Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 1993

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

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

This report was produced on October 20, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/03/1993 FUNGIZONE
ANDA #060570
SUPPL-7 AMPHOTERICIN B APOTHECON Manufacturing (CMC) Approval
05/03/1993 IBU
ANDA #070083
SUPPL-16 IBUPROFEN BASF Labeling Approval
05/03/1993 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089340
SUPPL-9 METHOTREXATE SODIUM WEST-WARD PHARMS INT Manufacturing (CMC) Approval
05/03/1993 METHOTREXATE SODIUM
ANDA #089341
SUPPL-9 METHOTREXATE SODIUM WEST-WARD PHARMS INT Manufacturing (CMC) Approval
05/03/1993 METHOTREXATE SODIUM
ANDA #089342
SUPPL-9 METHOTREXATE SODIUM WEST-WARD PHARMS INT Manufacturing (CMC) Approval
05/03/1993 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #089343
SUPPL-9 METHOTREXATE SODIUM WEST-WARD PHARMS INT Manufacturing (CMC) Approval
05/04/1993 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070795
SUPPL-10 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TEVA Manufacturing (CMC) Approval
05/04/1993 ALBUTEROL SULFATE
ANDA #072652
SUPPL-4 ALBUTEROL SULFATE MYLAN SPECLT Manufacturing (CMC) Approval
05/04/1993 PEDIATRIC LTA KIT
ANDA #085995
SUPPL-16 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
05/05/1993 TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019520
SUPPL-5 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/05/1993 ELIMITE
NDA #019855
SUPPL-1 PERMETHRIN MYLAN Efficacy Approval
05/05/1993 DIAZEPAM
ANDA #070662
SUPPL-7 DIAZEPAM ABRAXIS PHARM Labeling Approval
05/05/1993 METHYLDOPA
ANDA #072126
SUPPL-5 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072126
SUPPL-6 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072126
SUPPL-7 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072126
SUPPL-8 METHYLDOPA PLIVA Labeling Approval
05/05/1993 METHYLDOPA
ANDA #072127
SUPPL-5 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072127
SUPPL-6 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072127
SUPPL-7 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072127
SUPPL-8 METHYLDOPA PLIVA Labeling Approval
05/05/1993 METHYLDOPA
ANDA #072128
SUPPL-5 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072128
SUPPL-6 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072128
SUPPL-7 METHYLDOPA PLIVA Manufacturing (CMC) Approval
05/05/1993 METHYLDOPA
ANDA #072128
SUPPL-8 METHYLDOPA PLIVA Labeling Approval
05/05/1993 TRAZODONE HYDROCHLORIDE
ANDA #072192
SUPPL-8 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Manufacturing (CMC) Approval
05/05/1993 TRAZODONE HYDROCHLORIDE
ANDA #072193
SUPPL-7 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Manufacturing (CMC) Approval
05/05/1993 ATENOLOL
ANDA #073352
SUPPL-4 ATENOLOL WATSON LABS Labeling Approval
05/05/1993 ATENOLOL
ANDA #073353
SUPPL-6 ATENOLOL WATSON LABS TEVA Labeling Approval
05/06/1993 CHG SCRUB
NDA #019258
SUPPL-7 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
05/06/1993 CIDA-STAT
NDA #019258
SUPPL-7 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
05/06/1993 AREDIA
NDA #020036
SUPPL-1 PAMIDRONATE DISODIUM NOVARTIS Manufacturing (CMC) Approval
05/06/1993 AREDIA
NDA #020036
SUPPL-2 PAMIDRONATE DISODIUM NOVARTIS Manufacturing (CMC) Approval
05/06/1993 PEDIAZOLE
NDA #050529
SUPPL-30 ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL ROSS LABS Manufacturing (CMC) Approval
05/06/1993 ERYMAX
ANDA #062508
SUPPL-5 ERYTHROMYCIN MERZ PHARMS Labeling Approval
05/06/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070958
SUPPL-8 HYDROCHLOROTHIAZIDE; METHYLDOPA WATSON LABS Labeling Approval
05/06/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070959
SUPPL-8 HYDROCHLOROTHIAZIDE; METHYLDOPA WATSON LABS Labeling Approval
05/06/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070960
SUPPL-8 HYDROCHLOROTHIAZIDE; METHYLDOPA WATSON LABS Labeling Approval
05/06/1993 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #071069
SUPPL-8 HYDROCHLOROTHIAZIDE; METHYLDOPA WATSON LABS Labeling Approval
05/06/1993 FENOPROFEN CALCIUM
ANDA #072902
SUPPL-2 FENOPROFEN CALCIUM SUN PHARM INDUSTRIES Labeling Approval
05/06/1993 OCUSULF-10
ANDA #080660
SUPPL-44 SULFACETAMIDE SODIUM MIZA PHARMS USA Labeling Approval
05/06/1993 OCUSULF-30
ANDA #080660
SUPPL-44 SULFACETAMIDE SODIUM MIZA PHARMS USA Labeling Approval
05/06/1993 PROCAINAMIDE HYDROCHLORIDE
ANDA #089026
SUPPL-3 PROCAINAMIDE HYDROCHLORIDE WATSON LABS Manufacturing (CMC) Approval
05/06/1993 PROCAINAMIDE HYDROCHLORIDE
ANDA #089026
SUPPL-4 PROCAINAMIDE HYDROCHLORIDE WATSON LABS Manufacturing (CMC) Approval
05/06/1993 PROCAINAMIDE HYDROCHLORIDE
ANDA #089026
SUPPL-5 PROCAINAMIDE HYDROCHLORIDE WATSON LABS Manufacturing (CMC) Approval
05/07/1993 FUNGIZONE
NDA #050314
SUPPL-6 AMPHOTERICIN B APOTHECON Manufacturing (CMC) Approval
05/07/1993 CLEMASTINE FUMARATE
ANDA #073282
SUPPL-4 CLEMASTINE FUMARATE ANI PHARMS INC Manufacturing (CMC) Approval
05/07/1993 CLEMASTINE FUMARATE
ANDA #073283
SUPPL-2 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
05/07/1993 HYDROCHLOROTHIAZIDE
ANDA #085054
SUPPL-16 HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
05/07/1993 SPIRONOLACTONE
ANDA #089424
SUPPL-7 SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
05/10/1993 AVENTYL HYDROCHLORIDE
NDA #014684
SUPPL-28 NORTRIPTYLINE HYDROCHLORIDE LILLY Labeling Approval
05/10/1993 AVENTYL HYDROCHLORIDE
NDA #014684
SUPPL-29 NORTRIPTYLINE HYDROCHLORIDE LILLY Labeling Approval
05/10/1993 AVENTYL HYDROCHLORIDE
NDA #014684
SUPPL-31 NORTRIPTYLINE HYDROCHLORIDE LILLY Labeling Approval
05/10/1993 AVENTYL
NDA #014685
SUPPL-16 NORTRIPTYLINE HYDROCHLORIDE RANBAXY Labeling Approval
05/10/1993 AVENTYL
NDA #014685
SUPPL-17 NORTRIPTYLINE HYDROCHLORIDE RANBAXY Labeling Approval
05/10/1993 AVENTYL
NDA #014685
SUPPL-18 NORTRIPTYLINE HYDROCHLORIDE RANBAXY Labeling Approval
05/10/1993 LIDOPEN
NDA #017549
SUPPL-13 LIDOCAINE HYDROCHLORIDE MERIDIAN MEDCL TECHN Manufacturing (CMC) Approval
05/10/1993 DEPO-TESTADIOL
NDA #017968
SUPPL-5 ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE PHARMACIA AND UPJOHN Labeling Approval
05/10/1993 METRONIDAZOLE
NDA #018740
SUPPL-28 METRONIDAZOLE FOSUN PHARMA Labeling Approval
05/10/1993 HUMULIN R
BLA #018780
SUPPL-40 INSULIN HUMAN LILLY Approval
05/10/1993 HUMULIN R
BLA #018780
SUPPL-40 INSULIN RECOMBINANT HUMAN LILLY Approval
05/10/1993 HUMULIN R KWIKPEN
BLA #018780
SUPPL-40 INSULIN HUMAN LILLY Approval
05/10/1993 HUMULIN R PEN
BLA #018780
SUPPL-40 INSULIN RECOMBINANT HUMAN LILLY Approval
05/10/1993 CHG SCRUB
NDA #019258
SUPPL-6 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
05/10/1993 CIDA-STAT
NDA #019258
SUPPL-6 CHLORHEXIDINE GLUCONATE ECOLAB Manufacturing (CMC) Approval
05/10/1993 CYTOTEC
NDA #019268
SUPPL-17 MISOPROSTOL PFIZER Manufacturing (CMC) Approval
05/10/1993 DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
NDA #020000
SUPPL-1 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/10/1993 RINGER'S IN PLASTIC CONTAINER
NDA #020002
SUPPL-1 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
05/10/1993 PENTASA
NDA #020049
ORIG-1 MESALAMINE TAKEDA PHARMS USA Type 3 - New Dosage Form Approval
05/10/1993 FLOXIN
NDA #020087
SUPPL-2 OFLOXACIN ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/10/1993 FLOXIN IN DEXTROSE 5%
NDA #020087
SUPPL-2 OFLOXACIN ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/10/1993 FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020087
SUPPL-2 OFLOXACIN ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/11/1993 GLUCOTROL
NDA #017783
SUPPL-11 GLIPIZIDE PFIZER Manufacturing (CMC) Approval
05/11/1993 CARNITOR
NDA #018948
SUPPL-11 LEVOCARNITINE LEADIANT BIOSCI INC Manufacturing (CMC) Approval
05/11/1993 TENEX
NDA #019032
SUPPL-10 GUANFACINE HYDROCHLORIDE PROMIUS PHARMA Efficacy Approval
05/11/1993 FLUPHENAZINE HYDROCHLORIDE
ANDA #089804
SUPPL-2 FLUPHENAZINE HYDROCHLORIDE MYLAN Manufacturing (CMC) Approval
05/12/1993 CLINORIL
NDA #017911
SUPPL-15 SULINDAC MERCK Manufacturing (CMC) Approval
05/12/1993 MYCELEX
NDA #018181
SUPPL-7 CLOTRIMAZOLE BAYER HLTHCARE Manufacturing (CMC) Approval
05/12/1993 MYCELEX
NDA #018183
SUPPL-12 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
05/12/1993 CAPOTEN
NDA #018343
SUPPL-62 CAPTOPRIL PAR PHARM Manufacturing (CMC) Approval
05/12/1993 CAPOZIDE 25/15
NDA #018709
SUPPL-24 CAPTOPRIL; HYDROCHLOROTHIAZIDE APOTHECON Manufacturing (CMC) Approval
05/12/1993 CAPOZIDE 25/25
NDA #018709
SUPPL-24 CAPTOPRIL; HYDROCHLOROTHIAZIDE APOTHECON Manufacturing (CMC) Approval
05/12/1993 CAPOZIDE 50/15
NDA #018709
SUPPL-24 CAPTOPRIL; HYDROCHLOROTHIAZIDE APOTHECON Manufacturing (CMC) Approval
05/12/1993 CAPOZIDE 50/25
NDA #018709
SUPPL-24 CAPTOPRIL; HYDROCHLOROTHIAZIDE APOTHECON Manufacturing (CMC) Approval
05/12/1993 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931
SUPPL-16 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/12/1993 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931
SUPPL-16 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/12/1993 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931
SUPPL-16 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/12/1993 DDAVP
NDA #018938
SUPPL-8 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
05/12/1993 AMOXICILLIN
ANDA #064013
SUPPL-5 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/12/1993 TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #071851
SUPPL-9 HYDROCHLOROTHIAZIDE; TRIAMTERENE WATSON LABS Bioequivalence Approval
05/12/1993 DHC PLUS
ANDA #088584
SUPPL-7 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE PHARM RES ASSOC Labeling Approval
05/13/1993 IMODIUM A-D
NDA #019487
SUPPL-8 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
05/13/1993 AXID
NDA #019508
SUPPL-18 NIZATIDINE SMITHKLINE BEECHAM Labeling Approval
05/13/1993 AXID
NDA #019508
SUPPL-19 NIZATIDINE SMITHKLINE BEECHAM Manufacturing (CMC) Approval
05/13/1993 AMOXICILLIN
ANDA #064013
SUPPL-4 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/13/1993 MINOXIDIL
ANDA #071344
SUPPL-10 MINOXIDIL WATSON LABS Labeling Approval
05/13/1993 MINOXIDIL
ANDA #071345
SUPPL-11 MINOXIDIL WATSON LABS Labeling Approval
05/13/1993 VERAPAMIL HYDROCHLORIDE
ANDA #073568
SUPPL-9 VERAPAMIL HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
05/13/1993 ROXICET
ANDA #087003
SUPPL-15 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE HIKMA Labeling Approval
05/14/1993 ERYTHROMYCIN STEARATE
ANDA #061461
SUPPL-22 ERYTHROMYCIN STEARATE ANI PHARMS INC Labeling Approval
05/14/1993 DIAZEPAM
ANDA #070325
SUPPL-7 DIAZEPAM MYLAN Labeling Approval
05/14/1993 TIMOLOL MALEATE
ANDA #072668
SUPPL-3 TIMOLOL MALEATE MYLAN Labeling Approval
05/14/1993 CYCRIN
ANDA #081239
SUPPL-1 MEDROXYPROGESTERONE ACETATE ESI Manufacturing (CMC) Approval
05/14/1993 INTRON A
BLA #103132
SUPPL-1040 INTERFERON ALFA-2B SCHERING Approval
05/17/1993 PHOSPHOLINE IODIDE
NDA #011963
SUPPL-29 ECHOTHIOPHATE IODIDE WYETH PHARMS Manufacturing (CMC) Approval
05/17/1993 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #017584
SUPPL-27 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
05/17/1993 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #017702
SUPPL-12 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
05/17/1993 CISPLATIN
NDA #018057
SUPPL-62 CISPLATIN HQ SPCLT PHARMA Labeling Approval
05/17/1993 PLATINOL
NDA #018057
SUPPL-62 CISPLATIN HQ SPCLT PHARMA Labeling Approval
05/17/1993 PLATINOL-AQ
NDA #018057
SUPPL-62 CISPLATIN HQ SPCLT PHARMA Labeling Approval
05/17/1993 SULFAMETHOXAZOLE AND TRIMETHOPRIM
NDA #018812
SUPPL-45 SULFAMETHOXAZOLE; TRIMETHOPRIM TEVA Manufacturing (CMC) Approval
05/17/1993 SANDIMMUNE
NDA #050625
SUPPL-14 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
05/17/1993 CLORAZEPATE DIPOTASSIUM
ANDA #071858
SUPPL-8 CLORAZEPATE DIPOTASSIUM MYLAN Labeling Approval
05/17/1993 ZOVIA 1/35E-21
ANDA #072720
SUPPL-1 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE WATSON PHARMS TEVA Labeling Approval
05/17/1993 ZOVIA 1/50E-21
ANDA #072722
SUPPL-1 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE WATSON LABS Labeling Approval
05/17/1993 PINDOLOL
ANDA #074125
SUPPL-1 PINDOLOL PUREPAC PHARM Labeling Approval
05/17/1993 HYDROCORTISONE
ANDA #087796
SUPPL-6 HYDROCORTISONE ACTAVIS MID ATLANTIC Labeling Approval
05/17/1993 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #089067
SUPPL-16 ACETAMINOPHEN; BUTALBITAL; CAFFEINE GRAHAM DM Labeling Approval
05/17/1993 SULFACETAMIDE SODIUM
ANDA #089068
SUPPL-5 SULFACETAMIDE SODIUM ALCON PHARMS LTD Manufacturing (CMC) Approval
05/17/1993 SULFACETAMIDE SODIUM
ANDA #089560
SUPPL-6 SULFACETAMIDE SODIUM SANDOZ INC Manufacturing (CMC) Approval
05/18/1993 FURADANTIN
NDA #008693
SUPPL-20 NITROFURANTOIN PROCTER AND GAMBLE Efficacy Approval
05/18/1993 FURADANTIN
NDA #009175
SUPPL-15 NITROFURANTOIN CASPER PHARMA LLC Efficacy Approval
05/18/1993 ORTHO-NOVUM 1/50 21
NDA #012728
SUPPL-178 MESTRANOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 10-21
NDA #012728
SUPPL-178 MESTRANOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 2-21
NDA #012728
SUPPL-178 MESTRANOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 MACRODANTIN
NDA #016620
SUPPL-36 NITROFURANTOIN, MACROCRYSTALLINE ALVOGEN Labeling Approval
05/18/1993 ORTHO-NOVUM 1/50 28
NDA #016709
SUPPL-113 MESTRANOL; NORETHINDRONE ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
05/18/1993 MICRONOR
NDA #016954
SUPPL-77 NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/18/1993 MODICON 21
NDA #017488
SUPPL-91 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 1/35-21
NDA #017489
SUPPL-74 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 MODICON 28
NDA #017735
SUPPL-73 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 1/35-28
NDA #017919
SUPPL-55 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 10/11-21
NDA #018354
SUPPL-24 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 10/11-28
NDA #018354
SUPPL-24 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 7/7/7-21
NDA #018985
SUPPL-19 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 7/7/7-28
NDA #018985
SUPPL-19 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 7/14-21
NDA #019004
SUPPL-15 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 ORTHO-NOVUM 7/14-28
NDA #019004
SUPPL-15 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/18/1993 TILADE
NDA #019660
SUPPL-1 NEDOCROMIL SODIUM KING PHARMS LLC Efficacy Approval
05/18/1993 PCE
NDA #050611
SUPPL-12 ERYTHROMYCIN ARBOR PHARMS LLC Labeling Approval
05/18/1993 IBUPROFEN
ANDA #070493
SUPPL-20 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 IBUPROFEN
ANDA #070493
SUPPL-24 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 IBUPROFEN
ANDA #070908
SUPPL-22 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 IBUPROFEN
ANDA #070908
SUPPL-23 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 IBUPROFEN
ANDA #071462
SUPPL-19 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 IBUPROFEN
ANDA #071462
SUPPL-20 IBUPROFEN SUN PHARM INDUSTRIES Labeling Approval
05/18/1993 TRAZODONE HYDROCHLORIDE
ANDA #071525
SUPPL-7 TRAZODONE HYDROCHLORIDE PLIVA Labeling Approval
05/18/1993 PROPRANOLOL HYDROCHLORIDE
ANDA #072502
SUPPL-4 PROPRANOLOL HYDROCHLORIDE INWOOD LABS Bioequivalence Approval
05/18/1993 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #073209
SUPPL-1 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
05/19/1993 MACRODANTIN
NDA #016620
SUPPL-39 NITROFURANTOIN, MACROCRYSTALLINE ALVOGEN Labeling Approval
05/19/1993 GLUCOTROL
NDA #017783
SUPPL-12 GLIPIZIDE PFIZER Labeling Approval
05/19/1993 CHYMODIACTIN
BLA #018663
SUPPL-25 CHYMOPAPAIN DISCURE MEDICAL, LLC Approval
05/19/1993 TILADE
NDA #019660
SUPPL-3 NEDOCROMIL SODIUM KING PHARMS LLC Manufacturing (CMC) Approval
05/19/1993 ADRIAMYCIN PFS
ANDA #063165
SUPPL-7 DOXORUBICIN HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
05/19/1993 DESOWEN
ANDA #071425
SUPPL-4 DESONIDE GALDERMA LABS LP Labeling Approval
05/19/1993 DESOWEN
ANDA #072354
SUPPL-1 DESONIDE GALDERMA LABS LP Labeling Approval
05/19/1993 ANUSOL HC
ANDA #088250
SUPPL-2 HYDROCORTISONE SALIX PHARMS Labeling Approval
05/20/1993 ALTACE
NDA #019901
SUPPL-7 RAMIPRIL KING PHARMS LLC Manufacturing (CMC) Approval
05/20/1993 TOBRAMYCIN SULFATE
ANDA #063080
SUPPL-1 TOBRAMYCIN SULFATE HOSPIRA Manufacturing (CMC) Approval
05/20/1993 TOBRAMYCIN SULFATE
ANDA #063161
SUPPL-1 TOBRAMYCIN SULFATE HOSPIRA Manufacturing (CMC) Approval
05/20/1993 CEFUROXIME SODIUM
ANDA #064035
SUPPL-2 CEFUROXIME SODIUM WATSON LABS INC Labeling Approval
05/20/1993 CEFUROXIME SODIUM
ANDA #064036
SUPPL-1 CEFUROXIME SODIUM WATSON LABS INC Labeling Approval
05/21/1993 TAVIST
NDA #017661
SUPPL-41 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
05/21/1993 TAVIST-1
NDA #017661
SUPPL-41 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
05/21/1993 HALCION
NDA #017892
SUPPL-21 TRIAZOLAM PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
05/21/1993 XANAX
NDA #018276
SUPPL-27 ALPRAZOLAM UPJOHN Manufacturing (CMC) Approval
05/21/1993 SUDAFED 24 HOUR
NDA #020021
SUPPL-2 PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
05/21/1993 FLUDARA
NDA #020038
SUPPL-13 FLUDARABINE PHOSPHATE GENZYME CORP Manufacturing (CMC) Approval
05/21/1993 GENTAMICIN SULFATE
ANDA #062307
SUPPL-15 GENTAMICIN SULFATE PERRIGO NEW YORK Labeling Approval
05/21/1993 GENTAMICIN SULFATE
ANDA #062351
SUPPL-14 GENTAMICIN SULFATE PERRIGO NEW YORK Labeling Approval
05/21/1993 GENTAMICIN SULFATE
ANDA #062356
SUPPL-14 GENTAMICIN SULFATE FRESENIUS KABI USA Labeling Approval
05/21/1993 AMINOCAPROIC ACID IN PLASTIC CONTAINER
ANDA #070010
SUPPL-2 AMINOCAPROIC ACID HOSPIRA Labeling Approval
05/21/1993 TEMAZEPAM
ANDA #071446
ORIG-1 TEMAZEPAM WATSON LABS Approval
05/21/1993 TEMAZEPAM
ANDA #071447
ORIG-1 TEMAZEPAM WATSON LABS Approval
05/21/1993 NITROFURANTOIN
ANDA #073652
SUPPL-1 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Manufacturing (CMC) Approval
05/21/1993 NITROFURANTOIN
ANDA #073671
SUPPL-1 NITROFURANTOIN, MACROCRYSTALLINE IMPAX LABS INC Manufacturing (CMC) Approval
05/21/1993 SULFANILAMIDE
ANDA #088718
SUPPL-8 SULFANILAMIDE COSETTE Manufacturing (CMC) Approval
05/24/1993 DELTASONE
NDA #009986
SUPPL-56 PREDNISONE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
05/24/1993 MYCELEX-7
NDA #018182
SUPPL-12 CLOTRIMAZOLE BAYER HEALTHCARE LLC Labeling Approval
05/24/1993 CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #050589
SUPPL-11 CEFTIZOXIME SODIUM ASTELLAS Labeling Approval
05/24/1993 CEFIZOX IN PLASTIC CONTAINER
NDA #050589
SUPPL-11 CEFTIZOXIME SODIUM ASTELLAS Labeling Approval
05/24/1993 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070795
SUPPL-11 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TEVA Labeling Approval
05/24/1993 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070795
SUPPL-12 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TEVA Manufacturing (CMC) Approval
05/24/1993 SULINDAC
ANDA #072972
SUPPL-1 SULINDAC ANI PHARMS INC Manufacturing (CMC) Approval
05/24/1993 SULINDAC
ANDA #072973
SUPPL-1 SULINDAC ANI PHARMS INC Manufacturing (CMC) Approval
05/24/1993 METHYLPREDNISOLONE
ANDA #088497
SUPPL-35 METHYLPREDNISOLONE DURAMED PHARMS BARR Manufacturing (CMC) Approval
05/25/1993 TRANCOPAL
NDA #011467
SUPPL-24 CHLORMEZANONE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/25/1993 VALIUM
NDA #016087
SUPPL-80 DIAZEPAM ROCHE Manufacturing (CMC) Approval
05/25/1993 DALMANE
NDA #016721
SUPPL-72 FLURAZEPAM HYDROCHLORIDE VALEANT PHARM INTL Manufacturing (CMC) Approval
05/25/1993 HALCION
NDA #017892
SUPPL-26 TRIAZOLAM PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-12 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-13 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-14 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-15 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-16 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070035
SUPPL-17 METRONIDAZOLE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-12 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-13 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-14 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-15 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-16 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 METRONIDAZOLE
ANDA #070044
SUPPL-17 METRONIDAZOLE WATSON LABS INC Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #072938
SUPPL-3 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #072938
SUPPL-4 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #072939
SUPPL-3 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #072939
SUPPL-4 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073282
SUPPL-6 CLEMASTINE FUMARATE ANI PHARMS INC Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073282
SUPPL-7 CLEMASTINE FUMARATE ANI PHARMS INC Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073282
SUPPL-8 CLEMASTINE FUMARATE ANI PHARMS INC Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073283
SUPPL-4 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073283
SUPPL-5 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
05/25/1993 CLEMASTINE FUMARATE
ANDA #073283
SUPPL-6 CLEMASTINE FUMARATE TEVA Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #073419
SUPPL-4 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 ALBUTEROL SULFATE
ANDA #073419
SUPPL-5 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-15 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-16 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-18 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-19 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-20 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-21 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-22 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #085128
SUPPL-23 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 STATOBEX
ANDA #086013
SUPPL-12 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
05/25/1993 STATOBEX
ANDA #086013
SUPPL-13 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
05/25/1993 STATOBEX
ANDA #086013
SUPPL-15 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
05/25/1993 STATOBEX
ANDA #086013
SUPPL-16 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
05/25/1993 STATOBEX
ANDA #086013
SUPPL-17 PHENDIMETRAZINE TARTRATE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #088023
SUPPL-11 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #088023
SUPPL-12 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ADIPEX-P
ANDA #088023
SUPPL-13 PHENTERMINE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE HYDROCHLORIDE
ANDA #088615
SUPPL-4 PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE HYDROCHLORIDE
ANDA #088615
SUPPL-5 PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088627
SUPPL-14 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088627
SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628
SUPPL-22 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088628
SUPPL-23 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629
SUPPL-14 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #088629
SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE NOSTRUM LABS INC Manufacturing (CMC) Approval
05/25/1993 SULFANILAMIDE
ANDA #088718
SUPPL-11 SULFANILAMIDE COSETTE Manufacturing (CMC) Approval
05/25/1993 SULFANILAMIDE
ANDA #088718
SUPPL-12 SULFANILAMIDE COSETTE Manufacturing (CMC) Approval
05/25/1993 SULFANILAMIDE
ANDA #088718
SUPPL-13 SULFANILAMIDE COSETTE Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025
SUPPL-12 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025
SUPPL-13 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025
SUPPL-17 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025
SUPPL-18 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 PROPOXYPHENE COMPOUND 65
ANDA #089025
SUPPL-19 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
05/25/1993 CHLORZOXAZONE
ANDA #089859
SUPPL-7 CHLORZOXAZONE WATSON LABS Manufacturing (CMC) Approval
05/25/1993 CHLORZOXAZONE
ANDA #089859
SUPPL-8 CHLORZOXAZONE WATSON LABS Manufacturing (CMC) Approval
05/26/1993 ZESTRIL
NDA #019777
SUPPL-17 LISINOPRIL ALVOGEN Manufacturing (CMC) Approval
05/26/1993 PRILOSEC
NDA #019810
SUPPL-12 OMEPRAZOLE ASTRAZENECA PHARMS Manufacturing (CMC) Approval
05/26/1993 ACCUPRIL
NDA #019885
SUPPL-4 QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
05/26/1993 CEPHALEXIN
ANDA #062760
SUPPL-13 CEPHALEXIN TEVA Manufacturing (CMC) Approval
05/26/1993 CEPHALEXIN
ANDA #062760
SUPPL-14 CEPHALEXIN TEVA Manufacturing (CMC) Approval
05/26/1993 CEPHALEXIN
ANDA #062761
SUPPL-12 CEPHALEXIN TEVA Manufacturing (CMC) Approval
05/26/1993 CEPHALEXIN
ANDA #062761
SUPPL-13 CEPHALEXIN TEVA Manufacturing (CMC) Approval
05/27/1993 PROVENTIL
NDA #018062
SUPPL-11 ALBUTEROL SULFATE SCHERING Manufacturing (CMC) Approval
05/27/1993 THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018649
SUPPL-30 THEOPHYLLINE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/27/1993 TRANDATE
NDA #018716
SUPPL-18 LABETALOL HYDROCHLORIDE CNTY LINE PHARMS Labeling Approval
05/27/1993 TRANDATE
NDA #018716
SUPPL-20 LABETALOL HYDROCHLORIDE CNTY LINE PHARMS Labeling Approval
05/27/1993 PROVENTIL
NDA #019383
SUPPL-4 ALBUTEROL SULFATE SCHERING Manufacturing (CMC) Approval
05/27/1993 TRANDATE
NDA #019425
SUPPL-15 LABETALOL HYDROCHLORIDE SEBELA IRELAND LTD Labeling Approval
05/27/1993 ASACOL
NDA #019651
SUPPL-1 MESALAMINE APIL Labeling Approval
05/27/1993 DOXORUBICIN HYDROCHLORIDE
ANDA #062921
SUPPL-4 DOXORUBICIN HYDROCHLORIDE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
05/27/1993 AMOXICILLIN
ANDA #062946
SUPPL-2 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/27/1993 AMOXICILLIN
ANDA #062946
SUPPL-3 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/27/1993 AMOXICILLIN
ANDA #063001
SUPPL-2 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/27/1993 AMOXICILLIN
ANDA #063001
SUPPL-3 AMOXICILLIN TEVA Manufacturing (CMC) Approval
05/27/1993 DOXEPIN HYDROCHLORIDE
ANDA #071609
SUPPL-4 DOXEPIN HYDROCHLORIDE TEVA PHARMS Manufacturing (CMC) Approval
05/27/1993 MECLOFENAMATE SODIUM
ANDA #072809
SUPPL-5 MECLOFENAMATE SODIUM BARR Labeling Approval
05/27/1993 MECLOFENAMATE SODIUM
ANDA #072848
SUPPL-5 MECLOFENAMATE SODIUM BARR Labeling Approval
05/27/1993 TOLMETIN SODIUM
ANDA #073393
ORIG-1 TOLMETIN SODIUM MYLAN Approval
05/27/1993 SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
ANDA #073630
ORIG-1 PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM SANDOZ INC Approval
05/27/1993 ALPRAZOLAM
ANDA #074199
ORIG-1 ALPRAZOLAM ROXANE Tentative Approval
05/27/1993 NICOLAR
ANDA #083823
SUPPL-10 NIACIN SANOFI AVENTIS US Labeling Approval
05/27/1993 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #087804
SUPPL-18 ACETAMINOPHEN; BUTALBITAL; CAFFEINE SPECGX LLC Labeling Approval
05/27/1993 PHERAZINE VC
ANDA #088868
SUPPL-2 PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE HALSEY Labeling Approval
05/27/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089689
SUPPL-25 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
05/28/1993 CHORIONIC GONADOTROPIN
BLA #017016
SUPPL-142 GONADOTROPIN, CHORIONIC FERRING Approval
05/28/1993 KLONOPIN
NDA #017533
SUPPL-18 CLONAZEPAM ROCHE Manufacturing (CMC) Approval
05/28/1993 NORMODYNE
NDA #018686
SUPPL-18 LABETALOL HYDROCHLORIDE SCHERING Manufacturing (CMC) Approval
05/28/1993 NORMODYNE
NDA #018687
SUPPL-19 LABETALOL HYDROCHLORIDE SCHERING Manufacturing (CMC) Approval
05/28/1993 NUTRILIPID 10%
NDA #019531
ORIG-1 SOYBEAN OIL B BRAUN Type 5 - New Formulation or New Manufacturer Approval
05/28/1993 NUTRILIPID 20%
NDA #019531
ORIG-1 SOYBEAN OIL B BRAUN Type 5 - New Formulation or New Manufacturer Approval
05/28/1993 CECLOR
NDA #050521
SUPPL-15 CEFACLOR LILLY Labeling Approval
05/28/1993 CECLOR
NDA #050522
SUPPL-12 CEFACLOR LILLY Labeling Approval
05/28/1993 ROCEPHIN
NDA #050585
SUPPL-34 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Efficacy Approval
05/28/1993 ROCEPHIN KIT
NDA #050585
SUPPL-34 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Efficacy Approval
05/28/1993 VANTIN
NDA #050674
SUPPL-1 CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN Efficacy Approval
05/28/1993 NYSTATIN
ANDA #062613
SUPPL-6 NYSTATIN PADDOCK LLC Manufacturing (CMC) Approval
05/28/1993 NYSTATIN
ANDA #062832
SUPPL-2 NYSTATIN SOCORRO Manufacturing (CMC) Approval
05/28/1993 GENTAMICIN SULFATE
ANDA #063106
SUPPL-3 GENTAMICIN SULFATE TEVA PARENTERAL Manufacturing (CMC) Approval
05/28/1993 GENTAMICIN SULFATE
ANDA #063106
SUPPL-5 GENTAMICIN SULFATE TEVA PARENTERAL Manufacturing (CMC) Approval
05/28/1993 GENTAMICIN SULFATE
ANDA #063149
SUPPL-3 GENTAMICIN SULFATE TEVA PARENTERAL Manufacturing (CMC) Approval
05/28/1993 CEFOTAN
ANDA #063293
SUPPL-1 CEFOTETAN DISODIUM TELIGENT PHARMA INC Manufacturing (CMC) Approval
05/28/1993 VERAPAMIL HYDROCHLORIDE
ANDA #070225
SUPPL-7 VERAPAMIL HYDROCHLORIDE LUITPOLD Manufacturing (CMC) Approval
05/28/1993 VERAPAMIL HYDROCHLORIDE
ANDA #070617
SUPPL-6 VERAPAMIL HYDROCHLORIDE LUITPOLD Manufacturing (CMC) Approval
05/28/1993 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071296
SUPPL-13 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE MYLAN Labeling Approval
05/28/1993 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071297
SUPPL-13 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE MYLAN PHARMS INC Labeling Approval
05/28/1993 CYTARABINE
ANDA #071868
SUPPL-3 CYTARABINE HOSPIRA Manufacturing (CMC) Approval
05/28/1993 METAPROTERENOL SULFATE
ANDA #072761
SUPPL-4 METAPROTERENOL SULFATE COSETTE Manufacturing (CMC) Approval
05/28/1993 ATENOLOL
ANDA #073315
ORIG-1 ATENOLOL TEVA Approval
05/28/1993 ATENOLOL
ANDA #073316
ORIG-1 ATENOLOL TEVA Approval
05/28/1993 ALBUTEROL SULFATE
ANDA #073419
SUPPL-3 ALBUTEROL SULFATE TEVA Manufacturing (CMC) Approval
05/28/1993 EVALOSE
ANDA #073497
ORIG-1 LACTULOSE TEVA PHARMS Approval
05/28/1993 HEPTALAC
ANDA #073504
ORIG-1 LACTULOSE TEVA PHARMS Approval
05/28/1993 METAPROTERENOL SULFATE
ANDA #073632
SUPPL-2 METAPROTERENOL SULFATE LANNETT CO INC Manufacturing (CMC) Approval
05/28/1993 ACILAC
ANDA #073685
ORIG-1 LACTULOSE NOSTRUM LABS Approval
05/28/1993 LAXILOSE
ANDA #073686
ORIG-1 LACTULOSE NOSTRUM LABS Approval
05/28/1993 SULFASALAZINE
ANDA #080197
SUPPL-22 SULFASALAZINE HERITAGE PHARMS INC Labeling Approval
05/28/1993 SULFASALAZINE
ANDA #080197
SUPPL-23 SULFASALAZINE HERITAGE PHARMS INC Manufacturing (CMC) Approval
05/28/1993 HYDROCORTISONE
ANDA #081203
ORIG-1 HYDROCORTISONE FOUGERA PHARMS INC Approval
05/28/1993 PRONESTYL-SR
ANDA #087361
SUPPL-20 PROCAINAMIDE HYDROCHLORIDE APOTHECON Manufacturing (CMC) Approval
05/28/1993 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089673
SUPPL-2 ACETAMINOPHEN; CODEINE PHOSPHATE RHODES PHARMS Manufacturing (CMC) Approval
05/28/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089883
SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE WATSON LABS Manufacturing (CMC) Approval
05/28/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089883
SUPPL-8 ACETAMINOPHEN; HYDROCODONE BITARTRATE WATSON LABS Labeling Approval
05/28/1993 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #089883
SUPPL-9 ACETAMINOPHEN; HYDROCODONE BITARTRATE WATSON LABS Manufacturing (CMC) Approval

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