04/01/1993 |
PARLODEL NDA #017962 |
SUPPL-39 |
BROMOCRIPTINE MESYLATE |
ESJAY PHARMA |
Manufacturing (CMC) |
Approval |
04/01/1993 |
PARLODEL NDA #017962 |
SUPPL-40 |
BROMOCRIPTINE MESYLATE |
ESJAY 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 |
ESJAY 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 |
GENUS |
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 |
CHARTWELL RX |
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 |
HIKMA |
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 |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
04/22/1993 |
ZOVIRAX NDA #018828 |
SUPPL-12 |
ACYCLOVIR |
NORVIUM BIOSCIENCE |
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 |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
04/22/1993 |
ZOVIRAX NDA #020089 |
SUPPL-1 |
ACYCLOVIR |
NORVIUM BIOSCIENCE |
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 |
ENDO OPERATIONS |
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 |
NORVIUM BIOSCIENCE |
Manufacturing (CMC) |
Approval |
04/28/1993 |
PHENERGAN NDA #011689 |
SUPPL-13 |
PROMETHAZINE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
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 |