERLE LABS ep N71880001 AI! KENDALL HCGAH ~ N19633 001 APR OS, 1988 FEB 29, 1988 M lZot1GII N71881 001 APR OS, 1988 M t'lITUAL PHARH §2!P N71ft88 001 mm JAN 13, 1988 M JmP N71489 001 POHDERj ORAL JAN 13, 1988 IWI_~1 n$1N6d11 I~~~~~~~~ VINCRISTINE SULFATE a LYNE LABS 2.56tVBOT Nl88S6 001 HAR 26, 1987 INJECTABLE; INJECTION YDfCRE)( A! BRISTOL LABS 5HG/YIAl,II N70867 001 JUL 12, 1988

A! 1HG!VUlJI N71SS9001 APR 11, 1988 A! 211G/YUlJI N71560 001 APR 11, 1988 Af SHGI'IIAl,II N71S61 001 APR 11, 1988 Af QUAD PHARHS 1HG/YIA... N71222 001 HAR 07, 1988 A! 2HG!VU'" N71223 001 HAR 07, 1988 A! SHGIVIA ... N71937 001 HAR 07, 1988 ~.LdCtiS i Dtl !alJ.rAH PFI AI! BULL LABS ltI!t1:!J.II N71484 001 APR 19, 1988

HARFARIN POTASSIUM 11~~~~(1 1~(Jt)tlf~~W'/ I~I lt1ttIJtlddt+1 a PURDUE FRDRK SHG N11771 004

MATER FOR INJECTION. mRILE

LIQUID; Nl'A uaaL! NATa f'OR PJp:upH PI PLAI'ID apIfI'AItID AI! BAXTER .l22ZJI N18632 002 APR 19, 1988 ore DRUG PRODUCT LIST I CUMULATIVE SUPPLEMENT NUHBER 12 I JAN'88 - DEC'88 64

ACETAMINOPHEN CHLORPHENlRAHlNE MALEATE; PSEUDOEPHEDRINE HYDROCHLQRIDE SUPPOSITORY; RECTAL CAPSULE; CONTROLLED RELEASE; ORAL NEOPAP PSEUDOEPHEDRINE HCL AND CHLORPHENIRAHINE MALEATE l/lt~~~/~M~~1 n~~~1 1~~(,(t~tI~~tI CENTRAL PHARHS 8HG;12~ Nl942B 001 ALCON LABS 120HG N16401 001 AUG 02, 1988 TYLENOL >-.lli...> /j~t~tAft~~t~t/~Q~t~J!t1t~~~~J~t/rW.tl.ttJ/ HCNEIL CONSUtER 120HG Nl7756 002 >-.Ql.L> 650HG Nl7756 001 >-'U.L,> /~/~1t1~/~/ 1~,{~t~1 ,~~"11iU~~ l~t~t.I~# >...AWL> GRAHAM LABS Bt1Gil20t1G N1B844 001 ?J=~ ~~~~~!J~~ >...AWL> HAR 20, 1985

BROHPHENIRAMINE MALEATE; PHENYLPRopANOLAMINE DEXBROMPHENIRAHINE HALEATE; PSEUDOEPHEDRINE SULFATE TABLET, CONTROLLED RELEASE; ORAL ':f?~:t·:~~7~ttt~/~tt.tl$tJ'ltIIl.t.I RESPORAL l~t~~A1~1 I~~~J"~I PIONEER PHARHS 6HG;12~ Na91n 001 I ~~~~::~1iU~~ .AM 16, 1988

tRQt1PHENIRAMINE MALEATE i PHENYLPRopANOLAMINE HYDROCHLORIDE PEXTROHETHQRPHAN HYDR08RQHIDE; PROMETHAZINE HYDROCHLORIDE TABLET, CONTROLLED RELEASE; ORAL SYRUPi ORAL BROHATAPP PHENERGAN PH COPLEY PHARH 12t1Gi75t1G N71099 001 HYEIH AYERST LABS lSHG/SHL;6.25t1G/SHU. Nl1265 003 JUL 02, 1987 AUG 11, 1988

BUTYL HETHOXYDIBENZOyLHfTHANE i PADINATE 0 HYDROCORTISONE LOTIONi TOPICAL OINTMENT; TOPICAL PHOTOPLEX tIC I HYDROCORTISONE ) HERBERT LABS 3Xi7X. Nl9459 001 C&t1 PHARHA 0.5% NS0481 001 SEP 30, 1988 IBUPROFEN CHLORHEXIDINE GLucPNATE TABLET; ORAL SPONGE; TOPICAL IBU-TAB 200 >...AWL> PHARHASEAL SCRua CARE ALRA LABS 200HGII N71057 001 >....!l!JL> BAXTER 4X. N19793 001 AUG 11, 1988 >...AWL> DEC 02, 1988 IBUPROFEN DANBURY PHARHA 200HGII N71905 001 MAR 08, 1988 CHLQRPHENIRAHINE MALEATE INTERPHARH 200HGII N72199 001 MAY 23, 1988 CAPSULE, CONTROLLED RELEASE; ORAL INYAHED 200HGlll N71807 001 CHLORPHENIRAMINE MALEATE FEB 25, 1988 CORD LABS 12t1G11 N70797 001 HEPICOPHARHA 200HGll N71639 001 AUG 12, 1988 FEB 02, 1988 OTe DRUa PRODUCT LIST / t\I1ULAUYE SUPPLl!tENT tuBER 12 / .JAN'. - DEC'. 6&

IBUPROfEN LOPERAHIDE HYDROCHlORIDE

TABLEn ORAL SOLUTION; ORAL IBUPROfEN IHODIlI1 A-D HYLAN PHARHS 200HGll N71870 001 MCNEIL CONSU1ER 1HG/5I11M Nl9487 001 MAY OS, 1988 MAR 01, 1988 PRIVATE fHLTNS 200HGll N72299 001 JUL 01, 1988 ZENITH LABS 200HGll N72040 001 tPfQXVNQL-' APR 29, 1988 tlJPRIN SPONGE; VAGINAL BRISTOL HYERS 200HGll N7Z03S 001 TODAY fEB 16, 1988 /'J(.tl U~I 200101 N72036 001 I~~~~m~:~~ fEB 16. 1988 HHITEHALL LABS 1GH N18683 001 I~~~I #~f,tIr/;l I~H:~J./Jf~~1 'PR 01, 1983 #~~~I '~iji~d~~:~~~ I))~ltl:n~lI PHENYLEPHRINE HYDROCHLORIDE i PROHETHlZINE HYDROCHLORIDE a ZOOMS N19012 001 MAY 18. 1984 SYRUP; ORAL a 200HG N19012 003 PHENERGAN VC JUL 29, 1987 HYETH AYEBST LABS lOHG/5I1L ; 6. 2.5HG/5I1lM N08604 004 AUG 11, 1988

INSULIN SEMISYNTHETIC PURIfIED HUHANi INSULIN SUSP ISOPHANE SEMIsyNTHETIC PURIfIED HUMAN UOCONAZPLE

INJECTABLE; INJECUON CREAH; TOPICAL HIXTARD IU1AN 70/30 NDRDISK USA 30 ~TSlHL; U# 70 U.ITSlHlM N19S85 001 ~W~'~/~I MAR 11. 1988 TZ-3 "'~m1~~~~~ a PfIZER LABS IX N18682 001 fEB 18, 1983 INSULIN ZINt:: susp EXTENDED BIOSYNTHEIIC tu1AN

INJECTABLE; INJECTION HlIIJLIN U l(.t('('!1 1~~/~t~~('1 1~1~~~~:~~ a 40 ~TSlHL N19571 001 .Ju. 10. 1987

INSULIN ZINC susP puRIfIED BEEf/PORK >...Jt\.I...> It~t~~Ad~~flt~t¢lt~1 >.JU.L> >...Jt\.I...> 1~'1.~~~~~1 1~~~/~t~~('1 ItU6-w../~~~1 >-AIHL,> a SQUIBB NOVO 100 UNITSlHL N18384 001 DRUG PRODUCTS IN THE DIVISION OF BLOOD AND BLOOD PRODUCTS / CUHULATIVE SUPPLEMENT NUMBER 12 / JAN '88 - DEC '88 66 APPROVED UNDER SECTION SOS OF THE ACT LIST

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP HITH: AS-S: DEXTROSE USPi SODIUM CHLORIDE USPi MANNITOL USPj ADENINE r" \,..\ ~ j , .-.; .-~ .; / .I)~ 3~ INJECTABLEi INJECTION ('-\ 0 C "j"\"L/j' .. '02 OPTISOI. RED BLOOD CELL PRESERVATIVE SOLUTION O-·-6 TERUHO 0.9GH/I00HLiO.877GH1100HL; 0.S2SGMVI00HLjO.03GH1100HL N 880217 «PI'I/O V .,..--S OCT 07, 1988

DEXTRAN 70. 6Y, IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION MACRODEXIR) PHARHACIA INC 6GH1100HL;0.9GHII00HL N 06826 '~~~~~~l~~i~l~~~/~ft~ttttt~/A¢t~f' l~t~tIJ~t~~ft~~~II~~¢~j~~~tl Ittnj~~jf

" 67

ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL

SECTION 526 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT CONTAINS PROVISIONS WHEREBY FDA MAY DESIGNATE A SPONSOR I S DRUG, ANTIBIOTIC, OR BIOLOGICAL PRODUCT AS A "DESIGNATED ORPHAN DRUG". SECTION 527 OF THE ACT ESTABLISHES A PROCESS WHEREBY A SPONSOR MAY RECEIVE SEVEN YEARS OF EXCLUSIVE APPROVAL STATUS IF THAT SPONSOR IS THE FIRST TO ACHIEVE NEW DRUG, ANTIBIOTIC, OR BIOLOGICAL PRODUCT APPROVAL FOR A DESIGNATED ORPHAN DRUG FOR THE DESIGNATED INDICATION(S). THE EXCLUSIVE APPROVAL .MAY BE REVOKED BY WRITTEN CONSENT OF THE SPONSOR OR BY FDA ACTION AFTER FINDING THAT THE SPONSOR HOLDING EXCLUSIVE APPROVAL CANNOT ASSURE THE AVAILABILITY OF SUFFI­ CIENT QUANTITIES OF THE DRUG TO ~lEET THE NEEDS OF PATIENTS WITH THE DESIGNATED ORPHAN INDICATION(S).

ORPHAN DRUG EXCLUSIVE APPROVAL STATUS (CODED ODE) APPLIES ONLY TO THE APPROVED OR LICENSED INDICATION(S) FOR WHICH ORPHAN DRUG DESIGNATION HAS BEEN GRANTED PURSUANT TO SECTION 526 OF THE ACT.

FOR THE FOLLOWING DRUG PRODUCTS WITH ORPHAN DRUG EXCLUSIVE APPROVAL STATUS, THE SPONSOR HAS SEVEN YEARS OF EXCLUSIVE APPROVAL FOR THE APPROVED INDICATION BEGINNING ON THE DATE OF NDA, ANTIBIOTIC APPLICATION, OR BIOLOGICAL LICENSE APPROVAL FOR THE DRUG. NO SUBSEQUENT SPONSOR MAY RECEIVE APPROVAL OF AN NDA, BIOLOGICAL LICENSE, PAPER NDA, ANTIBIOTIC APPLICATION, ANDA, OR ABBREVIATED ANTIBIOTIC APPLICATION DURING THE SEVEN YEAR PERIOD FOR THE DRUG AND INDICATION{S) FOR WHICH ODE STATUS IS MAINTAINED UNLESS THE EXCLUSIVE APPROVAL HAS BEEN REVOKED AS DESCRIBED ABOVE OR THE SUBSEQUENT SPONSOR HAS OBTAINED WRITTEN CONSENT FROM THE SPONSOR WHO HAS RECEIVED EXCLUSIVE APPROVAL.

BIOLOGICAL PRODUCTS, ANTIBIOTICS, AND DRUGS THAT HAVE BEEN APPROVED UNDER SECTION 505 OR 507 OF THE ACT OR UNDER SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT FOR MARKETING AND HAVE BEEN GIVEN ORPHAN DRUG EXCLUSIVE APPROVAL WILL BE NOTED BY THE ABBREVIATION ODE IN THE PATENT AND EXCLUSIVITY INFORMATION ADDENDUM. DRUG PRODUCTS THAT HAVE RECEIVED THE WRITTEN PERMISSION OF THE SPONSOR THAT HAS ORPHAN DRUG EXCLUSIVE APPROVAL TO BE APPROVED UNDER SECTION 527 (b )(2) OF THE ACT ARE ALSO NOTED BY THE ABBREVIATION ODE IN THE PATENT AND EXCLUSIVITY INFORMATION ADDENDUM. THESE DRUG PRODUCTS DO NOT HAVE ANY EXCLUSIVE APPROVAL RIGHTS OF THEIR OWN, BUT CAN BE MARKETED BECAUSE OF THE CONSENT GIVEN BY THE SPONSOR THAT HAS EXCLUSIVE APPROVAL. THESE PRODUCTS ARE MARKED BY AN (*) NEXT TO THE APPLICANT'S NAME.

REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 8TH EDITION FOR A FULL LISTING OF ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL DATA •. ONLY NEW DATA WILL BE ADDED TO THE CUMULATIVE SUPPLEMENT. 68

ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL

BIOLOGICAL PRODUCTS

ACTIVE INGREDIENT(S) TRADE NAME LICENSE NUMBER EXCLUSIVITY STRENGTH(S) DOSAGE FORM; ROUTE APPLICANT APPROVAL DATE EXP. DATE

INTERFERON ALFA-2A ROFERON-A ROCHE 136 ODE INJECTABLE; INJECTION NOV 21, 1988 NOV 21, 1995

INTERFERON ALFA-2B INTRON-A SCHERING 994 ODE INJECTABLE; INJECTION NOV 21, 1988 NOV 21, 1995

.' 69

ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL

DRUG PRODUCTS

ACTIVE INGREDIENT(S) TRADE NAME APPL. PROD. NO. EXCLUSIVITY STRENGTH(S) DOSAGE FORM; ROUTE APPLICANT APPROVAL DATE EXP. DATE

ETHANOLAMINE OLEATE ETHAHOLIN GLAXO 19357 001 ODE 5m·1G/ML INJECTABLE; INJECTION DEC 22, 1988 DEC 22, 1995 I FOS FAM IDE IFEX BRISTOL rHERS 19763 001 ODE 1GM/VIAL INJECTABLE; INJECTION DEC 30, 1988 DEC 30, 1995 I FOSFAt-HOE IFEX BRISTOL MYERS 19763 002 ODE 3Gt·1/VIAL INJECTABLE; INJECTION DEC 30, 1988 DEC 30, 1995 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM LEDERLE LABS 08107 001 ODEl EQ 3~1G BASE/ML INJECTABLE; INJECTION AUG 31, 1988 AUG 31, 1995 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM LEDERLE LABS 08107 002 ODEl EQ 50MG BASE/VIAL INJECTABLE; INJECTION AUG 31, 1988 AUG 31, 1995 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM LEDERLE LABS 08107 004 ODEl EQ 100MG BASE/VIAL INJECTABLE; INJECTION AUG 31, 1988 AUG 31, 1995 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM LEDERLE LABS 08107 003 ODEl EQ 6or~G BASE/VIAL POWDER FOR AUG 31, 1988 AUG 31, 1995 RECONSTITUTION; ORAL

lODE PERTAINS ONLY TO INDICATION 1-79 (SEE EXCLIISIVITY TERMS) .n. ,.. , r () I t';> .r~ (' C/(/-"/"'" ,()v ';;'-"-. <:..~.,<. I} () o ~.~" .. t/' 1«/ / !,,/ 70

ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL

DRUG PRODUCTS

ACTIVE INGREDIENT(S) TRADE NAME APPL. PROD. NO. EXCLUSIVITY STRENGTH(S) DOSAGE FORM; ROUTE APPLICANT APPROVAL DATE EXP. DATE

MESNA MESNEX BRISTOL MYERS 19884 001 ODE 100MG/ML INJECTABLE; INJECTION DEC 30, 1988 OEr, 30, 1995 METHOTREXATE SODIUM METHOTREXATE LEDERLE LABS 11719 001 ODE2 EQ 20MG BASE/VIAL INJECTABLE; INJECTION APR 07, 1988 APR 07, 1qC)~ METHOTREXATE SODIUM METHOTREXATE LEDERLE LABS 11719 003 ODE2 EQ 50MG BASE/VIAL INJECTABLE; INJECTION APR 07, 1988 APR 07, 1995 METHOTREXATE SODIUM METHOTREXATE LEDERLE LABS 11719 006 ODE2 EQ 100MG BASE/VIAL INJECTABLE; INJECTION APR 07, 1988 APR 07, 199~ METHOTREXATE SODIUM METHOTREXATE LEDERLE LABS 11719 009 00E2 EQ 1(]t·1 BAS E/V I AL INJECTABLE; INJECTION APR 07, 1988 APR 07, 1995 METHOTREXATE SODIUM METHOTREXATE LPF LEDERLE LABS 11719 007 ODE2 EQ 25MG BASE/ML INJECTABLE; INJECTION APR 07, 1988 APR 07, 1995 METRONIDAZOLE METROGEL CURATEK PHARMS 19737 001 ODE 0.75% GEL; TOPICAL NOV 22, 1988 NOV 22, 1995 POTASSIUM CITRATE POTASSIUM CITRATE UNIV TEXAS 19647 002 ODE 10MEQ/PACKET POWDER, FOR OCT 13, 19A8 AUG 30, 1992 RECONSTITUTION; ORAL

20DE PERTAINS ONLY TO INDICATION 1-78 (SEE EXCLUSIVITY TER~'S) 71

ORPHAN DRUG PRODUCTS WITH EXCLUSIVE APPROVAL

DRUG PRODUCTS

ACTIVE INGREDIENT(S) TRADE NAME APPL. PROD. NO. EXCLUSIVITY STRENGTH(S) DOSAGE FORM; ROUTE APPLICANT APPROVAL DATE EXP. DATE

POTASSIur, CITRATE POTASSIUM CITRATE UNIV TEXAS 19647 001 ODE 20MEQ/PACKET POWDER, FOR OCT 13, 1988 AUG 30, 1992 RECONSTITUTION; ORAL TIOPRONIN TIOPROtHN UNIV TEXAS 19569 001 ODE 100MG TABLET; ORAL AUG 11, 1988 AUG 11, 1995 72 DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION cJ2?,,~' ? 7 NO DfetMHtR 1988 ADDITIONS

.' 73 BIOPHARMACEUTIC GUIDANCE AVAILABILITY

THE FOLLOWING IS A LIST OF GUIDANCES AVAILABLE FOR IN VIVO BIOEQUIVALENCE STUDIES AND IN VITRO DISSOLUTION TESTING AVAILABLE FROM THE DIVISION OF BIOEQUIVALENCE--, HFN-250, ROOM 17B-06, 5600 FISHERS-rANE, ROCKVILLE, MD 20857. COMMENTS AND SUGGESTIONS CONCERNING THESE GUIDANCES ARE ENCOURAGED AND SHOULD SE SENT TO THE DIVISION OF BIOEQUIVALENCE. REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 8TH EDITION FOR A FULL LISTING OF BIOPHARMACEUTIC GUIDANCE AVAILABILITY DATA. ONLY NEW DATA WILL BE ADDED TO THE CUMULATIVE SUPPLEMENT.

DRUG NAME (DOSAGE FORM) DATE REVISED DATE

ACETOHEXAMIDE (TABLET) NOV 15, 1985 AUG 01, 1988 ALBUTEROL; METAPROTERENOL SULFATE (METERED DOSE INHALER) AUG 25, 1988 AMOXAPINE (TABLET) SEP 10, 1987 AUG 05, 1988 ATENOLOL (TABLET) OCT 06, 1988 CARBAMAZEPINE (TABLET) JAN 01, 1988 CLINDAMYCIN (CAPSULE) MAY 31, 1988 ~0"~~g~7~~ ~~7~0g~" t7~~~~7J* l'U 17 J "~~ CYCLOBENZAPRINE HYDROCHLORIDE (TABLET) JAN 25, 1988 DOXYCYCLINE HYCLATE (CAPSULE AND TABLET) APR 11, 1988 ERYTHROMYCIN (CAPSULE, ENTERIC COATED PELLETS) SEP 21, 1988 FENOPROFEN (CAPSULE AND TABLET) AUG 27, 1987 FEB 03, 1988 INDOMETHACIN (CAPSULE) JUN 04, 1985 JAN 27, 1988 LEUCOVORIN CALCIUM (TABLET) APR 28, 1987 AUG 04, 1988 MESTRANOL; NORETHYNODREL (TABLET) MAY 13, 1988 METAPROTERENOL SULFATE (TABLET) MAR 18, 1988 NORETHINDRONE; ETHINYL ESTRADIOL (TABLET) MAR 18, 1988 PRAZEPAM (CAPSULE AND TABLET) JUL 26, 1988 RIFAMPIN (CAPSULE) SEP 08, 1988 TIHOLOL MALEATE (TABLET) AUG 09, 1988

*THE METHODOLOGY IN THE BIOPHARMACEUTICAL AVAILABILITY GUIDANCE IS NO LONGER ACCEPTED BY THE AGENCY. £~» ,,,{,/ -/ ! t ..J ~7' CIt,·? (i~~~'~~r""" ct' ('\ qytj t. (J I 74 t~ 1 o!'~'"'''' tJ ~ v.!u d { t-'\ , q'-.Gr~ C"-PFrr; v. '''''"' ANDA SUITABILITY PETITIONS

THE FOLLOWING ARE TWO LISTS OF PETITIONS FILED UNDER SECTION 505(j)(2)(C) OF THE ACT WHERE THE AGENCY HAS DETERMINED THAT THE REFERENCED PRODUCT: (1) IS SUITABLE FOR SUBMISSION AS AN ANDA (PETITIONS APPROVED) OR (2) IS NOT SUITABLE FOR SUBMISSION AS AN ANDA (PETITIONS DENIED). THE OETER~lINATIO~' THAT AN ANDA ~IILL BE APPROVED IS NOT ~AnF lINTIl. THE ANDA ITSELF IS SUBMITTED AND REVIEWED BY THE AGENCY. A COpy OF EACH PETITION IS LISTED BY DOCKET NUMBER ON PUBLIC DISPLAY IN FOAlS DOCKETS MANAGEMENT BRANCH, HFA-305, ROOM 4-62, 5600 FISHERS LANE, ROCKVILLE, MO 20857. REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 8TH EDITION FOR A FULL LISTING OF ANOA SUITABILITY PETITIONS DATA. ONLY NEW DATA WILL BE ADDED TO THE CUMULATIVE SUPPLEMENT.

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

ACETYLCYSTE I NE 20% 88 P-0237/CP DEY LABS NEW STRENr,TH APPROVErJ SOLUTION; INHALATION NOV 29, 1988 ASPIRIN; 325MG 87 P-0376/ ANABOLIC NEW STRENGTH APPROVED HYDROCODONE BITARTRATE 5MG CPOOO2 FEB 12, 1988 TABLET; ORAL ASPIRIN; 650MG 87 P-0376/CP ANABOLIC NEW STRENGTH APPROVED HYDROCODONE BITARTRATE 5MG FEB 12, 1988 TABLET; ORAL CHLORHEXIDINE GLUCONATE 4% 88 P-0295/CP BRIAN PHARMS NEW STRENGTH APPROVED TOWELLETE; TOPICAL NOV 03, 1988

CHLORHEXIDINE GLUCONATE 0.5% 88 P-0036/CP ARENT, FOX, KINTNER, NEl~ DOSAGE APPROVED SPRAY; TOPICAL PLOTKIN & KAHN FORM AUG 19, 1988 75 ANDA SUITABILITY PETITIONS

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

CHLORZOXAZONE SOOMG 82 N-0032/ rHKART NEW DOSAGE APPROVED CAPSULE; ORAL CPOO06 FORM JAN 13, 1988 CIS PLATIN 1MG/ML 87 P-0421/CP BULL LABS NEW DOSAGE APPROVED INJECTABLE; INJECTION (10ML/VIAL) FORM FEB 29, 1988 (50ML/VIAL) NEW STRENGTH (100ML/VIAL) CISPLATIN 1MG/ML 88 P-OOl O/CP LYPHOMED NEW DOSAGE APPROVED INJECTABLE; INJECTION (20ML/VIAL) FORM APR 01, 1988 NEW STRENGTH CLEMASTINE FUMARATE; EQ 1MG BASE 88 P-0350/CP SC I CONSULTING NEW DOSAGE APPROVED PHENYLPROPANOLAMINE 75MG FORM DEC 13, 1988 HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL CYCLOPHOSPHAMIDE 20MG/ML 88 P-00l1/CP BAXTER HLTHCARE NEW DOSAGE APPROVED INJECTABLE; INJECTION (500ML/CONTAINER) FORM JUN 10, 1988 NEW STRENGTH 76 ANDA SUITABILITY PETITIONS

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

FLUOROURACIL 50MG/ML 8R P-0052/CP BEN VENUE LABS NEl4 STRENGTH APPROVED INJECTABLE; INJECTION (5ML/VIAL) MAR 21, 1988 HOMATROPINE METHYLBROMIDE; 1.5MG 88 P-0061/CP KLEINFELD, KAPLAN NEW DOSAGE APPROVED HYDROCODONE BITARTRATE 5MG AND BECKER FORM MAY 12, 1988 SOFT GELATIN CAPSULE; ORAL

HYDROCHLOROTHIAZIDE; 25MG/5ML 87 P-0399/CP BURDITT, BOl-!LES, NEW DOSAGE APPROVED PROPRANOLOL HYDROCHLORIDE 40MG/5ML RADZIUS AND RUBERRY FORM FEB 16, 1988 SOLUTION; ORAL

HYDROCHLOROTHIAZIDE; 25MG/5ML 87 P-0399/CP BURDITT, BOWLES, NEl~ DOSAGE APPROVED PROPRANOLOL HYDROCHLORIDE 80MG/5ML RADZIUS AND RUBERRY FORM FEB 16, 1988 SOLUTION; ORAL

HYDROCHLOROTHIAZIDE; 25MG 87 P-0335/CP PAR PHARM NEW DOSAGE APPROVED TRIAMTERENE 50MG FORM . FEB 26, 1988 TABLET; ORAL

LEUCOVORIN CALCIUM EQ H1G BASE/ML 88 P-0l49/CP ROXANE LABS NEW DOSAGE APPROVED SOLUTION; ORAL FORM JUL 25, 1988 ..

77 ANDA SUITABILITY PETITIONS

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

MEPERIDINE HYDROCHLORIDE 10MG/rR 88 P-0008/CP LYPHOMED NEW STRENGTH APPROVED INJECTABLE; INJECTION (50ML/CONTAINER) APR 01, 1988 METOCLOPRAMIDE 10MG/ML 88 P-0164/CP ROXANE LABS NEW STRENGTH APPROVED HYDROCHLORIDE INTENSOL JUN 28, 1988 CONCENTRATE; ORAL

NIFEDIPINE 10MG 88 P-0072/ MARTEC PHARMS NE\~ DOSAGE APPROVED CAPSULE; ORAL CPOOO2 FORM MAY 11, 1988 NIFEDIPINE 20MG 88 P-0072/CP MARTEC PHARMS NEW DOSAGE APPROVED CAPSULE; ORAL FORM MAY 11, 1988 PHENYLPROPANOLAMINE 15Of1G 88 P-0265/CP BIO AMERICAN NEW DOSAGE APPROVED HYDROCHLORIDE FORM OCT 07, 1988 FILM, CONTROLLED NEW STRENGTH RELEASE; PERCUTANEOUS NEW INDICATION PHENYTOIN SODIUM 100MG/VIAL 87 P-0367/CP LYPHOMED NEW DOSAGE APPROVED INJECTABLE; INJECTION 250MG/VIAL FORM FEB 16, 1988 78 ANDA SUITABILITY PETITIONS

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/ML 88 P-0235/CP PAN At1 PHARMS NEW STRENGTH APPROVED SOLUTION; ORAL AUG 24, 1988 QUINIDINE SULFATE 300MG 88 P-0277 /CP ROBINS NEI4 DOSAGE APPP'OVE[) CAPSULE, EXTENDED FORM DEC 13, 1988 RELEASE; ORAL

QUINIDINE GLUCONATE 648MG 87 P-0276/CP FOREST LABS NEVI STRENGTH APPROVED TABLET, CONTROLLED NOV 22, 1988 RELEASE; ORAL

SODIUM CHLORIDE 0.9% 900MG/100ML 87 P-0391/CP LYPHOMED NE!~ STR ENGTH APPROVED IN PLASTIC CONTAINER (lOOML/CONTAINER) AUG 11, 1988 INJECTABLE; INJECTION

STERILE WATER 100% 87 P-0392/CP LYPHm1ED NEW STRENr,TH APPROVED IN PLASTIC CONTAINER (lOOML/CONTAINER) AUG 11, 1988 INJECTABLE; INJECTION

THEOPHYLLINE 450MG 88 P-0119/CP RIKER LABS NEW STRENGTH APPROVED CAPSULE, CONTROLLED MAY 11, 1988 RELEASE; ORAL •

79 ANDA SUITABILITY PETITIONS

PETITIONS APPROVED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

THEOPHYLLINE 500MG 88 P-0226/CP SAVAGE LABS NE\~ STRENGTH APPROVED CAPSULE, CONTROLLED AUG 25, 1988 RELEASE; ORAL THEOPHYLLINE 160MG!15ML 88 P-0301/CP FLEMING NEW STRENGTH APPROVED SOLUTION; ORAL NOV 04, 1988 THIOTEPA, STERILE 15MG/VIAL 87 P-0382/CP LYPHOHED NEW DOSAGE APPROVED (WITH DILUENT) FORM MAY 12, 1988 INJECTABLE; INJECTION VERAPAMIL HYDROCHLORIDE 120MG 87 P-0233/CP SEARLE NEW DOSAGE APPROVED CAPSULE, CONTROLLED 240MG FORM FEB 26, 1988 RELEASE; ORAL NEW STRENGTH VINCRISTINE SULFATE 1MG/ML 87 P-0210/CP LYPHOMED NEW STRENGTH APPROVED INJECTABLE; INJECTION (1.5HL/CONTAINER) JUL 28, 1987 80 ANDA SUITABILITY PETITIONS

PETITIONS DENIED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

BENZOYL METRONIDAZOLE 20or~G/5ML 85 P-0258/CP APKON LABS NEW INGREDIENT DENIED SUSPENSION; ORAL (NEW ESTER) MAR 19, 1986 BROMDIPHENHYDRAMINE 12.5MG/5ML 85 P-0255/CP '·11 KART NEW DENIED HYDROCHLORIDE; COMBINATION MAY 11, 1988 HYDROCODONE BITARTRATE 2.5MG/5ML S{)lUTION; ORAL

BRor~DI PHENHYDRAMINE 12.5MG/5ML 85 P-0255/CP tlIKART NEW DENIED HYDROCHLORIDE; COMB INATION MAY 11, 1988 HYDROCODONE BITARTRATE 2.5MG/5ML SYRUP; ORAL

BROMPHENIRAMINE 2MG/5ML 85 P-0237/CP tHKART NEl4 DENIED MALEATE; COMBINATION MAY 11, 1988 HYDROCODONE BITARTRATE; 2.5MG/5ML PHENYLPROPANOLAMINE 12.5MG/5ML HYDROCHLORIDE SYRUP; ORAL CYCLOBENZAPRINE 15MG 86 P-0386/CP CENTRAL PHARMS NEW STRENGTH DENIED HYDROCHLORIDE AUG 15, 1988 TABLET; ORAL 81 ANDA SUITABILITY PETITIONS

PETITIONS DENIED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

CYCLOPHOSPHAMIDE lOOMG/ML 87 P-0283/CP LYPHOMED NEW DOSAGE DENIED INJECTABLE; INJECTION (1ML/VIAL) FORM JAN 21, 1988 (2ML/VIAL) NEW STRENGTH CYCLOPHOSPHAMIDE 5OOMG/ML 87 P-0283/CP LYPHOMED NEW DOSAGE DENIED INJECTABLE; INJECTION (1ML/VIAL) FORM JAN 21, 1988 (2r~L/VIAL) NEW STRENGTH (4ML/VIAL) DI PHENHYDRM'1 I NE 75MG 87 P-0355/CP PARKE DAVIS NEW DOSAGE DENIED HYDROCHLORIDE FORM MAY 11, 1988 CAPSULE, SUSTAINED NEW STRENGTH RELEASE; ORAL HYDROCODONE BITARTRATE; 1.66MG/5ML 85 P-0389/CP UAD LABS NEW DENIED PHENYLEPHRINE 5MG/5ML COMBINATION MAY 11, 1988 HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP; ORAL 82 ANDA SUITABILITY PETITIONS

PETITIONS DENIED

DRUG NAME STRENGTH REASON FOR DOSAGE FORM; ROUTE (CONTAINER SIZE) DOCKET NUMBER PETITIONER PETITION STATUS

HYDROCODONE BITARTRATE; 2.5MG/5ML 85 P-0256/CP MIKART NEH DENIED PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML COMBINATION MAY 11, 1988 SYRUP; ORAL IBUPROFEN 20m1G/5ML 88 P-0291/ BIOCRAFT LABS NEW DOSAGE DENIED LIQUID; ORAL CP-0001 FORM DEC 15, 1988

IBUPROFEN 400MG/10ML 88 P-0291/ BIOCRAFT LABS Nn~ DOSAGE DENIED LIQUID; ORAL CP-0002 FORM DEC 15, 1988 MAGNESIUM ASCORBATE 10% 88 P-0200/CP RIM CONSULTING NHI INGREDIENT DENIED INJECTABLE; INJECTION 20% JUN 10, 1988 METOCLOPRAMIDE 1MG/ML 87 P-0090/CP H!Tl MEDTN SYS NEW STRENGTH DENIED HYDROCHLORIDE (50ML/VIAL) FEB 08, 1988 INJECTABLE; INJECTION (75Ml/VIAL) (1 OO~'L/VIAL)

.' 83 EXCLUSIVITY TERMS

DUE TO SPACE LIMITATIONS IN THE EXCLUSIVITY COLUMN, ABBREVIATIONS AND REFERENCES HAVE BEEN DEVELOPED. REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 8TH EDITION FOR A FULL LISTING OF EXCLUSIVITY TERMS (ABBREVIATIONS, NEW DOSING SCHEDULE, NHI INDICATIONS AND PATENT USE CODES). ONLY NEW CODES WILL BE ADDED TO THE CUMULATIVE SUPPLEMENT. ;Y'~;R~ \.------,--~-"'.---" NEW DOSING SCHEDULE

~/l~ ~~~71~~ 0~~1"B ~, ~~0~B ,~~ 7~~~~~"7 0-12 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER 0-13 INCREASED MAXIMUM nAILY DOSAGE RECOMMENDATION 0-14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER 0-15 SINGLE DAILY DOSE OF 25MG/37.5MG f--NEw -;N~~CA~~ ~----.----,.--, 111~ ~"71~~7~/'~~/~~~7~1"~'~~"/~Y~~~~~~~~ 1-19 CHOLANGIOPANCREATOGRAPHY 1-72 PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT 1-73 FOLLICULAR STIMULATION IN IN VITRO FERTILIZATION 1-74 MANAGEMENT OF CONGESTIVE HEART FAILURE 1-75 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY I~76 HERNIOGRAPHY 1-77 KNEE ARTHROGRAPHY 1-78 HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY TUMOR 84 EXCLUSIVITY TERMS

REFERENCES

NEW INDICATION 1-79 RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA 1-80 SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER 1-81 TREATMENT OF RHEUMATOID ARTHRITIS 1-82 ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL, RENAL AND PERIPHERAL VESSELS 1-83 TREATMENT OF LIVER FLUKES

PATENT USE CODE U-26 METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER U-27 METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS U-28 METHOD FOR IMPROVING MEMORY IN MAMMALS U-29 METHOD FOR TREATING AMNESIA U-30 METHOD OF POTENTIATING CODEINE ANALGESIA IN MAMMALS U-31 USE IN LUNG SCANNING PROCEDURES U-32 TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS U-33 METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS U-34 TREATMENT OF INFLAMMATION U-35 PROCESS FOR INHIBITING THE SECRETION OF PROLACTIN IN MAMMALS U-36 PROCESS FOR TREATING A PATIENT SUFFERING FRat1 PARKINSON'S SYNDRat1E AND IN NEED OF TREATHENT U-37 METHOD FOR CHOLESTEROL LOWERING U-38 TREATMENT OF HUMANS SUFFERING FROM UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY CYTOSTATICALLY ACTIVE ALKYLATINGAGENTS U-39 METHOD OF COMBATING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND METABOLISM IN WARM-BLOODED ANIMALS U-40 METHOD OF EFFECTING CORONARY VASCULAR DILATION IN HUMANS AND ANIMALS PRESCRIPTION AND OTC DRUG PRODUCT 85 PATENT AND EXCLUSIVITY DATA

APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES

19489 001 ALBUTEROL SULFATE; VENTOLIN ROTACAPS 3705233 DEC OS, 1989 3644353 FEB 22, 1989 NDF MAY 04, 1991 18116 002 AMCINONIDE; CYCLOCORT 4158055 JUN 12, 1996 U-34 18498 001 AHCINONIDE; CYCLOCORT 4158055 JUN 12, 1996 U-34 >ADD> 19402 001 ASTEMIZOLE; HISMANAL 4219559 AUG 26, 1997 NCE DEC 29, 1993 19716 001 BETAMETHASONE DIPROPIONATE; DIPROLENE NP AUG 01, 1991 18644 001 BUPROPION HYDROCHLORIDE; WELLBUTRIN 4507323 MAR 26, 2002 18644 002 BUPROPION HYDROCHLORIDE; WELLBUTRIN 4507323 MAR 26, 2002 18644 003 BUPROPION HYDROCHLORIDE; WELLBUTRIN 4507323 HAR 26, 2002 >DLT> 19,(559 ""I BYIyr MflM6Xyg1BfMZIYrMflM~ft PM616prfX '(:a87"89 .lYM "7( ZI"" MP SfP :a,,( 1991 >ADD> 19459 001 BUTYL HETHOXYDIBENZOYLHETHANE; PHOTOPLEX 4387089 JUN 07, 2000 NCE >DLT> SEP 30, 1993 185555" ""Z ~A~P~6'fMt ~1KA9Yr :a89t5U55 .lyr ZZ( 199Z M~f IIf~ :aI( 199Z >ADD> 18550 002 CARPROFEN; RIHADYL 3896145 JUL 22, 1994 >DLT> NCE DEC 31, 1992 185555" "s;a ~A~P~6'fMt ~1KA9Yr :a89t5UH .lyr ZZ( 199Z M~f life :aI( 1992 >ADD> 18550 003 CARPROFEN; RIHADYL 3896145 JUL 22, 1994 NCE DEC 31, 1992 >ADD> 19204 001 CARTEOLOL HYDROCHLORIDE; CARTROL 3910924 OCT 07, 1992 NCE DEC 28, 1993 >ADD> 19204 002 CARTEOLOL HYDROCHLORIDE; CARTROL 3910924 OCT 07, 1992 NCE DEC 28, 1993 >ADD> 19204 003 CARTEOLOL HYDROCHLORIDE; CARTROL 3910924 OCT 07, 1992 NCE DEC 28, 1993 >ADD> 19574 001 CHLORTHALIDONE; THALl TONE NS DEC 20, 1991 71621 001 CHOLESTYRAMINE; CHOLYBAR 4778676 OCT 18, 2005 71739 001 CHOLESTYRAHINE; CHOLYBAR 4778676 OCT 18, 2005 >ADD> 19824 001 CICLOPIROX OLAHINE; LOPROX 3883545 HAY 13, 1992 NCE DE<: 30, 1992 >ADD> NDF DEC 30, 1991 17920 002 CIMETIDINE; TAGAHET 4024271 HAY 17, 1994 D-14 MAR 31 J 1991 3950333 APR 13, 1993 0-12 APR 30, 1989 17920 003 CIHETIDINE; TAGAHET 4024271 HAY 17, 1994 D-14 MAR 31, 1991 3950333 APR 13, 1993 0-12 APR 30, 1989 17920 004 CIMETIDINE; TAGAHET 4024271 HAY 17, 1994 0-14 MAR 31, 1991 3950333 APR 13, 1993 D-12 APR 30, 1989 17920 005 CIHETIDINE; TAGAHET 4024271 HAY 17, 1994 0-14 MAR 31, 1991 3950333 APR 13, 1993 D-12 APR 30, 1989 17924 001 CIHETIDINE HYDROCHLORIDE; TAGAHET 4024271 HAY 17, 1994 D-14 MAR 31, 1991 3950333 APR 13, 1993 0-12 APR 30, 1989 18057 004 CISPLATIN; PLATINOL-AQ 4310515 JAN 12, 1999 4177263 DEC 04, 1996 18891 001 CLONIDINE; CATAPRES-TTS-1 4201211 HAY 06, 1997 4060084 JUN 28, 1994 3996934 JUL 29, 1992 18891 002 CLONIDINE; CATAPRES-TT5-2 4201211 HAY 06, 1997 4060084 JUN 28, 1994 3996934 JUL 29, 1992 18891 003 CLONIDINE; CATAPRES-TT5-3 4201211 HAY 06, 1997 4060084 JUN 28, 1994 3996934 JUL 29, 1992 PRESCRIPTION AND OTC DRUG PRODUCT 86 PATENT AND EXCLUSIVITY DATA

APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXCLUS EXClUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES

19201 001 DICLOfENAC SODIUM; VOL TAR EN 3652762 MAR 28, 1989 NCE JUL 28, 1993 19201 002 DICLOfENAC SODIUM; VOLTAREN 3652762 MAR 28, 1989 NCE JUL 28, 1993 19201 003 DICLOfENAC SODIUM; VOLTAREN 3652762 MAR 28, 1989 NCE JUL 28, 1993 18998 001 ENALAPRIL MALEATE; VASOTEC 1-74 JUN 24, 1991 18998 002 ENALAPRIL MALEATE; VASOTEC 1-74 JUN 24, 1991 18998 003 ENALAPRIL MALEATE; VASOTEC 1-74 JUN 24, 1991 18998 005 ENALAPRIL MALEATE;~ VASOTEC 4374829 fEB 22, 2000 NCE DEC 24, 1990 1-74 JUN 24, 1991 19309 001 ENALAPRILAT; VASOTEC 4374829 fEB 22, 2000 NDf fEB 09, 1991 18981 002 ENCAINIDE HYDROCHLORIDE; ENKAID RE30811 DEC 20, 1996 U-32 18981 003 ENCAINIDE HYDROCHLORIDE; ENKAID RE30811 DEC 20, 1996 U-32 18981 004 ENCAINIDE HYDROCHLORIDE; ENKAID RE30811 DEC 20, 1996 U-32 19386 001 ESMOLOL HYDROCHLORIDE; BREVI BLOC 4593119 JUN 03, 2003 NCE DEC 31, 1991 4387103 JUN 07, 2000 U-16 >ADD> 19357 001 ETHANOLAMINE OLEATE; ETHAHOLIN ODE DEC 22, 1995 >ADD> NP DEC 22, 1991 19462 001 fAMOTIDINE; PEPCID 1-80 OCT 17, 1991 19462 002 fAMOTIDINE; PEPCID 1-80 OCT 17, 1991 19510 001 fAMOTIDINE; PEPCID 1-80 OCT 17, 1991 19527 001 fAMOTIDINE; PEPCID 1-80 OCT 17, 1991 18830 003 fLECAINIDE ACETATE; TAHBOCOR 4005209 JAN 25, 1996 NS JUN 03, 1991 3900481 AUG 19, 1992 NCE OCT 31, 1990 18830 004 fLECAINIDE ACETATE; TAHBOCOR 4005209 JAN 25, 1996 3900481 AUG 19, 1992 NCE OCT 31, 1990 19452 001 fLUOCINOLONE ACETONIDE; DERMA-SHOOTHE/fS NDf fEB 03, 1991 18936 001 fLUOXETINE HYDROCHLORIDE; PROZAC 4683235 JUL 28, 2004 U-30 4647591 MAR 03, 2004 U-28 4647591 MAR 03, 2004 U-29 4626549 DEC 02, 2003 U-26 4626549 DEC 02, 2003 U-27 >DLT> I.aIM81 'fB eZi 11J1J1J >ADD> 4314081 fEB 02, 2001 4194009 APR 19, 1994 18766 002 fLURBIPROfEN; ANSAID 3793457 fEB 19, 1993 ~Cf... DEC 31, 199J~ 3755427 AUG 28, 1990 NDf ocr 31, 1991 18766 003 fLURBIPROfEN; ANSAID 3793457 fEB 19, 1993 HCE DE!: 3]. ]99l... 3755427 AUG 28, 1990 NDf OCT 31, 1991 19404 001 fLURBIPROfEN SODIUM; OCUfEN 3793457 fEB 19, 1993 • • ..

PRESCRIPTION AND OTC DRUG PRODUCT 87 PATENT AND EXCLUSIVITY DATA

APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXClUS EXCLUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES

19596 001 GADOPENTETATE DIMEGLUMINE; MAGNEVIST 4647447 MAR 03, 2004 NCE JUN 02, 1993 18422 001 GEMFIBROZIL; LOPID 3674836 JAN 04, 1993 18422 002 GEMFIBROZIL; LOPID 3674836 JAN 04, 1993 >ADD> 19032 002 GUANFACINE HYDROCHLORIDE; TENEX 3632645 JAN 04, 1991 NCE OCT 27, 1991 >ADD> 19032 003 GUANFACINE HYDROCHLORIDE; TENEX 3632645 JAN 04, 1991 NCE OCT 27, 1991 18061 001 HYDROCHLOROTHIAZIDE; TIHOLIDE 10-25 3655663 APR 11, 1989 0-2 FEB 03, 1991 >ADD> 19129 003 HYDROCHLOROTHIAZIDE; MAXZIDE-25 4444769 APR 24, 2001 NS MAY 13, 1991 0-15 MAY 13, 1991 >ADD> 19763 001 IFOSFAMIDE; IFEX 3732340 MAY 08, 1990 ODE DEC 30, 1995 >ADD> NCE DEC 30, 1993 >ADD> 19763 002 IFOSFAMIDE; IFEX 3732340 MAY 08, 1990 ODE DEC 30, 1995 >ADD> NCE DEC 30, 1993 >.!ll.I> 19A-~Z 91JI 10YlIAMIMl MYaRBfMf0Rla2 1~IZ~( ZPlflAMIM2 A-~&nlI MIV Z~( 1999 Mfl Uf ZM 199Z >ADD> 19432 001 IOFETAMINE HYDROCHLORIDE 1-123; SPECTAHINE 4360511 NOV 23, 2001 NCE DEC 24, 1992 18956 002 IOHEXOL; OHNIPAQUE 240 1-19 JUL 29, 1991 1-60 JUL 29, 1991 1-75 JUL 29, 1991 1-76 JUL 29, 1991 1-71 JUL 29, 1991 18956 003 IOHEXOL; OHNIPAQUE 300 4021481 MAY 03, 1994 I-55 FEB 01, 1988 I-58 FEB 01, 1988 1-60 JUL 29, 1991 1-71 JUL 29, 1991 18956 004 IOHEXOL; OHNIPAQUE 350 I-56 MAY 24, 1991 1-71 JUL 29, 1991 18956 005 IOHEXOL; OHNIPAQUE 140 4396597 JUL 14, 1998 1-82 NOV 30, 1991 4250113 DEC 26, 1999 NCE DEC 26, 1990 4021481 MAY 03, 1994 NS NOV 30, 1991 >ADD> 19710 001 IOVERSOL; OPTIRAY-320 NCE DEC 30, 1993 >ADD> 19710 002 IOVERSOL; OPTIRAY-24O NCE DEC 30, 1993 >ADD> 19710 003 IOVERSOL; OPTIRAY-160 NCE DEC 30, 1993 19085 001 IPRATROPIUM BROMIDE; ATROVENT 3681500 AUG 01, 1991 NCE DEC 29, 1991 08107 001 LEUCOVORIN CALCIUM; LEUCOVORIN CALCIUM ODE AUG 31, 1995 1-79 AUG 31, 1995 08107 002 LEUCOVORIN CALCIUM; LEUCOVORIN CALCIUM ODE AUG 31, 1995 1-79 AUG 31, 1995 08107 003 LEUCOVORIN CALCIUM; LEUCOVORIN CALCIUM ODE AUG 31, 1995 1-79 AUG 31, 1995 08107 004 LEUCOVORIN CALCIUM; LEUCOVORIN CALCIUM ODE AUG 31, 1995 1-79 AUG 31, 1995 PRESCRIPTION AND OTC DRUG PRODUCT 88 PATENT AND EXCLUSIVITY DATA

APPL/PROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES

>DLT> 19!H18 SSl ~ISIM0PRI~1 PRIMIYI~ Ita7148Z9 ,n ZZ/ ZSSS Nff IiIff Z9,( 199Z >ADD> 19558 001 LISINOPRIL; PRINIVIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 >DLT> 19S58 ssz ~ISIM0PRI~1 PRIMIYI~ Ita7148Z9 ,n ZZ/ ZSSS Mff IiIff Z9,( 199Z >ADD> 19558 002 LISINOPRIL; PRINIVIL 4374829 >DLT> DEC 30, 2001 NCE DEC 29, 1992 19S58 in ~ISIM0PRI~1 PRIMlYI~ Ita7148Z9 ,n ZZ,( ZiSS Nff IiIff Z9,( 199Z >ADD> 19558 003 LISINOPRIL; PRINIVIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 >ADD> 19558 004 LISINOPRIL; PRINIVIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 >DLT> 19777 S91 ~ISIM0PRI~1 ZfS1RI~ Ita7148Z9 ,n ZZ,( ZiiO Nff IiIff Z9,( 199Z >ADD> 19777 001 LISINOPRIL; ZESTRIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 >DLT> 19777 ssz ~ISIN0PRI~1 ZfS1RI~ Ita7148ZIJ ,n ZZ,( ZiSO Nff IiIff Z9,( 199Z >ADD> 19777 002 LISINOPRIL; ZESTRIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 >DLT> 19777 isa ~ISIM0PRI~1 ZfS1RI~ Ita7lt8Z9 ,n ZZ/ ZiSO Nff iff Z9,( 199Z >ADD> 19777 003 LISINOPRIL; ZESTRIL 4374829 DEC 30, 2001 NCE DEC 29, 1992 19487 001 LOPERAMIDE HYDROCHLORIDE; IMODIUM A-D 3714159 JAN 30, 1990 19643 003 LOVASTATIN; MEVACOR 4231938 NOV 04, 1999 NCE AUG 31, 1992 >ADD> 19643 004 LOVASTATIN; MEVACOR 4231938 NOV 04, 1999 NCE AUG 31, 1992 18006 001 MECLOFENAMATE SODIUM; MECLOMEN 1-68 AUG 30, 1991 18006 002 MECLOFENAMATE SODIUM; MECLOMEN 1-68 AUG 30, 1991 >ADD> 19884 001 MESNA; MESNEX 4220660 SEP 02, 1997 U-38 ODE DEC 30, 1995 >ADD> NCE DEC 30, 1993 08085 002 METHOTREXATE SODIUM; METHOTREXATE 1-81 OCT 31, 1991 11719 001 METHOTREXATE SODIUM; METHOTREXATE ODE APR 07, 1995 1-78 APR 07, 1995 11719 003 METHOTREXATE SODIUM; METHOTREXATE ODE APR 07, 1995 1-78 APR 07, 1995 11719 006 METHOTREXATE SODIUM; METHOTREXATE ODE APR 07, 1995 1-78 APR 07, 1995 11719 007 METHOTREXATE SODIUM; METHOTREXATE LPF ODE APR 07, 1995 1-78 APR 07, 1995 11719 009 METHOTREXATE SODIUM; METHOTREXATE ODE APR 07, 1995 1-78 APR 07, 1995 09048 001 METHOXSALEN; 8-MOP 1-72 MAR 23, 1991

" ....

PRESCRIPTION AND OTC DRUG PRODUCT 89 PATENT AND EXCLUSIVITY DATA

APPLIPROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXCLUS EXCLUS NUMBER NUHBER EXPIRES CODE CODE EXPIRES

19737 001 METRONIDAZOLE; MET ROGEL NDF NOV 22, 1991 ODE NOV 22, 1995 18654 001 MIDAZOLAM HYDROCHLORIDE; VERSED 4280957 DEC 20, 1999 NCE DEC 20, 1990 18654 002 MlDAZOLAM HYDROCHLORIDE; VERSED 4280957 DEC 20, 1999 NCE DEC 20, 1990 >Q.\.I> 19'(:a6 991 HI~~IM0M[ ~AlIAl[( HI~~IM0M[ ~AlIA1[ ,(U:a91l YU 921 1999 MU 11[[ U I 1992 >ADD> 19436 001 MILRINONE LACTATE; MILRINONE LACTATE 4313951 FEB 02, 2001 NCE DEC 31, 1992 19501 001 MINOXIDlL; ROGAINE 4596812 FEB 13, 1996 4139619 FEB 13, 1996 NDF AUG 17, 1991 >ADD> 19268 001 MISOPROSTOL; CYTOTEC 4459310 JUL 10, 2001 U-37 >ADD> 4301146 NOV 17, 1998 >ADD> 4060691 JUN 22, 1993 >ADD> 3965143 JUN 22, 1993 NCE DEC 27, 1993 >ADD> 19297 001 MITOXANTRONE; NOVANTRONE 4278689 JUL 14, 2000 19516 002 MORPHINE SULFATE; MS CONTIN NDF MAY 29, 1990 18677 001 NABILONE; CESAMET 4087545 MAY 02, 1997 U-7 19599 001 NAFTIFINE HYDROCHLORIDE; NAFTIN 4282251 AUG 04, 1998 NCE MAR 01, 1993 >ADD> 19488 001 NICARDIPlNE HYDROCHLORIDE; CARDENE 3985758 OCT 12, 1993 NCE DEC 21, 1993 >ADD> 18869 001 NIMODlPlNE; NIMOTOP 3799934 MAR 26, 1991 NCE DEC 28, 1993 >ADD> 3932645 JAN 13, 1993 U-40 >AQQ.> 4406906 SEP 27, 2000 U-39 19508 001 NlZATlDlNE; AXlD 4760075 MAY 03, 2000 U-33 4382090 MAY 03, 2000 U-33 4375547 MAR 01, 2000 NCE APR 12, 1993 19508 002 NlZATlDlNE; AXID 4760075 MAY 03, 2000 U-33 4382090 MAY 03, 2000 U-33 4375547 MAR 01, 2000 NCE APR 12, 1993 19667 001 OCTREOTIDE ACETATE; SANDOSTATIN 4395403 JUL 26, 2000 NCE OCT 21, 1993 19667 002 OCTREOTIDE ACETATE; SANDOSTATIN 4395403 JUL 26, 2000 NCE OCT 21, 1993 19667 003 OCTREOTIDE ACETATE; SANDOSTATIN 4395403 JUL 26, 2000 NCE OCT 21, 1993 >ADD> 19828 001 OXICONAZOLE NITRATE; OXISTAT NCE DEC 30, 1993 >ADD> 19385 001 PERGOLIDE MESYLATE; PERHAX 4797405 .JAN 10, 2006 >ADD> 4180582 DEC 25, 1996 U-35 >ADD> 4180582 DEC 25, 1996 U-36 >@Q> 4166182 AUG 28, 1996 NCE DEC 30, 1993 >ADD> 19385 002 PERGOLIDE MESYLATE; PERHAX 4797405 JAN 10, 2006 >ADD> 4180582 DEC 25, 1996 U-35 >ADD> 4180582 DEC 25, 1996 U-36 >ADD> 4166182 AUG 28, 1996 NCE DEC 30, 1993 >ADD> 19385 003 PERGOLIDE MESYLATE; PERHAX 4797405 JAN 10, 2006 >ADD> 4180582 DEC 25, 1996 U-35 >ADD> 4180582 DEC 25, 1996 U-36 >@Q> 4166182 AUG 28, 1996 NCE DEC 30, 1993 19009 001 PIRBUTEROL ACETATE; MAXAIR 4175128 NOV 20, 1996 3786160 JAN 15, 1993 3700681 OCT 24, 1989 NCE DEC 30, 1991 PRESCRIPTION AND OTC DRUG PRODUCT 90 PATENT AND EXCLUSIVITY DATA

APPLIPROD INGREDIENT NAME; TRADE NAME PATENT PATENT USE EXCLUS EXCLUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES

19561 003 POTASSIUM CHLORIDE; MICRO-K LS 4259315 MAR 31, 1998 19647 001 POTASSIUM CITRATE; POTASSIUM CITRATE ODE AUG 30, 1992 19647 002 POTASSIUM CITRATE; POTASSIUM CITRATE ODE AUG 30, 1992 18714 001 PRAZIQUANTEL; BILTRICIDE 1-83 NOV 09, 1991 17535 002 PROBUCOL; LORELCO 3862332 JAN 21, 1992 >ADD> 19675 001 RANITIDINE HYDROCHLORIDE; ZANTAC 4585790 APR 29, 2003 NCE JUN 09, 1993 >ADD> 4521431 JUN 04, 2002 1-43 MAY 30, 1989 >ADD> 4128658 DEC OS, 1995 1-42 MAY 30, 1989 >DLT> S09lYM S[MZ0Al[t Yf[PMAM 19n" "IJI ..28M ..7 AYS 18/ 1998 y,cu Mf[ Im~ 27./ 1992 >ADD> 19530 001 SODIUM BENZOATE; UCEPHAN 4284647 AUG 18, 2000 U-24 NCE DEC 23, 1992 >ADD> 19387 001 SUPROFEN; PROFENAL 4559343 DEC 17, 2002 NCE DEC 24, 1990 >ADD> 4035376 JUL 12, 1996 NDF DEC 23, 1991 17881 001 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT; TECHNETIUM TC 99M 3872226 MAR 18, 1992 3863004 JAN 28, 1992 U-31 19057 001 TERAZOSIN HYDROCHLORIDE; HYTRIN 4251532 FEB 17, 2000 U-5 NCE AUG 07, 1992 4112097 SEP OS, 1995 U-5 4026894 MAY 31, 1994 19057 002 TERAZOSIN HYDROCHLORIDE; HYTRIN 4251532 FEB 17, 2000 U-5 NCE AUG 07, 1992 4112097 SEP OS, 1995 U-5 4026894 MAY 31, 1994 19057 003 TERAZOSIN HYDROCHLORIDE; HYTRIN 4251532 FEB 17, 2000 U-5 NCE AUG 07, 1992 4112097 SEP OS, 1995 U-5 4026894 MAY 31, 1994 19057 004 TERAZOSIN HYDROCHLORIDE; HYTRIN 4251532 FEB 17, 2000 U-5 NCE AUG 07, 1992 4112097 SEP Os., 1995 U-5 4026894 MAY 31, 1994 >DLT> 19B79 "IJI 1[Rf0MAZ0r[t 1[RAZ0r 7 ..7.B8U9 Melf "9/ 1999 Mf[ liJ[f 7.1/ 1992 >ADD> 19579 001 TERCONAZOLE; TERAZOL 7 4358449 NOV 09, 2001 NCE DEC 31, 1992 >DLT> 198M ""1 1[Rf0MAZer[t l[RAZer 7. .. 7.18 .... 9 M0lf "9/ 1999 Mf[ liJ[f 7.1/ 1992 >ADD> 19641 001 TERCONAZOLE; TERAZOL 3 4358449 NOV 09, 2001 NCE DEC 31, 1992 NDF MAY 24, 1991 19569 001 TIOPRONIN; TIOPRONIN NCE AUG 11, 1993 ODE AUG 11, 1995 18207 003 TRAZODONE HYDROCHLORIDE; DESYREL 4258027 MAR 24, 1998 4215104 JUL 29, 1997 >ADD> 19049 001 TRETINOIN; RETIN-A 3906108 SEP 16, 1992 NS SEP 16, 1991 3729568 APR 24, 1990 19415 002 UROFOLLITROPIN; METRODIN 1-73 MAR 01, 1991 18817 003 VERAPAMIL HYDROCHLORIDE; CALAN I-50 DEC 16, 1989 I-51 DEC 16, 1989 18817 004 VERAPAMIL HYDROCHLORIDE; CALAN I-50 DEC 16, 1989 I-51 DEC 16, 1989

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