Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

All Approvals
April 1993

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on December 12, 2018.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/1993 PARLODEL
NDA #017962
SUPPL-39 BROMOCRIPTINE MESYLATE US PHARMS HOLDINGS I Manufacturing (CMC) Approval
04/01/1993 PARLODEL
NDA #017962
SUPPL-40 BROMOCRIPTINE MESYLATE US PHARMS HOLDINGS I 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 DAVA PHARMS INC Labeling Approval
04/01/1993 BETA-VAL
NDA #018642
SUPPL-10 BETAMETHASONE VALERATE G AND W LABS INC Manufacturing (CMC) Approval
04/01/1993 VIRAZOLE
NDA #018859
SUPPL-22 RIBAVIRIN VALEANT PHARM INTL 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 G AND W LABS INC Manufacturing (CMC) Approval
04/01/1993 AMPICILLIN TRIHYDRATE
ANDA #062882
SUPPL-4 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC Labeling Approval
04/01/1993 AMPICILLIN TRIHYDRATE
ANDA #062883
SUPPL-3 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC 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 G AND W LABS INC 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 G AND W LABS INC 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 #072972
SUPPL-2 SULINDAC ANI PHARMS INC Manufacturing (CMC) Approval
04/01/1993 SULINDAC
ANDA #072972
SUPPL-3 SULINDAC ANI PHARMS INC Manufacturing (CMC) Approval
04/01/1993 SULINDAC
ANDA #072973
SUPPL-2 SULINDAC ANI PHARMS INC Manufacturing (CMC) Approval
04/01/1993 SULINDAC
ANDA #072973
SUPPL-3 SULINDAC ANI PHARMS INC 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 INC 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 #088627
SUPPL-13 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088627
SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088627
SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628
SUPPL-21 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628
SUPPL-24 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628
SUPPL-25 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629
SUPPL-13 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629
SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629
SUPPL-17 ACETAMINOPHEN; CODEINE PHOSPHATE TEVA Manufacturing (CMC) Approval
04/01/1993 SULFANILAMIDE
ANDA #088718
SUPPL-10 SULFANILAMIDE G AND W LABS INC 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 GD SEARLE 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 WEST-WARD PHARMS INT Labeling Approval
04/05/1993 AZULFIDINE
NDA #007073
SUPPL-90 SULFASALAZINE PHARMACIA AND UPJOHN Labeling Approval
04/05/1993 AZULFIDINE
NDA #007073
SUPPL-91 SULFASALAZINE PHARMACIA AND UPJOHN Labeling Approval
04/05/1993 AZULFIDINE EN-TABS
NDA #007073
SUPPL-90 SULFASALAZINE PHARMACIA AND UPJOHN Labeling Approval
04/05/1993 AZULFIDINE EN-TABS
NDA #007073
SUPPL-91 SULFASALAZINE PHARMACIA AND UPJOHN 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 TELIGENT Labeling Approval
04/05/1993 ZANTAC IN PLASTIC CONTAINER
NDA #019593
SUPPL-21 RANITIDINE HYDROCHLORIDE TELIGENT 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 MERCK Manufacturing (CMC) Approval
04/05/1993 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050639
SUPPL-8 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN 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 SALES LLC Manufacturing (CMC) Approval
04/06/1993 FIORINAL W/CODEINE
NDA #019429
SUPPL-3 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN SALES LLC Manufacturing (CMC) Approval
04/06/1993 FIORINAL W/CODEINE
NDA #019429
SUPPL-4 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN SALES LLC Manufacturing (CMC) Approval
04/06/1993 ACEPHEN
ANDA #072218
SUPPL-1 ACETAMINOPHEN G AND W LABS Labeling Approval
04/06/1993 ACEPHEN
ANDA #072344
SUPPL-1 ACETAMINOPHEN G AND W LABS 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 PHARMACIA AND UPJOHN 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 WATSON LABS Labeling Approval
04/07/1993 DISOPYRAMIDE PHOSPHATE
ANDA #070470
SUPPL-11 DISOPYRAMIDE PHOSPHATE AUROLIFE PHARMA LLC Labeling Approval
04/07/1993 DISOPYRAMIDE PHOSPHATE
ANDA #070471
SUPPL-11 DISOPYRAMIDE PHOSPHATE AUROLIFE PHARMA LLC Labeling Approval
04/07/1993 FUROSEMIDE
ANDA #071594
SUPPL-11 FUROSEMIDE WATSON LABS Labeling Approval
04/07/1993 ATENOLOL AND CHLORTHALIDONE
ANDA #072302
SUPPL-4 ATENOLOL; CHLORTHALIDONE ALVOGEN MALTA Labeling Approval
04/07/1993 ATENOLOL
ANDA #073025
SUPPL-3 ATENOLOL SANDOZ Labeling Approval
04/07/1993 ATENOLOL
ANDA #073026
SUPPL-3 ATENOLOL SANDOZ Labeling Approval
04/07/1993 ATENOLOL
ANDA #074052
SUPPL-3 ATENOLOL SANDOZ 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 MYLAN 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 WATSON LABS 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 G AND W LABS INC 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 VALEANT INTL 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 COVIS PHARMA BV 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 SANDOZ Labeling Approval
04/14/1993 OXAZEPAM
ANDA #071813
SUPPL-3 OXAZEPAM SANDOZ Labeling Approval
04/14/1993 OXAZEPAM
ANDA #071814
SUPPL-2 OXAZEPAM SANDOZ 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 HANFORD GC Approval
04/15/1993 AMPICILLIN SODIUM
ANDA #063142
ORIG-1 AMPICILLIN SODIUM HANFORD GC 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
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
04/17/1993 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 DR REDDYS LABS INC Labeling Approval
04/19/1993 AMOXIL
ANDA #062226
SUPPL-17 AMOXICILLIN DR REDDYS LABS INC Labeling Approval
04/19/1993 LAROTID
ANDA #062226
SUPPL-17 AMOXICILLIN DR REDDYS LABS INC 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 INC Labeling Approval
04/19/1993 ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
ANDA #084697
SUPPL-21 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE SEPTODONT INC 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 MYLAN 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 WEST-WARD PHARMS INT Manufacturing (CMC) Approval
04/20/1993 AMIKACIN SULFATE
ANDA #063275
SUPPL-1 AMIKACIN SULFATE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
04/20/1993 INDOMETHACIN
ANDA #070624
SUPPL-12 INDOMETHACIN MYLAN 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 ALVOGEN 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 UPSHER SMITH LABS Labeling Approval
04/21/1993 DIAZEPAM
ANDA #070303
SUPPL-8 DIAZEPAM UPSHER SMITH LABS Labeling Approval
04/21/1993 DIAZEPAM
ANDA #070304
SUPPL-7 DIAZEPAM UPSHER SMITH LABS 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 PHARMS INC Labeling Approval
04/22/1993 ZOVIRAX
NDA #018828
SUPPL-12 ACYCLOVIR MYLAN PHARMS INC 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 PHARMS INC Labeling Approval
04/22/1993 ZOVIRAX
NDA #020089
SUPPL-1 ACYCLOVIR MYLAN PHARMS INC 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
04/22/1993 THEOPHYLLINE
ANDA #087571
SUPPL-12 THEOPHYLLINE RHODES PHARMS Labeling 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 WEST-WARD PHARMS INT Labeling Approval
04/26/1993 CLINDAMYCIN PHOSPHATE
ANDA #063068
SUPPL-4 CLINDAMYCIN PHOSPHATE WEST-WARD PHARMS INT 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 IVAX 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 INC Labeling Approval
04/27/1993 NYSTATIN
ANDA #061966
SUPPL-11 NYSTATIN G AND W LABS INC 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 WEST-WARD PHARMS INT Labeling Approval
04/27/1993 TOBRAMYCIN SULFATE
ANDA #063117
SUPPL-1 TOBRAMYCIN SULFATE WEST-WARD PHARMS INT Labeling Approval
04/27/1993 TOBRAMYCIN SULFATE
ANDA #063118
SUPPL-1 TOBRAMYCIN SULFATE WEST-WARD PHARMS INT 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 PHARMS 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 PHARMS INC Manufacturing (CMC) Approval
04/28/1993 PHENERGAN
NDA #011689
SUPPL-13 PROMETHAZINE HYDROCHLORIDE MYLAN PHARMS INC 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 NOVARTIS PHARMS CORP Labeling Approval
04/28/1993 ZOFRAN PRESERVATIVE FREE
NDA #020007
SUPPL-13 ONDANSETRON HYDROCHLORIDE NOVARTIS PHARMS CORP 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 VALEANT INTL 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 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 ALVOGEN MALTA 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 ALVOGEN MALTA Labeling Approval
04/29/1993 TENORETIC 50
NDA #018760
SUPPL-16 ATENOLOL; CHLORTHALIDONE ALVOGEN MALTA 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 PFIZER Labeling Approval
04/29/1993 ZESTRIL
NDA #019777
SUPPL-16 LISINOPRIL ALVOGEN MALTA 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 TELIGENT Labeling Approval
04/29/1993 FORTAZ
NDA #050578
SUPPL-17 CEFTAZIDIME TELIGENT Labeling Approval
04/29/1993 VANCOCIN 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 PHARMA INC Approval
04/29/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070265
SUPPL-11 HYDROCHLOROTHIAZIDE; METHYLDOPA MYLAN Labeling Approval
04/29/1993 FLURAZEPAM HYDROCHLORIDE
ANDA #070345
SUPPL-6 FLURAZEPAM HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
04/29/1993 INDOMETHACIN
ANDA #070719
SUPPL-4 INDOMETHACIN IVAX SUB TEVA PHARMS Labeling Approval
04/29/1993 INDOMETHACIN
ANDA #070719
SUPPL-5 INDOMETHACIN IVAX SUB TEVA PHARMS 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 INC Approval
04/29/1993 LIDOCAINE HYDROCHLORIDE
ANDA #081318
ORIG-1 LIDOCAINE HYDROCHLORIDE G AND W LABS INC Approval
04/29/1993 HYDROCORTISONE
ANDA #086155
SUPPL-36 HYDROCORTISONE TARO PHARM INDS LTD Labeling Approval
04/29/1993 HYDROCORTISONE
ANDA #086257
SUPPL-25 HYDROCORTISONE TARO Labeling Approval
04/29/1993 HYDROCORTISONE
ANDA #088799
SUPPL-25 HYDROCORTISONE TARO PHARM INDS LTD 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 PHARMACIA AND UPJOHN Labeling Approval
04/30/1993 KLONOPIN
NDA #017533
SUPPL-17 CLONAZEPAM ROCHE Labeling Approval
04/30/1993 KLONOPIN
NDA #017533
SUPPL-19 CLONAZEPAM ROCHE 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 YAOPHARMA CO LTD Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070183
SUPPL-16 HYDROCHLOROTHIAZIDE; METHYLDOPA YAOPHARMA CO LTD Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070543
SUPPL-13 HYDROCHLOROTHIAZIDE; METHYLDOPA YAOPHARMA CO LTD Labeling Approval
04/30/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070544
SUPPL-14 HYDROCHLOROTHIAZIDE; METHYLDOPA YAOPHARMA CO LTD Labeling Approval
04/30/1993 PROMPT PHENYTOIN SODIUM
ANDA #080259
SUPPL-41 PHENYTOIN SODIUM ANI PHARMS INC 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 WEST-WARD PHARMS INT 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
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English