21 /IGao~ /fl/5: 99f/:ill¥! ~4qq-{~,{)5 s
WITH THERAPEUTIC EQUIVALENCE E'i~UUATIONS
18THEDITION
U.S. DE•/Jl.ttaMENT !l)f ~ND HUMM
OF DMm0N ._,":DATA~ Ml;) IRIIVl!li;a 1MI e New 19th Edition APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 19m EDITION 1999 CONTENTS • Prescription Drug Product list • OTC Drug Product list • Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research list • Discontinued Drug Product List • Orphan Drug Product Designations • Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution • Patent and Exclusivity Information See Subscriptwn Form Inside Back Cover ·re . ___ ,, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 18TH EDITION Cumulative Supplement 7 JULY 1998 CONTENTS PAGE 1.0 INTRODUCTION...... iii l. l How to Use the Cumulative Supplement...... 111 1.2 Applicant Name Changes...... 1v 1.3 Acyclovir 200 mg Tablet-Reference Listed Drug ...... v 1.4 Diclofenac Sodium Ophthalmic Solution...... vi 1.5 Follitropin Alfa and Beta ...... v1 1.6 Availability of the Publication and Updating Procedures...... v1 I. 7 Report of Counts for the Prescription Drug Product List...... vii 2.0 DRUG PRODUCT LISTS ...... 2.1 Prescription Drug Product List ...... 2.2 OTC Drug Product List...... 51 2.3 Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research List...... 53 2.4 Orphan Product Designations and Approvals List ...... 54 2.5 Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution ...... 63 PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Terms...... 64 B. Patent and Exclusivity Lists...... 67 APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 18TH EDITION CUMULATIVE SUPPLEMENT 7 JULY 1998 1.0 INTRODUCTION I. l HOW TO USE THE CUMULATIVE SUPPLEMENT This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations, 18th Edition (the List). The List is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations, over-the-counter (OTC) drug products that require approved applications as a condition of marketing, drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research and products that have never been marketed, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons. The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data. The Addendum contains appropriate drug patent and exclusivity information required of the Agency by the "Drug Price Competition and Patent Term Restoration Act of 1984" for the Prescription, OTC, and Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Lists. The Patent and Exclusivity Lists are arranged in alphabetical order by active ingredient name. For those products with multiple active ingredients, only the first active ingredient (in alphabetical sort) wilt appear. In addition, the trade name will be displayed to the right of the active ingredient name for each product. Also shown is the application number and product number (FDA's internal file number) for reference purposes. All patents with their expiration dates are displayed for each application number. Use patents are indicated with the symbol "U" followed by a number representing a specific use. Patent and Exclusivity information for a specific drug is indicated by an abbreviation followed by the date upon which the patent and/or exclusivity expires. Refer to the Patent and Exclusivity Terms section in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations. Information regarding drug patents and exclusivity for an approved product will appear in this addendum as it is received and may not correspond with the month the drug product is approved and published in the Rx/OTC sections of the Cumulative Supplement. iii 1 ✓ Because all parts of the publication are subject to changes, additions, or deletions, the List must be used in conjunction with the most current Cumulative Supplement. Users may wish to 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 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.) New additions to the Prescription Drug Product List, OTC Drug Product List, and the Patent and Exclusivity Data are indicated by the symbol >ADD> to the left of the line on which new information exists. The >ADD> symbol is then dropped in ~ubsequent Cumulative Supplements for that item. New deletions to the Prescription Drug Product List, OTC Drug Product List, and the Patent and Exclusivity Data are indicated by the symbol >DLT> (DELETE) to the left of the line. The >DLT> symbol is dropped in subsequent Cumulative Supplements for that item. The shaded print remains in the Prescription Drug Product List and OTC Drug Product Lists in all Cumulative Supplements (hard copy only) for this edition. However, the overstruck data in the Patent and Exclusivity Data is dropped in subsequent Cumulative Surplements (hard copy). Products that have never been marketed, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" c:ymbol in the 12th Cumulative Supplement of the 18th Edition List will then be added to the "Discontinued Drug Product List" appearing in the 19th Edition. 1.2 APPLICANT NAME CHANGES It is not practical to identify in the Cumulative Supplement each and every product involved when an applicant transfers its entire line of approved drug products to another applicant, or when an applicant changes its name. Therefore, the cumulation of these transfers and name changes will be identified in this section only. Where only partial lines of approved products are transferred between applicants, each approved product involved will appear as an applicant name change entry in the Cumulative Supplement. iv v' It is also not practical to identify each and every product involved when an applicant name is changed to meet internal publication standards (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively, to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this occurs, each product involved (either currently in the Cumulative Supplement or in the following year's edition) will automatically reflect the new abbreviated name. Consequently, it will not appear as an applicant name change entry in the Cumulative Supplement nor will the cumulation of these name changes appear in this section. However, when the applicant name change is one which may not be easily recognized or located in the listing (e.g., White Towne Paulsen [Former Abbreviated Name] is changed to Whiteworth Towne PLSN [New Abbreviated Name], the name change will appear in this section and will be identified with an asterisk. APPLICANT NAME CHANGES FORMER APPLICANT NAME NEW APPLICANT NAME (FORMER ABBREVIATED NAME) (NEW ABBREVIATED NAME) ASTRA MERCK INC ASTRA PHARMACEUTICALS LP (ASTRA MERCK) (ASTRA PHARMS) ASTRA USA INC ASTRA PHARMACEUTICALS LP (ASTRA) (ASTRA PHARMS) DUPONT RADIOPHARMACEUTICALS DIV DUPONT PHARMACEUTICALS COMi'ANY (DUPONT) (DUPONT PHARMS) FUJISAWA USA INC AMERICAN PHARMACEUTICAL PARTNERS INC (FUJISAWA) (AM PHARM PARTNERS) 1.3 ACYCLOVIR 200MG TABLET-REFERENCE LISTED DRUG Novopharm's single source acyclovir tablets have been declared to be a reference listed drug for the 200 mg tablet in addition to the acylcovir (Zovirax) 800 mg tablet of the innovator. A generic firm wishing to submit an ANDA for a duplicate of the 200 mg acyclovir tablet will be eligible for a waiver of the in vivo determination of bioequivalence (I) if their product is proportionally similar in its active and inactive ingredients to their own 800 mg acyclovir tablet and (2) by doing an acceptable comparative dissolution test (dissolution profile) against Novopharm's 200 mg acyclovir reference listed drug. Before a waiver of the in vivo determination of bioequivalence can be granted for the 200 mg acyclovir tablet, the generic firm must have completed an acceptable fasting and fed study comparing their acyclovir 800 mg tablet against the Zovirax 800 mg tablet. For further information on the study designs, you should contact the Division of Bioequivalence, Office of Generic Drugs. V VI 1.4 DICLOFENAC SCDIUM OPHTHALMIC SOLUTION 0.1 % Two NDAs have been approved for diclofenac sodium ophthalmic solution 0.1 % (DSOS), (I) Ciba's NOA 20-037 for Voltaren and (2) Alcon's NOA 20-809 for DSOS. Alcon was required to do a study comparing their DSOS to Voltaren and to a placebo control in post cataract surgical inflammation. This study was necessary to demonstrate that the different formulation of the Alcon drug product did not affect the safety and/or effectiveness of the proposed drug product for this indication. Prior to the approval of Alcon's DSOS Ciba did clinical studies and was approved for two additional indications for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery. Three years of Waxman-Hatch marketing exclusivity was granted to Ciba for these two new uses. Since the treatment of pain has a different site of action than the anti-inflammatory or photophobia indications the Agency did not have information to support a recommendation that the Alcon and Ciba DSOS are therapeutically equivalent for the treatment of pain. The designation of therapeutic equivalence at this time applies only to the anti-inflammatory indication. The therapeutic equivalence designation will apply to the photophobia indication upon expiration of Ciba's marketing exclusivity. 1.5 FOLLITROPIN ALF A AND BETA Based on available data derived from physico-chemical tests and bioassay, follitropin alfa and follitropin beta are indistinguishable. 1.6 AVAILABILITY OF THE PUBLICATION AND UPDATING PROCEDURES The Approved Drug Products with Therapeutic Equivalence Evaluations (Prescription Drug Products, OTC Drug Products and the Discontinued Drug Product Lists) is available on diskette, on a quarterly basis, from the National Technical Information Service. The telephone number for the Subscription Department is (703) 487-6430. Written inquiries regarding this subscription may be forwarded to 5285 Port Royal Road Springfield, VA 22161. The following Approved Drug Products with Therapeutic Equivalence Evaluations files are available on Internet: Prescription Drug Product Lisi: OTC Drug Products; Discontinued Drug Products; Prescription and OTC Drug Product Patent and Exclusivity Data; and Appendices. These files may be ..:ccessed on the Internet's World Wide Web. To access the CDER Home Page, use this Uniform Resource Locator (URL): http://www.fda.gov/cder. You do not need an Internet connection to reach the FDA Home Page; you can use the free dial-up connection (800) 222-0185 for text based, non graphical use only. For further assistance. please call (30 I) 443-4908. The Prescription Drug Products and OTC Drug Product files will be available on a monthly basis in the near future. vi VI/ 1.7 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST DESCRIPTION OF REPORT This report provides summary counts derived from the product information in the Prescription Drug Product List and the current Cumulative Supplement. Products included in the counts are domestically marketed drug products approved for both safety and effectiveness under section 505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved drug products marketed by distributors; those marketed solely abroad; and those now regarded as medical devices, biologics or foods. The baseline column (Dec 1997) 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 ccunt. DEFINITIONS Drug Product For this report. a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts. esters and derivatives) either as a single ingredient or as a combination product provided in a specific dosage form and strength for a given route of administration with approval for marketing by a firm under a particular generic or trade name. New Molecular Entity A ne,,, 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 VI/ I REPORTOF COUNTSFOR THE PRESCRIPTION DRUG PRODUCT LIST COUNTSCUMULATIVE BYQUARTER CATEGORIESCOUNTED DEC1997 MAR1998 JUN 1998 SEP 191J8 DRUGPRODUCTS LISTED 9624 9711 9768 SINGLESOURCE 2462 (25.6%) 2484 (25.6%) 2494 (25.6%) MULTISOURCE 7052 (73.3%) 7117 (73.3%) 7164 (73.3%) THERAPEUTICALLYEQUIVALENT 6673 (69.3%) 6746 (69.5%) 6790 (69.5%) NOTTHE,APEUTICALLY EQUIVALENT 379 C 4.0%) 371 C 3.8%) 374 C 3.8%) EXCEPTIONS 110 C 1. 1%) 110 C 1.1%) 110 ( 1. 1%) NEWMOLECULAR ENTITIES APPROVED 8 9 NUMBEROF APPLICANTS 551 529 538 'Amino acid-containing products of varying composition (see Introduction, page xx of the List). viii J~ l'USCRIPTIOII DRUG HO~ LIST 1 18TH IDlT"O'i U DJl'OO HODl1CT LIST / CUIIULATIVB IIUPl'Lt:llllff lnllBBll 7 / JAK' 98 • J'OL' 98 ACARBOSE ACETAMINOPHENi HYDROCQDQNE BITl'I.RTRATE TABLET; ORAL TABLET; ORAL PRECOSE PJPIQCOPOUIJW'BA'fl MP M!UWNQUP iiM !A MALLINCKRODT ~Jlll!i N40201 002 ••• ..1w1 ■ F 2SMG N20482 004 ii --,~ UM'ft;:M MAY 29, 1997 A ACETAMINOPHEN;BUTALBITAL; CAFFEIIDi: Ii -~-MM!M4M TABLET; ORAL ii HN!dM BUTALDITAL, ACBTAMINOPUII NIP WPBIQ > ADD > !! + MIKART ~J~J!!ll!i N89451 001 Ii DWN >""'iii5i> > MAY 23, 1988 >"1i'.i5o"> AB WATSONLABS N40267 001 g tnlfb/HM >~> - ~·~•!!mi JUL 30, 1998 M WATSONLABS ~1~ N40123 003 MAR04, 1996 ACETAMINOPHEN;CODEINE PHOSPHATE M ll,2!iJ!NG N40122 001 MAR04, 1996 M ll.2!!!•~ 1140123 004 MAR04, 1996 ~ M !ll!G•~ N40123 001 MAR04, 1996 M UUMhW M !ll!GJ lll!i N40123 002 MAR04, 1996 a aoBiJM M ll9E1~ 1140\22 002 -~11111, MAR04, 1996 M WATSONLABS lll!!!!i•ll!!!! N89997 001 -DEC 28, 1994 AA ~130NG W89998 001 ACETAMINOPHEN;OXYCODONE DEC 28, 1994 M 300NG160NG N89999 001 CAPSULE; ORAL DEC 28, 1994 oncopog MP ACITAMil!OPJl'l! M HALSEY S0ONG;!NG !Jf40219 001 JAN 22, 1998 ACETAMINOPHEN;HYDROCODONE BITARTRATE ELIXIR; ORAL ACETAMINOPHEN;OXYCODONE HYDROCHLORIDE HYDROCO:DONBBITARTllTB AND ACff~lifOPBBN AA + MIKART 500NG/1si7.SNG/1SNL N81051 001 CAPSULE; ORAL AUG 28, 1992 ,.,.... ACBTANINOilt··•·-,... AA PHARMASSOC S00MG/15HL;7.SNG/15HL N40182 001 0,...·•.·:,:,·· ... MAR13, 1998 . :!A WATSONLABS ll,2!!i1!!!i N4023t ooi TABLET; ORAL OCT 30, 1997 HYDRQCOPOfflllIIIT~.11.TRA~ AND ACflWlifOPHP !A MALLINCKRODT .'>!2!iJ7 .SMG llt0201 001 FEB 27, 1998 U DllOG HOD17C'l' LH'l' / CUHVLA'l'IVR IHJPPLD'D'l' NUNBD 7 / JAH' 911 • JUL' H 2 AC§TMINQfHP;QXXCOOQNI IM>ROCHLQRIDI ACYCLOVIR TASLrr; ORAL TABLET; ORAL 01JC9PM MP ACUMP!9llll M OUM.MED J.llm1Bi H40272 001 .('~-i,- @ 200MG N74556 001 APR 22, 1997 .M -..WATSONLABS --J.llm,m ACYCLOVIRSODIUM ACETAMINOPHEN;PROPQXYPHJNI HYDROCHLORIDE INJECTA!ILK; INJECTION ACJCLOill sop:mas TABLET; ORAL H, ABSGEN IQ HM MP(YUL Jl'7!5015 001 M n212mgg Her. :M!P APR 30, 1998 H, APOTHECON IQ soomWB/VDL 1174897 001 ~ FEB 27, 1998 .wi■ M WATSONLABS !ll.li, um H40139 001 H. IQ MWWI/JW Jl'7H97 002 DEC 16, 1996 7 >_DliL> • D:f .. iiFMW?tfWDIM >_DliL> ACETICACID, GLACIAL >..11,D,!2_> + EQ S0MG BASE/ML !174930 001 >..11,D,!2_ > MAY13, 1998 SOLUTION; IRRIGATION, URETHRAL ACl',l'!C AC!D 0.25\ IH AI 1,3.·:··~UN llllrffl N?PQSIQ II - INJECTABLE; INJECTION ADDOCARO ACYCLOVIR + FUJISAWA HLTHCARE 3MG/ML 1'19937 002 8 CAPSULE; ORAL , 11m1nm Acyg.ovn Y CHELSEALABS llM H75101 001 ADENOSCAN -- 0Oil. APR 15, 1998 + FUJISAWA HLTHCARE 3MG/ML 1120059 y GENPHARM llM H7O77 001 APR 13, 1998 l ditiia TABLET; ORAL ACJCLOVU - y COPLEYPHAru4 il2& H75021 001 ALBPIPQL StJLfAT§ MAR 18, 1998 y .!.2.2!fi H75021 002 SOLUTION; IHHALATION MAR 18, 1998 ALJV1POL mirm y GENPHARM il2& H7U76 001 AN BAUSCHAND LOMB IQ 9,1' MP 1175050 001 APR 13, 1998 JUN 18, 1998 y .!.2.2!fi H7U7S 002 AN HI TECH PHARMA IQ 9,1' MP Jl'74H3 001 APR 13, 1998 JM 15, 1998 U DRUG HODVC'l' LIST / CIJNtlLA'l'IVI\I SU'HL!lllla'l' man 7 / JMII' H • JU'L' 98 3 ALBllflROLSYJtf'AD Af'INITADIQHYPRQCHLORJP§ SYRUP1 ORAL TABLBT1 ORAL ALIJJ'l'BOLEMMI SYMMBTUL M HI TBCH PHARMA IP M WJ/SML 1174749 001 i •11--. md.t?~1 + ~l00MG Nl1.1101 001 ii iiM MM!fii9dl!M ::illli FQ 2MG BASE/SML N74302 001 AMCINONIDII • SEP 30, 1994 OINTMENT; TOPICAL ALPRAZOI.ffl ib.\ tiilfifiii ifiCY-+ WYETH AYUST 0.1' 11111498 001 TABLBT; ORAL NtUMOLM U GBNEVA PHARMS MILQRJP1 HYQR.~. m· HYmlOCHLQROTHWJPI II Dd!Htm - ii ··MM • T~;111;. V • ~ffL,lBt g WATSON LABS IP M MUP!991•UE 1173334 001 J1J'L 19, 1991 •u WATSON LABS .11.dl& 117H79 001 - JAN 21, 1997 u L.a!i 117H79 002 MIQPMQII HYQR.QCHLORIPI JAN 21, 1997 u 117H79 003 TABLBT; ORAL JAN 21, 1997 QPMMM 61 + HYBTH AYIRST .i!?M 1118972 001 - DIC 24, 1985 ALPRQSTAPJL QCP9P U UPSHD SMITH .i!?M 1175135 001 INJBCTABLB:1 INJECTION APR 30, 1998 NtQOUWL at HDFORl) 9,Mhle 1174815 001 JM 20, 1998 MiffiifmIQ ffYPBOCHI.tOBIPI;PJRPfflPWJU ram:mD mu.me UlHH 001 TABLBT; ORAL at ~. PHARMACIA Am> UPJOHN ,,~-- f .. .: .. ,, -?Ml • NW!IN>JU ffYPRQCHLORJPI • 11116023-@- 002 • U DaVQ NODOC'l' Liff / CIIINUL&TIW RHLlilllllft' .._ 7 / illJI' H • ,JUL• H 4 AMITRIPTYLIQHYPBQCHLQBIPI I PQPHIPZIQ MIWMDI HYPBQCHLQBIPI TABLIT; ORAL INJEC'l'A8LB; INJECTION tP!DIMDI MP WDHTUeDI A GIDQUIA y WATSON LABS lll.il- 1173007 001 + GUSIA AUTOMIDICS O.OSMG/ML llf20420 001 OCT 17, 1991 Slll:P 12, 1997 y 1M,.m 1173009 001 OCT 17, 1991 y .um,_ 1173008 001 ASPIRIN;WflIQ; Q!lfflPN>RJQCJDAII OCT 17, 1991 y .um,.m 1173010 001 OCT 17, 1991 y ll&i1.!.M1.llm 1175141 001 MAY29, 1998 AMMONIUMCHLQRIPI y 2.llli, .tm, um 1175141 002 INJECTABLB; INJECTION MAY 29, 1998 AMMONIUMCHLORIDE: 2 .14' N85734 001 'If:.-. .~=UN ~-!~-~- ~I. · ift.i~trm ASPIRI!iOJXC9P0Q HYPROCJ:ILORJPI;QXYCOOOQ TJRIPHTHALAII TABLET; OIM. AMQXICILLIN om:cpqp MP YUIW >..!Im..> M IW.SEY lla!l1.L.Ui!i!1!.:.1M llf402H 001 >..!Im..> TABLBT; ORAL >..!Im..> JUL 17, 1998 >..!Im..> MOXIL M WATSON LUS lla!I, .L.Ui!i!1!.:.lM IK0255 001 >..!Im..> + SMITHICLINBBEECHAM SOONG NS0754 002 RB 27, 1998 >..!Im..> JUL 10, 1998 >..!Im..> + 87SMG 1150754 001 >..!Im..> JUL 10, 1998 AIPQLQL I c;m.oRDJN,IPQQ TULIT; OIi.AL AMRil!Qfflli LACTATJ y llli 117HH 001 INJECTABLB; INJECTION MAY14, 1998 I1i:ft y 12.M•llm 117HH 002 i!KR.JimR MAY 14, 1998 + BQ SMGBASE/ML Nl8700 001 ---JUL 31, 1984 ATQRVASTATINCALCIUM TABLET; OIi.AL ARBUTAMIQHYDROCJ:ILORJP§ LIPITOR INJECTABLB; INJECTION •-1=• GINISA •t-iliili .. .,ti ,~;:~ -- JL'III ' IF.:IMf:f.aB U: J>lll'UQ PlllOJ>UC'l' LH'1' / CUIIIJLATIVI SVHLllllmff IIUtlUa 7 / JUI' H • J'IJL' H 5 BACITRACIN PQLYMYXINSULFATE ATQRVASTATINCALCIUM ZINC; P OINTMBll'l'1 OPHTHALMIC TABLET; ORAL LIPITOR MS!WCWHG M WAR.ND IN.i!IR.T EXPOR IQ lOMG BASE N20702 001 AI DBC 17, 1996 IIH028 001 JAN 30, 1995 IQ 20MG BASE N20702 002 DBC 17, 1996 + EQ 40MG BASB N20702 003 • l°IBI~ DBC 17, 1996 ifmt.tffl at + MONARCH PHARMS IIIU229 001 ATRACVBJQMBJSJLATE INJECTABLE; INJECTION 13ACLOnN AmcpJt,111 Yf!IMTE 1117H45 001 TABLET; ORAL >..AmL> At MARSAM 191WR, >..AmL> JUL 28, 1998 A'J'WiD!WYSJLATE DR • 9illf.da .. lYfftIYI 11174944 001 >..AmL> !! >..AmL> JUL 28, 1998 J'M • WATSONLABS 11173092 001 M um JU 28, 1994 11173093 001 M nm JAN 28, 1994 nmtmt__. HfflIPIL HYDRQc;HLORIDI 5,000,000 UNITS/BOT N62456 001 • JUL 27, 1983 l'Hlillif BACITRACINZINC; N§OOCIN §ULfATE; PQLYMYXIN §tJLfATE B f- OINTNBNT; OPHTHAU4IC + 300MG 11119002 002 -- DBC 28, 1990 40014G 1119002 003 al~ • DIC 28, 1990 at + MONARCH PH.ARMS Q'1MITW9Q VALpATI P:CI'fRACJNZINC; PQLYMYXIN P SULfATE • OINTNBNT; OPHTHAU4IC ii U DllUG PRODUCT LIIT / CUIIULI.Trt'I IVHLBBIIT waD 1 / JMI' H • JUL' H ' BITAMBTHASONBVALpAU CREAM;TOPICAL MIMlfflYOII vwe:111 INJECTABLE; INJECTION 8 CUY PARK EQ O. 1t BASE N700S3 001 ISOLYT~ BIN DEXTROSES JUN 10, 1986 BRINZOLAMID§ - SUSPENSION/DROPS;OPHTHALMIC AZOPT CALCIUMCHLQRIDB1 DQTRQSI; POTASSIUMCHLORIDE; SODIUMCHLORIDE + ALCON 1t N20816 001 APR Ill, 1998 INJECTABLE; INJECTION RIP!Bfp__n xpram at '301ffl/109fi1 BRQMOCRIPTIN§MESYLATE Nl.82545 001 at 3'ffl{½VVffld30Hljl/100fi1 TABLET; ORAL N20000 001 aaONCCRxn:mpsxuu 17, 1992 !.! LEK PHARM 10 2: 519 WI H74'31 001 JAN 13, 1998 •II !.! ♦•~IS 10 2.519 WI Nl.7962 001 - CALCIUMCHLORIDE; DEXTROSE;MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACITATE; SODIUMCHLORIDE INJECTABLE; INJECTION ISOLYTE R IN DEXTROSESt IN PLASTIC CONTAINER INJECTABLE; INJECTION B BRAUN 37MG/100ML;SGM/lOOML;3lMG/lOOML; DEXTROSESt IN LACTATEDRINGER'S IN PLASTIC CONTAINER l20MG/lOOML;330MG/lOOML; 8 B BRAUN 20MG/lOOML;SGM/lOOML;30MG/lOOML; 88MG/lOOML Nl9864 001 ·- ~,~{!.9.!~!~ull2~h:9R.~,.J!Y.~,M - CALCIUMCHLQRIDJ; MAGNESIUMCHLQR.IDI: POTASSIUM CHLORJDI; SODIUM A£1TATJ;SODIUM CHLQRIQI, SODIUMCI'fMD CALCIUMCHLORIDE; DjOC.dl.QSI;MAGNESIUM CHLORIDE; POTASSIUM INJECTABLE; INJECTION CHLORIDE; SODIUMAC§TbTE; SODIUMCHLORIDE; SODIUMCI'fMTIF ISOLYTE E IN PLASTIC CONTAINER ~ B BRAUN 3SMG/lOOML;30MG/lOOML;74MG/100ML; INJECTABLE; INJECTION 640MG/lOOML;SOOMGilOOML; ISOLYTE I IN DEXTROSESt IN PLASTIC CONTAINER 74MG/l00ML Nl9718 001 B BRAUN 3SMG/100ML;SGM/lOOML;30MG/100ML; SEP 29, 1989 74MG/100ML;640MG/lOOML;SOOMG/lOOML; 74MG/100ML Nl9867 001 DEC 20, 1993 U DllUG H.ODUC'l' Liff / CDIULJ.TIVB SVHLIIIID'l' fflMlll!D 7 / JAIII' 98 - JUL' H ., CALCIUMCHLORIQB; MAGQSIUM CHLORIDE; POTASSIUM CHLORIDB: SODIUM CALCIUMCHLORIO§; PQTM§IUM CHLQJlIPI; §ODIUM CHLQRJPI ACBTAIJ;SODIUM CHLORIDE; SODIUM CITRAT§ SOLUTION; IRRIGATION INJECTABLE; INJECTION , ISOLYTB BIN PLASTIC D ..:.::.:;..~:::., m.Hlfffl - CALCIUMCHLORIQ§; POTASSIUM CHLORJPI; SODIUM CHLORIDE; §ODIW LACTAT§ CALCIUMCHLORIQ§; MAGN§SIUM CHLQRID§; POTASSIUM CHLORIPli SODIUM INJECTABLE; INJECTION, CHLQRIO§ If. B BRAUN , HMtieom., SOLUTION; PERFUSION, CARDIAC IIUH32 001 PLEGISOL IN PLASTIC CONTAI rn 29, 19118 lit 20MG/100ML;30MG/100ML;600MG/100ML; MMt 1J . 001 ·•·-❖:-..":- - SOLUTION; 'E'BRFUSION/CARI>IAC it PLEGISOl IN PLASTIC CONTAINER + ABBOTT 17.6MG/100ML;325.3MG/100ML; • 119.3MG/100ML;643MG/100ML Nl8608 001 FD 26, 1982 SOLUTION; IRRIGATION, u CALCIUMCHLORIO§; POTASSIUM CHI..ORIQ§; SODIUM CHLQRIQ§ INJECTABLB;, INJECTION ii It llfl8721 001 - NOV 09, 1982 It >.ARR._> CW'A£l'MI 00002 001 APR 17, 1992 >.ARR._> INJECTABLE; INJECTION a >.ARR._> INFASUU' PRESERVATIVEPRU .. >.ARR._> + 0IIY 3SMG/ML H20521 001 • >.ARR._> J11L 01, 1998 CMPUMIP CU:PITH• SOLUTION;, IRRIGATION TABLET; ORAL AT u •Hlil1905• >..miI,.> ...... llflUH 001 >..miI,.> - Ol'IO N ... 0 ...... I 0 I ...... Ill Ill Ill UI Ill - •"'...... • •"'... 1ft ... -- _.,. .. :~ • • • ••••••••U'l"4U'l"4111"4U'l"4 • Iii! Iii ; ; &fflG!G!lii! 11111111-111 I I I I I I I i ~ !I !I I I I I ,,:;e,: I.. . (,,.,, . .. Ill Ill Ill 111 1111 I I 11 I I in 0 "4 Ill %F$i)fib,;'', ,·r?•~""~-:.w,-~,~~~~- , U Dit'O'Q nODVCT Llff / C1!NULA'1':nll ~ - 7 / JNll'H • .mL'H t• CAfUW&YVXU CAAil9D9PQL CAPSULB, UTDDBD Rm.BASK; ORM, T.MLIT; ORM, CAUATROL CUJRlaPJ, .. M WATSONI.MS llJ.li IIKH!53 901 iaiili - DSC 03, lH6 + SHIU 200MG 1'20712 001 SIIIP 30, 1997 + 300MG 1'20712 002 CVA.CLQll --SIP 30, 1997 POffl>Dcp.p,a FOR UCOWSTITUTION; 00.L cwzpo,a y MMBM 19 HM HQ/M, fl42K OH nm u, 1998 TABLBT; OitAl, Y 19 lf'!E MM(M fl42H OH lFD 18, 1998 >..miL> -.1mt1a Y 19 HMMMtMe flUH OH >-ii&..> ~~,~---:. DUPON'i"PJWms 25MG Nl7830 001 FD 18, 19911 -- Y 19 37MMMlM fl4207 OH FD 18, 19911 CWIPQPA;1,IVOl)OPA C§f'AZQLIP§OQIW >..miL> INJBCTABLB; INJBCTION >..miL> CVMOWIA;tPI >..miL> ~ Al FOJISMA 191p MU{YUL flU70 OH I MAR >-ii&..> y D'CJPONT PHARMS H17555 001 18, 1998 >-ii&..> y H17555 003 K 19 2991 MU{YUL flU70 002 >...!l?!L> y ♦ 1117555 002 MAR 18, 1998 TABLBT, BXTINDEDRELEASE; ORAL SINEMET CR C§PTIZOXIMB§QPIUM >..W...> ~:'- iafa~ >..W...> INJECTABLE; INJECTION >..W...> + lWU~ CElll'IZOX >..W...> .,....-..,...,. ..,.,.-· ...... -·•'· fiffliM iir.ifl-ji:: >...!l?!L> DUPONT PHMMS 2SMG; lOOMG Nl9856 002 * >...M!JL> DEC 24, 1992 i >...!l?!L> + SOMG;200MG Nl9856 001 > ADD > MAY 30, 1991 --wt•~~ ' sn.-.nMtim»i CAAISOPRODOL + FOJISAWA HLTHCAR.£ EQ SOOMGP1'SB/VIAL 1150560 001 TABLET; ORAL SEP 15, 1983 + EQ lGM USE/VIAL HS0560 002 • ~~ H'M .11111 SBP 15, 1983 U moo HODUCY Lil'l' / CUNULA'l'lft 811HLDD'l' fflaD 1 / JU' H • .rm.•H 10 CIP'fIZOJIUSQPIYM C1Ear:v11 INJBCTABLB; INJBCTIOH PONDD FOR RBCOHSTITUTIOH;ORAL CDIZOX UPLU + PVJISAWA HLTHCARB BQ 2GM IBASI/VIAL N50560 003 flt LILLY BQ lOOMG BUI/ML N50406 003 SBP 15, 1983 + BQ lOONG IBASll:/ML N62U.7 001 BQ lOOM BABB/VIAL N50560 005 MM 19, 1993 CHI.QMNfflPICQL 9 PVJISAWA HLTHCARB BQ 40MG IBASI/ML N50589 002 OCT 03, 1984 CIFIZOX IW PLASTIC COHTAIND ;. - ii)!~-:t- • i M + PllRJCEDALB .a.um llfHHl 002 J Jl'f!.. Jtd#.i- SONG N60591 001 + lOOMG N60591 003 + PVJISAKA HLTHCARI EQ 20MG BABB/ML N50589 003 APR 13, 1995 OPH'l'HAU4IC ♦ BO 40MG BASE/ML 55051119 004 APR 13, 1995 D ll 1150155 001 CIPQROXIpSQPIUM PONDll:RFOR RBCOMSTITUTION;OPH'l'HAU4IC --- CHLOROMYCl'l'IM IWJBCTABLB;c:pnomg INJECTION iw..-. _.. atm!M + PARDDALII: 2SMG/VIAL N50143 001 y ASTRA PHARMS IQ 75M WlfYWe 11114192 002 APR 16, 1998 SOLUTION/mtoPS; OPHTHALMIC !l IQ 1.sq11 w1111yw. RH192 001 APR 16, 1998 It ,.._ !l IQ 7. sa w11yw. NH191 001 u PllRJCEDALII: lliH220 001 APR 16, 1998 fl SOLUTION/mtOPS; OTIC -- CIPIW..JXJN :==°\'llliilt .. . :•, .. + PllRJCEDALII: 0.51 11150205 001 CAPSULII:;ORAL •• CR!NP..., M Zll:NITH GOLDLINE IHUH 001 -- CHI,,0R,MPHPICQl,;HXPIOCQllIJSOQ ACIIl'II mftlUiii !llU!:@!I PONDD FOR RBCOMSTITUTIOH;OPHTHALMIC CHLOROMYCl'l'IMHYDROCORTISOHII: I , '81if1.. PONDD FOR RECONSTITUTION;ORAL w-..:ta,__,_,.. UFLU + PARKBDALII: 12.5MG/VIAL;2SMG/VIAL 11150202 001 , sat 1:::•i: •!Ill -- U DltUQ ~ Liff / ~Tffl nnUlllllllft --. 'I I JU' 98 • .JUL• H 11 c;m.qp.lffllpJCQL; iM!BQCOllTJ§9R ACUATf; J'Qt.WJD I fPLlATf 00:P!W!PPPI mpcqp.Tf OIN'l'MDIT; OPH'.fHALMIC IOLUTICM; DDTAL m:rne ~---f·I It + ZIIA .!Wa flH28 t01 ~ AUG 13, l!:IH ct PARUDALI lOIG/GM;SNG/GM; 10,000 ffllITS/GM !150201 002 TMI.BT; DmlTAL - PDIOCHIP + PDIO PRODI (IS) 2.SNG 11130174 001 c.::m.oR»lfflPJSoL soo1wsuccwn MY 15, l!:1911 IMJBC:TMLB; IHJBCTIOM • i"'tlElil 00!9Vl&NIPII VP:191lP:9!!PI K ♦ PARUDALI ~---1150155 001 CHLORpJNVQXIQI :• • 2SNG/ML IIIHSG3 001 TABLff I ORAL • Aft 15, 1911111 LIBRITABS + IOI SMG Ill lOMG c;m..ovmtYM Ill ~,~~ TMLft; ORAL i ~i .w WATSCM 11181049001 M LOS .u.a CHLORpJNIPQXJQIHYDJtQCHLORIQ§ - AUG 22, 19119 CAPSULB; ORAL LJUUI CJfPLlifflMNR M IOI H!IIHl 001 1885472 001 ORAL y ♦ ~; nrnmwa M !WVOPJWtM IA 1174347 001 w ww-nr MY 21, 1H8 M IA ♦W mpt,coonm. fltH'I 002 l • - MY 28, l!:1911 "l9lrM'MWP WC CHLQRHIXIQINJGLUCONA'TII Y !WVOPJWtM IA W U,Dl:t,nr fltHI 001 MY 21, lHI SOLUTION; DDTAL M 117,630 002 MY 28, 19911 a "'"1111.:::'jfif:~ um w:rm ,. 117'5'1 001 .• M - IA •• wrtrnr MJO 15, 199' U DRUG PllODVCT Liff / ~TIVII IIIVHLIIIIIDft' 1118D 7 / JUI' H • .m:t.• H 12 CHQLHTYIWIIQ CIMET;tpxg IXPBQgll,QRIQI PONOIR; ORAL SOLUTION; ORAL LOCIIQWT CJIIUDIQ D M BON 10 191 WJltfCOOUPL >..APP..> M COPLff PHARM 10 HM MQ/m. llflHH 001 >..APP..> JUL 09, 1998 i iiUM- i iiltflMiUDiW'~ CIPRGfLOXACIHHYJ>ROCHLQRIPI t.QCIOLU'l' LI(ffl'l' OIN'l'MENT;OPHTHALMIC M EON 10 1Cil WIH/l'ACUT ar,4552 001 CILOXAN AUG 15, 1996 + ALCON BO 0.3% BASE N20369 001 M 10 teasmwscoouur. ar,4552 002 MAR 30, 1998 i id='::i!M=fiiffli~ A°L'htit CIPROfLOXACINHYJ>ROCHLQRIQE; HYDRQCQRTISOQ I iij}iOif:miit~ :-LIii SUSPDSION/OROPS; OTIC CIPRO HC + BAYER BO 0.21 BASB;ll N20805 001 CIMETIDINE FEB 10, 1998 SOLUTION; ORAL cxmxpm P CISAfRIQEMOffl)HYDRAII M DURAMBD 3oom1m. llf15110 001 JUN 111, 1998 TABLET; ORAL PROPULSIOQUICKSOLV TABLET; ORAL >...12.il..> .. I#HI·:··m1 IOitti!Mdn >...12.il..> u ~-··:·" ...... U'M =- TABLBT, ORALLYDISINTEGRATING; ORAL ------PROPULSIOQUICKSOLV >..APP..> + JANSSEN BO 20MG BASE "20767 001 • NOV 07, 1997 ii - >..APP..> a UM · >..APP..> CIT.M.OJ>INIIXPBQMQMIQI M ZENITH LABS a.om lll'7H24 001 JUL 28, 1995 >..APP.,.> TABLBT; ORAL M llOHG llf1H24 002 >..APP.,.> CBLUA JUL 28, 1995 >..APP..> FOREST LABS 111:Q20MG BASIi: N20822 002 M i9R!.!'i ar,4424 003 >..APP..> JUL 17, 1998 JUL 28, 1995 >..APP..> 111:Q40MG BASE N20822 003 M !om lll'7HH 004 >..APP..> JUL 17, 1998 JUL 28, 1995 >..APP.,.> + 111:Q60MG BASIE N20822 004 >..APP,_> JUL 17, 1998 U RN nOD1JC'f Liff / ~'l'lft ID~ - 7 / JU' H • ifUL' H 13 c;;t.PN',l'JP flNM'fl SYRUP;crmrmrwnu 0ltAL M NOllTOH GllOW 19 pgfm. lf'IHS3 001 !,Pl MM. 13, 1991 CLJfflWIXC11 fflOSM'fl - CUNI; VMIDL I CLIOCilf 3 - + P!WtMCIA MD UNOHN BQ 21 IDISI lfSOHO 002 MAR 02, 1991 TMLIIT, OIIM.LY DISilfTBGIIATDIG;- 0ltAL KialOPIII !RAPIDLYDIIIIIll'.l'latATIIIG + llOCHll 0.125"13 1120813 001 DIC 23, 1997 0.25"13 112H13 002 II DIC 23, 1997 ffli2913 001 O.SMG 1120813 003 BQ lSONG IDISI/ML DIC 23, 1997 • OCT 20, 19H 11G 1120113 004 DIC 23, 1997 SOLUTICllll; TOPICAL 2MG 1120813 005 + DIC 23, 1997 • ~ kt••·- Wff1'WW BQ 1' IDISI ffli23S3 001 • FD 08, 1H2 COJ,,JUPIFJ'Mtl AIW I~; IIIJIIC'l'IO!f CLQMJfflHl1P HJPftOCHL9RJPI ~c:iiilllnL •111181l BQ lSOMG !DAU/VIAL •so1oe 002 CAPSULB; 0ltAL + IP~ c;.awrem, A M MYLlm lf'ltH'I 001 ll& AM 30, 1991 cqtTIWIIQlJI DE lf'ltH'I 002 M An 30, 1991 I~; IIIJIIC'l'IO!f ..,.,.., 003 M ll& AM 30, 1991 pl1111mm111111m11 25 UlHftl/VIAL Df083l7 002 -·~• 40 UJHftl/VIAL Df083l7 004 j U RN nomJCT Lift / ~ 8VffLIIIIIIIIII .._ 7 / .:wt• H • oNL' H H qpg.;g AW/! WPP. SOLUTION/DllOPS I OPHTJW.MIC CANULS; OlAL u amla.AIIDLOMaD lfl'6H3 001 M --- lfl'6H2 01113 ==•· ... MY 2', 1998 I M .WIii 117'512 ff2 • MY 29, 19H £ltllNI.. RIii u D 11'7'706 001 M 1117117 ff3 APR 29, 1998 ... M 1117117 ON 9ffl£RI U + ALLDGAN D 1111115!5 001 PNPPIPIJSP! UPl9QIL9BJPI INJBCTUUI; INJBCTION -~-. cml'OIIDID >~> + UDPOltD BQ 20NG M.Slll:/VIAL NH103 001 CYCLOJPWNU HYpllOCIILQRJPI >...am!,.> FD 03, 1995 TABLff I ORAL >....W...> ~PIP >...,W..> K • UDPOltD 1150731 001 -~M WATSON LABS ll.B lflHH 001 JAN 30, 1998 - NOV 30, 1994 It GDSIA SICOR PRAMS 110aw Nim» RH212 001 JON 23, 19H QACTINQMYCIN PHQGHTMLrmmm, UTllpIOL INJBCTABLB; INJECTION COSMBGD TABLBT; OlAL-28 ~+ MDOC_f_}_ MIRCITTIII: &ill~ li.llrll + ORGANON 0.1SMG;0.02MG N20713 001 APR 22, 19H QALTIPARIN§QPUJtl pg0XDg'l'AS0fg INJECTABLB; INJECTION FRAGMIN GIL; TOPICAL , tiMi«mw:MJitt'~ unmrnw1•r• >~> PM9UFM9P -11111 >~> M TARO .2.Jll lflHH 001 + 10,000 IU/ML N20287 004 >~> JUL 14, 19H JAN 30, 1998 ffl1COU >~> 61 + HOECHST MARION RSSL .2.Jll 11185H 001 >~> MM 29, 1982 OIH'l'MDT; TOPICAL PP9PB'N"ffl 61 ALTAM .Lm ll"IHH 001 APR 01, 1998 U: Dlltffl HomlC'l' Liff / c:vamLATIVI IIIU111Pr.maaff lrl1HJSD 7 / JD' H • JUL' H 15 INJECTABLE; INJECTION j$.Uttlffi:t ISOLYTI HIN DEXTROSi;51 IN PLASTIC CONTAINER N13u3···00·1 B BRAUN SGM/100ML;30MG/100ML;97MG/100ML; 220MG/100ML;l40MG/100ML N19844 001 BM 1993 »:w m.◄ icnitiii,::-lfijj tutm @ EQ O.lMG PHOSPHATE/INH N14242 001 DEXTROAMPH§TAMINESULFATE PIXIRQSI; MAGNESIUMCHLQBIPI; POTASSIUMCW&RJPI; soprUM ACETAT§; SODIUMCHI,QRIPE; SQPIUMGLUCQNATE TABLET; ORAL >..!2!1I..> a ,l'IIILw,•~ iilllil?li'H >ADD> M ~ 1184935 001 ~ .... 0111'1',...... >..!2!1I..> A .··?it·-~ - mit.Cltt NHOSl 001 >..MIL> M + -~ a ~ DEXTROSE t:m itff.3 INJECTION ~ 1118046 001 I ffittuflll ~ 1116730 001 AP • ii 1116730 002 - II 11111::11 DEXTROSE;POTASSIUM CHLORIDE DEXTROSE;MAGNESIUM CHLORIDE; POTASSIUMCHLORIDE; POTASSIUM INJECTABLE; PHOSPHATE.QIBASIC; SOQIUMACETATE INJECTABLE; INJECTION ~ N:1.8744 001 ISOLYTE PIN DEXTROSE51 IN PLASTIC CONTAINER B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML; MIMfflY1Nl¥M 26MG/100ML;320MG/100ML Nl9873 001 • ~ gf4.ffMii~iMU~U!~-iii- U DllVG PltODVC:T Liff / CUIIDLA'l'Ift IUIIPLmllft IDBD 7 / JD' H • ilVL' H 15 PUPO§I: POTASSIUMCHLQRIP§: POTASSIUM fflOSPMD, PIWIC; PICYCLOMJIIIJXPROCHLORIJ>I §OPIUMACUATli §OPIUMCHLQRIPI 'll'MLBT; ORAL INJSCTULB; INJBCTION ISOLYTB M IN DBXTROSIII:SI IN PLUTIC CONTAIIIIIR II P1119'1II A 1M B BllUN SGM/l0OML1lSOMG/l0OML1130MG/lOOML1 ..-@Bl 280MG/100ML191MG/100ML 1119870 001 nr&Mrtm e 20MG NHGO0 001 93 JUL 29, 19115 - PifLOMSQNIPIN:IIAD c:u»I; TOPICAL PUTRQSI;SODIUM CHLQRIPI P1lh91M911 PIACUAD INJICTULB; INJECTION Y ALTANA .L.ll1 lf75187 001 MAR 30, 19911 Dlll:XTJlOSIII:101 AND SODIUM CHLORIDE 0. 9' IN PLASTIC CONTAINER HPI®' : law tililUIUHaiia lllvi;li y ♦ Dl!W4IIC LABS .L.ll1 DEXTROSE 5' AND SODIUM CHLORIDE O. 9' IN PLASTIC CONTAINER u ¥. i:dlli : a.UN 11aa~m1,1•11111:t:=i~i DIAZIPAM DILTIAZPID'PRQCHLORIPI CAPSULI, IXTINDID RILUSE; ORAL INJBCTULI; INJECTION >~> CAR.TIA XT II PI~fw.! >~> ft ANDRX PHARMS 120MG 1174752 002 MM JUL 09, 1998 ,.1:11111 UI0MG 001 SMG/ML >~> N74752 • 1172371 001 • JUL 09, 1998 JAN 29, 1993 GD 240MG N747S2 003 >~> JUL 09, 1998 300MG N74752 004 PICLQF§NACSODIUM >~> >~> • JUL 09, 1998 PIL'll'D:111111!£II SOLUTION/DROPS; OPHTHALMIC >~> MYLAN t>ICLOnpc fODitJN m .w!li lf751H 002 t MAR 111, 1998 y ALCON ,Lll N20809 001 m 1.1.!1& N7S12t 003 MAY04, 1998 VOLTARp MAR 111, 19911 N7S12t 001 ♦ CIBA m .li.!li !! .Lll H20037 001 MAR 18, 1998 MAR 28, 1991 TIAZAC itMfti -BC ♦ -120MG ic: HR t SEE SECTION 1. 4 OF INTRODUCTION 11 U DRUG DODUC'l' Liff / CIJHULATIVII nPPYHDff -- 1 I JD' H • JUL' H QIPJllIQ»PLI QILTIMRJ mrmtOCHLORJDI INJECTABLE; INJECTION CAPSULI, DTDl>BD ULBSE; ORAL wmmw:v 117493' 001 TIADC Bllrol"ORD DC + BIOVAIL 180MG It ail& APR 13, 1998 rt P1§QPYJl,N4IQIPHQSPMtl DC + --240MG ,> CAPSULE, BXTDmilD RBLIIUB; ORAL DISOPYMMIDB PHOSPHATE > N71929 001 3- > II KV PIWIM RQ l0OMG BASE • 300MG AUG 19, 19H BC + > ~~ 360MG N20401 005 DQM:N11N§ HYP!:QCHLOR1PI + SEP 11, 1995 INJECTABLE; INJECTION P21WMW p 11'14545 001 INJBCTABJ,B; INJECTION LUITPOLD 19 !f H:M WltlL JUN 25, 19911 QIL'QMP A il'HHl 001 It ABBOTT ail& • 1174219 001 APR 15, 1998 It MARSM 19 H ·M WltlL PD 111, UH 11750H 001 It TAYLOR PHARMA ail& 1174995 001 APR 09, 1991 It 19 H-M WltlL MM 31, 19H PJNOPROS'l'Offll PQRZQW1PII!HYP!-OCHLQR 1PI; TIMQLQLMlMD INSDT, DTDl>BD RBI.BASE; VAGINAL SOLUTION/DROPS;OPHTHALMIC CDVIDIL COSOPT >..W...> iJ. liiltifA.k1•:iif. i'M + MDC!C RQ 2'lr BASE;RQ 0.5t BASE N20H9 001 >..W...> APR 07, 1998 + FOREST LABS l0MG N20411 001 >...!P!L> MAR 30, 1995 >...!P!L> ---- DQXl!Ji'IffHJPltQCHLOR 1PI DIPHDffiIPMMIN§HYQRQCHLORJPI CAPSULE; ORAL II.... ~.,,,..... r,r,e (f'\fflt:W II !Ill ·;mr N83237 001 • @ 12.SMG/5ML JAN 25, 1982 ... 1172915 001 • MATSON LABS M 191919 WI MAil 29, 1991 U DltUG JIJtODUC'l Liff / ~'fffll IVJI~ lfllNID 7 / AJ/1' H - nL' H 18 oom11 IXPN&9UPI CAPSULIII; OftAL P91PPA ,M WATSON LMS 10 aw NI llf729H 001 NAil 29, 1991 .. M IR IMNI 111'72'87 001 2SMG NlllHl 002 NAil 29, 1991 • DIC 24, 19H 3SMG lflllHl 003 • DIC 24, · 19as PQXQRUIICINHMQCHLOR.JPI INJBCTABLB; INJECTION BNODPNI.JiNi9PJW :xrr:w INJBCTABLB; INJBCTION LOVUOX -~- + RHOn POULDC ROUR 40MG/0.4ML N201H 002 • JU 30, 1998 + 60MG/0.6ML lf201H 003 W1R 27, 1998 M BRISTOL MYIRS SQUIBB lMfYINe 111'2921 001 + IIOMG/0.IIML N201H 004 APR 13, 19119 NAil 27, 1998 M IMfYINe MIIHH 002 + l00MG/ML lf201H 005 APR 13, 1989 MAR 27, 19'8 l00MG/VIAL Ni2926 003 APR 13, 1989 IPIJUMIJPI INJBCTABLB; INJBCTIOH INTBGRILIH + COR 7SMG/100ML 1120718 002 MAY 18, 19911 + 2MG/ML 1120718 001 ---2S0MG/ML -r•H09088 001 MAY 18, 19911 lij)ROPHONIUMCHLQRIPI PXTiffi.OMYCII INJECTABLI; INJECTION ROfPU!I CfflMJPI M ABBOTT lOffll/NL 1140131 001 ..,,_ FD 24, 1998 • •• AI AJCORlf LB 111114030001 JUL 111, 1996 lfflCAINIPIijYpROCHLORIPI OIN'l'MENT; TOPICAL ~}~ ADB-MYCilf -fM'B?iUlii ~ I MMtm fl r,!iiii!ilWIW U DllUG HODUC'l' Lil'l' / cuamLATrnl IUHI.Dmff _. 'I / JU' H • JUL' H 19 P.YJPONYCJN fflM9LftM OIN'l'MDT; TOPICAL T.DLft; ORAL AIOOM4YCIN + BM INDS 21 NS0SH 001 ...... JAN 10, 198S . TABLIT, DBLATim RBLDSIII:; ORAL - •M WATSON I.US N'IHH 001 ~ :·a.l::mJI..'... '""'·"·'"-'" AW 19, 199'1 1111111111,--_,,~ - IIH2'12. ·00·2 M N'IUH 002 M - AW 19, 199'1 • Alial, - - I . IU'MPJQL FILM, IXTlll:NI)ID ULDSB; TRANSDlll:RMAL + 11112298 003 M mm A.LORA MAR... ,. PROCTlll:RAND GNGLB 0. 0SMG/24HR N206SS 001 RG22H 002 DBC 20, 1996 •M + BX 0.0'ISMG/24HR N206SS 002 Dlll:C 20, 1996 BX 0.1MG/24HR N206SS 003 P.YJPONYCJt!moo,succINAD SOSPDSION; ORAL f:ii:fOi- 111:RYTHROMYCIN111:THYLSOCC •I •liIIH'i'* --.....-~·-r•·- CLDWtA I.SMOLOLHYDRocm..oR:tP§ BX + Bmu..D 0.0'ISMG/24HR 11120375 003 MAR 23, 19H INJlll:CTABLIII:; INJBCTION BUVISLOC + BAXTlll:R PHAM PROD lOMG/ML N193H 001 TMLlll:T; ORAL AW 1S, 191118 UflN)lQli DDDVOR •o:ue 001 l0OMG/ML B1193H 003 M L.111 JM 30, 19H • Dlll:C 31, 19H IMO:UI 002 + 2SOMG/ML N193H 002 M JM 30, 19H ,_ DSC 31, .. 1H6 IM0138 003 l_. M - JM 30, 19H i - ;, utMPJQL CJPJQMTI --- IIIIJlll:CTMLII; INJBC'l'ION 1°11mlllilm1.1111mmmw. IUilllffll!iU. a NW nODVC'f Liff / ~ RPRIIIIIBft Jil1IIIRa 7 / .ra•H • offlL'H 20 HfW>IOL CJPJQMD mnoo, PIMPJ9L: YY9!!"11flrr-5 IlfJBCTAILI; INJBCTION i,illll~tJMltlD - flllill • lNG/ML 1115470 ~-001 1115470 002 • WATIOII LABS 1173H2 001 • 3118/ML U Ym•.t..Jai DIC 13, 1993 iSTMPJ9L YNtQAD >...MIL> TMLBT; ORAI.·2111 >...MIL> LBVLITB IKJBCTABLB; INJECTION >...MIL> BER.LU LABS 0.02MG;0.1MG 1120860 002 PP:IM9911 >ADD_> JUL 13, 1998 AQ + BRISTOL MYERS SQUIBB A2 + ... i •U WATSON LABS Ym•.t..Jai 11735'4 001 I i DEC 13, 1993 j - mJiffi l§TMDJQL; AffllIAOQ ISTRADJQLVALpAT;B; TESTO§TPOQPWMD IlfJBCTABLB; INJBCTION DBLN>UMOffl!I > • ltttfflf• 1109545 001 > >-AmL> : I-MIL MYIR.S SQUIBB >.JlliI...> atm > u WATSON LABS o,ouw,a 1171410 001 DELADtJIMONI OB > APR 12, 1911111 >-AmL> N09545 002 : MYUS SQUID !m~Lllf,II~•. >.JlliI...> • ~L :ta' ~=~:,a~· iB --18.ftlfM >...miL> • §S'l'RQNI >...miL> >...MIL> u WATSON LABS 0.03Nh1m 117HH 001 INJBCTABLE; INJECTION >...MIL> -- APR 12, 191111 rtlil::::-. : BTOOOI..AC e PARUDALB lMG/ML N03977 001 CAPSULB; ORAL 2MG/ML N03977 002 l'1'9PQW& • SMG/ML N03977 003 U ABSGBN .uom 1174929 001 • JAN 30, 19919 U TARO ll..!M Jf15071 001 APR 30, 1998 mxm l§IMPIOL; LIVOMORGISTRBL u .uom 1175071 002 TABLBT; ORAL·21 APR 30, 1998 >-AmL> LBVLITB >-AmL> HR.LU LABS 0.02MG;0.1MG N20860 001 >-AmL> JUL 13, 1998 U: »a.VG l'RODUC'l' LIST / C'O'IIOLA'i'IVIII SU'PIPLl!Rn ffl8D 7 / JM' H • JUL' H 21 IIQPOl,M; fMQTIPIQ TABLBT; OOAL TABLBT, ORALLY DISINTIGRATIIJfG; ORAL U9P9W& PIIIPCID RPD CHBLSU. I.MS + MDCIC 40MG N207S2 002 M il2li MAY 211, 1998 M MYLAN il2li ~-- 1175074 001 •M TARO il2li MAil 11, 19H WATSON LABS - 117092 001 iBWf.i:!dl M il2li ..20MG N166111 001 APR 16, 1997 TABLBT, BXTBNDED RELEASE; ORAL LODINB XL fPOFIBRAD + NYBTH AYBRST SOONG lf20SH 003 JAN 20, 1998 CAPSULI; ORAL LIPIDIL 9 ABBOTT lOONG ITQPQSIPI • rm:,--llli BM INJBCTULB; IlfJBCTION mmm n1c.'()R. (MICROIIIZID) K rwtSM 20ffil/ffle 117HH 001 + ABBOTT 67MG N19304 002 JAN 09, 1998 FD 09, 1998 ION .ION ~tBM B.ll'.Mlf- • Mft7fTT77WM BTOroPHos PRESDVATIVE RBI 111..-.BM + BRISTOL MYERS SQtJIBB BQ lOONG BABB/VIAL lf20457 001 MAY17, 1996 DR!m SJND + BQ SOONG BASE/VIAL 11120906 001 K llMR3:£:ilruntwe PD 27, 1998 K + BLICIIIS SID & o.ogp MPflL f'MQTIPIQ K IIWUWI TABLET, ORALLY DISINTIGRATIW; OOAL ~ PBPCID RPO MDCIC 20NG if207S2 001 MY 28, 1998 K + JAIISSDI lflHH 001 U DllVQ HODUCT Liff / ~'l'J:Q SUHLlllllft lla8D 7 / JAIi' H • JUL' H 22 goMYCIJ §WAD 11im:awt.£ FLUOROURACIL r1.mw,ffi.fij lit PARKE DAVIS PHARMS 200MG INJECTABLE; INJECTION N18422 001 lit 300MG N18422 002 it ~~:==iMib~ lMM TABLET; ORAL J.fBIII GWIUQIIL 61 ♦ SONG/Jq, N81225 001 >..612JL> y TORPHARM .§.2.0lg !175034 001 AUG 28, 1991 >..612JL> JUL 20, 1998 Ii i.PJ.id.U,,Md# FLUPH§NAZINEQECANQATI ♦ •• Al PARKE DAVIS PHARMS .§.2.0lg INJECTABLE; INJECTION U1H22 003 NOV 20, 1986 n.YfDIAZID PICUQA'l'B ~ KING PHARMS 2SNG/IIL !174966 001 APR 16, 1998 GENTAMICINSULFATB INJECTABLE; 61 U DaW HOD'OC'r LIS'l' / CUll'OLA'Hft 8VHL!INDl'l' llftaa 7 / JD' H • JUL' H 23 9MMJSJP SVW:.ft.U • gmM:tC:tllJSVW:6U INJBC'l'ABLB; INJECTION I~1 INJBCTION ca:nmc;p§UW'AU IP fOPJWQILOIJPI 9, H JP fwtJS cgm:Hm It B BRAUN 19 ,., MQ/1001,L IIIG28H 009 AUG 28, 1987 ii 19 7M w11111005 INHH 010 AUG 28, 1987 It 19 9,M WI/IL 11128H 001 • AUG 28, 1987 It 19 PM Wl/1991,L 11128H 011 •ii wrw::=-:rr11 It AUG 28, 1987 It 19 9919 w1111100KL IIS28H 012 it WlilM'lffffff AUG 28, 1987 It 19 19M WltlOOl,L lfS28H 013 AUG 211, 19117 19 1.219 IHI/IL 111211H 002 9LJJCMOIHYmtQOIJ.fflIPI ucommwn: AUG 211, 1987 It 19 HM Wl/1091,L lfS28H OH INJBCTABLI; INJECTION AUG 28, 1987 GLUCAGDI It 101,119 IMl!5 11128H 003 + NOVONORDISK IEQ lMG BASE/VIAL Sf20'18 001 AUG 2111, 1987 JUN 22, 199111 It 19 1.919 IHI/IL lfS28H OH AUG 28, 1987 It 19 l,M WI/IL 1111128H00!5 GLfflllIPI AUG 28, 1987 It 19 M MUllL 11128H OH TABLIT; ORAL AUG 2111, 19117 &JDUPI oaamm>. It 192,119 WI/IL llf6HH 007 y INI/Mlm 1Jl9 lf75174 001 Aoi:.n. un JUN 22, 19H ii Mfdlt'MM:tr·· lf7!5174 002 y - JUN 22, 1'98 II 11'.~=W:tttfetM y MYLNf 1Jl9 1176792 001 ·- JUN 26, 1998 11rw-~err11M y 117<1792 002 • JUN 26, 1998 ii MillWFMWi'l - II IM)i!illtMMPM mt»tic:tpJJ1 QOMYCJISVW:ltU1 PQLPOOSJI I SVW:AU Mf!MMM!ftttte· SOLUTION/DROPS;OPH'l'HALMIC •ii a ~-.at.nm • M'. + MOSIA1lCHPHARMS U Dlt'N ftODUC'l' Liff / CUIIUL&T!ft SVPn.lllllllft maD 7 / JAJI• H • .nn.•H 24 G1W!1Sffl9N umtOCHLOllJPI HALOQRIDOL TABLIT; ORAL TULBT; OltAL JCY'1'1lIL p 8 SMITHICLIMIBUCHM BQ 2MO IWll 1120305 002 ii ..... JON 15, 19H I :.:.:.. ;;;:.:::. - 1111'71071 • O.SMG 001 @VAPLOpCif UXPIQCHLORJPI • - NOV OJ, 19H TABLIT; ORAL 1MO 1111072 001 • NOV 03, 19H 2MO 11?1073 001 ~,miiii~ 8'1:.-.- • NOV 03, 19H BQ 200MO IWll 1120695 001 SMO N?1074 001 NOV 06, 1997 • NOV 03, 19H BQ 400MG IWll 1120695 002 lOMO 11?10?5 001 MAY 14, 1998 • AUG 04, lH? + BQ 600MG IASB 1120695 003 20MG 1111'71076001 MAY 14, 1998 • AUG 04, 19117 Gt.WlfACIQ IM>ROCHLQR.JPI HAL9fPJP9LPJCPOAD TABLIT; ORAL INJBCTULB; INJBCTIOII DLOQUDOLPICMOID 62 Bllmmu> 19 SM M,Qtll,, 1111'74111001 -~ .,,.~., JAJI 30, 1998 •M WATSONLUS 19WIYI 1111'74'112001 HAL9PPJP9LLftCTAD JUN 25, 1997 M 19MIYI 1111'74'112002 IIIJBCTABLB; IIIJBCTIOII JUN 25, 1997 f.;:: HAL9:PPJP9L -~ ■ r=w,.,., • BQ SMO IWllll/ML 1111'72516001 • FD 25, 1993 BQ SMO BABB/ML 1111'7251?001 ii ,. • FD 25, 1993 • - HBP,NtINSOQitlM • INJBCTABLB; IIIJBCTIOII ii DP PLUSH KIT IN PLASTIC CONTAIIID - Gt AM PHARMPARTNlllRS 10 WITS/ML N17029 017 >..!m!..> - >..!m!..> DBC OS, 1985 25 U DllllW HODUC'l' Liff / c:tJHULl.'l'IVB SUPIPLaa'l' m:aD 7 / JD' H - JUL' H UIPMU!§QPIUM HEPARIN§QPIUM INJBCTABLE; INJECTION INJBCTABLE; INJECTION HEP FLUSH KIT IN PLASTIC CONTAINER BIM!.IJl!ftv.l Nl7029 018 >..!mL> @ AM PHARMPARTNERS 100 UNITS/ML >..W..> 1••·· >..!mL> >..W..> . >...!2ltI-> litmfM >..W..> >...!2ltI-> -~~ >...!2ltI-> j i'iffidiiMtl& >..W..> >..W..> . > DLT > >..W..> DUllll LQC.lt PLY§B AM PHARMPARTNERS Nl7029 007 >..W..> >..!mL> ll MAY 06, 1982 >..W..> >..!mL> - N17029 006 >..W..> >..!mL> ll IU 165:t. 010 >..!mL> ..... >..W..> >...!2ltI-> ,g @ iti,Uim >...!2ltI-> .... 200 ffl'l'§/100§ >...!2ltI-> M ll > DLT > i "'l"!': ADD > SEP 22, 1987 ii IIF-tlW > ADD> Nl7029 012 >ADD> Iii 100 UNITS/ML ftil\ffiftd)t~ > ADD > > DLT > tt/iiml~ ' - > DLT > ·~~ > DLT > i :tc:crrtiitlttt~ ii di.Ill.II >...!2ltI-> @ 10,000 UNITS/lOOML Nl8911 006 HEPARIN LOCK FLUSH PRESERVATIVE FREE IN PLASTIC CONTAINER JAN 30, 19il5 Nl7029 008 > ADD > @ AM PHARMPARTNERS 10 UNITS/ML >-;J5o> -SEP 22, 1987 Nl7029 009 >-;J5o> @ 100 UNITS/ML .,111 SE!?.. ;1.~, .. J,.?.!l.7. ■ >°"ii5o> @ 5,000 UNITS/lOOML Nl8911 007 >75°LT> i ~:i:iAWi tc' Wi'liilit JAN 30, 1985 >75°LT> id~i:111111 - LI >75°LT> /Ji itli>WX'i'ltMt > DLT > uliJ!:~tlf DPARIN SODIUN B dBi!■ >ADD> AP AM PHARMPARTNERS N17029 001 5,000 UNITS/lOOML N19339 001 >-;J5o> ii N17979 001 MAR27, 1985 >-;J5o> 11117'51 006 ii N17029 003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.451 IN >°"ii5o> ii Nl7979 002 PLASTIC CONTAINER >°"ii5o> ii @ B BRAUN 5,000 UNITS/lOOML >°"ii5o> ii N17029 004 @ Nl7651 005 >°"ii5o> - Nl7029 002 ~Ji®Mitifili~ >ADD> @ @ Nl7979 003 >ADD> Nl7651 003 >'""iii5o" > @ i- Nl7651 008 > ADD > @ U DaUG HOl>1JCT LIST / CUH'OLATIVB SUHLIIIHlft RtlK9D 'I / JMI' !II • JUL' !II 2G HEPARINSODIUM H§PARINSQPIUM INJECTABLE; INJECTION INJECTABLE; INJECTION HEPARIN SODIUM2,000 UNITS IN SODIUMCHLORIDE 0.9' IN HEPARIN son:::UM 25,000 UNITS IN SODIUMCHLORIDE 0.91 IN PLASTIC CONTAINER PLASTIC CONTAINER 11 B BRAUN 200 UNITS/lOOML N19042 002 II B BRAUN 5,000 UNITS/lOOML MAR 29 1985 t - ~J.ckmMt1't.8 • 5,000 UNITS/lOOML fflAltIII SODIUM 20,000 mg't§ Ill DUJllOSIII S\ IN lPWTIC•• i:Ut:iitlJMMlii& COffle'Nm M B BRAUN 4.ooomg't§/lOOHL N19952 001 i iltif.iHmffifiJliR JUL 20, 19_92 · ii M,•• 1,000 UNITS/lOOML II ili®.lmi!WJliR ii tiHOOf'lCtfllM .:n!\'l,.,.,lti.,.,.,.,ff.~US DWIN SODIUMIN lPW'1' : con&m 5,000 UNITS/lOOML ~1•N18911 009 >..amL> M AM PHARMPARTNERS 000 ML IJl17029 013 • JAN 30, 1985 ·- 1 DEC 05, 1985 >..amL> @ 10,000 UNITS/lOOML N18911 008 >..amL> M s.:iootmIT§tm. Nl'I029 014 JAN 30, 1985 >..amL> DEC 05, 1985 mlllPllIN SODIUM 25.000 UNITS IN DIIIXftOSI 5111lN PLASTIC >..amL> M 10.000 ffl't§/NL H17029 015 CONTAIIIB!t > ADD > DEC 05, 1985 M B BRAUN 5.000 UNITS/lOOHL N19952 004 > ADD > M 20.000 mgTs{HL H17029 OH JUL 20, 1992 >..amL> DE£)>.~L19!,~ M 10.000 fflTS/lOOML N19952 005 >.J2ll..> II M1nwi HN?RDllMi JUL 20, 1992 >.J2ll..> @ 5,000 UNITS/lOOML N19134 001 >.J2ll..> ii >.J2ll..> •=••w-• ii > DLT > HtlBtlilD'IM >.J2ll..> ii II > DLT > II > DLT > ltlm!F- 11111•.u1wsODIPff •usnv.11.Trn nu >..amL> M + AM PHARMPARTNERS 1.000 fflTS/NL N17029 010 .-HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.451 IN >..amL> PLASTIC CONTAINER > DLT > ♦. HIIPNPll& @ B BRAUN 5,000 UNITS/lOOML N19802 005 >.J2ll..> •t• :ii.1111 JUL • =• 20, 1992 mllPPLV§B-10 @ 10,000 UNITS/lOOML N19802 002 >..amL> M AM PHARMPARTNERS 10 fflTS/NL H17H1 009 ~- ~9., ...;!.?.9.2. >ADD> 1t~•®ct=·m;.mti~ > DLT > II Mi'iU'iWiA JlfaJIU!W ~ilil~IU dtlli1lll >.J2ll..> ,fflit:HK!tffl tei'fQ'ij:c)J~tt•tt(i~ ....IJ!t.f!~/'~ ·- ifflti=•=•J=ti:t:•:•ttft ----~ U IDRVGHODVC'l' Liff / CUIIULl.'lffl nPILDllft maD 7 / JMI' H • JVL' H 21 HYQIQCHLOIOTHWIPJ;IJlUSMW l:lm,ltOCHlQBOTHIAZIPI;VAL§MTA,1 TABLIT; ORAL TABLIT; OftAL AVAP!tO HCT DIOV»I HCT 8 SAKOPI 12.Sl4G;7SMG N20758 001 NOVARTIS 12.SMG;IOMG N20818 001 SIP 30, 1997 MAR05, 1998 + 12.SMG;lSOMG N20758 002 + 12. SMG;160MG N20818 002 SIP 30, 1997 MAR06, 1998 HYQIOCQUI§PU ; iiiiMUUM CUAM; TOPICAL ...... ~-_ RW HYPRQCHLQRQTHIAZIQI;¥'fHYLPOPA a& u PARDl>ALB Lll dl:250 001 TABLET; ORAL -- JmJ o,, 1984 SOLUTION; TOPICAL • • ;}··•iii. .a iliftl?ffl • ,,.,::;; U + MBDICIS ll n11iit:2s"'·oo1 15MG;2SOMG N70829 001 • MAR09, 1987 --2514G;2SOMG N70830 001 IM>RQCOR.Ttsog:QQMYCIN SQ'W'AD; POLJMXXIN B SQl,fADi • MM 09, 1987 SUSPENSION/DROPS; OTIC IM>RQCHLOAAIHIMIPI;SPIRQNQLACTONJ WBDlifi U +~ MONARCH PBARMS NG0613 001 M. NHHl 001 II RfflMiit.l HYPBOMOJlPHOffl!iHYDROCHLOR.IPI SOLUTION; ORAL IM>RQCHLOROTHIAZIQI;TIU::NfTPW DIMJIPJD _,_ >~> M + ICNOLL PIWU4 Nl9Hl 001 CAPSULE; ORAL >~> DIC 07, 1992 DW'lPPI PP IJPl~ODWIPJ >~> BYP1919PAI R M. BARR , ll.Jm N7H70 001 >~> M ROXAn 5111i1/5JIL N74'53 001 JAN 05, 1998 >~> JUL 29, 1998 TABLET; ORAL TABLIT; ORAL DM!3PP pxuwm M. N712Sl 002 >~> y + ICNOLL P.!WtM 11119892 001 MAY OS, 1998 >~> - DIC 07, 1992 U DllVO PllODUC'l' Liff / CVJl'IJLATI'Q IWlPLDlllllft' IWNIU 7 / JM' H • JUL' H 28 HYQRQM()RPHONIHJPRQCHLQRIP§ HYDROXYZINE HYpRQCHLORIPI TABLET; ORAL TABLET; OW. >...APIL> IJPBONOUl9D p >...APIL> y ROXANE 1174597 001 >...APIL JUL 29, 1998 - -~• -;HM HYDROXYAMPHBTAMINEHYDROBRQMIDE; TROPICNW2! ii SOLUTION/DROPS; OPHTHALMIC y WATSONLABS um lf81149 001 PAREMYD - MAR 18, 1994 + AKORN lt;0.251 Nl9261 001 y ll!!i 1181150 001 J~,--~.Q.,.... ;1-.?.~.?. MAR 18, 1994 i:'f:Hfi::ii:it y mm N81151 001 +.- ~,11,~iui MAR 18, 1994 HYDROXYCHLOROOUINESULFATE IBUPROFEN TABLET; ORAL SUSPENSION; ORAL IM>ROXYCBLOROQID ::IULPATI CHILDREN'S ADVIL y MYLAN ~ N40274 001 mt MUiMl- Ul'BtR MAY 29, 1998 -1111~11 ~~~~_c>OUID SULP~iL,. BX WHITEHALLROBINS 100MG/5ML N19833 002 at:ttbtitl SEP 19, 1989 • •t~IW::l•ii IlilUPROfP y WATSONLABS N40133 001 y AI.PHARMA l0OHG/sm. 1174978 001 ~ NOV 30, 1995 MAR 25, 1998 !2DD! y + MCNEIL 1QOHG/5NL 001 HYDROXYUREA d I ii.CWJtm CAPSULE; ORAL DROXIA ax=mtt'en1stidaiil 3~ TABLET; ORAL Hllllill 1 200MG Nl6295 002 II 1UDf FEB 25, 1998 JOOMG Nl6295 003 a n·• FEB 25, 1998 - + 400MG Nl6295 004 FEB 25, 1998 .. • 400MG N72064 001 !!mYA lfl6295 001 • JAN 14, 1988 :. liiiL MYERSSQUIBB JUI I tiiiittlli @ 600MG N72065 001 HYDRQXYYUA JAN 14, 1988 >...APIL> y DURAMED SOONG M75020 001 800MG N71938 001 >...APIL> JUL 30, 1998 • JAN 14, 1988 - U DRUG JltOD1JCT LIST / CUNULAT:tff IIUl'PLllmff IIUDD 7 / JAIi' 98 • JUL' 98 29 JNPAPMIQB IQ'1'ROIM TABLBT; OltAL IIIJBCTABLB; INTRATHICAL IIPHMlRI OSMOVIST240 >..aim..> y ALPHAPHA.IIU4 1.a.lll!I 1175105 001 BIRLIX LIi.BS 51.31 N19580 002 >..Alm..> JUL 23, 1998 DIC 07, 19119 >..Alm.,.> y Lai 1175105 002 >..Alm.,.> JUL 23, 1998 y TEVA 1.a.lll!I 117408 002 Ioyp.sor. FD 12, 1998 IIIJBCTAIIILI; INJBCTIOH OPTIRAY240 INQOM§THACIN + MALLINCKRODT 511 N20923 001 MAY28, 1998 CAPS~; ORAL OPTIRAY 320 ~D! + MALLINCKRODT 681 1120923 002 y 10H :zm 117HH 001 MAY29, 1998 MAY28, 1998 OPTIRAY350 + MALLINCKRODT 741 lf20923 003 MAY28, 1998 IOPAMIOOL INJBCTAIIILI; INJECTION If!All!,Qfim:f BROMIQI JOf,NIIPOL !t ELKINS SINN m 1174629 OH UROSOL, METD£D; INHALATION MAR31, 19911 ATROVD'l' 19!MlR2L•£1H l:liilJl'ftiilM?NIIKWN ~rn•t• !t ABBO'l'T m 1175005 001 ...,.,.,.,..;,~_.- ...... ,...,.--.. FEB 24, 1998 + O.OlSMG/INH 1'19085 001 lQE»aDOL-;U! DEC 29, 1986 ABBOTT 1175005 002 !t ill FD 24, 1998 19!MlP9L•!7! !t ABBOTT m 1175005 003 FD 24, 1998 T~INGUAL >J21,L.> . ' , >..mit..> IOTRQW >..mit..> b- >..mit..> INJECTAIIILI; INTRATHECAL >..mit..> OSMOVIST190 >..Nm_> 2.5MG W16191 002 ti.JD >..Nm_> • - APR 01, 1996 >..Nm_> 5!40 1'16191 001 ---l':IBRLU LABS 40.61 N19580 001 >..Nm_> • APR 01, 1996 ~-DEC 07, 1989 OSMOVIST--240 tilii U DOG HODVCT Lift / ~TIVB IUHLIDIDT lfflll8n 7 / JAIi' H • JUL' H 30 l§QSUW:MILVI 1PIY9IWJMOLWWII INJBC'l'MLB; INJECTION INJBCTABLlll; INJECTION ~L~.e ,LEVCM>ROMORAN ,_ - >.JW'L> + OS SURGCL Nl8310 001 >.JWL.> .. 1t TABLET; ORAL - QTN!JQ HYDROCHlQRJPI LEVO-DROMORAN >..AWL> + ICN 2MG INJBCTABLlll; INJECTION >..AWL> >.JWL.> , .. I if°lil·wn f .. >.JWL.> i - !:t + PARUIW.E N1H13 002 LJDQCAIQ H + N1H13 003 + N16812 001 DISC;~NI ORAL KETOPRQQN + ASTRA PHARMS 101 ~Nl4394 001 CAPSOLB,BXTENDID RELEASE; ORAL - OROVAIL LIOOCAJNB;fflILOCAJQ ~ WifiU- ·1.ia DISC; TOPICAL ~- UR BMLA + ASTRA PHARMS 2.51;2.5\ N20962 001 lOOMG Nl9.816 003 HB 04, 1998 FEB 08, 1995 15014G Nl9816 002 FEB 08, 1995 LIDOCAIQHJDROCHLQRIDJii INJBCTABLIII;INJECTION LEPIRUDIN LJpocug & ,U AM PHARM PARTNERS INJECTABLE; INJECTION REFLUDAN + HOECHSTMARION RSSL 50MG/VIAL N20807 001 MAR06, 1998 I~ I LISINOPRIL LEVORPWQL WTRAT!f!i TABLET; ORAL INJECTABLE; INJECTION ...... ____Zllllilii LEVO-DROMORAN II ~ !.?.± ifM >.AIDL> + ICN 214G/ML N08719 001 >.AIDL> DEC 19, 1991 y N19777 005 ~ APR 29, 1993 31 U Dlll.UQ HOJ>1JCT LIST / ~'l'IVII IIHJHLDD'l' HUHBD 7 / JUI' 98 • JUL' H LQT§fMPNQL UABQNAU LI§INQPRIL SUSPIIISION/OROPS; OPHTHALMIC TABLIT; ORAL ALRBX N20803 001 + PHARMOS 0.21 ii ZlfimlL m'llillt MAR 09, 1998 1119777 002 LOTBMAX o.s, N20583 001 y + li!i MAY 19, 1988 + PHARMOS MAR 09, 19911 - N20114l 001 o.s, + MAR 09, 1998 LOXAPiffliiHYpROCHLORIP:lii iW CONCENTRATE;ORAL Jtllllll LOXITANEC iatiHfmitii ti'ff.Mff:ffl EQ 2SMG BASE/ML Nl7658 001 TABLET, ORALLY DISINTEGRATING; ORAL ;+ WATSONLABS CLARITIN REOITABS N20704 001 + SCHERING l0MG INJECTABLE;-· INJECTION DEC 23, 1996 ! ,OXITANEIM iif!~,.W.JUBB #iiti.iMiil * Nl8039 001 + ~jWATSON LABS EQ S0MGBASE/ML LORAZEPAM INJECTABLE; INJECTION LOXAPINESUCCINATE LOWJIPAM 1174!174 001 >...amL> !!. AKORN ~ JUL 23, 1998 CAPSULE; ORAL >...amL> 1175025 001 ....L9jjl)L, >...amL> !!. TAYLOR ~ JUL 23, 1998 >...amL> * TABLET; ORAL 1117525 001 Iy WATSONLABS H17525 002 L9MiltM . g ··•lMS UM y lfl7525 003 y + 1117525 004 y • TABLET; ORAL - 1172926 001 LOXITANE • WATSONLABS y ~ OCT 31, 1991 111r···--·· - 1172927 001 I-• y !!!! •OCT 31, 1991 l0MG Nl7525 006 Ii WATSONLABS EQ BASE Nl7525 007 1172928 001 • EQ 2SMG BASE y m OCT 31, 1991 Ii Nl7525 008 @ EQ S0MG BASE U DllUG Pl\ODUC'1' Lift / ~'DYi SUHLIBNDT RtaD '1 / JAJI' H • JOI,• H 32 NfPIQI ACll'l'ATJ lffll,ATHIQM CltUM; TOPICAL SULPAMYLON ~~+ BDTBKPHM ._IP.JtW~:f!1: ..~~,L.a:,,g - I - •tm•NH738 001 M 1120006 OH MAGNESIUMCHLORIDE; POTASSIUM CHLORIDE; SODIUM ACl'fATI; SODIUM II fMVMi CHLORIDE;SODIUM GLUCQNAT£ ~!9!t_S, J! PW'l'JC !! - == 001 !! II .,,. !! SOLUTION;- IRRIGATION RESECTISOL IN PLASTIC CONTAINER D mmrmN16772 002 II ... UN -- MECAMYI.»JIN§HYDROCHLORIDE TABLET; ORAL INVERSINE + LAYTON ~~t,iM f •liNffliiiJ¥iR iili ~~~ ..~ .. -~.... 33 U DRUGHODUCT Llft / ~'l'?VII IVHLDD'l' llltmlD 7 / JUl'H • JVL'H rqTHAl)Olffl IJYPilOCHLOBIDI tffiG!STRQLACE'6TII CONCDTRATB1 ORM, TABLBT; ORM, ntilWXlRI p R9lfflOL .a.cutD ROXJUR loW/IL 11140110 001 y PHAMACHBMIB 1174745 001 M APR 30, 1998 im FD 21, 1998 TABLBTI ORAL fi'ID,l)()R p MEP§RIDilfflHYDROCHLORIDE ION IH02U 001 M MAY 29, 1998 TABLET; ORM, lllli lff02U 002 II ~n Ill M - MAY 29, 1998 TABLBT, DISPBRSIBLB; ORAL M WATSONLABS llli ICITU.D0D p ION 1175082 001 M illi w.R 25, 19911 M!SAWJlffl CAPSULE, BXTBNDBI>RELEASE; ORAL PBNTASA >...mJ..> i -t-mOmt.i .._ >_DLl'...> '"' Jlltlll ur·wrw >..ll,WL> + ROBERTSLABS 2S0MG N20049 001 II MAY 10, 1993 >..ll,WL> l00MG/ML N891149 001 • DBC 21, 1991 M§STRANOL; NQMTHINDRQNE TABLBT; ORM,·21 M§IOCLOPWJPIHYDRogq,oRIDI ~ 1/SON·U UHMtm TABLBT; ORAL >...mJ..> a >...mJ..> Ii ._-PIP >..ll,WL> y WATSONLABS iPlif'ffl >..ll,WL> ~1- Mw:::'ee TABLBT; ORAL-28 • BQ SMG BA.SB N12436 001 '911111/SON-2@ • Jtm 22, 1989 >_DLl'...> ii lhl'Mta BQ l0MG BASE N10850 001 >...mJ..> ·:■ • FD 03, 1981 >..ll,WL> y WATSONLABS 1171540 001 >ADD> ~1- APR 12, 1988 Mffl>PROLOLTARTRATII INJBCTABLB1 INJECTION FOQOLOL '1:MNTII 1175160 001 >.Alm,_> it ABBOTT 1IIUll! J11L 06, 1998 >..ll,WL> U DaVG HODUCT Llff / C'UIIIJLATlVIIIIUHLIINIM' IIUIIBI 7 / JAIi' H • o'.JVL'H 34 MQIUTIQ HYQRQCHLORJPI MQVHIQ SUW:61'1 CAPSULE; ORAL CAPSULB, DTENDBD RBLBASI; ORAL IPJ':l'l'PI A M DANBURY PHARMA nm R'IHH 001 >..W..> ~KN>At··•w..•i.W. APR 13, 1998 >..W..> M a.um R74H5 002 APR 13, 1998 TABLBT, DTENDBD RILBASB; ORAL M llD!i R74H5 003 >..aim..> RflPI IPWID APR 13, 1998 >..aim..> II AB GBNBRICS lll!i R74H2 001 >..aim..> JUL 07, 1998 >..aim..> M 1M 1174812 002 MITOMYCIN >..aim..> JUL 07, 1998 >..aim..> M !OE R74H2 003 INJECTABLB; INJECTION >..aim..> JUL 07, 19911 IIINIJCJI >..aim..> M ll.OE R747H 001 It SUPERGEN WtYJAL !HUH 001 >..Alm..> JUL 02, 1998 APR 30, 1998 >..Alm..> M llOE 117476' 002 H 20E/YJAL IIHH4 002 >..aim..> JUL 02, 1998 APR 30, 1998 u connr >..aim..> M + PmtDUI FmmERICK llli 111951' 003 >..aim..> SIP 12, 1989 MQNTELUKASTSODIUM >..aim..> M + !OE 111951' 001 >..aim..> MAY 29, 1987 TABLET; ORAL >..aim..> M + !OE i1195H 002 SINGULAR >..aim..> APR 011, 1988 + MERCK EQ lOMG BASIi: N20829 002 >..aim..> II + ll.OE 111951' OH FEB 20, 1998 >..aim..> JAM H, 1990 >..aim..> II + llOE Df195H 005 TABLET, CHEWABLE;ORAL m>y._.08, 1993. >..aim..> ~ .... .iili SINGULAIR >..W..> - :9t + MERCK EQ SMG BASE N20830 001 FEB 20, 1998 :_m_:m ~· HM >..W..> ...... >..W..> IC ii; lH MORPHINE SULFATE >.J2LI...> ;;;.;,;; .·.• >.J2LI...> - :9t 1- CAPSULE, EXTENDEDRELEASE; ORAL >.J2LI...> KADIAN >.JY2!L> + FAULDING 20MG N20616 001 >.JY2!L> JUL 03, 1996 NADQLQL >.JY2!L> + SOMG N20616 002 >.JY2!L> JUL 03, 1996 TABLET; ORAL > ADD > + lOOMG N20616 003 coaqyp >ADD> >.llmL> II BRISTOL MYERSSQUIBB .i9E i1180'3 005 >..!2R,.> ij: tiuti«/~ >.llmL> OCT 28, 1986 > DLT > JJi:!:~li >.llmL> M 11180'3 001 ~ illi 11111053 002 > DLT > ♦ lQMiil (~f®-1 >.llmL> II !OE > DLT > .w:::tm>ADD> M ll.OE i1180'3 003 ,. .- U DRVG HODUCT LH'l' / C'ONIJL1&'l'IVBSUPPLDIBlff IMIBD '7 / JD' H - JUL' H 35 NADQIQL MLIMXQNIHYPRQCHLO!:IPI TABLIT; ORAL TABLIT; ORAL coaqyp IUinDOU & BARR 111'14911 001 >..AR!2..> • + MYERS SQUIBB - M llli >.J2liL.> aiL MAY 08, 1991!1 >.J2liL.> lmA >..!2liL.> M 1· DUPONTMIRCK llli NJ.8932 001 >.J2liL.> NOV 20, 1984 >.J2liL.> >.J2liL.> I ' N/',PROXP TABLff, DBLAYBDRJII.BASB; ORAL NALBUfHifflliHYDROCHLORIDE G•DnOID INJICTABLB; INJBCTION M + SYNTU llJE Df200G7 002 m.pugm p OCT 14, 1994 !l KING PHARMS IM4 lll'IH'71 001 M + llD.9 llf20067 003 MAR 19, 1998 OCT 14, 1994 Al 2om4 lll'IH'71 002 PQOPI MAR 19, 1998 M INVAMBD llJE 111'15061 001 FD 18, 1998 M llD.9 111'15061 002 NALQXQNI IM>ROCHLORIDE PD 18, 1998 M PUUPAC PHARM llJE 111'1493$ 001 INJECTABLE; INJECTION PD 24, 1998 y llD.9 111'14935 002 iQM01 PD 24, 1998 111'15227 001 -~& n.11111■ M TIIWA llJE (i 0.4MG/ML N70172 001 JUN 30, 1998 SEP 24, 1986 M llD.9 111'15227 002 JUN 30, 1998 NALOXONEIM>ROCHLORIDE; POOAZOCINI!: IM>ROCHLORIDE NAPRQlp §QDIJ;!! ORAL TABLBT; ORAL maom &Im! y AL Hil TABLBT; ORAL »IBRGE GLAXOWELLCOME EQ lMG BASE N20763 002 PD 10, 1998 ll DRUG PltOD'UCT LIST / CUIIVLI.TIVS SVHLIIIIDff llfUNBD 7 / JD' 98 - JUL' 98 36 JlAMTRIPTAJ!H)'1)1lOCHJ ~ NITRQGLYCQIN TABLET; ORAL FILM, BXTENDBDRELEASE; TRANSDBRMAL AMERGB ♦ GLAXO IIBLLCOME BQ 2. SMG BASE N20763 001 jj ,'!'WI FEB 10, 1998 -· Jllfll m o.gq,n 1189773 001 A~-- NBOMYCINSULFATE ii EM'tft TABLET; ORAL m 0.611G/D NEOMYCINSULFATE mi fil.:liiiitia•.ii ~'ff?®.-\. IIIftO-Dtrlt ♦ BQ 3SOMG BASE N60304 001 ii .l il:Ht- 14WW 6!! + O.lNG/D NEOMYCINSULFATE; POLY!afYXINB SULFATE ; fiWW SOLUTION; IRRIGATION . DOSPORDr 0.0. IUICDJl'!l' Ml+ 0.2NG/JUl 002 it i't&dMiltili! ifitl'1Hffl • ♦- HMtli w. !! MONARCHPHARMS Mittflkif.m. 1160707 001 Ml+ 0.4NO/mt lf20H5 OH APR. 04, 19.95 ii l EMlP NICARDIPINE HYDROCHLORIDE .Will Ml+ 0.6NO/mt lf20H5 005 CAPSULE; ORAL APR 04, 1995 NICARDIPID BCL NITROOLYCRRIII !!_ GENPHARM 1174928 001 m MYLAN O.lllG/mt 1175033 001 ~ MAR 19, 1998 1174928 002 ~ ~ B t\Ml# ~~-.. MAR 19, 1998 ... ,,:=Jiil?t.t-'Q.iu~i! m 0.2NO/D 1174609 001 NITROGLYCERIN :illili .FILM, EXTENDEDRELEASE; TRANSDERMAL •m 0.411G/mt 1174607 001 NINITRAN - AUG 30 1996 II UI !I-W?P a ♦iMM ~-aflli Jllif■ lll 0. lNG/mt 1189771 001 m 0.6NO/D 1174559 001 AUG 30, 1996 AUG 30, 1996 D UMl# TRDSDBRN-NITRO .,.,,111111 m + NOVARTIS O.lNG/IIJI. 1120144 001 lll 0.2NO/mt 1189772 001 FE~---~?ti~~ AUG 30, 1996 ; ihWJjj . ... ~i,:fm U DRUG PRODUCT LIST / CUlilULA'l'IVB SUPPLDD'l' JIIUIIBD 7 / JAJI' H • JVL' 98 37 NI~OGLYCERIN ORPHENAQRIQCITRATE PILM, BXTBNDBDRELEASE; TRANSDERMAL TABLET, EXTENDED RELEASE; ORAL TWl§PPll-nno !OULU Yi+ NOVARTIS o,m1p M + 3M ll!li N12157 001 ou.mw>JtmCJWTJ ii l fiWM M INVAMED J..!!.9.19 11140284 001 JUN 19, 1998 Yi+ o.tNGJp N20H4 003 FD 27 1996 II * QXYBUTYNINCHLORIDE Yi+ 0.§!19/mt N20H4 004 SYRUP; ORAL --■FD27, 1996 PJD2'M f. - ii O:\:~ ,,Iii .. II~M t,...... ,,,,mf'jjfii#j :.,,,1 ....,,, - . llitli TABLET; ORAL NORETHINDRONE Pll'!OlM 11117577 001 TABLET; ORAL II i ~awu~oim II ...,N,a. f. . tM:t• at1~fgjjj ---i'- + WATSONLABS 0.3SMG Nl10,·o .. oii1 OXYTOCIN INJECTABLB; INJECTION NYSTATIN 11...., .I ''ill••· . t ...._. ·.. Mffft?ift SUSPENSION; ORAL !! + PARKEDALE 1111,·2,1'''·001 IIJ8'l'A'l'IN M UDL 100,000 mrITS/Jg, NHH2 001 JUN 25, 1998 PARICALCITOL INJECTABLB; INJECTION OLANZAPINE ZIMPLAR + ABBOTT O.OOSMG/ML N20819 001 TABLET; ORAL APR 17, 1998 ZYPREXA >ADD> @ LILLY lSMG N20592 005 >ADD> SEP 09, 1997 PAROMOMYCINSULFATE @ 20MG N20592 006 >ADD> SEP 09, 1997 ORAL >ADD> CAPSULB; ...... IIUIIATIN...... I ♦.lfMU\MVU OMEPRAZOLE -/!!/If AB + PARKEDALE N60521 001 CAPSULE, DELAYEDREL PELLETS; ORAL AB N62310 001 PRILOSEC PAilONOIIJCIN SULFATII + ASTRA MERCK 40MG Nl9810 002 M CARACO BO 250NG BASE NH171 001 JAN 15, 1998 JUN 30, 1997 JtX DJlOOHOJ>t1C'l' LIST/ cmro'LATIVB SUPPLBN'IIITMOMBBll 7 / JAH'H - JVL'98 38 PAROMOMYCINSULFATE PHENTERMINEHYDROCHLORIDE CAPSULI; ORAL CAPSULE; ORAL II Pll..._eJCIH SULPATI ..... P!IIPfflDHCL #W#@IIPM ••Ifill • ij@jjj &.llltlJ lit 37.5MG NB8414 001 OCT 19, 1983 PENTOSANPOLYSULFATE SODIUM TABLET; ORAL CAPSULE; ORAL PHENTERMINEHCL ELMIRON ifi iM .....Rllflriffl + ALZA l00MG N20193 001 Eilllii?U.l1. Sll:P 26, 1996 lit 30MG N88605 001 .. iiffi:iif]iim.mt i'O:ow.il SEP 28, 1987 iil■ll■ PHENTOLAMINEMESYLATE PENTOXIFYLLINE INJECTABLE; INJECTION TABLET, EXTENDEDRELEASE; ORAL PHBHTOLMIIQ MBSYLATE PDTOXIPYLLINB !!, BEDFORD 5111G/VIAL H40235 001 >ADD> AB BIOVAIL 40011G 1175028 001 MAR11, 1998 >ADD> - -- JUL 20, 1998 UGITIQ AP + NOVARTIS 5111G/VIAL 11108278 003 PERMETHRIN PINDOLOL CREAM; TOPICAL BLIIIITB TABLET; ORAL !J! + ALLERGAN .ll 1119855 001 AUG 25, 1989 • Pillii((- PIIIIIIITBJlIH !J! ALPHARMA 5\ 1174806 001 IM JAN 23, 1998 - • ® SMG N74125 001 APR 28, 1993 PHENAZOPYRIDINEHYDROCHLORIDE; SULFISOXAZOLE @ l0MG -N74125 002 1 a t&mI~s di APL.~·'-···i''·~.~i 11f.-t-tl m::::IIIi/t& + RiXSI iilim:Hrn~ &iiU~lt®.i ii Uili .Mt.h=l:ii?=ifiiIHI ·-~:tit ® 50MG;500MG Nl9358 001 AB WATSONLABS SIIQ 1174437 001 AUG 31, 1990 FEB 27, 199S y ll!9 1174437 002 FEB 27, 1995 U DRUGPRODUCT LIST/ CUIIULA.TIVBSUl'PLIDIDT HUIIID 7 / JAll'98 - JUL'98 39 PIPERACILLIN SODIUM; TAZOBACTAMSODIUM POLYMYXINB SULFATE INJECTABLE; INJECTION INJECTABLE; INJECTION ZOSYN IN PLASTIC CONTAINER P~N B SULPATB + LEOERLE EQ 40MG BASE/ML; > DLT > II IPffl®llfWlf''Pffm iffiiiHffi.:t EQ SMG BASE/ML NS0750 001 FEB 24, 1998 POWDER; FOR RX COMPOUNDING + EQ 4GM BASE/lOOML; 0 EQ SOOMGBASE/lOOML NS0750 003 ii • iilLM1ti J~iffli:Jg,:,:~ HU:'7.lfil'i FEB 24, 1998 N61S78 001 + EQ 60MG BASE/ML; + ~::::iqgfi.ft EQ 7.SMG BASE/ML NS0750 002 ii llliMli@J/- FEB 24, 1998 .-rlli.l: @ 100,000,000 UNITS/BOT N62455 001 JUL 27, 1983 PIROXICAM CAPSULE; ORAL POLYMYXINB SULFATE; TRIMETHOPRIMSULFATE PIROXIgM .... B ~QY.(m.:~ M>W ii !! PATB ~ :lillllili N64211 001 !! WATSONLABS N74460 001 APR 13, 1998 ~ SEP 29, 1995 AB N74460 002 SEP 29, 1995 POTASSIUMCHLORIDE INJECTABLE; INJECTION POLYETHYLENEGLYCOL 3350; POTASSIUM~ CHLORIDE; SODIUM POTASSIUN CHLORIDB BICARBONATE;SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS B BRAUN ~8-~.8-7.11...<1.~l, ; ~j H$U1.tK:ltl: POWDERno;tmFOR RECONSTITUTION; ORAL M :J:NV»m:P POTASSIUM CHLORIDE; SODIUM-CHLORIDE 11:11111?.B!•»ln!Jll~f~~i INJECTABLE; INJECTION @ 236GM/BoT; 2. 97GM/BOT;6. 74GM/saf'; .., SODIUM CHLORIDE 0.91 AND POTASSIUMCHLORIDE 0.0751 IN 5.86GM/BOT;22.74GM/BOT N73098 001 PLASTIC CONTAINER AUG 31, 1993 @BBRAUN 75MG/100ML;900MG/100ML Nl8722 001 NOV 09, 1982 • t!lWJlitffiiii~tlMGlitNm POLYMYXINB SULFATE ~ a'Rltli SODIUM CHLORIDE 0.9t AND POTASSIUMCHLORIDE 0.151 IN INJEC'rAfi~!;:.; INJECTION PLASTIC CONTAINER @ B BRAUN 150MG/lOOML;900MG/lOOML Nl8722 002 U +AD-=$¢.jji$ 10,''Mifi'ooo;::,,,1mtvt@ "-$'all' Ml @ EQ 500,000 U BASE/VIAL N62036 001 tioile)iwtwts6'ili«iti@Mt ::ilmr:ifii POLYMYXINB SULFATE -~ >..Mm_> !f + BEDFORD EO S00 1 000 U BASB/VIAL N60716 001 lltX DRUGPRODUCT LIST / CUIIULATIVBSUPPLBMBlfT IIUNBBJt 7 / JAN' 98 - JUL' 98 40 POTASSIUMCHLORIDE; SODIUM C'HLORIDE PRIMIDONE INJECTABLE; INJECTION SUSPENSION; ORAL SODIUMCHLORIDE 0.91 AND POTASSIUM CHLORIDE 0.221 IN MYSOLINE PLASTIC CONTAINER + ELAN PHARMA ~!?.9.~l~~ N10401 001 @ B BRAUN 220MG/100ML;900MG/100ML Nl8722 003 ♦ iNE':'A- aa1:m ti~'iitff.t NOV 09, 1982 i~W iaatt'i>fflffiiWH\Kltti;:m¢...... ,;~:t~:{[email protected] TABLET; ORAL ffiW:,iO,l#ilffl NYSOLIIIB SODIUMCHLORIDE 0.91 AND POTASSIUM CHLORIDE 0.3' IN PLASTIC !! + ELAN PHARMA ill!!!! N09170 002 CONTAINER + 50MG N09170 003 @ B BRAUN 300MG/100ML;900MG/100ML Nl8722 004 ii t iNEti- IN it.111.iEm . NOV .09, . 19.82 ,~ iii:i#ifJ)'o:j •~w ,J~Kltt'i>:~1.iii:~tt'i>m Jii::;rtl PROCAINAMIDEHYDROCHLORIDE PRAMIPEXOLEDIHYDROCHLORIDE TABLET, EXTENDEDRELEASE; ORAL PROCAIIIAMIDBRCL TABLET; ORAL II :tmi'MmU uw MIRAPEX Jllllilf PHARMACIAAND UPJOHN 0.5MG N20667 006 Iii 500MG N89284 001 FEB 12, 1998 ii itfiiiWfi~/10 HR Ji1~ii PREDNISOLONE (ii) 250MG N88958 001 DEC 02, 1985 SYRUP; ORAL P.ROCAH SR .. P.111oon~v:tt ••••1nmi >.J2!iL> M HER I .·.... ll1lUM!ti >...Q!i!'._> ~ ~lll~tlll PRBDNISOLOHB II * ,11i1:III >ADD> AA WE PHARMS 15MG/5ML N40192 001 • ~'::tf:#ilt'l:t > ADD > - MAY 28, 1998 AB + PARKEDALE ll2!!!! H86065 001 PRBLOHB AB + -ll!!!m N87510 001 AA + MURO 15MG/5ML N89081 001 APR 01, 1982 FEB 04, 1986 y + llf8H89 001 ~ JAN 16, 1985 TABLET; ORAL PREDNISOLONE u nmtm·W:'~ a "-•:iflSiiJm.i PROCHLORPERAZINEEDISYLATE BX + 5MG N80354 001 ji t ~tffltiAAs ~ ii.iiJif'Ml:i INJECTABLE; INJECTION (ii) 5MG N80339 001 PROCBLORPBRAZIHBBDISYLATB ii iiliEi»i q,,,,g,hNUOI -1111111 Iii EQ 5MG BASE/ML N89675 001 DEC 05, 1988 \~ U DJltJQ PRODUCT LIST / CUNULA'l'IVB SUPPLBNml'l' llll'IJDD 7 / JAN' 98 • JUL' 98 '1 PROPRANOLOLHYJ)ROCHLORIDE PROCHLORPER.AZINEMALEATE TABLET; ORAL TABLET; ORAL PROCJILOJlPBllZIHB MALD'l'B II PRi!,Wlli9L HCL TRIGEN BOSBIG lil40268 001 !! WI FEB 27, 1998 !! BO 1011G BASB 1i140268 002 ii FEB 27, 1998 - lilt0162 001 ,. !! ZENITH GOLDLINE BO SBIG WB JAN 20, 1998 • - BO 1011G BASB lil40162 002 Ii !! JAN 20, 1998 d - :JIii■ @ l0MG N716S8 001 PROGESTERONE - JUL OS, 198R @ 20MG N71687 001 CAPSULE; ORAL JUL OS, 1988 PROMETRIUM @ 40MG N71688 001 + SCHERING PLOUGH l00MG Nl9781 001 JUL 05, 1988 MAY 14, 1998 @ 60MG N72197 001 JUL OS, 1988 @ B0MG N71689 001 PROMETHAZINEHYDROCHLORIDE JUL 05, 1988 @ 90MG N72198 001 INJECTABLE; INJECTION JUL OS, 1988 PROMB'l'HAZINEHCL g tiiifiM ~ ~1111~1111 OUINIDINE SULFATE g ...JW:t.t.11::f®I 5:MM MYH>t}:,:t:u:a TABLET; ORAL @ 25MG/ML N89463 001 MAY 02, 1988 OUililIDIHB SULPA'l'B iffiiilii=:':iim jjijjj-J}ffl @ S0MG/ML N89477 001 HM N84003 001 MAY 02, 1988 • @ 200MG TABLET, EXTENDEDRELEASE; ORAL QUililIDID PROPOXYPHENEHYDROCHLORIDE lil12796 002 AB + ROBINS AH 30011G ffl'i:H?'o.12 CAPSULE; ORAL ii ; WffliH1.~ imii ,un~ur:10:1 M PR=-x:=-~1B RANITIDINE HYDROCHLORIDE @ 6SMG N83278 001 SYRUP; ORAL PROPRANOLOLHYDROCHLORIDE ~r~ icf==:~=iwil~ tilfl1illll TABLET; ORAL N1967S 001 + EQ lSMG BASE/ML PJlOPRAHOLOLHCL DEC 30, 1988 Ai ioiG niitataiii ;I~ .1.#.W:ii.llt:dlii:lf~ 25 I. 0 :! 11111-2s 11111 - ~ i: lliE~ 111112.2 :1111i_g = 40 2.0 11111 u 25 4 6 111111. 11111 '· 111111. _ ___J... 6" I U DRUG PRODUCT LIST / CUIIUltATIVB 8UPPLIIIODIT NUIIIIID 7 / JUI' 98 • JUL' 98 42 RJI\NITIDINE HYDROCHLORIDE RIZATRIPTANEENZOATE TABLET; ORAL TABLET, ORALLY DISINTEGRATING; ORAL JWIITIDIIIB DCL MAXALT >..!PP...> al MYLAN RO 15011G WR N7'1552 001 >_ADD_> MERCK EQ SMG BASE N20864 001 > ADD JUL 30, 1998 >_ADD_> JUN 29, 1998 >..!PP...> y RO 30011G WR N74552 002 >_ADD_> + EQ lOMG BASE N20864 002 >..!PP...> JUL 30, 1998 >_ADD_> JUN 29, 1998 y RANBAXY RO 15011G BUB N75000 001 MAXALT·MLT JAN 30, 1998 MERCK EQ SMG BASE N20865 001 y RO 300119 WB N?S000 002 JUN 29, 1998 JAN 30, 1998 + EQ lOMG BASE N20865 002 JUN 29, 1998 RIFAMPIN SACROSIDASE CAPSULE; ORAL RIPA.DIN SOLUTION; ORAL al HOECHSTMARION RSSL ,llgNG N62303 001 SUCRAID RIPAMPIN + ORPHANMEDCL 8,500 IU/ML N20772 001 al EON 15011G NH150 002 APR 09, 1998 JAN 02, 1998 SAOUINAVIR RIFAPENTINE CAPSULE; ORAL TABLET; ORAL FORTOVASE PRIFTIN ;. ~ 11:f''i._/ + HOECHSTMARION RSSL lSOMG N21024 001 .. dBi.ill JUN 22, 1998 + 200MG N20828 001 NOV 07, 1997 ~ISEDRONATE SODIUM SELEGILINE HYDROCHLORIDE TABLET; ORAL ACTONEL TABLET; ORAL + PROC'rER AND GAMBLE 30MG N20835 001 HLBGILIQHCL MAR 27, 1998 y ESI LEDERLE ~ N74H1 001 RIZATRIPTAN BENZOATE :illil y -STASON ~ N7U12 001 TABLET; ORAL . APR - 30, 1998 MAX.ALT >....!lliL.> ~ ia':==IMi.=i'mi ... itffij@~i > DLT > >""'5i:F" > +. t.o)t=Btmi > DLT > iffll::='H-ltD.ft~-i■ U DRUGlPROJ>UCT LIST / cmmLAT?VB SUHLDD'l' llflNIID 7 / JAJI' H - JUL' H 43 SILDENAFIL CITRATE SODIUMCHLORIDE INJECTABLE; INJECTION TABLET; ORAL SODIUMCHLORIDE CONTAINER VIAGRA 31 IN PLASTIC PFIZER 2SMG N20895 001 /fmut~ MAR 27, 1998 •- J■I■ SOMG N20895 002 SODIUMCHLORIDE St IN PLASTIC CONTAINER MAR 27, 1998 8 B BRAUN SGM/lOOML Nl9635 004 + lOOMG N20895 003 MAR 27, 1998 tilil@.'B Jit=1II SIMVASTATIN ·- SODIUMLACTATE TABLET; ORAL ZOCOR INJECTABLE; INJECTION SODIUMLACTATE 0.167 MOLARIN PLASTIC CONTAINER >...mu:..> 5m Nl8186 001 > DLT > : UN ltlBil.M > DLT > .. -tffi -- i• SODIIJJI LACTAU 1/6 NOLD f'JZHTifCOll'l'AIDJl >.J2LL,> • :111111 B BRAUN 1. 7 00 1120004 001 >..Alm..> + SMG Nl9766 001 At >ADD> DEC 23, 1991 >°Ai>i>> 40MG Nl9766 004 R Uffl'iUl!M >..Alm..> DEC 23, 1991 :ill■ >..Alm..> + 80MG Nl9766 005 >ADD> JUL 10, 1998 - SODIUM POLYSTYRENESULFONATB POWDER; ORAL, RECTAL SODIUMCHLORIDE °llltn tdiffttffl INJECTABLE; INJECTION lf11287 001 SODIIJJI cm.o11t1p•0.45\ IN :m-rorAIDll M + B BRAUN 450 1 -~U2DI lf40029 001 At 0 PADDOCK 04@1/IQT M FEB 06, 1998 it t "--li~:R SQTALQLHYDROCHLORIDE · )I At M17U4 001 TABLET1 ORAL At 11919635 002 iBETAPACE _.,,,,mi SW I - ll1tl .. SODIUMCHLORIDE 31 IN PLASTIC CONTAINER @ B BRAUN 3GM/l00ML Nl9635 003 - Nl9865 005 MAR 09, 1988 l20MG -- APR 20, 1994 U DaUG 1PllOD17C'l'LIST / cmlULATIVII SUIPIPLDl!llff IIUIIIIID 7 / JU' 98 - JUL' 98 44 §OTALQLHYDROCHLORIPB SUCRALFATB TABLET; ORAL TABLET; ORAL BETAPACB IIIUCUW'ID + BBRLEX LABS 160MG Nl9865 002 y RATIOPHARM Ml! 1174415 001 OCT 30, 1992 JUN 08, 1998 240MG Nl9865 003 OCT 30, 1992 SUFENTANILCITRATE SOYBEANOIL INJECTABLE; INJECTION Su,pTA INJECTABLE; INJECTION H + AKORN llllQ O. 0511G WIii/BiL lfl.9050 001 IllffllALIIPID 30\ MAY .. 04~ .1984 H + PHARMACIAAND UPJOHN ,!!! N19H2 001 II .~ ,_... MPltUWPWIM DEC 30, 1993 mWi.ll LIPO§YN III 30\ H + ABBOTT m 1120181 001 JAN 13, 1998 SULFACBTAMIDESODIUM mmtILllPID 10\ H + B BRAUN m 1119531 001 ...DROPS; OPHTHALMIC MAY 28, 1993 II m d m ifmt.Ju.i ...,. @ 10, N80025 001 'mmtILIIPID 20\ H + -B BRAUN !!!' SULFAMBTHQXAZQLB;TRIMBTHOPRIM ;. Bi • > DLT > SU•--- - > DLT > M ·.... · IMiMMN&m STREPTOMYCINSULFATE >...QLI...> INJECTABLE; INJECTION awt#Ji'PDMtlll §TUPTOHYCIN SULPAft • H + PFIZER 1Hi0076 001 • ....1,vMMt!ffl ,~:(!::::t:..:Y:i:~i:::: •• VI.-: &.,tl.=Ui@.:.t a + EQ lGM BASE/2.SML N60111 001 H PHARMATEK 1110lQN WB/VlAL 1164210 001 JUN 30, 1998 y TBVA 1118812 001 JAN 28, 1983 y 1118812 002 SUCCINYLCHOLINECHLORIDE JUN 10, 1983 >ADD> y 1170028 001 INJECTABLE; INJECTION >..!:Im...> JUN 02, 1987 • ~•vmtaL. .W:t\ftl lit !MW N08847 001 a MTY'ff.lW -- U Dlt'UGHODUCT Liff / cuamr.&TIW 81DIPLDDT ffllllD 7 / JD' H - JUL' H H TRIMfflQPRJM TACROLJfflJS CAPSULE; ORAL PROGRAF ~ ..... Rf.tMf:m. • ~-1'18242 001 + FUJISAWA HLTHCARB SQ lMG BASE N50708 001 M. aoop,I!J!!i 1118242 002 APR oa, 1994 M. ' + IEQ SMGBASE N50708 002 APR 08, 1994 SQLFASAJMINB INJECTABLE; INJECTION TABLET; ORAL ,... PROGRAF 11:::au•1u.• dl!ltll ;-+ FUJISAWAHLTHCARE EQ SMGBASE/ML SOONG N89339 001 -~• OCT 26, 1987 TECHNETIUMTC-99M ALBUMINAGGREGATED KIT TACRINEHYDROCHLORIDE INJECTABLE; INJECTION TECHNETIUMTC 99M ALBUMINAGGREGATED KIT CAPSULE; ORAL Nl7881 001 COGNEX BS DRAXIMAGE N/A MitiCiiM iifiRfmJ DEC:::30, 1987 u -=:::-.am.•wM lif;i&ifim .l■fll NlJ.B\mt TECHNETIUMTC-99M DISOfENIN KIT i;(iR.fmJ INJECTABLE; INJECTION • HBPATOLITE PARKEDAVIS PHARMS EQ lOMG BASE ili EQ 20MG BASE iiJfa DUPONTPHARMS N/A Nl8467 001 MAR16, 1982 EQ 30MG BASE - + EQ 40MG BASE TECHNETIUMTC-99M GLUCBPTATBKIT INJECTABLE; INJECTION TACROLIMUS DSPlfCM 9J.il1CIIPTA'fll a! DRAXIMAGE !Lit CAPSULE; ORAL PROGRAF _.:tim.itliii:li *- ... NlUif'mi .11111 • - U D1tUQ HODUC'J.' LIST / CUHULA'l'IVII IU'fPLIIIIID'l' llfUIIBD 7 / JAIi' H • JUL' H u TECHNETIUMTC·99M LIDQFBNIN KIT T§RAZQSINHYDROCHLORIDE INJECTABLE; INJECTION CAPSULE; ORAL TBCHNBSCANHIDA mu.I DRAXIMAGE N/A N18489 001 :Y ABBOTT IQlMWIII 1120347 004 OCT_?,h,,½.l,lf DEC 14, 1994 ._ m ~=,-,,:;,:;:::d,Ul IIW9fII G _,,.:,t ;J;$:8:=:--.. :Y GINIVA PHARMS &WMH 1174823 001 MAR 30, 1998 :Y &MUSI 1174823 002 TBCHNETIUMTC-99M MBDRQNATBKIT MAR 30, 1998 :Y 1174823 003 INJECTABLE; INJECTION &MUSI MAR 30, 1998 TJCPUCA! am,ntIT :Y IQ 1O:NGWI 11174823004 I l.li~r- Ii ltilrHl MAR 30, 1998 TBRBINAPINE TECHNBTIUMTC-99M PBNTBTATBKIT GEL; TOPICAL INJECTABLE; INJECTION LAMISIL DTPA + NOVARTIS Ur N20846 001 H, DRAXIMAGE ~ APR 29, 1998 m a - TJSTQSTBRQNB FILM, BXTENDE1>RELEASE; TRANSDERMAL TECHNETIUMTC-99M SULFURCOLLOID KIT ANDRODBRM u i - iMMV:im SOLU'l'ION; INJECTION, ORAL ••••r- m ntmnnt: + 2.SMG/24HR • • m: N17858 001 >...QLT...> ...... >...QLT...> • ... tilinl:di TBTRACYCLINJHYDROCHLORIDE >..Alm.,.> @ ~ N16923 001 CAPSULE; ORAL ACQOVCpl V T§RAZOSINHYI>ROCHLORIDB :Y ESI LEDERLE .uom CAPSULE; ORAL m!I! 1 f :Y ABBOTT GlWWB 1120347 001 :- DEC 14, 1994 :Y + IQMWF 1120347 002 DEC 14, 1994 >.J2LT...> :Y 1110sm WI 1120347 003 >.Jll!T..> DIC 14, 1994 >..!RP..> • -SOMG )161147 003 U DltUG HODUCT Lift / CU1111LA'l'IVBIIVHLDllff IIUlaD 7 / JAIi' H • JUL' H .., TfflACJCLIQHYDROCHLQRIDI THIOPHJLLIQ TABLBT; ORAL TABLBT, DTBNDID RBLJIASB; ORAL SUMYCIN QUIBROH·T/SR >-!ml.> eAPOTHBCON lOOMG N61147 002 BC MONARCHPHARMS 300MG Nll7563 001 JUN 21, 1983 >-!ml.> THALIDQMIDI >-!ml.> CAPSULE; ORAL >-!ml.> THALOMID m_. + CELGINB SONG N20785 001 >-!ml.> JUL 16, 1998 ; >-!ml.> t 9 PARXBDALB lGM/VIAL • SGM/VIAL • lOGM/VIAL f.\M •ii i THIORIDAZIQHYDROCHLORIDB CONCENTRATB; ORAL • lOOMG mouwm s - M PHARM ASSOC 19MflL llt0213 001 • 200MG MAY 29, 1998 'ID RBLDSB; ORAL TICLQPIDIQHYDROCHLQRIDB :fti - TABLBT; ORAL • TICLID ~ >..!PR..> 9 ROCHB 12SMG 1119979 001 >..!PR..> MAR 2t, 1993 • 12SMG N86826 001 >..!PR..> + 2SOMG 1119979 002 - JAN 29, 1985 >-!ml.> 2SOMG N86826 002 >...PltI,.> • JAN 29, 1985 >...PltI,.> >...PltI,.> TABLBT; ORAL >...PltI,.> - QUIBROH·T '· + MONARCHPHARMS 300MG N88656 001 - AUG 22 1985 IJ89fJW HYDROCHLQRJDB ♦.~::::-.. lU.. INJBCTULB; INJBCTIOH AGGRASTAT TABLBT, BXTBNDID RBLEASB; ORAL + MUCK BQ O.OSMG BASB/ML N20913 001 QU------MAY 14, 1998 • j- .,-~::~' U DRUG HODVCT LH'l' / ClllmJLA'l'IVB SU'PIPLlDlllft' lll1l!IIUlt 7 / JAR• 98 • JUL' 98 H IIP.9UW HJPR.OCHLOIUPIII TOMPIJPIII INJBCTABLB; INJBCTION TABLBT; ORAL AOORASTAT DDW>IIIX + NBRCJC BQ 0.25MG BABB/ML N20912 001 Roam lOMG N20136 002 MAY 14, 1998 AUG23, 1993 20MG H20136 003 AUG23, 1993 TOLCAP0Q + lOOMG N:20136 004 AUG 23, 1993 TULIT; ORAL TASMM. ROCHB lOOMG N20697 001 tMIJffl>JI JM 29, 19911 + 200MG N:20697 002 CRIW4; TOPICAL JAN 29, 19911 II l'il·ll:IH t:lftf TQLTJROPJUtMTMD u i.:B.ll laHH 003 JAN 14, 1997 TULIT; ORAL DBTROL GBL; TOPICAL PIIARMACIA AND UPJOffll lMG N20771 001 AVITA MAR 25, 19911 BX IPBNBDDM 0.025" + 2MG N:20771 002 MAR 25, 19911 RBTIN-A ~APIDI --- BX ,_+ JOffllSOH AND JOffllSON Nl7579 002 0.025" INJBCTABLB; INJBCTIOH DIDW>D ---- SOLUTION; TOPICAL i w· ·1ffti~;Ulo·1······Bi DW1M ,na·tml + Roam lOMG/ML N:20137 002 U + JOffllS0N AND JOHNSON Lm 191.'921 001 AUG 23, 1993 nnnyop ~- U COPLEY PHlWt -1....tB 11174173 001 TULIT; ORAL JUR 19, 19H 0 ,&Y-ff.:er•s•:oc:···•• DJMCiffl>LOJI ACffOJJPIII i CRBM; TOPICAL iM DJMCP91QP l&l'ffll'IJPI 8 ALPRARMA 0. 025" i B:M it lff:Hf ROCHB SMG N20136 001 AUG 23, 1993 - U: DaVG nODVCT Liff / CffillULA'l'rnl SVHLmlllllff ...._ 7 / JUI' H - JUL' H H TRJPLUQUMZJQHYDROCHLORJDI TBOGJ«JTNOIQ TABLBT; ORAL Tut.BT; ORAL fflftt1JOQWIIQ R y ZDITH GOLDLID 19WNP • Yfll~::Jmi - ~~ y 19MWI y PAlllD DAVIS ?KIWIS .a.u1!! ~fff!~ JAN 29, 1997 • _.rt111 IPtllFM y .um H20120 003 AUG 04, 1997 II MiW/fttt y ilmi H20720 002 JAN 29, 1997 TBJHmfHPJPXLHYDRQCHLORJPI TRQPICMJPI TABLBT; ORAL SOLUTION/DROPS; OPHTHAIMIC fflPIJUIIIXPJL R M CIRCA H401H 001 a ll nB 06, 1998 ~ M 11401H 002 lit n NHH7 001 - nB 06, 1998 AUG 28, 1985 YRQPQLLITRQPIN IlfJBCTABLB; DffRMUSCOLM nlllTIDX + SBlllONO 75 IU/MP N19415 002 SONG/ML --':tfflN0ll983 001 SBP 18, 1986 + 150 IU/MP 1819415 003 - SBP 18, 1986 TBJHffllXATI 9Ji9£URQPTI ttitiliR INJECTABLE; INJECTION NJm'l'lllBXIN i--i m:\lGIM >.AmL> + US BIOSCIDCE BQ 200MG BASB/VIAL N20326 002 >.AmL> JUL 31, 1998 YPN'MJLHYDRQCHLORJPII! TRQGLJIAZQ!I INJIBCTABLB1 IlfJBCTION TABLBT; ORAL • "Iii,\_. .. -~gr, • • • 2.5MG/ML N72233 001 - PD 26, 1993 91• ~ • •91 i ...... I I I.... I; :i . Ii I ·. iii"a I ...·a I ·r: . •... I . 01 ;;a.,.. N : 1111 ;W ... OTC DaVG UODVC'r Liff / ~'flft IUHLIIIIBft --- 7 / JM' H • .mio' H !51 AQTWl9PIPi MPJBP!i WQIQ SPW'IPIQ TMLIT; 0RAI, TULft; 0RAI, UCIDRIII INIGRAID) CIMBTIDID ♦ IIIRISTOL NYIRS 250MG;250MG;6SMG 1120802 001 NUIOO lOOMG 1174972 001 JU 14, 19H Jm 19, 19H PDNlrOM 200MG 11749'3 001 Jm 19, 19981 AAPPIJIM!HYmtOXIPPh N@WIJII! 'fflJSILICATJ '1'0UDM lOOMG 1174948 001 Jm 19, 19981 TMLIT, ~; ORAL iOA1lllirairnm• illifA.• SIPDPNPWF 80MG;20MG TMLft I VJIGIIIAL GlfflIX ♦ 1'0MG140MG COPLn!PJWIM lOOMG 1173249 001 ,a 13, 19981 i GAV,.$~~~ fiifillWt._ . -----·---··-----·---·-·--·-···-- IlfflODI SUSPDSIOR; ORAL CIILORHUI!;!IQGL1JCOIIIAQ 01 iill' S 111.-VU.,,, i rllililll-HiltUilllllill■· SOLUTIOll1 TOPICAL aiGSatUB 100MG/5ML 1120519 002 BCOLU 41 ffl>V 07, 1997 1•11"1lif.lM:- SUSPDSI0R/DROPS1 ORAL • nDIAftIC ADVIL CIDA-ffAT + lfflIDDLL ROBIIIS lOOMG/2.SML 1120812 001 BCOLU 2\ JM 30, 19981 TULft; OM.I, • 1111..r_-. ,.. Ji i! 11!'.i!..JIU c1g,r1p1p 200MG R'71773 001 • JUL 16, 1987 TABLBT; ORAL >---> IIIUPROl'D Clllffl'l'IDID >---> lliCM>PHAM 200MG 1174931 001 LIXPHMM lOOMG 11875122 001 >.Amt.> JUL 20, 19H Jm 19, 1998 >---> PHAM rOM 200MG 1174782 001 200MG N75122 002 >---> JUL OS, 19H JUII 19, 1998 1180VOPIWUI 200MG 1174961 001 TULft, ORAi, JUII 19981 ~; 19, ~mtaeml NO'l'RIII - I ...I ..• s I I ..• i ...... IJ I - I·1! . I ,,...... , N ...... OCII ....OCII 0 .... 0 00\ 00\ 01ft...... ,..01ft ... 0 0 00\... OOI... 0 • N • N.. N.. fl'I • •IO • .. '8111 11110 Ill fl'I Ort Ofl'I ...... I.... UIN 00 .. .. ,.. I; ;I ;I Is Ii: ;~ :3 -~ I I a1111 I I I :~I I~ 0 I N 0 i r i ... "'.. ~ .• ~ ll fl I .I ... II I ii ~ I i§ I ~ ~,,. s ...~' ~ ~ M ~ ! ~§, M It .. II I~r ~11 I :11 I i1 I gl°' I 11~ ,,. I; ; a I....!M... -• •·,:,t;< I+ A A ~::: ~~ijij ~~ 53 DRUGPRODUCTS wnH APPROVALUNDER SECTION SIS OF THE ACT ADMINISTDW) IY THI CENTER roR BIOLOGICS !VALUATION AND RUURCH LIST CUMULATIVE SUPPLEMENT NUMBER 1 JUL '91 NO JULY 1991APPROVALS 54 This data is provided to the Division of Data Management and Services from the Office of Orphan Products Development and it is not edited prior to publication. Orphan Product Designations and Approvals List January ~998 through July 1998 Name Sponsor & Address '-'..:aerie Name DD- Date Desipated TN•Trade Name MA•Marketins Approval 1,5-(Butylimino) Treatment of Pal:)ry•s disease. Oxford Glycosciences -1,S 10, The Quadrant dideoxy,D-glucit Abington Science Park, ol Abington TN• Oxfordshire OX14 3YS OIC, DDa05/12/1998 1,5-(Butylimino) Treatment of Gaucher disease. Oxford GlyeoSciencea -1,5 10, The Quadrant dideoxy,D-glucit Abington Science Park, ol Abington TN• Oxfordshire OX14 3YS tJK, DD•05/29/1998 Aldesleukin Treatment of metastatic Chiron Corporation TN• Proleukin melanoma. 4560 Horton Street Emeryville, CA 94608 DD•09/10/1996 MA•0l/09/1998 Aldesleukin Treatment of acute myelogenous Chiron Corporation TN• Proleukin leukemia. 4560 Horton St. Emeryville, CA 94601 DDa07/31/l'J98 Aliperetinate For the topical treatment of Ligand Pharmaceutical• TN• Panretin cutaneous leaiona in patient& Inc. with AIDS-related bpoai•• 10275 Science center sarcoma. Drive San Diego, CA 92121 DD•0l/24/1998 55 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name DO- Date Desisnated TN•Trade Name Indication Designated MA•Marketin1 Approval Alpha-galactosid Long-term enzyme replacement Transkaryotic ase A therapy for the treatment of Therapies Inc. TN• Fabry disease. 195 Albany St. Cambridge, MA 02139 00•06/22/1998 Amifostine Reduction of the incidence and U.S. Bioscience, Inc. TN• Ethyol severity of radiation-induced one Tower Bridge xerostomia. 100 Front Street, Suite 400 Conshohocken, PA 19428 00=05/12/1998 Arsenic trioxide Treat:nent of acute promyelocytic PolaRx, Inc. TN• leuke:nia. 787 7th Ave., 48th Floor New York, NY 10019 00•03/03/1998 Basiliximab Prophylaxis of solid organ Novartis TN• Simulect rejection. Pharmaceuticals Corporation 59 Route 10 East Hanover, NJ 07936 00.. 12/12/1997 MA•0S/12/1998 Beclomethasone For oral administration in the George B. McDonald, dipropionate treatment of intestinal M.O. TN• graft-versus-host disease. Fred Hutchinson Cancer Research Center 1100 Fairview Avenue North (SC-113); PO Box 19024 Seattle, WA 98109 DD•0l/27/1998 Benzydamine Prophylactic treatment of oral Angelini hydrochloride mucositis resulting from Pharmaceuticals, Inc. TN• Tantum radiation therapy for head and 70 Grand Avenue neck cancer. River Edge, NJ 07661 00•05/18/1998 56 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name DD- Date Desipated TN•Trade Name Indication Designated MA•Marketin1 Approval Bindarit Treatment of lupus nephritis. Angelini TN• Pharmaceuticals, Inc. 70 Grand Ave."lue River Edge, NJ 07661 DD•02/03/1998 Carbamylglutamic Treatment of N-acetylglutamate Orphan Europe acid synthetase deficiency. Immeuble "Le TN• Guillaumet" 60 avenue du President Wilson 92046 Paris France, DD•0l/20/1.998 Corticotropin-re Treatment of peritumoral brain Neurobiolcgical leasing factor, edema. Technologies, Inc. human 1387 Marina ~ay soutn TN• Xerecept Richmond, c;., 94804 DD•04/06/1998 Dimethylsulfoxid Treatment of palmar-plantar Cancer Tecr.r.clogies, e erythrodysethesia syndrome. Inc. TN• 7301. East 22:d Street Suite l0E Tucson, AZ 85710 DD•04/06/1998 Filgrastim Reduction in the duration of Amgen, Inc. TN• Neupogen neutropenia, fever, antibiotic l.840 DeHavilland Drive use, and hospitalization, Thousand oaks, CA following induction and 91320 consolidation treatment for DD•ll/07/1996 acute myeloid leukemia. MA•04/02/19H Fructose-1,6-dip Treatment of painful Cypros Pharmaceutical hosphate vaso-occlusive episodes Corporation TN• associated with sickle cell 2714 Loker Avenue Weat disease. Carlsbad, a 92008 DD•0S/29/lHB 57 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name Dl)a Date Designated TN•Trade Name Indication Designated MA•Marketing Approval Hydroxyurea Treatment of patients with B~istol-Myers Squibb TN• Droxia sickle cell anemia as shown by Pharmaceutical the presence of hemoglobins. Research Institute P.O. Box 4000 Princeton, NJ 08543 DD•l0/0l/1990 MA=-02/25/1998 L-baclofen Treatment of trigeminal Pharmascience, Inc. TN• neuralgia. 8400 Darnley Road Montreal, Quebec Canada H4T lM4, DD==0l/06/1998 Lepirudin Treatment of heparin-associated Hoechst Marion Roussel TN• ~efluden thrombocytopenia type II. Frankfurt am Main Germany DD•02/l3/l997 MA=0l/06/1998 Liposomal For aerosolized administration Vernon Knight, M.D. Cyclosporin A in the prevention and treatment Baylor College of TN• Cyclospire of lung allograft rejection Medicine, Dept. of and pulmonary rejection events Molecular Physiology associated with bone marrow One Baylor Plaza transplantation. Houston, TX 77030 DD=04/30/l998 Liposomal Treatment of osteosarcoma. Endorex Corp. N-Acetylglucosmi 900 North Shore Drive nyl-N-Acetylmura Lake Bluff, IL 60044 mly-L-Ala-D-isoG DD•06/l0/l998 ln-L-Ala -gylcerolidpalmi toyl TN• ImmTher 58 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name DO- Date Designated TN•Trade Name Indication Designated MA•Marketing Approval Liposomal Treatment of Ewing's sarcoma. Endo:rex Corp. N-Acetylglucosmi 900 North Shore Drive nyl-N-Acetylmura Lake Bluff, IL 60044 mly-L-Ala-D-isoG DD•06/10/1998 ln-L-Ala -gylcerolidpalmi toyl TN• ImmTher Mafenide acetate For use as an adjunctive topical Mylan Laboratories, solution antimicrobial agent to control Inc. TN• Sulfamylon bacterial infection when used 781 Chestnut Ridge solution under moist dressings over Road meshed autografts on excised P.O. Box 4310 burn wounds. Morgantown, WV 26504 00 .. 07/18/1990 MA=06/05/1998 PEGASYS Treatment of renal cell Hoffman-La Roche Inc. TNa carcinoma. 340 ~ingsland St. Nutley, NJ 07110 DDs07/13/l998 Pentostatin Treatment of cutaneous T-cell SuperGen, Inc. TN= lymphoma. Two Annbel Lane, Suite 220 San Ramon, CA 94583 DD=03/27/1998 Phenylacetate For use as an adjunct to Targon Corporation TN• surgery, radiation therapy and 307 College Road East chemotherapy for the treatment Princeton, NJ 08540 of patients with primary or DD=0J/06/1998 recurrent malignant glioma. 59 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name DO- Date Designated TN•Trade Name Indication Designated MA•Marketing Approval Pilocarpine HCl Treatment of xerostomia and MGI Pharma, Inc. TN• Salagen keratoconjunctivitis sicca in 9900 Bren Road East Sjogren•s syndrome patients. Suite 300E Minneapolis, MN 55343 DD•02/28/1992 MA•02/11/1998 Prostaglandin El Treatment of Fontaine Stage IV Alpha Therapeutic encl ester chronic critical limb ischemia. Corp. (AS-013) 5555 Valley Blvd. TN• Los Angeles, CA 90032 DDm06/12/1998 Radiolabeled Treatment of non-Hodgkin's Immunomedics, Inc. monoclonal lymphoma. 300 American Rd. antibody to CD22 Morris Plains, NJ antigen on 07950 B-cells DD•07/13/1998 TN• LymphoCIDE Recombinant Treatment of severe Xoma Corporation bactericidal/per meningoccccal disease. 2910 Seventh Street meability-increa Berkeley, CA 94710 sing protein DDm06/22/1998 TN• Neuprex Recombinant Prevention of neonatal Claragen, Inc. human Clara Cell bronchopulmonary dysplasia in 335 Paint Branch Drive l0kDa protein premature neonates with College Park, MD TN= respiral-'. .y distress syndrome. 20742 DO•07/13/1998 Recombinant Treatment of immune Biogen, Inc. humanized thrombocytopenic purpura. 14 Cambridge Center monclonal Cambridge, MA 02142 antibody 5c8 DD•02/03/1998 TN• 60 Orphan Product Designations and Approvals List January 1998 through July 1998 Name Sponsor & Address Generic Name DD- Date Desipated TN•Tnde Name Indication Designated MA•Marketinc Approval Recombina-.t Treatment of systemic lupus Biogen, Inc. humanized erythematosus. 14 Cambridge Center monoclonal Cambridge, MA 02142 antibody sea DD•02/18/1998 TN• Rifapentine Treatment of pulmonary Hoechst Marion Roussel TN• Priftin tuberculosis. P.O. Box 9627 H3-M2516 Kansas City, MO 64134 DD•06/09/1995 MA•06/22/1998 Rifaximin Treatment of hepatic Salix Pharmaceuticals, TN• Normix encephalopathy. Inc. 3600 w. Bayshore Road Palo Alto, CA 9430~. DD•02/10/1998 s-adenosylmethio Treatment of AIDS-myelopathy. Di Rocco, Alessandro nine M.D. TN• Beth Israel Medical Center, Dept. of Neurology Philips Building, suite 2Q; 10 union Square New York, NY 10003 DD•04/30/19H Sacrosidase Treatment of congenital Orphan Medical, Inc. TN• Sucraid sucrase-isomaltase deficiency. 13911 Ridgedale Drive Suite 475 Minnetonka, MN 55305 DD•l2/10/1993 MA•04/09/19H Sodium For use as an adjuct to surgery, Targon Corporation phenylbutyrate radiation therapy and 307 College Road Bast TN• f chemotherapy for the treatment Princeton, NJ 01540 of patients with primary or DD•04/24/19H recurrent malignant glioma. 61 Orphan Product Designations and Approvals List January 1998 through July 1998 Nam, Sponsor & Address Generic Name DO- Date Desipated TN•Trade Name Indication Designated MA•Marketing Approval TAlt-603 Treatment of Crohn•s disease. TAP Holdings Inc. TN• 2355 Waukegan Road Deerfield, IL 600i5 DDa05/13/l998 Tacrolimus Prophylaxis of Fujisawa USA, Inc. TN• Prograf graft-versus-host-disease. 3 Parkway North Center Deerfield, IL 60015 DD•04/06/1998 Tetrabenazine Treatment for moderate/severe Lifehealth Limited TN• tardive dyskinesia. Richmond House, Old Brewery Ccurt, Sandyford Road Newcastle upon Tyne NB2 lXG England, DD•05/12/1998 Thalidomide Treatment of erythema nodosum Celgene Corporation TN• Thalomid leprosum. P.O. Box 4914 7 Powder Horn Drive Warren, NJ 07059 DDa07/26/l995 MA•07/16/l998 Thalidomide Treatment of primary brain BntreMed, Inc. TN• malignancies. 9610 Medical Center Drive, Suite 200 Rockville, MD 20850 DDa02/27/l998 Thalidomide Treatment of Kaposi's sarcoma. BntreMed, Inc. TN• 9610 Medical Center Dr., suite 200 Rockville, MD 20850 DDa07/29/1998 Thymalfasin Treatment of DiGeorge anomaly SciClone TN• Zadaxin with immune defecta. Pharmaceuticals, Inc. 901 Mariner's Island Blvd. San Mateo, CA 94404 DD•0l/08:'1998 Tiapride Treatment of Tourette•s TH• syndrome. Transgenic human Treatment of cystic fibrosis. alpha 1 antitrypsin TH• U.IC., I>D•Ol/06/1998 DRUG PRODUCTS WHICH MUST DEMONSTRATE IN nvo IHOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION NO JULY 1998 ADDITIONS 64 PATENT AND EXCLUSMTY TERMS PATENT AND EXCLUSMTY TERMS DUE TO SPACE LIMITATIONS IN THE PATENT AND EXCLUSIVITY COLUMNS, ABBREVIATIONS AND REFERENCES HAVE BEEN DEVELOPED. PLEASE REFER BACK TO THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 18TH EDITION FOR A FULL LISTING OF PATENT AND EXCLUSIVITY TERMS (ABBREVIATIONS, NEW DOSING SCHEDULE. NEW INDICATIONS AND PATENT USE CODES). ONL V NEW CODES WILL BE ADDED TO THE CUMULATIVE SUPPLEMENT. ABBREVIATIONS PED PEDIATRIC EXCLUSIVITY REFERENCES NEW DOSING SCHEDULE D-38 CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION D-3? CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN SYMPTOMS FROM" ... 112-1 HOUR BEFORE EATING ..."TO" ... RIGHT BEFORE EATING OR UPTO 60 MIN BEFORE CONSUMING ..." D-40 ONCE-A-DA\' DOSING REGIMEN D-41 DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR AN\' TIME UP TO 30 MIN BEFORE EATING OR DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS D-42 TEN DA\' DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH CLARITHROM\'CIN AND AMOXICCLIN, FOR THE ERADICATION OF H. PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE NEW INDICATION 1-212 TREATMENT OF SYMPTOMS OF DR\' MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME 1-213 TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE SURGERY 1-214 TREATMENT OF OSTEOPOROSIS 1-215 PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS 1-216 FOR THE LONG-TERM TWICE-DAIL\' (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA 1-217 PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY 1-218 USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV) 1-219 USE OF LIPITOR BY PATIENTS WITH PRIMARY DVSBETALIPOPROTEINEMIA (FREDERICKSON TYPE Ill) WHO 00 NOT RESPOND ADEQUATELY TO DIET 1-220 TREATMENT OF EPISODIC HEARTBURN, ACID INDIGESTION AND SOUR STOMACH 1-221 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE TO IMPROVE SYMPTOMS. REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE RISK OF THE NEED OF SURGERY 1-222 PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN 1-223 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOICATED WITH ALLERGIC AND NONALLERGIC PERENNIAL RHINITIS IN CHILDREN AGE 6-11 \'EARS 1-224 FOR THE USE IN PEDIATRIC PATIENTS 4 TO ti YEARS OF AGE FOR THE MANAGEMENT OF THE NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS 1-225 USE IN PATIENTS WITH PREVIOUS Ml AND NORMAL CHOLESTEROL LEVELs. TO REDUCE RISK OF RECURRENT Ml, MYOCARDIAL REV ASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS 1-226 FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN COMBINATION WITH CISPLATIN 65 PATENT AND EXCLUSMTY TERMS NEW INDICATION 1-ffl SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (GED) 1-228 PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN »a MIN PRIOR TO A . MEAL 1-229 PRILOSEC (OMIEPRAZOLE). AMOXICILLIN AND CLAlllTHROMYCIN FOR THE ERADICATION OF H. PYLORI IN PATIENTS WITII DUODENAL ULCER DISEASE 1-231 IN COMBINATION WITII CISPLATIN, FOR THE FIRST-LINE TREATMENT OF NON-SMALL CELL LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY AND/OR RADIATION 1-231 TREATMENT OF PATIENTS WITII LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY 1-232 TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED PATIENTS AT A DOSE OF SNMG TWICE DAILY 1-233 PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD TRANSFUSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF CORONARY .GTERY BYPASS GRAFI' SURGERY 1-234 FOR USE IN COMBINATION WITII CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITII INOPERABLE LOCALLY ADVANCED (STAGE 111A OR 11111) OR METASTATIC (STAGE IV) NON-SMALL CELL LUNG CANCER PATENT USE CODE ll-215 TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING CARIIAMAZEPINE ·INA DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-12MCG/ML OVER 12 HOURS U-216 TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE 82-C, BY ADMINISTERING AN AGONIST OF LR-RH AND FLUTAMIDE U-217 METHOD OF PRODUCING ANESTHESIA ll-218 METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT ll-219 TREATMENT OF PARKISON'S DISEASE U-221 METHOD OF DIAGNOSIS U-221 SELECTIVE VASOOBLATION BY CONTINUOUS ADENOSINE INFUSION u-m METHOD OF TREATING PAGETS DISEASE USING ACTONIEL ll-223 TREATMENT OF BACTERIAL CONJUNCTIVms CAUSED BY SUSCEPTBBLIE STRAINS OF MICROORGANISMS U-224 CONTROLLING INTRAOCULAR PRESSURE ll-225 METHOD FOR DELIVERY U-226 METHOD OF ENHANCING THE DISSOLUTION PR01 .,LE OF A PHARMACEUTICAL FROM A SOLID DOSAGE FORM CONTAINING THE PHARMACEUTICAL AND SIMETHICONE ll-227 NASAL ADMINISTRATION ll-228 ASTHMA ll-229 CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE) ll-231 PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS U-231 USE IN PARKINSON'S DISEASE 1.1°232 METHOD OF TREATING MIGRAINE PATENT AND EXCLUSMTY TERMS PATENT USE CODE ll-233 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE ll-234 METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS ll-235 METHOD OF MODULATING THI AND TIil RESPONSE IN ACTIVATED T CELLS OF A HUMAN COMPRISING ADMINISTERING RIBA VIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE THI RESPONSE AND SUPPRESSES THE TIil RESPONSE ll-236 TREATING MALE PATTERN BALDNESS WITH e.os TO 3 MG/DAY U-237 METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE PATIENT AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS ll-238 IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY. ADMINISTERING AN AMOUNT OF PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES UNDERGOING NMR DIAGNOSIS. WHEREBY THE IMAGE CONTRAST IN ENHANCED .... ll-239 TREATING OR CONTROLLING OCULAR INFLAMMATION WHICH COMPRISES TOPICALLY ADMINISTERING TO THE AFFECTED EYE A COMPOSmON COMPRISING A NSAID. A POLYMERIC QUATERNARY AMMONIUM COMPOUND AND BORIC ACID U-248 TREATMENT OF ACUTE MIGRAINE ATTACKS U-241 FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER. MAINTENANCE THERAPY FOR DUODENAL ULCER PATIENTS AT REDUCED DOSAGE AFl'ER HEALING OF ACTIVE ULCER. SHORT TERM TREATMENT ACTIVE BENIGN GASTRIC ULCER & GERO. PATHOLOGICAL HVPERSECRETORY CONDmONS ll-242 USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION U-243 TOPICAL ADMINISTRATION '7 PRESCIUIPTIONMD OTCDRUG PIIOOUCT PATENTAND EXCLUSIVITY DATA ~ and HD represent Pediatric Exclusivity AIPIPL/IPIOD INGHDIENTNAME; TRADE NAME PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS tlMBER tlMBER EXPIRES COOE COOE EXPIRES 020482 004 ACARIOSE;PRECOSE 4904769 FEil 27, 2007 NCE .SEP06, 2000 020802 001 ACETAMINOIPIIEN;EXCEDRIN(Mic.RAINE) NIP JAN 14, 2001 020059 001 ADENOSIIIE;ADENOSCAN 5070877 DEC10, 2008 U·116 5731296 MAR24, 2015 u-221 020503 001 ALIUTEROLSULFATE;IPROVENTIL·HFA 5766573 JUN 16, 2015 020560 001 ALENORONATESODIUM;FOSAMAX 5804570 FEB17, 2015 > 020560 002 ALENORONATESODIUM;FOSAMAX 5804570 FEil 17, 2015 ~>ADD> 020560 003 ALENORONATESODIUM;FOSAMAX 5804570 FEB17, 2015 020511 001 AMLEXANOX;APHTHASOL 5362737 NOV08, 2011 U·243 019787 001 AMLOOIIPIIIEIESYLATE;NORVASC 4572909 JUL 31, 2006 019787 002 AMLOOIPIIIEIESYLATE;NORVASC 4572909 JUL 31, 2006 019787 003 AMLOOIPINEIESYLATE;NORVASC 4572909 JUL 31, 2006 >ADI)> 020304 001 APROTININIIOVIIIE;TRASYLOL 1·233 AUG28, 2001 020420 001 ARBUTAMINEHYDROCHLORIDE;GENESA 5108363 APR28, 2009 u-220 5234404 AUG10, 2010 u-220 5395970 MAR07, 2012 020702 001 ATORVASTATINCALCIUM;LIPITOR 4681893 SEP 24, 2009 u-161 1-218 JUL 10, 2001 1·219 JUL 10, 2001 020702 002 ATORVASTATINCALCIUM;LIPITOR 4681893 SEP 24, -2009 U-161 1·218 JUL 10, 2001 1·219 JUL 10, 2001 020702 003 ATORVASTATINCALCIUM;LIPITOR 4681893 SEP 24, 2009 u-161 1-218 JUL 10, 2001 1·219 JUL 10, 2001 020114 001 AZELASTINEHYDROCHLORIDE;ASTELIN 5164194 NOV01, 2010 u-201 018521 001 BECLOMETHASOIIEDIPROPIONATE;VANCENASE 4364923 DEC21, 1999 017573 001 BECLOMETHASONEDIPROPIONATE;VANCERIL 4364923 DEC21, 1999 020486 001 BECLOMETHASONEDIPROPIONATE;VANCERIL DOUBLE STRENGTH 4364923 DEC21, 1999 019408 001 BETAMETHASONEDIPROPIONATE;DIPROLENE 4489070 MAY13, 2003 020816 001 BRINZOLAMIDE;AZOPT 5240923 AUG31, 2010 U-224 NCE APR01, 2003 5378703 AUG31, 2010 U·224 5461081 OCT24, 2012 u-225 020711 002 BUPROPIONHYOROCHLORIDE;ZYBAN 5731000 AUG12, 2013 020711 003 BUPROPIONHYOROCHLORIOE;ZYBAN 5731000 AUG12, 2013 ~ 020524 001 BUTENAFIIIEHYDROCHLORIDE;MENTAX 5021458 OCT18, 2010 U-177 020554 001 CALCIPOTRIEIIE;DOVONEX 4S66048 DEC29, 2007 020611 001 CALCIPOTRIENE;OOVONEX 4S66048 DEC29, 2007 020313 002 CALCITONIN,SALMON;MIACALCIN 5733569 MAR31, 2015 u-221 020521 001 CALFACTANT;INFASURFPRESERVATIVE FREE NCE JUL 01, 2003 020838 001 CANOESARTANCJLEX£Tll;ATACANO '5196444 APR18, 2011 u-3 NCE JUN 04, 2003 5508297 FEB24, 2014 u-3 5534534 JUL 09, 2013 5703110 APR18, 2011 5705517 APR18, 2011 020838 002 CANOESARTANCILEXETIL;ATACANO 5196444 APR18, 2011 u-3 NCE JUN 04, 2003 5508297 FEB24, 2014 u-3 5534534 JUL 09, 2013 5703110 APR18, 2011 5705517 APR18, 2011 020838 003 CANDESARTANCllEXETll;ATACANO 5196444 APR18, 2011 u-3 NCE JUN 04, 2003 5508297 FEB24, 2014 u-3 5534534 JUL 09, 2013 5703110 APR18, 2011 5705517 APR18, 2011 61 61 PRESCIUPTIOIIANO OTC DRUG PIODUCT PATENTANO EXCLUSIVITY DATA "PED and PEDrepresent Pediatric Exclusivity PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS APPL/PltOO INGREDIENTNME; TRADENME IUER NUMl£1t EXPIRES CODE CClH EXPIRES APlt 18, 2011 U·3 ICE JUN 04, 2003 020838 004 CANOESAltTANCILEXETIL;ATACANO 5196444 5508297 FEB24, 2014 U·3 5534534 JUL 09, 2013 5703110 APR18, 2011 5705517 AP1t UI, 2011 ICE AP1t 30, 2003 CAPECITABIIIE;XELOOA 020896 001 ICE AP1t 30, 2003 020896 002 CAPECITABIIIE;XELOOA 5326570 JUL 05, 2011 U·215 020712 001 CARIINIAZEPINE;CAl!IATROL U-215 020712 002 Cll,RBAMAZEPINE;CAl!IATROL 5326570 JUL 05, 2011 MAR05, 2007 u-3 020297 001 CARVEDILOL; COREG 4503067 5760069 JUN 07, 2015 u-233 MAR05, 2007 U·3 020297 002 CAltVEDILOL;COIIEG 4503067 5760069 JUN 07, 2015 u-m MAR U·3 020297 003 CARVEDILOL;COREG 4503067 05, 2007 5760069 JUN 07, 2015 U·233 5760069 JUN 07, 2015 u-233 020297 004 CAltVEDILOL;COIIEG MY 2001 CHLORIIEXIDIIIEGLUCOIIATE;PERIOCHIP NP 15, 020774 001 JUN 05, 2001 CIIIETIDIIIE;TAGAMET 0·41 020238 002 Ill MAR 2001 CIPROFLOXACINHYDROCHLORIDE;CILOXAN 4670444 JUN 02, 2004 U·223 NDF 30, 020369 001 IIC FEI 10, 2001 020805 001 CIPROFLOXACINHYDROCHLORIDE;CIPRO HC 4670444 DEC09, 2003 4844902 FEIII11,- 2008 020780 001 CIPROFLOXACIN;CIPRO 4670444 DEC09, 2003 CIPROFLOXACIN;CIPRO 4670444 DEC09, 2003 020780 002 ICE JUL 17, 2003 020822 002 CITALOPIIAMHYDROIIIRONIDE;CELEXA JUL 17, 2003 CITALOPRAMHYDROIIIRONIDE;CELEXA ICE 020822 003 ICE JUL 17, 2003 02011122004 CITALOPRAMHYDROIRONIDE;CELEXA 020839 001 CLOPIDOORELIISULFATE;PLAVIX 4529596 JUL 05, 2003 4847265 FEB12, 2008 5576328 JAN31, 2014 017922 001 DESMCPRESSINACETATE;OOAVP 5763407 DEC23, 2013 017922 002 DESffllPRESSllilACETATE;OOAVP 5763407 DEC23, 2013 017922 003 DESffllPRESSINACETATE;OOAVP 5763407 DEC23, 2013 018938 001 DESMOPRESSINACETATE;OOAVP 5763407 DEC23, 2013 DESffllPRESSINACETATE;OOAVP 5763407 DEC23, 2013 D18938 002 MAR25, 2001 DESffllPRESSINACETATE;OOAVP 5763407 DEC23, 2013 1·40 019955 001 PW! 25, 2001 DESMOPRESSINACETATE;OOAVP 5763407 DEC23, 2013 1·40 019955 002 NP AP1t22, 2001 020713 001 DESOGESTREL;MIRCETTE U·133 020344 001 DEXFENFLURAMINEHYDROCHLORIDE;REDUX 4309445 FEB19, 2004 ~ 020809 001 DICLOFEIIACSODIU14;DICLOFENAC SODJUl4 5603929 NOV16, 2014 u-239 5653972 NOV16, 2014 u-239 1·213 FEB25, 2001 020037 001 DICLOFEIIACSODIUl4;VOLTAREN 020148 001 DIHYDROERGOTAMINEIIESYLATE;MIGRANAL 4758423 JUL 31, 2001 4462983 JUL 31, 2001 U-227 5169849 DEC08, 2009 U-227 1-133 JAN 30, 2001 020401 001 DILTIAZEMHYDROCHLORIDE;TIAZAC JAN30, 2001 DILTIAZENHYDROCHLOltlDE;TIAZAC 1-133 020401 002 JAN 30, 2001 DILTIAZEMHYDROCHLORIDE;TIAZAC 1-133 020401 003 1-133 JAN 30, 2001 020401 004 DILTIAZENHYDROCHLORJDE;TIAZAC 6( 69 PRESCRIPTIONMID OTC HUG PftODUC1 PATENTMID EXCLUSIVITY DATA "'PEDand PED represent Pediatric Exclusivity APPL/PROO INGlt£0IENTNAME; TRADE NAME PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS IUIBElt NUMBER EXPIRES CODE CODE EXPIRES 020401 005 OILTIAZatlfYOROCHLOltlOE;TIAZAC 1-133 JAN30, 2001 020449 001 DOCETAKEL;TAKOTEltE 1-231 JUN 22, 2001 020690 001 OOIIEPEZILHYDltOCHLOltlOE;AltlCEPT 4895841 NOV 25, 2010 ~ 020690 002 OOIIEPEZILHYOltOCHLOltlOE;AltlCEPT 4895841 NOV 25, 2010 020869 001 DOltZOLAMIOEH~OltOCHLOltlDE;COSOPT NC AP1t 07, 2001 ~ 020164 001 ENOKAPARINSOOJUM;LOVENOK 1-217 JAN30, 2001 1-222 MAR27, 2001 020164 002 ENOKAPARJNSODIUM;LOVENOK 1-222 MAR 27, 2001 1-217 JAN30, 2001 020738 004 EPltDSARTANNESYLATE;TEVETEN 5185351 FEB09, 2010 U-3 020738 005 EPltDSARTANNESYLATE;TEVETEN 5185351 FEB09, 2010 U-3 020718 001 EPTJFIIBATIDE;INTEGRILIN 5756451 NOV 11, 2014 NCE MAY 18, 2003 > 5686570 NOV 11, 2014 > 020718 002 EPTIFIIBATIOE;INTEGRILIN 5756451 NOV 11, 2014 NCE MAY 18, 2003 E 5686570 NOV 11, 2014 ~ 020375 003 ESTRADIOL;CLIMARA 5223261 JUN 29, 2010 083209 001 ESTROGENS,ESTERIFIEO;ESTRATAB 1-214 MAR10, 2001 086715 001 ESTROGENS,ESTERIFIEO;ESTRATAB 1-214 MAR10, 2001 020363 001 FAMCICLOVIR;FAMVIR NCE JUN 29, 1999 >ADO> 1-232 JUN 12, 2001 >ADD>020363 002 FAMCICLOVIR;Fl'WIR 1-232 iUN 12, 2001 >ADO> 020363 003 FAMCICLOVIR;FAAVIR 1-232 JUN 12, 2001 020752 001 FAMDTIOINE;PEPCIORPO 4283408 OCT15, 2000 4305502 DEC 15, 1998 4371516 JAN31, 2000 U-241 020752 002 FAMDTIOIHE;PEPCIORPO 4283408 OCT15, 2000 4305502 DEC15, 1998 4371516 JAN31, 2000 U-241 >ADO> 020625 001 FEXOFEHAOINEHYOltOCHLOltiDE;ALLEGRA 4254129 FEB18, 2001 U-139 020786 001 FEXOFENADINEHYOltOCHLOltlDE;ALLEGRA·D 4254129 FEB 18, 2001 NCE JUL 25, 2001 ~ 5375693 AUG03, 2012 5578610 NOV 26, 2013 020788 001 FINASTERIOE;PltOPECIA 5547957 OCT15, 2013 U-236 020180 001 FINASTERIDE;PROSCAR 1-221 MAR20, 2001 018830 001 FLECAINIOEACETATE;TAMBOCO!t 4642384 FEEi 10, 2004 018830 002 FLECAINIOEACETATE;TAMBOCOlt 4642384 FEIi 10, 2004 018830 003 FLECAINIOEACETATE;TAMBOCOlt 4642384 FEIi 10, 2004 018830 004 FLECAINIOEACETATE;TAMBOCOlt 4642384 FEB10, 2004 018554 001 FWTMIDE;EULEXIN 4472382 SEP 18, 2001 U-24 5712251 SEP 18, 2001 U-216 020121 001 FLUTICASONEPltOPIONATE;FLONASE 1-224 OCT31, 2000 020378 001 FOLLITROPIHALFA/81:TA;GONAL·F 4589402 JUL 26, 2004 U-242 5767251 JUN 16, 2015 020378 002 FOLLITROPINALFA/81:TA;GONAL·F 4589402 JUL 26, 2004 U-242 5767251 JUN 16, 2015 020961 001 FONIVIRSENSODIUM;VITRAVENE PRESERVATIVE FREE NCE AUG26, 2003 ~ 020450 001 FOSP!tl:NYTOINSODIUM;CEREBYX 4260769 AP1t 07, 2003 019596 001 GAOOPEHTETATEOINEGLUMINE;MAGNEVIST 5560903 OCT01, 2013 ~ '" 70 PRESCRIPTIONAND OTC DRUG PRODUCT PATENTAND EXCLUSIVITY DATA *PEDand PEDrepresent Pediatric Exclusivity APPL/PROD INGREDIENTNAME; TRADE NAME PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS NUMBER IUIIER EXPIRES CODE CODE EXPIRES ?a? D20460 001 GANCICLOVIR;CYTOVENE 4423050 MAY21, 2001 U·64 ?a? 4642346 JUN24, 2005 4507305 MAY12, 2001 U·64 > 020509 001 GEMCITABINEHYDROCHLORIDE;GEMZAR 1·234 AUG26, 2001 > 020509 002 GEMCITABINEHYDROCHLORIDE;GEMZAR 1·234 AUG26, 2001 E GREPAFLOXACINHYDROCHLORIDE;RAXAR 020695 001 5563138 OCT08, 2013 020818 001 HYOROCHLOROTHIAZIDE;DIOVANHCT 5399578 MAR21, 2012 U·3 HCE DEC23, 2001 NC MAR06, 2001 020818 002 HYDROCHLOROTHIAZIDE;DIOVANHCT 5399578 MAR21, 2012 U·3 NCE DEC23, 2001 NC MAR06, 2001 020716 001 HYDROCOOONEBITARTRATE;VICOPIIOFEN 4587252 DEC18, 2004 u-55 016295 002 HYOROXYUREA;DROXIA ODE FEB25, 2005 016295 003 HYOROXYUREA;DROXIA ODE FEB 25, 2005 HYOROXYUREA;DROXIA 016295 004 ODE FEB 25, 2005 >ADD> 019771 001 IBUPROFEN;ADVILCOLD ANO SINUS 4552899 NOV 2002 >ADD> 12, 4552899*PED MAY12, 2003 >ADD> 019833 002 IBUPROFEN;CHILDREN'SADVIL 4788220 NOV 29, 2005 >ADD> 4788220*PED MAY29, 2006 -•ADD> 020589 001 IBUPicOFEN;CHILDREN'SADVIL 4788220 JUL 08, 2007 NP JUN 16, 1998 >ADO> 4788220*PED JAN08, 2008 PED DEC16, 1998 >ADD>020516 001 IBUPROFEN;CHILDREN'SMOTRIN 5374659 DEC20, 2011 NP JUN 16, 1998 >A6Ti> 5374659*PED JUN 20, 2012 PED DEC16, 1998 >ADI)> 020601 001 IBUPROFEN;CHILDREN'SMOTRIN 5215755 JUN 01, 2010 NP NOV 15, 1999 >ADD> 5215755*PED DEC01, 2010 PED MAY15, 2DDD >ADD> 020603 001 IBUPROFEN;CHILDREN'SMOTRIN 5374659 DEC20, 2011 NP JUN 16, 1998 >ADO> 5374659*PED JUN20, 2012 PED DEC16, 1998 >ADD>020267 002 IBUPROFEN;JUNIORSTRENGTH ADVIL NP JUN 16, 1998 >ADI)> PED DEC16, 1998 >ADD> 020601 003 IBUPROFEN;JUNIORSTRENGTH MOTRIN 5215755 JUN01, 2010 NP NOV 15, 1999 >ADD> 5215755*PED DEC01, 2010 PED MAY >ADD> 15, 2000 020602 001 IBUPROFEN;JUNIORSTRENGTH MOTRIN NP JUN 16, 1998 >ADD> PED DEC16, 1998 >ADD> 019842 001 IBUPROFEN;MOTRIN 5374659 DEC20, 2011 >ADD> 5374659*PED JUN >ADD> 20, 2012 020135 001 IBUPROFEN;MOTRIN 5215755 JUN01, 2010 >ADD> 5320855 JUN 14, 2011 >ADO> 5215755*PED DEC01, 2010 >ADO> 5320855*PED DEC14, 2011 >IE> 020135 002 IBUPROFEN;MOTRIN 5215755 JUN 01, 2010 >AD> 5320855 JUN14, 2011 >ADI)> 5215755*PED DEC01, 2010 5320855*PED DEC14, 2011 > 020812 001 IBUPROFEN;PEDIATRICADVIL NP M 16, 1998 E> PED DEC16, 1998 020903 001 INTERFERONALFA-2B;REBETRON 4530901 JUL 23, 2002 NP JUN 03, 2001 4211771 JUL 08, 1999 u-234 5767097 JAN23, 2016 u-235 020923 001 IOVERSOL;OPTIRAY240 4396598 DEC30, 2002 020923 002 JOVERSOL;OPTIRAY320 4396598 DEC30, 2002 'lo 71 PRESCRIPTIONAIID OTC DU PRODUCT PATENTAIID EXCLUSIVITY DATA ~ and PEDrepresent Pediatric EKcluslvfty APPL/NOD INGREDIENTNAME; TRADE NAME PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS IUIHR NUMIER EXPIRES CCOE CCOE EXPIRES 020923 003 IOVERSOL;OPTIRAV350 4396598 DEC30, 2002 020393 001 IPRATROPIUM8RCJMIDE;ATROVENT J •223 APR 01, 2001 ?!I&? 020571 001 IRINOTECANHYOROCHLORIDE;c»IPTOSAII 4604463 AUG 20, 2007 020657 001 ITRACOIIAZOLE;SPORANOX 4267179 JUN 23, 2000 019927 001 ICETOCOIIAZOLE;NIZORAL 4942162 FEB11, 2003 020241 001 LAMOTRIGJNE;LAMICTAL ODE AUG 24, 2005 > 020241 002 LAMOTRJGJNE;LAMICTAL ODE AUG 24, 2005 > 020241 003 LAMOTRIGINE;LAMJCTAL ODE AUG 24, 2005 LAMOTRJGINE;LAMICTAL 020241 004 LAMOTRJGINE;LAMICTAL ODE AUG 24, 2005 > 020241 005 ODE AUG 24, 2005 > 020241 006 LAMOTRIGINE;LAMICTAL ODE AUG 24, 2005 • 020764 001 LAMOTRJGJNE;LAMJCTALCD ODE AUG ?!I&? 24, 2005 ?!I&? 020764 002 LAMOTRJGINE;LAMICTALCO ODE AUG 24, 2005 ~ 020764 003 LAMOTRIGINE;LAMJCTALCO ODE AUG 24, 2005 • 020406 001 LANSOPRAZOLE;PREVACID MAR I ·227 12, 2001 D-42 JUL 20, 2001 020406 002 LANSOPRA20LE;PREVACJD 1·227 MAR 12, 2001 D·42 JUL 20, 2001 020807 001 LEPJRUOJN;REFLIJDAN 5180668 JAN19, 2010 ODE MAR06, 2005 NCE MAR06, 2003 019732 001 LEUPROLIDEACETATE;LUPRON DEPOT 5716640 SEP 02, 2013 020011 001 LEUPROLIDE~CETATE;LUPRON DEPOT 5716640 SEP 02, 2013 020517 001 LEUPROLIDEACETATE;LUPRON DEPOT 5716640 SEP 02, 2013 020263 002 LEUPROLJDEACETATE;LUPRON DEPOT-PED 5716640 SEP 02, 2013 020263 003 LEUPROLIDEACETATE;LUPRON DEPOT-PED 5716640 SEP 02, 2013 020263 004 LEUPROLIDEACETATE;LUPRON DEPOT-PED 5716640 SEP 02, 2013 020263 005 LEUPROLIDEACETATE;LUPRON DEPOT-PED 5716640 SEP 02, 2013 020263 006 LEUPROLIDEACETATE;LUPRON DEPOT-PED 5716640 SEP 02, 2013 020708 001 LEUPROLJDEACETATE;LUPRON DEPOT·3 5716640 SEP 02, 2013 020517 002 LEUPROLIDEACETATE;LUPRON DEPOT·4 5716640 SEP 02, 2013 019941 001 LJDOCAINE;EMLA 1·215 FEB04, 2001 020962 001 LIOOCAJNE;EMLA NP FEB04, 2001 020606 001 LOPERAMIDEHYDROCHLORIDE;JMOOJUM ADVANCED 5716641 NAY21, 2012 u-226 020803 001 LOTEPREDNOLETABONATE;ALREX 4996335 FEB26, 2008 NCE MAR 09, 2003 5540930 OCT25, 2013 020583 001 LOTEPREDNOLETABONATE;LOTEMAX 4996335 FEB26, 2008 NCE MAR 09, 2003 5540930 OCT25, 2013 020841 001 LOTEPREDNOLETABONATE;LOTEMAX 4996335 FEB26, 2008 NCE MAR09, 2003 5540930 OCT25, 2013 019832 003 NAFENIDEACETATE;SULFAMYLON NDF JUN 05, 2001 ODE JUN 05, 2005 020652 001 MANGAFODIPIRTRJSODIUM;TESLASCAN 4933456 JUN 12, 2007 4992554 FEB12, 2008 5091169 FEB25, 2009 5223243 JUN29, 2010 U-237 4647447 MAR 03, 2004 U-238 019618 001 MESALAMINE;ROWASA 4657900 APR 14, 2004 RE33239 MAY12, 2004 020208 001 METRONIDAZOLE;METROGEL·VAGINAL D-40 MAY16, 2000 '7/ n PHSCRIPTlotlAND OTC DM PRODUCT PATENTAND EXCLUSIVITY OATA ~D and PEDrepresent Pediatric E11elusfvity APPL/NOD IIIGIEDIENTIIIME; TRADE lilME PATENT PATENT/PEDEXCL USE EXCLUSEXCLUS IIIUl48ER lillll8ER EXPIRES CODE CODE EICPlltES 020827 001 MICONAZOLENITRATE;MOIIIISTAT 3 NP MM30, 2001 020762 001 MOMETASotlEFUROATE IIINOIIYDRATE;lilASotlEIC 4472393 SEP 18, 2001 020830 001 MOIIITELUICASTSODIUM;SINGULAIR 5565473 1i10Y30, 2010 U·228 lilCE FEB20, 2003 020829 002 DTELUICASTSODIUM;SINGULAR 5565473 1i10Y30, 2010 U·228 lilCE FEB20, 2003 020763 001 IIIARATRIPTANHYDROCNLORIOE;AMERGE lilCE FEB10, 2003 020763 002 IIIARATRIPTANHYDROCHLORIOE;AMERGE lilCE FEB10, 2003 020536 001 NICOTIIIIE;NICOTROL 4915950 FEB12, 2006 020555 001 NIZATIDIIIIE;AXIDAR 1·220 APR01, 2001 D·39 APR01, 2001 020799 001 OFLOICACIN;FLOICIN NDF OEC16, 2000 020688 001 OLOPATADINEHYDROCHLORIOE;PATANOL 5116863 DEC18, 2010 ~ 019810 001 MPRAZOLE;PRILOSEC 1·229 JUN 29, 2001 019810 002 MPRAZOLE;PRILOSEC 1·229 JUN 29, 2001 020262' 001 PACLITAXEL;TAl PRESCRIPTIONAND OTC DRUG PRCIDUCT PATENTAND EXCLUSIVITY DATA ~ and PEDrepresent Pediatric Exclusivity PATENT/PEDEXCL USE EXCLUSEXCLUS APPL/PftDD INGREDIENTNAME; TRADE NAME PATENT EXPIRES CODE CODE EXPIRES NUMIER MUNIER MAY U•240 NCE JUN 29, 2003 020865 002 RIZATRIPTANHNZOATE;MAXALT·NLT 5602162 10, 2015 ~ 4305502 DEC15, 1998 5298520 JAN28, 2012 U•240 4758598 DEC15, 1998 4371516 FEB01, 2000 020533 001 ROPIVACAINEHYDROCHLORIDE MONOIIYDRATE;NAROPIN 4870086 JUL 28, 2010 > 020533 003 ROPIVACAINEHYDROCHLORIDE MONOIIYDRATE;NAROPIN 4870086 JUL 28, 2010 > 020533 004 ROPIVACAINEHYDROCHLORIDE MONDHYDRATE;NAROPJN 4870086 JUL 28, 2010 E 020533 005 ROPIVACAINEHYDROCHLORIDE MONOIIYDRATE;NAROPIN 4870086 JUL 28, 2010 ~ 020m 001 SACROSIDASE;SUCRAID ODE APR09, 2005 NCE APft 09, 2003 FEB 2001 020236 001 SALMETEROLXINAFOATE;SEREVENT 5126375 FEB12, 2008 1•216 05, 020692 001 SALMETEROLXINAFOATE;SEREVENT 5225445 FEB12, 2008 u-211 5380922 JAN10, 2012 5590645 MAR01, 2011 5126375 FEB12, 2008 D342994 JAN04, 2008 020828 001 SACIUINAVIR;FORTOVASE 5196438 NOV 19, 2012 ~ 020443 001 SERMDRELINACETATE;GEREF 4517181 MAY14, 2002 4703035 DEC28, 2004 020443 002 SERMDRELINACETATE;GEREF 4517181 MAY14, 2002 4703035 DEC28, 2004 020895 001 SILDENAFILCITRATE;VIAGRA 5250534 JUN 18, 2011 NCE MAR27, 2003 020895 002 SILDENAFILCITRATE;VIAGRA 5250534 JUN 18, 2011 NCE MAR27, 2003 020895 003 SILDENAFILCITRATE;VIAGRA 5250534 JUN 18, 2011 NCE MAR27, 2003 019676 001 SOMATROPIN,BIOSYNTHETIC;NUTROPIN ODE OCT29, 2004 ODE OCT 2004 019676 002 SOMATROPIN,BIOSYtlTHETICiNUTROPIN 29, 020181 001 SOYHANOIL;LIPOSYN Ill ~ox NP JAN 13, 2001 020626 001 SUMATRIPTAN;IMITREX 5037845 AUG06, 2008 5307953 DEC02, 2012 5554639 SEP 10, 2013 U-232 5705520 DEC10, 2011 U-232 020626 002 SUMATRIPTAN;IMITREX 5037845 AUG06, ·2008 5307953 DEC02, 2012 5554639 SEP 10, 2013 U-232 5705520 DEC10, 2011 U-232 020626 003 SUMATRIPTAN;IMITREX 5037845 AUG06, 2008 5307953 DEC02, 2012 5554639 SEP 10, 2013 U-232 5705520 DEC10, 2011 U-232 020791 001 TESTOSTERONE;TESTODERM 4379454 FEB 17, 2001 JUL 020785 001 TNALIDOMIDE;THALOMID NCE 16, 2003 ODE JUL 16, 2005 020912 001 TIROFIBANHYDROCHLOR:DE;AGGRASTAT 5292756 MAR08, 2011 U-230 NCE MAY14, 2003 5658929 MAR08, 2011 5733919 OCT23, 2016 MY 020913 001 TIROFIBANHYDROCHLORIDE;AGGRASTAT 5292756 MAR08, 2011 U-230 NCE 14, 2003 5658929 MAR08, 2011 5733919 OCT23, 2016 7~ 74 PRESCRIPTIONAND OTC OftUG PROOUCT PATENTAND EXCLUSIVITY DATA *PEDand PEDrepresent Pediatric Exclusivity APPL/PROD INGREDIENTNAME; TRADE NAME PATENT PATENT/PEDEXCL USE EXCLUSElCCLUS NUMBER NUMBER EXPIRES CODE CODE EXPIRES 020697 001 TOLCAPOIE;TASMAR 5236952 AUG17, 2010 NCE JAN29, 2003 5476875 DEC19, 2012 u-219 020697 002 TOLCAPONE;TASMAR 5236952 AUG17, 2010 NCE JAN29, 2003 5476875 DEC19, 2012 U-219 020771 001 TOLTEROOINETARTRATE;DETROL 5382600 JAN17, 2012 NCE MAR25, 2003 020771 002 TOLTERODINETARTRATE;DETROL 5382600 JAN17, 2012 NCE MAR25, 2003 020671 001 TOPOTECANHYDROCHLORIDE;HYCAMTIN 5004758 MAY28, 2010 ~ 020137 002 TORSEMIDE;DEMADEX D-38 FEB13, 2001 020528 001 TRANDOLAPRIL;MAVIK 5744496 APR28, 2015 U-229 020528 002 TRANDOLAPRIL;MAVIK 5744496 APR28, 2015 U·229 020528 003 TRANDOLAPRIL;MAVIK 5744496 APR28, 2015 U·229 ~ 020719 001 TROGLITAZONE;PRELAY 4572912 NOV09, 2008 >ADD> 020719 002 TROGLITAZONE;PRELAY 4572912 NOV09, 2008 >ADD> 020719 003 TROGLITAZONE;PRELAY 4572912 NOV09, 2008 >ADD> 020720 001 TROGLITAZONE;REZULIN 4572912 NOV09, 2008 >ADD> 020720 002 TROGLITAZONE;REZULIN 4572912 NOV09, 2008 020720 003 TROGLITAZONE;REZULIN 4572912 NOV09, 2008 ~ 020675 001 URSOOIOL;URSO 4859660 AUG22, 2006 020699 001 VENLAFAXINEHYOROCHLORIDE;EFFEXOR XR 4535186 DEC13, 2007 020699 002 VENLAFAXINEHYOROCHLORIDE;EFFEXOR XR 4535186 DEC13, 2007 020699 003 VENLAFAXINEHYOROCHLORIOE;EFFEXOR XR 4535186 DEC13, 2007 020699 004 VENLAFAXINEHYOROCHLOR!OE;EFFEXOR XR 4535186 DEC13, 2007 020388 001 VINORELBINETARTRATE;NAVELBINE 4307100 JUL 08, 2002 >ADO> 020471 001 ZILEUTON;ZYFLO 4873259 DEC10, 2010 U·168 >ADP> 020471 003 ZILEUTON;ZYFLO 4873259 DEC10, 2010 u-168 GovernmentPrinting Office: 1998- 454-723/00001 1'/ New 19th Ed·ition APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS U>mEDfflON Superintendent of Documents Subscription Order Form Order Processing Code * 8240 Charge your order. 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