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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 1993

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on May 06, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/1993 PARLODEL
NDA #017962		 SUPPL-39 BROMOCRIPTINE MESYLATE SS PHARMA Manufacturing (CMC) Approval
04/01/1993 PARLODEL
NDA #017962		 SUPPL-40 BROMOCRIPTINE MESYLATE SS PHARMA Manufacturing (CMC) Approval
04/01/1993 NOLVADEX
NDA #017970		 SUPPL-24 TAMOXIFEN CITRATE ASTRAZENECA Efficacy Approval
04/01/1993 FUROSEMIDE
NDA #018415		 SUPPL-22 FUROSEMIDE STRIDES PHARMA Labeling Approval
04/01/1993 BETA-VAL
NDA #018642		 SUPPL-10 BETAMETHASONE VALERATE COSETTE Manufacturing (CMC) Approval
04/01/1993 VIRAZOLE
NDA #018859		 SUPPL-22 RIBAVIRIN BAUSCH Labeling Approval
04/01/1993 CARDIZEM SR
NDA #019471		 SUPPL-15 DILTIAZEM HYDROCHLORIDE BIOVAIL Labeling Approval
04/01/1993 PROSTEP
NDA #019983		 SUPPL-4 NICOTINE AVEVA Manufacturing (CMC) Approval
04/01/1993 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #040057		 SUPPL-1 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE EASTMAN KODAK Labeling Approval
04/01/1993 NEBCIN
NDA #050477		 SUPPL-16 TOBRAMYCIN SULFATE LILLY Labeling Approval
04/01/1993 NEBCIN
NDA #050519		 SUPPL-18 TOBRAMYCIN SULFATE LILLY Labeling Approval
04/01/1993 DOXY-LEMMON
ANDA #062497		 SUPPL-16 DOXYCYCLINE HYCLATE TEVA Manufacturing (CMC) Approval
04/01/1993 NYSTATIN
ANDA #062506		 SUPPL-9 NYSTATIN TEVA Manufacturing (CMC) Approval
04/01/1993 NYSTATIN
ANDA #062506		 SUPPL-10 NYSTATIN TEVA Manufacturing (CMC) Approval
04/01/1993 NYSTATIN
ANDA #062506		 SUPPL-11 NYSTATIN TEVA Manufacturing (CMC) Approval
04/01/1993 DOXY-LEMMON
ANDA #062581		 SUPPL-10 DOXYCYCLINE HYCLATE TEVA Manufacturing (CMC) Approval
04/01/1993 DOXY-LEMMON
ANDA #062581		 SUPPL-11 DOXYCYCLINE HYCLATE TEVA Manufacturing (CMC) Approval
04/01/1993 NYSTATIN
ANDA #062776		 SUPPL-9 NYSTATIN COSETTE Manufacturing (CMC) Approval
04/01/1993 AMPICILLIN TRIHYDRATE
ANDA #062882		 SUPPL-4 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
04/01/1993 AMPICILLIN TRIHYDRATE
ANDA #062883		 SUPPL-3 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
04/01/1993 CLINDAMYCIN PHOSPHATE
ANDA #062930		 SUPPL-2 CLINDAMYCIN PHOSPHATE VINTAGE PHARMS Manufacturing (CMC) Approval
04/01/1993 COTRIM
ANDA #070034		 SUPPL-16 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
04/01/1993 COTRIM
ANDA #070034		 SUPPL-17 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070035		 SUPPL-9 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070035		 SUPPL-10 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070035		 SUPPL-11 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070044		 SUPPL-9 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070044		 SUPPL-10 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
04/01/1993 METRONIDAZOLE
ANDA #070044		 SUPPL-11 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
04/01/1993 COTRIM D.S.
ANDA #070048		 SUPPL-24 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
04/01/1993 COTRIM D.S.
ANDA #070048		 SUPPL-25 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
04/01/1993 BETA-VAL
ANDA #070072		 SUPPL-7 BETAMETHASONE VALERATE COSETTE Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070266		 SUPPL-13 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070266		 SUPPL-14 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070266		 SUPPL-15 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070267		 SUPPL-14 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070267		 SUPPL-15 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 INDO-LEMMON
ANDA #070267		 SUPPL-16 INDOMETHACIN TEVA Manufacturing (CMC) Approval
04/01/1993 BETAMETHASONE DIPROPIONATE
ANDA #071467		 SUPPL-2 BETAMETHASONE DIPROPIONATE COSETTE Manufacturing (CMC) Approval
04/01/1993 BETAMETHASONE DIPROPIONATE
ANDA #071476		 SUPPL-6 BETAMETHASONE DIPROPIONATE TEVA Manufacturing (CMC) Approval
04/01/1993 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #072038		 SUPPL-7 METOCLOPRAMIDE HYDROCHLORIDE ROXANE Labeling Approval
04/01/1993 FLUOCINONIDE
ANDA #072488		 SUPPL-4 FLUOCINONIDE TEVA Manufacturing (CMC) Approval
04/01/1993 FLUOCINONIDE EMULSIFIED BASE
ANDA #072490		 SUPPL-3 FLUOCINONIDE TEVA Manufacturing (CMC) Approval
04/01/1993 FLUOCINONIDE EMULSIFIED BASE
ANDA #072490		 SUPPL-4 FLUOCINONIDE TEVA Manufacturing (CMC) Approval
04/01/1993 FLUOCINONIDE
ANDA #072511		 SUPPL-1 FLUOCINONIDE TEVA Manufacturing (CMC) Approval
04/01/1993 ALBUTEROL SULFATE
ANDA #072938		 SUPPL-6 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
04/01/1993 ALBUTEROL SULFATE
ANDA #072939		 SUPPL-6 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
04/01/1993 SULINDAC
ANDA #072973		 SUPPL-2 SULINDAC ANI PHARMS Manufacturing (CMC) Approval
04/01/1993 SULINDAC
ANDA #072973		 SUPPL-3 SULINDAC ANI PHARMS Manufacturing (CMC) Approval
04/01/1993 LOPERAMIDE HYDROCHLORIDE
ANDA #073192		 SUPPL-2 LOPERAMIDE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 CLEMASTINE FUMARATE
ANDA #073282		 SUPPL-5 CLEMASTINE FUMARATE ANI PHARMS Manufacturing (CMC) Approval
04/01/1993 CLEMASTINE FUMARATE
ANDA #073283		 SUPPL-3 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
04/01/1993 ALBUTEROL SULFATE
ANDA #073419		 SUPPL-6 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
04/01/1993 TRIACET
ANDA #084908		 SUPPL-45 TRIAMCINOLONE ACETONIDE TEVA Manufacturing (CMC) Approval
04/01/1993 ADIPEX-P
ANDA #085128		 SUPPL-17 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 STATOBEX
ANDA #086013		 SUPPL-11 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
04/01/1993 STATOBEX
ANDA #086013		 SUPPL-14 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
04/01/1993 ADIPEX-P
ANDA #088023		 SUPPL-10 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 PROPOXYPHENE HYDROCHLORIDE
ANDA #088615		 SUPPL-6 PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-13 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629		 SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
04/01/1993 SULFANILAMIDE
ANDA #088718		 SUPPL-10 SULFANILAMIDE COSETTE Manufacturing (CMC) Approval
04/01/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025		 SUPPL-11 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025		 SUPPL-15 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025		 SUPPL-16 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
04/01/1993 CHLORZOXAZONE
ANDA #089859		 SUPPL-6 CHLORZOXAZONE WATSON LABS Manufacturing (CMC) Approval
04/01/1993 CHLORZOXAZONE
ANDA #089859		 SUPPL-9 CHLORZOXAZONE WATSON LABS Manufacturing (CMC) Approval
04/01/1993 EPOGEN/PROCRIT
BLA #103234		 SUPPL-1015 EPOETIN ALFA AMGEN Approval
04/02/1993 FLAGYL I.V. RTU IN PLASTIC CONTAINER
NDA #018657		 SUPPL-16 METRONIDAZOLE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 DAYPRO
NDA #018841		 SUPPL-1 OXAPROZIN PFIZER Labeling Approval
04/02/1993 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-12 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-13 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-12 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-13 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-12 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-13 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
04/02/1993 STADOL
NDA #019890		 SUPPL-1 BUTORPHANOL TARTRATE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/02/1993 KEFZOL
ANDA #061773		 SUPPL-54 CEFAZOLIN SODIUM ACS DOBFAR Manufacturing (CMC) Approval
04/02/1993 ROCEPHIN
ANDA #062654		 SUPPL-9 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Manufacturing (CMC) Approval
04/02/1993 TAZIDIME IN PLASTIC CONTAINER
ANDA #062739		 SUPPL-7 CEFTAZIDIME LILLY Manufacturing (CMC) Approval
04/02/1993 TOBRAMYCIN SULFATE
ANDA #063111		 SUPPL-2 TOBRAMYCIN SULFATE HOSPIRA Manufacturing (CMC) Approval
04/02/1993 TOBRAMYCIN SULFATE
ANDA #063112		 SUPPL-2 TOBRAMYCIN SULFATE HOSPIRA Manufacturing (CMC) Approval
04/02/1993 INDOMETHACIN
ANDA #072410		 SUPPL-7 INDOMETHACIN INWOOD LABS Labeling Approval
04/02/1993 VINBLASTINE SULFATE
ANDA #089395		 SUPPL-4 VINBLASTINE SULFATE HIKMA Labeling Approval
04/05/1993 AZULFIDINE
NDA #007073		 SUPPL-90 SULFASALAZINE PFIZER Labeling Approval
04/05/1993 AZULFIDINE
NDA #007073		 SUPPL-91 SULFASALAZINE PFIZER Labeling Approval
04/05/1993 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-90 SULFASALAZINE PFIZER Labeling Approval
04/05/1993 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-91 SULFASALAZINE PFIZER Labeling Approval
04/05/1993 ZANTAC 150
NDA #018703		 SUPPL-48 RANITIDINE HYDROCHLORIDE GLAXO GRP LTD Labeling Approval
04/05/1993 ZANTAC 300
NDA #018703		 SUPPL-48 RANITIDINE HYDROCHLORIDE GLAXO GRP LTD Labeling Approval
04/05/1993 ESTRADERM
NDA #019081		 SUPPL-22 ESTRADIOL NOVARTIS Labeling Approval
04/05/1993 ZANTAC
NDA #019090		 SUPPL-32 RANITIDINE HYDROCHLORIDE PAI HOLDINGS PHARM Labeling Approval
04/05/1993 ZANTAC IN PLASTIC CONTAINER
NDA #019593		 SUPPL-21 RANITIDINE HYDROCHLORIDE PAI HOLDINGS PHARM Labeling Approval
04/05/1993 ZANTAC
NDA #019675		 SUPPL-14 RANITIDINE HYDROCHLORIDE GLAXO GRP LTD Labeling Approval
04/05/1993 LUTREPULSE KIT
NDA #019687		 SUPPL-12 GONADORELIN ACETATE FERRING Labeling Approval
04/05/1993 MONOPRIL
NDA #019915		 SUPPL-8 FOSINOPRIL SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/05/1993 PROSCAR
NDA #020180		 SUPPL-4 FINASTERIDE ORGANON Manufacturing (CMC) Approval
04/05/1993 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639		 SUPPL-8 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
04/05/1993 BACTOCILL IN PLASTIC CONTAINER
NDA #050640		 SUPPL-2 OXACILLIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/05/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-2 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Manufacturing (CMC) Approval
04/05/1993 ALCAINE
ANDA #080027		 SUPPL-19 PROPARACAINE HYDROCHLORIDE ALCON LABS INC Labeling Approval
04/05/1993 SLO-PHYLLIN
ANDA #085187		 SUPPL-26 THEOPHYLLINE SANOFI AVENTIS US Manufacturing (CMC) Approval
04/05/1993 NITROGLYCERIN
ANDA #087355		 SUPPL-15 NITROGLYCERIN FOUGERA PHARMS INC Labeling Approval
04/05/1993 HYDROCORTISONE
ANDA #088082		 SUPPL-2 HYDROCORTISONE PADDOCK LLC Manufacturing (CMC) Approval
04/05/1993 HYDROCORTISONE
ANDA #088082		 SUPPL-4 HYDROCORTISONE PADDOCK LLC Manufacturing (CMC) Approval
04/05/1993 HYDROCORTISONE
ANDA #088082		 SUPPL-5 HYDROCORTISONE PADDOCK LLC Manufacturing (CMC) Approval
04/05/1993 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA #088763		 SUPPL-22 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Manufacturing (CMC) Approval
04/06/1993 HYDERGINE
NDA #009087		 SUPPL-41 ERGOLOID MESYLATES NOVARTIS Manufacturing (CMC) Approval
04/06/1993 PROGESTERONE
NDA #017362		 SUPPL-85 PROGESTERONE ACTAVIS LABS UT INC Labeling Approval
04/06/1993 FIORINAL W/CODEINE
NDA #019429		 SUPPL-2 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Manufacturing (CMC) Approval
04/06/1993 FIORINAL W/CODEINE
NDA #019429		 SUPPL-3 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Manufacturing (CMC) Approval
04/06/1993 FIORINAL W/CODEINE
NDA #019429		 SUPPL-4 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Manufacturing (CMC) Approval
04/06/1993 ACEPHEN
ANDA #072218		 SUPPL-1 ACETAMINOPHEN COSETTE Labeling Approval
04/06/1993 ACEPHEN
ANDA #072344		 SUPPL-1 ACETAMINOPHEN COSETTE Labeling Approval
04/06/1993 NAPHCON FORTE
ANDA #080229		 SUPPL-16 NAPHAZOLINE HYDROCHLORIDE ALCON Labeling Approval
04/06/1993 ACETIC ACID
ANDA #088638		 SUPPL-15 ACETIC ACID, GLACIAL TARO Labeling Approval
04/07/1993 TICAR
NDA #050497		 SUPPL-47 TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
04/07/1993 BENZAMYCIN
NDA #050557		 SUPPL-14 BENZOYL PEROXIDE; ERYTHROMYCIN VALEANT INTL Manufacturing (CMC) Approval
04/07/1993 CLEOCIN T
NDA #050600		 SUPPL-1 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
04/07/1993 ERYTHROMYCIN ESTOLATE
ANDA #062353		 SUPPL-20 ERYTHROMYCIN ESTOLATE ALPHARMA US PHARMS Labeling Approval
04/07/1993 ERYTHROMYCIN ESTOLATE
ANDA #062409		 SUPPL-19 ERYTHROMYCIN ESTOLATE ALPHARMA US PHARMS Labeling Approval
04/07/1993 AMPHOTERICIN B
ANDA #062728		 SUPPL-10 AMPHOTERICIN B ABRAXIS PHARM Labeling Approval
04/07/1993 FUROSEMIDE
ANDA #070412		 SUPPL-12 FUROSEMIDE WATSON LABS Labeling Approval
04/07/1993 FUROSEMIDE
ANDA #070413		 SUPPL-12 FUROSEMIDE ANI PHARMS Labeling Approval
04/07/1993 DISOPYRAMIDE PHOSPHATE
ANDA #070470		 SUPPL-11 DISOPYRAMIDE PHOSPHATE RISING Labeling Approval
04/07/1993 DISOPYRAMIDE PHOSPHATE
ANDA #070471		 SUPPL-11 DISOPYRAMIDE PHOSPHATE RISING Labeling Approval
04/07/1993 FUROSEMIDE
ANDA #071594		 SUPPL-11 FUROSEMIDE ANI PHARMS Labeling Approval
04/07/1993 ATENOLOL AND CHLORTHALIDONE
ANDA #072302		 SUPPL-4 ATENOLOL; CHLORTHALIDONE TWI PHARMS Labeling Approval
04/07/1993 ATENOLOL
ANDA #073026		 SUPPL-3 ATENOLOL HLTHCARE Labeling Approval
04/07/1993 APRESAZIDE
ANDA #084735		 SUPPL-33 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
04/07/1993 APRESAZIDE
ANDA #084810		 SUPPL-27 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
04/07/1993 APRESAZIDE
ANDA #084811		 SUPPL-27 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
04/08/1993 VANTIN
NDA #050674		 SUPPL-2 CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN Labeling Approval
04/08/1993 VANTIN
NDA #050675		 SUPPL-2 CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN Labeling Approval
04/08/1993 BANAN
NDA #050687		 SUPPL-3 CEFPODOXIME PROXETIL SANKYO Labeling Approval
04/08/1993 BANAN
NDA #050688		 SUPPL-3 CEFPODOXIME PROXETIL SANKYO Labeling Approval
04/08/1993 CHLORAMPHENICOL SODIUM SUCCINATE
ANDA #062365		 SUPPL-9 CHLORAMPHENICOL SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
04/08/1993 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #062847		 SUPPL-9 ERYTHROMYCIN ETHYLSUCCINATE AUROBINDO PHARMA USA Labeling Approval
04/08/1993 FUROSEMIDE
ANDA #070449		 SUPPL-18 FUROSEMIDE WATSON LABS TEVA Labeling Approval
04/08/1993 FUROSEMIDE
ANDA #070450		 SUPPL-17 FUROSEMIDE WATSON LABS Labeling Approval
04/08/1993 FUROSEMIDE
ANDA #070528		 SUPPL-18 FUROSEMIDE WATSON LABS TEVA Labeling Approval
04/08/1993 FUROSEMIDE
ANDA #071379		 SUPPL-13 FUROSEMIDE ANI PHARMS Labeling Approval
04/08/1993 MANNITOL 25%
ANDA #080677		 SUPPL-34 MANNITOL FRESENIUS KABI USA Labeling Approval
04/08/1993 TRIAMCINOLONE ACETONIDE
ANDA #086275		 SUPPL-33 TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/08/1993 TRIAMCINOLONE ACETONIDE
ANDA #086276		 SUPPL-48 TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/08/1993 TRIAMCINOLONE ACETONIDE
ANDA #086277		 SUPPL-45 TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/08/1993 TRIAMCINOLONE ACETONIDE
ANDA #087902		 SUPPL-31 TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/08/1993 TRIAMCINOLONE ACETONIDE
ANDA #089129		 SUPPL-13 TRIAMCINOLONE ACETONIDE COSETTE Labeling Approval
04/09/1993 VANCOMYCIN HYDROCHLORIDE
ANDA #062931		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/09/1993 VANCOMYCIN HYDROCHLORIDE
ANDA #062933		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/09/1993 EMGEL
ANDA #063107		 SUPPL-4 ERYTHROMYCIN ALTANA Manufacturing (CMC) Approval
04/12/1993 CLARITIN
NDA #019658		 ORIG-1 LORATADINE BAYER HEALTHCARE LLC Type 1 - New Molecular Entity Approval
04/12/1993 CLARITIN HIVES RELIEF
NDA #019658		 ORIG-1 LORATADINE BAYER HEALTHCARE LLC Type 1 - New Molecular Entity Approval
04/13/1993 XYLOCAINE
NDA #006488		 SUPPL-53 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/13/1993 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-53 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/13/1993 NESACAINE
NDA #009435		 SUPPL-28 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/13/1993 NESACAINE-MPF
NDA #009435		 SUPPL-28 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/13/1993 BLEPHAMIDE
NDA #012813		 SUPPL-39 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM ALLERGAN Manufacturing (CMC) Approval
04/13/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM
NDA #018242		 SUPPL-36 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Labeling Approval
04/13/1993 FUROSEMIDE
NDA #018487		 SUPPL-22 FUROSEMIDE MYLAN Labeling Approval
04/13/1993 CARDIZEM
NDA #018602		 SUPPL-41 DILTIAZEM HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
04/13/1993 PILOPINE HS
NDA #018796		 SUPPL-7 PILOCARPINE HYDROCHLORIDE ALCON Manufacturing (CMC) Approval
04/13/1993 RENACIDIN
NDA #019481		 SUPPL-2 CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE UNITED GUARDIAN Manufacturing (CMC) Approval
04/13/1993 BETAPACE
NDA #019865		 SUPPL-1 SOTALOL HYDROCHLORIDE LEGACY PHARMA Manufacturing (CMC) Approval
04/13/1993 TICAR
NDA #050497		 SUPPL-43 TICARCILLIN DISODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
04/13/1993 BENZAMYCIN
NDA #050557		 SUPPL-13 BENZOYL PEROXIDE; ERYTHROMYCIN VALEANT INTL Manufacturing (CMC) Approval
04/13/1993 GRIFULVIN V
ANDA #062483		 SUPPL-11 GRISEOFULVIN, MICROSIZE VALEANT LUXEMBOURG Labeling Approval
04/13/1993 FUROSEMIDE
ANDA #070082		 SUPPL-8 FUROSEMIDE MYLAN Labeling Approval
04/13/1993 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #072011		 SUPPL-6 HYDROCHLOROTHIAZIDE; TRIAMTERENE SANDOZ Labeling Approval
04/13/1993 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #073281		 SUPPL-1 HYDROCHLOROTHIAZIDE; TRIAMTERENE SANDOZ Labeling Approval
04/13/1993 DIGOXIN
ANDA #083391		 SUPPL-17 DIGOXIN WEST-WARD PHARMS INT Labeling Approval
04/14/1993 AMBENYL
NDA #009319		 SUPPL-28 BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE FOREST LABS Manufacturing (CMC) Approval
04/14/1993 IV PERSANTINE
NDA #019817		 SUPPL-4 DIPYRIDAMOLE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/14/1993 DOXYCYCLINE HYCLATE
ANDA #062031		 SUPPL-27 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
04/14/1993 STATROL
ANDA #062339		 SUPPL-5 NEOMYCIN SULFATE; POLYMYXIN B SULFATE ALCON Labeling Approval
04/14/1993 DOXYCYCLINE HYCLATE
ANDA #062421		 SUPPL-20 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
04/14/1993 KEFUROX IN PLASTIC CONTAINER
ANDA #062590		 SUPPL-9 CEFUROXIME SODIUM LILLY Manufacturing (CMC) Approval
04/14/1993 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071111		 SUPPL-14 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE BARR Labeling Approval
04/14/1993 OXAZEPAM
ANDA #071756		 SUPPL-3 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/14/1993 OXAZEPAM
ANDA #071813		 SUPPL-3 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/14/1993 OXAZEPAM
ANDA #071814		 SUPPL-2 OXAZEPAM EPIC PHARMA LLC Labeling Approval
04/14/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #072507		 SUPPL-3 HYDROCHLOROTHIAZIDE; METHYLDOPA DAVA PHARMS INC Labeling Approval
04/14/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #072508		 SUPPL-5 HYDROCHLOROTHIAZIDE; METHYLDOPA DAVA PHARMS INC Labeling Approval
04/14/1993 VINBLASTINE SULFATE
ANDA #089565		 SUPPL-9 VINBLASTINE SULFATE HOSPIRA Labeling Approval
04/14/1993 VINBLASTINE SULFATE
ANDA #089565		 SUPPL-10 VINBLASTINE SULFATE HOSPIRA Labeling Approval
04/15/1993 CAFERGOT
NDA #006620		 SUPPL-46 CAFFEINE; ERGOTAMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
04/15/1993 CAFERGOT
NDA #009000		 SUPPL-16 CAFFEINE; ERGOTAMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
04/15/1993 GYNE-LOTRIMIN
NDA #018052		 SUPPL-23 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-27 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-27 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018609		 SUPPL-27 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 HYDERGINE LC
NDA #018706		 SUPPL-18 ERGOLOID MESYLATES NOVARTIS Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018814		 SUPPL-17 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018814		 SUPPL-17 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018814		 SUPPL-17 HEPARIN SODIUM BAXTER HLTHCARE Manufacturing (CMC) Approval
04/15/1993 METHADOSE
ANDA #040050		 ORIG-1 METHADONE HYDROCHLORIDE SPECGX LLC Approval
04/15/1993 AMPICILLIN SODIUM
ANDA #062772		 ORIG-1 AMPICILLIN SODIUM HQ SPECLT PHARMA Approval
04/15/1993 AMPICILLIN SODIUM
ANDA #063142		 ORIG-1 AMPICILLIN SODIUM HQ SPECLT PHARMA Approval
04/15/1993 AMPICILLIN SODIUM
ANDA #063147		 ORIG-1 AMPICILLIN SODIUM HANFORD GC Approval
04/15/1993 LORAZEPAM
ANDA #071193		 SUPPL-6 LORAZEPAM SANDOZ Labeling Approval
04/15/1993 LORAZEPAM
ANDA #071194		 SUPPL-7 LORAZEPAM SANDOZ Labeling Approval
04/15/1993 LORAZEPAM
ANDA #071195		 SUPPL-6 LORAZEPAM SANDOZ Labeling Approval
04/15/1993 TUSSIGON
ANDA #088508		 SUPPL-7 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE KING PHARMS Labeling Approval
04/16/1993 STADOL
NDA #017857		 SUPPL-49 BUTORPHANOL TARTRATE APOTHECON Labeling Approval
04/16/1993 STADOL
NDA #017857		 SUPPL-50 BUTORPHANOL TARTRATE APOTHECON Labeling Approval
04/16/1993 STADOL PRESERVATIVE FREE
NDA #017857		 SUPPL-49 BUTORPHANOL TARTRATE APOTHECON Labeling Approval
04/16/1993 STADOL PRESERVATIVE FREE
NDA #017857		 SUPPL-50 BUTORPHANOL TARTRATE APOTHECON Labeling Approval
04/16/1993 NIMOTOP
NDA #018869		 SUPPL-5 NIMODIPINE BAYER PHARMS Labeling Approval
04/16/1993 RENACIDIN
NDA #019481		 SUPPL-1 CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE UNITED GUARDIAN Manufacturing (CMC) Approval
04/16/1993 STADOL
NDA #019890		 SUPPL-2 BUTORPHANOL TARTRATE BRISTOL MYERS SQUIBB Labeling Approval
04/16/1993 LUPRON DEPOT-PED KIT
NDA #020263		 ORIG-1 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Type 5 - New Formulation or New Manufacturer Approval
04/16/1993 PROLIXIN
ANDA #070533		 SUPPL-10 FLUPHENAZINE HYDROCHLORIDE APOTHECON Manufacturing (CMC) Approval
04/16/1993 POTASSIUM CHLORIDE
ANDA #070980		 SUPPL-14 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
04/16/1993 NIACIN
ANDA #081134		 SUPPL-3 NIACIN WOCKHARDT Labeling Approval
04/16/1993 DHC PLUS
ANDA #088584		 SUPPL-6 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE PHARM RES ASSOC Labeling Approval
04/17/1993 POLYTRIM
NDA #050567		 SUPPL-4 POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE ALLERGAN Manufacturing (CMC) Approval
04/19/1993 SYMMETREL
NDA #016023		 SUPPL-23 AMANTADINE HYDROCHLORIDE ENDO PHARMS Efficacy Approval
04/19/1993 SYMMETREL
NDA #018101		 SUPPL-2 AMANTADINE HYDROCHLORIDE ENDO PHARMS Efficacy Approval
04/19/1993 AMOXIL
ANDA #062216		 SUPPL-14 AMOXICILLIN US ANTIBIOTICS Labeling Approval
04/19/1993 AMOXIL
ANDA #062226		 SUPPL-17 AMOXICILLIN US ANTIBIOTICS Labeling Approval
04/19/1993 LAROTID
ANDA #062226		 SUPPL-17 AMOXICILLIN US ANTIBIOTICS Labeling Approval
04/19/1993 ATENOLOL
ANDA #073475		 SUPPL-1 ATENOLOL SUN PHARM INDUSTRIES Labeling Approval
04/19/1993 ATENOLOL
ANDA #073476		 SUPPL-1 ATENOLOL SUN PHARM INDUSTRIES Labeling Approval
04/19/1993 ISOCAINE HYDROCHLORIDE
ANDA #080925		 SUPPL-22 MEPIVACAINE HYDROCHLORIDE SEPTODONT Labeling Approval
04/19/1993 ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
ANDA #084697		 SUPPL-21 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE SEPTODONT Labeling Approval
04/19/1993 ORTHO-EST
ANDA #089567		 SUPPL-1 ESTROPIPATE SUN PHARM INDS INC Labeling Approval
04/19/1993 ORTHO-EST
ANDA #089582		 SUPPL-1 ESTROPIPATE SUN PHARM INDS INC Labeling Approval
04/20/1993 METHADOSE
NDA #017116		 SUPPL-12 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
04/20/1993 INDOMETHACIN
NDA #018858		 SUPPL-20 INDOMETHACIN RISING Labeling Approval
04/20/1993 VOLTAREN
NDA #019201		 SUPPL-14 DICLOFENAC SODIUM NOVARTIS Manufacturing (CMC) Approval
04/20/1993 AMIKACIN SULFATE
ANDA #063274		 SUPPL-1 AMIKACIN SULFATE HIKMA Manufacturing (CMC) Approval
04/20/1993 AMIKACIN SULFATE
ANDA #063275		 SUPPL-1 AMIKACIN SULFATE HIKMA Manufacturing (CMC) Approval
04/20/1993 INDOMETHACIN
ANDA #070624		 SUPPL-12 INDOMETHACIN RISING Labeling Approval
04/20/1993 TESTOSTERONE CYPIONATE
ANDA #086029		 SUPPL-80 TESTOSTERONE CYPIONATE WATSON LABS Labeling Approval
04/20/1993 TESTOSTERONE CYPIONATE
ANDA #086030		 SUPPL-18 TESTOSTERONE CYPIONATE WATSON PHARMS INC Labeling Approval
04/21/1993 TALWIN
NDA #016194		 SUPPL-59 PENTAZOCINE LACTATE HOSPIRA Manufacturing (CMC) Approval
04/21/1993 GYNE-LOTRIMIN
NDA #018052		 SUPPL-21 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
04/21/1993 RESTORIL
NDA #018163		 SUPPL-34 TEMAZEPAM SPECGX LLC Manufacturing (CMC) Approval
04/21/1993 HALDOL
NDA #018701		 SUPPL-34 HALOPERIDOL DECANOATE JANSSEN PHARMS Labeling Approval
04/21/1993 ADALAT CC
NDA #020198		 ORIG-1 NIFEDIPINE NORWICH Type 5 - New Formulation or New Manufacturer Approval
04/21/1993 METHYLDOPA
ANDA #070060		 SUPPL-20 METHYLDOPA SUN PHARM INDUSTRIES Labeling Approval
04/21/1993 METHYLDOPA
ANDA #070073		 SUPPL-18 METHYLDOPA SUN PHARM INDUSTRIES Labeling Approval
04/21/1993 METHYLDOPA
ANDA #070074		 SUPPL-18 METHYLDOPA SUN PHARM INDUSTRIES Labeling Approval
04/21/1993 DIAZEPAM
ANDA #070302		 SUPPL-8 DIAZEPAM CHARTWELL RX Labeling Approval
04/21/1993 DIAZEPAM
ANDA #070303		 SUPPL-8 DIAZEPAM CHARTWELL RX Labeling Approval
04/21/1993 DIAZEPAM
ANDA #070304		 SUPPL-7 DIAZEPAM CHARTWELL RX Labeling Approval
04/21/1993 IBUPROFEN
ANDA #071163		 SUPPL-25 IBUPROFEN OHM Manufacturing (CMC) Approval
04/21/1993 IBUPROFEN
ANDA #071163		 SUPPL-26 IBUPROFEN OHM Labeling Approval
04/22/1993 TAVIST
NDA #017661		 SUPPL-40 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
04/22/1993 TAVIST-1
NDA #017661		 SUPPL-40 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
04/22/1993 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-54 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/22/1993 CISPLATIN
NDA #018057		 SUPPL-61 CISPLATIN HQ SPCLT PHARMA Efficacy Approval
04/22/1993 PLATINOL
NDA #018057		 SUPPL-61 CISPLATIN HQ SPCLT PHARMA Efficacy Approval
04/22/1993 PLATINOL-AQ
NDA #018057		 SUPPL-61 CISPLATIN HQ SPCLT PHARMA Efficacy Approval
04/22/1993 ZOVIRAX
NDA #018603		 SUPPL-10 ACYCLOVIR SODIUM GLAXOSMITHKLINE Labeling Approval
04/22/1993 ZOVIRAX
NDA #018603		 SUPPL-13 ACYCLOVIR SODIUM GLAXOSMITHKLINE Labeling Approval
04/22/1993 ZOVIRAX
NDA #018828		 SUPPL-5 ACYCLOVIR MYLAN Labeling Approval
04/22/1993 ZOVIRAX
NDA #018828		 SUPPL-12 ACYCLOVIR MYLAN Labeling Approval
04/22/1993 MESNEX
NDA #019884		 SUPPL-3 MESNA BAXTER HLTHCARE Manufacturing (CMC) Approval
04/22/1993 ZOVIRAX
NDA #019909		 SUPPL-4 ACYCLOVIR MYLAN Labeling Approval
04/22/1993 ZOVIRAX
NDA #020089		 SUPPL-1 ACYCLOVIR MYLAN Labeling Approval
04/22/1993 CERUBIDINE
NDA #050484		 SUPPL-5 DAUNORUBICIN HYDROCHLORIDE WYETH AYERST Labeling Approval
04/22/1993 SUPRAX
NDA #050622		 SUPPL-11 CEFIXIME LEDERLE Manufacturing (CMC) Approval
04/22/1993 VANTIN
NDA #050675		 SUPPL-4 CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN Labeling Approval
04/22/1993 ERYTHROMYCIN ESTOLATE
ANDA #062087		 SUPPL-14 ERYTHROMYCIN ESTOLATE WATSON LABS Labeling Approval
04/22/1993 BETAMETHASONE DIPROPIONATE
ANDA #072276		 SUPPL-7 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
04/22/1993 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #087398		 SUPPL-19 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE WATSON LABS Manufacturing (CMC) Approval
04/23/1993 STREPTOMYCIN SULFATE
ANDA #060111		 SUPPL-1 STREPTOMYCIN SULFATE PFIZER Manufacturing (CMC) Approval
04/23/1993 STREPTOMYCIN SULFATE
ANDA #060111		 SUPPL-2 STREPTOMYCIN SULFATE PFIZER Labeling Approval
04/23/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072499		 SUPPL-4 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Labeling Approval
04/23/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072500		 SUPPL-5 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Labeling Approval
04/23/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072501		 SUPPL-4 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Labeling Approval
04/23/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072502		 SUPPL-5 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Labeling Approval
04/26/1993 PROTOPAM CHLORIDE
NDA #014134		 SUPPL-19 PRALIDOXIME CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
04/26/1993 MONISTAT 7
NDA #017450		 SUPPL-38 MICONAZOLE NITRATE MEDTECH PRODUCTS Efficacy Approval
04/26/1993 GYNE-LOTRIMIN
NDA #018052		 SUPPL-24 CLOTRIMAZOLE BAYER HEALTHCARE LLC Efficacy Approval
04/26/1993 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 7.7% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
04/26/1993 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019632		 SUPPL-13 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
04/26/1993 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #019633		 SUPPL-11 STERILE WATER FOR INJECTION B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
04/26/1993 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
04/26/1993 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-13 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1993 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-13 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1993 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-13 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1993 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-13 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1993 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-13 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1993 OMNISCAN
NDA #020123		 SUPPL-1 GADODIAMIDE GE HEALTHCARE Manufacturing (CMC) Approval
04/26/1993 MONISTAT 7 COMBINATION PACK
NDA #020288		 ORIG-1 MICONAZOLE NITRATE MEDTECH PRODUCTS Type 3 - New Dosage Form Approval
04/26/1993 GYNE-LOTRIMIN COMBINATION PACK
NDA #020289		 ORIG-1 CLOTRIMAZOLE BAYER HEALTHCARE LLC Type 3 - New Dosage Form Approval
04/26/1993 KANTREX
ANDA #062726		 SUPPL-3 KANAMYCIN SULFATE APOTHECON Labeling Approval
04/26/1993 CLINDAMYCIN PHOSPHATE
ANDA #062889		 SUPPL-6 CLINDAMYCIN PHOSPHATE HIKMA Labeling Approval
04/26/1993 CLINDAMYCIN PHOSPHATE
ANDA #063068		 SUPPL-4 CLINDAMYCIN PHOSPHATE HIKMA Labeling Approval
04/26/1993 NALOXONE HYDROCHLORIDE
ANDA #070171		 SUPPL-2 NALOXONE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/26/1993 NALOXONE HYDROCHLORIDE
ANDA #070172		 SUPPL-2 NALOXONE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/26/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #073303		 SUPPL-4 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA PHARMS USA Labeling Approval
04/26/1993 TOLBUTAMIDE
ANDA #087093		 SUPPL-33 TOLBUTAMIDE ANI PHARMS Manufacturing (CMC) Approval
04/27/1993 BENOQUIN
NDA #008173		 SUPPL-7 MONOBENZONE VALEANT PHARM INTL Manufacturing (CMC) Approval
04/27/1993 BENOQUIN
NDA #008173		 SUPPL-8 MONOBENZONE VALEANT PHARM INTL Manufacturing (CMC) Approval
04/27/1993 HALDOL
NDA #018701		 SUPPL-36 HALOPERIDOL DECANOATE JANSSEN PHARMS Labeling Approval
04/27/1993 CHIBROXIN
NDA #019757		 SUPPL-2 NORFLOXACIN MERCK Efficacy Approval
04/27/1993 TETRACYCLINE HYDROCHLORIDE
ANDA #061471		 SUPPL-14 TETRACYCLINE HYDROCHLORIDE ANI PHARMS Labeling Approval
04/27/1993 NYSTATIN
ANDA #061966		 SUPPL-11 NYSTATIN COSETTE Labeling Approval
04/27/1993 CEFACLOR
ANDA #062206		 SUPPL-35 CEFACLOR FACTA FARMA Manufacturing (CMC) Approval
04/27/1993 CEFACLOR
ANDA #062206		 SUPPL-36 CEFACLOR FACTA FARMA Manufacturing (CMC) Approval
04/27/1993 NYSTATIN
ANDA #062457		 SUPPL-21 NYSTATIN TARO Labeling Approval
04/27/1993 AMPICILLIN TRIHYDRATE
ANDA #062982		 SUPPL-1 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC Labeling Approval
04/27/1993 E-BASE
ANDA #062999		 SUPPL-5 ERYTHROMYCIN BARR Labeling Approval
04/27/1993 E-BASE
ANDA #063028		 SUPPL-5 ERYTHROMYCIN BARR Labeling Approval
04/27/1993 E-BASE
ANDA #063086		 SUPPL-5 ERYTHROMYCIN BARR Labeling Approval
04/27/1993 TOBRAMYCIN SULFATE
ANDA #063113		 SUPPL-1 TOBRAMYCIN SULFATE HIKMA Labeling Approval
04/27/1993 TOBRAMYCIN SULFATE
ANDA #063117		 SUPPL-1 TOBRAMYCIN SULFATE HIKMA Labeling Approval
04/27/1993 TOBRAMYCIN SULFATE
ANDA #063118		 SUPPL-1 TOBRAMYCIN SULFATE HIKMA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070252		 SUPPL-7 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070253		 SUPPL-7 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070254		 SUPPL-6 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070255		 SUPPL-6 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070256		 SUPPL-6 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 NALOXONE HYDROCHLORIDE
ANDA #070257		 SUPPL-6 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
04/27/1993 PHENDIMETRAZINE TARTRATE
ANDA #085402		 SUPPL-23 PHENDIMETRAZINE TARTRATE SANDOZ Labeling Approval
04/27/1993 PHENDIMETRAZINE TARTRATE
ANDA #085588		 SUPPL-23 PHENDIMETRAZINE TARTRATE VIRTUS Labeling Approval
04/27/1993 PHENDIMETRAZINE TARTRATE
ANDA #085830		 SUPPL-20 PHENDIMETRAZINE TARTRATE SANDOZ Labeling Approval
04/28/1993 PHENERGAN
NDA #010926		 SUPPL-14 PROMETHAZINE HYDROCHLORIDE MYLAN Manufacturing (CMC) Approval
04/28/1993 PHENERGAN
NDA #011689		 SUPPL-13 PROMETHAZINE HYDROCHLORIDE MYLAN Manufacturing (CMC) Approval
04/28/1993 GLUCAGON
NDA #012122		 SUPPL-34 GLUCAGON HYDROCHLORIDE LILLY Labeling Approval
04/28/1993 DEMULEN 1/50-21
NDA #016927		 SUPPL-60 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE GD SEARLE LLC Labeling Approval
04/28/1993 DEMULEN 1/50-28
NDA #016936		 SUPPL-39 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE GD SEARLE LLC Labeling Approval
04/28/1993 NOVAMINE 11.4%
NDA #017957		 SUPPL-33 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/28/1993 NOVAMINE 15%
NDA #017957		 SUPPL-33 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/28/1993 NOVAMINE 8.5%
NDA #017957		 SUPPL-33 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/28/1993 VEINAMINE 8%
NDA #017957		 SUPPL-33 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE HOSPIRA INC Manufacturing (CMC) Approval
04/28/1993 EMCYT
NDA #018045		 SUPPL-6 ESTRAMUSTINE PHOSPHATE SODIUM PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
04/28/1993 DEMULEN 1/35-28
NDA #018160		 SUPPL-28 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE GD SEARLE LLC Labeling Approval
04/28/1993 DEMULEN 1/35-21
NDA #018168		 SUPPL-24 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE GD SEARLE LLC Labeling Approval
04/28/1993 ZOFRAN
NDA #020007		 SUPPL-13 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/28/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-13 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
04/28/1993 CARDIZEM
NDA #020027		 SUPPL-3 DILTIAZEM HYDROCHLORIDE BIOVAIL LABS INTL Labeling Approval
04/28/1993 CARDIZEM CD
NDA #020062		 SUPPL-5 DILTIAZEM HYDROCHLORIDE BAUSCH Labeling Approval
04/28/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #062599		 SUPPL-10 NYSTATIN; TRIAMCINOLONE ACETONIDE FOUGERA PHARMS INC Labeling Approval
04/28/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #062602		 SUPPL-1 NYSTATIN; TRIAMCINOLONE ACETONIDE FOUGERA PHARMS INC Labeling Approval
04/28/1993 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #071536		 ORIG-1 METOCLOPRAMIDE HYDROCHLORIDE SUN PHARM INDUSTRIES Approval
04/28/1993 LEUCOVORIN CALCIUM
ANDA #071962		 SUPPL-10 LEUCOVORIN CALCIUM XANODYNE PHARM Manufacturing (CMC) Approval
04/28/1993 PINDOLOL
ANDA #074125		 ORIG-1 PINDOLOL PUREPAC PHARM Approval
04/28/1993 ISOPTO CETAPRED
ANDA #087547		 SUPPL-11 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM ALCON Labeling Approval
04/28/1993 SULFINPYRAZONE
ANDA #087770		 SUPPL-8 SULFINPYRAZONE IVAX PHARMS Manufacturing (CMC) Approval
04/29/1993 TENORMIN
NDA #018240		 SUPPL-20 ATENOLOL TWI PHARMS Labeling Approval
04/29/1993 LOZOL
NDA #018538		 SUPPL-17 INDAPAMIDE SANOFI AVENTIS US Efficacy Approval
04/29/1993 TENORETIC 100
NDA #018760		 SUPPL-16 ATENOLOL; CHLORTHALIDONE TWI PHARMS Labeling Approval
04/29/1993 TENORETIC 50
NDA #018760		 SUPPL-16 ATENOLOL; CHLORTHALIDONE TWI PHARMS Labeling Approval
04/29/1993 TENORMIN
NDA #019058		 SUPPL-7 ATENOLOL ASTRAZENECA Labeling Approval
04/29/1993 TRIPHASIL-28
NDA #019190		 SUPPL-23 ETHINYL ESTRADIOL; LEVONORGESTREL WYETH PHARMS INC Labeling Approval
04/29/1993 TRIPHASIL-21
NDA #019192		 SUPPL-23 ETHINYL ESTRADIOL; LEVONORGESTREL WYETH PHARMS Labeling Approval
04/29/1993 CARDURA
NDA #019668		 SUPPL-4 DOXAZOSIN MESYLATE VIATRIS Labeling Approval
04/29/1993 ZESTRIL
NDA #019777		 SUPPL-16 LISINOPRIL TWI PHARMS Manufacturing (CMC) Approval
04/29/1993 NULYTELY
NDA #019797		 SUPPL-1 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BRAINTREE Manufacturing (CMC) Approval
04/29/1993 NULYTELY-FLAVORED
NDA #019797		 SUPPL-1 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BRAINTREE Manufacturing (CMC) Approval
04/29/1993 NEOSAR
ANDA #040015		 ORIG-1 CYCLOPHOSPHAMIDE TEVA PARENTERAL Approval
04/29/1993 FORTAZ
NDA #050578		 SUPPL-15 CEFTAZIDIME PAI HOLDINGS PHARM Labeling Approval
04/29/1993 FORTAZ
NDA #050578		 SUPPL-17 CEFTAZIDIME PAI HOLDINGS PHARM Labeling Approval
04/29/1993 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #050671		 ORIG-1 VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE Type 3 - New Dosage Form Approval
04/29/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #062347		 SUPPL-24 NYSTATIN; TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/29/1993 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #062347		 SUPPL-25 NYSTATIN; TRIAMCINOLONE ACETONIDE TARO Labeling Approval
04/29/1993 CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
ANDA #063221		 ORIG-1 CEFTAZIDIME SODIUM BAXTER HLTHCARE Approval
04/29/1993 CEFOTAN
ANDA #063293		 ORIG-1 CEFOTETAN DISODIUM TELIGENT Approval
04/29/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070265		 SUPPL-11 HYDROCHLOROTHIAZIDE; METHYLDOPA RISING Labeling Approval
04/29/1993 FLURAZEPAM HYDROCHLORIDE
ANDA #070345		 SUPPL-6 FLURAZEPAM HYDROCHLORIDE RISING Labeling Approval
04/29/1993 INDOMETHACIN
ANDA #070719		 SUPPL-4 INDOMETHACIN HERITAGE PHARMA Labeling Approval
04/29/1993 INDOMETHACIN
ANDA #070719		 SUPPL-5 INDOMETHACIN HERITAGE PHARMA Manufacturing (CMC) Approval
04/29/1993 ATENOLOL AND CHLORTHALIDONE
ANDA #073582		 ORIG-1 ATENOLOL; CHLORTHALIDONE SUN PHARM INDUSTRIES Approval
04/29/1993 METHADOSE
ANDA #074184		 ORIG-1 METHADONE HYDROCHLORIDE SPECGX LLC Approval
04/29/1993 FLUPHENAZINE HYDROCHLORIDE
ANDA #081310		 ORIG-1 FLUPHENAZINE HYDROCHLORIDE ANI PHARMS Approval
04/29/1993 LIDOCAINE HYDROCHLORIDE
ANDA #081318		 ORIG-1 LIDOCAINE HYDROCHLORIDE COSETTE Approval
04/29/1993 HYDROCORTISONE
ANDA #086155		 SUPPL-36 HYDROCORTISONE TARO Labeling Approval
04/29/1993 HYDROCORTISONE
ANDA #086257		 SUPPL-25 HYDROCORTISONE TARO Labeling Approval
04/29/1993 PHERAZINE W/ CODEINE
ANDA #088739		 SUPPL-1 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE HALSEY Labeling Approval
04/29/1993 HYDROCORTISONE
ANDA #088799		 SUPPL-25 HYDROCORTISONE TARO Labeling Approval
04/30/1993 FLOROPRYL
NDA #010656		 SUPPL-21 ISOFLUROPHATE MERCK Manufacturing (CMC) Approval
04/30/1993 PROVERA
NDA #011839		 SUPPL-62 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
04/30/1993 KLONOPIN
NDA #017533		 SUPPL-17 CLONAZEPAM CHEPLAPHARM Labeling Approval
04/30/1993 KLONOPIN
NDA #017533		 SUPPL-19 CLONAZEPAM CHEPLAPHARM Labeling Approval
04/30/1993 METHYLDOPA
ANDA #070070		 SUPPL-20 METHYLDOPA ACCORD HLTHCARE Labeling Approval
04/30/1993 METHYLDOPA
ANDA #070084		 SUPPL-22 METHYLDOPA ACCORD HLTHCARE Labeling Approval
04/30/1993 METHYLDOPA
ANDA #070085		 SUPPL-21 METHYLDOPA ACCORD HLTHCARE Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070182		 SUPPL-17 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070183		 SUPPL-16 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070543		 SUPPL-13 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070544		 SUPPL-14 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
04/30/1993 PROMPT PHENYTOIN SODIUM
ANDA #080259		 SUPPL-41 PHENYTOIN SODIUM ANI PHARMS Manufacturing (CMC) Approval
04/30/1993 LIDOCAINE HYDROCHLORIDE
ANDA #083173		 SUPPL-28 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
04/30/1993 VINBLASTINE SULFATE
ANDA #089395		 SUPPL-5 VINBLASTINE SULFATE HIKMA Labeling Approval
04/30/1993 AZDONE
ANDA #089420		 SUPPL-16 ASPIRIN; HYDROCODONE BITARTRATE SCHWARZ PHARMA Manufacturing (CMC) Approval
04/30/1993 AZDONE
ANDA #089420		 SUPPL-17 ASPIRIN; HYDROCODONE BITARTRATE SCHWARZ PHARMA Labeling Approval
04/30/1993 AZDONE
ANDA #089420		 SUPPL-18 ASPIRIN; HYDROCODONE BITARTRATE SCHWARZ PHARMA Manufacturing (CMC) Approval
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