Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 1979

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 August 14, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/02/1979 LASIX
NDA #016273
SUPPL-34 FUROSEMIDE US PHARM HOLDINGS Labeling Approval
07/02/1979 LASIX
NDA #016363
SUPPL-27 FUROSEMIDE SANOFI AVENTIS US Labeling Approval
07/03/1979 ALDOCLOR-150
NDA #016016
SUPPL-41 CHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
07/03/1979 ALDOCLOR-250
NDA #016016
SUPPL-41 CHLOROTHIAZIDE; METHYLDOPA MERCK Labeling Approval
07/03/1979 TOPICORT
NDA #017856
SUPPL-3 DESOXIMETASONE TARO PHARM INDS LTD Manufacturing (CMC) Approval
07/03/1979 WESTCORT
NDA #017950
SUPPL-1 HYDROCORTISONE VALERATE SUN PHARM INDS INC Labeling Approval
07/03/1979 RETIN-A
NDA #017955
SUPPL-1 TRETINOIN VALEANT INTL Manufacturing (CMC) Approval
07/03/1979 LIPOSYN 10%
NDA #018203
SUPPL-1 SAFFLOWER OIL ABBOTT Efficacy Approval
07/03/1979 LIPOSYN 10%
NDA #018203
SUPPL-2 SAFFLOWER OIL ABBOTT Labeling Approval
07/03/1979 DAPSONE
ANDA #086841
ORIG-1 DAPSONE JACOBUS Approval
07/03/1979 DAPSONE
ANDA #086842
ORIG-1 DAPSONE JACOBUS Approval
07/05/1979 HYPAQUE
NDA #011386
SUPPL-14 DIATRIZOATE SODIUM GE HEALTHCARE Manufacturing (CMC) Approval
07/05/1979 DANTRIUM
NDA #017443
SUPPL-19 DANTROLENE SODIUM PAR STERILE PRODUCTS Manufacturing (CMC) Approval
07/05/1979 PROCHLORPERAZINE EDISYLATE
ANDA #086348
ORIG-1 PROCHLORPERAZINE EDISYLATE WYETH AYERST Approval
07/06/1979 COUMADIN
NDA #009218
SUPPL-37 WARFARIN SODIUM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
07/06/1979 TESSALON
NDA #011210
SUPPL-19 BENZONATATE PFIZER Manufacturing (CMC) Approval
07/06/1979 CARBOCAINE
NDA #012125
SUPPL-19 MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Manufacturing (CMC) Approval
07/06/1979 CARBOCAINE
NDA #012125
SUPPL-20 MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Labeling Approval
07/06/1979 CARBOCAINE W/ NEO-COBEFRIN
NDA #012125
SUPPL-19 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Manufacturing (CMC) Approval
07/06/1979 CARBOCAINE W/ NEO-COBEFRIN
NDA #012125
SUPPL-20 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Labeling Approval
07/06/1979 MAXIDEX
NDA #013422
SUPPL-10 DEXAMETHASONE NOVARTIS Labeling Approval
07/06/1979 MAXIDEX
NDA #013422
SUPPL-11 DEXAMETHASONE NOVARTIS Manufacturing (CMC) Approval
07/06/1979 HALDOL
NDA #015921
SUPPL-25 HALOPERIDOL ORTHO MCNEIL Labeling Approval
07/06/1979 HALDOL
NDA #015922
SUPPL-15 HALOPERIDOL LACTATE ORTHO MCNEIL Labeling Approval
07/06/1979 HALDOL
NDA #015922
SUPPL-17 HALOPERIDOL LACTATE ORTHO MCNEIL Labeling Approval
07/06/1979 HALDOL
NDA #015923
SUPPL-13 HALOPERIDOL LACTATE JANSSEN PHARMS Labeling Approval
07/06/1979 SILVADENE
NDA #017381
SUPPL-14 SILVER SULFADIAZINE KING PHARMS LLC Manufacturing (CMC) Approval
07/06/1979 DIPROSONE
NDA #017536
SUPPL-4 BETAMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
07/06/1979 DIPROSONE
NDA #017781
SUPPL-3 BETAMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
07/06/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018090
SUPPL-3 SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/09/1979 TRANXENE
NDA #017105
SUPPL-29 CLORAZEPATE DIPOTASSIUM RECORDATI RARE Manufacturing (CMC) Approval
07/09/1979 TRANXENE SD
NDA #017105
SUPPL-29 CLORAZEPATE DIPOTASSIUM RECORDATI RARE Manufacturing (CMC) Approval
07/09/1979 NAPROSYN
NDA #017581
SUPPL-19 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
07/09/1979 NAPROSYN
NDA #017581
SUPPL-20 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
07/09/1979 INTRALIPID 10%
NDA #017643
SUPPL-22 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
07/09/1979 CLEOCIN HYDROCHLORIDE
NDA #050162
SUPPL-69 CLINDAMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
07/09/1979 CLEOCIN HYDROCHLORIDE
NDA #050162
SUPPL-70 CLINDAMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
07/10/1979 LIDOCAINE HYDROCHLORIDE
NDA #017508
SUPPL-3 LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM Labeling Approval
07/10/1979 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #017584
SUPPL-9 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
07/10/1979 LASIX
NDA #017688
SUPPL-4 FUROSEMIDE SANOFI AVENTIS US Labeling Approval
07/10/1979 CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #086212
ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE IMPAX LABS Approval
07/10/1979 CHLORDIAZEPOXIDE HYDROCHLORIDE
ANDA #086213
ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE IMPAX LABS Approval
07/10/1979 NOVOCAIN
ANDA #086797
ORIG-1 PROCAINE HYDROCHLORIDE HOSPIRA Approval
07/11/1979 FURACIN
NDA #005795
SUPPL-4 NITROFURAZONE SHIRE Manufacturing (CMC) Approval
07/11/1979 SINOGRAFIN
NDA #011324
SUPPL-21 DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE BRACCO Manufacturing (CMC) Approval
07/11/1979 SODIUM IODIDE I 123
NDA #017630
SUPPL-3 SODIUM IODIDE I-123 GE HEALTHCARE Manufacturing (CMC) Approval
07/12/1979 OPTIMINE
NDA #017601
SUPPL-2 AZATADINE MALEATE SCHERING Manufacturing (CMC) Approval
07/12/1979 LIDOCAINE HYDROCHLORIDE
NDA #017701
SUPPL-1 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Labeling Approval
07/13/1979 DIURIL
NDA #011145
SUPPL-41 CHLOROTHIAZIDE OAK PHARMS AKORN Labeling Approval
07/13/1979 DIURIL
NDA #011145
SUPPL-41 CHLOROTHIAZIDE SODIUM OAK PHARMS AKORN Labeling Approval
07/13/1979 DIURIL
NDA #011870
SUPPL-16 CHLOROTHIAZIDE SALIX PHARMS Labeling Approval
07/13/1979 IVADANTIN
NDA #012402
SUPPL-17 NITROFURANTOIN SODIUM PROCTER AND GAMBLE Labeling Approval
07/13/1979 DEPO-PROVERA
NDA #012541
SUPPL-48 MEDROXYPROGESTERONE ACETATE PHARMACIA AND UPJOHN Labeling Approval
07/13/1979 DECADRON W/ XYLOCAINE
NDA #013334
SUPPL-17 DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE MERCK Labeling Approval
07/13/1979 HEPARIN SODIUM
NDA #017651
SUPPL-3 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
07/13/1979 THEOPHYLLINE
ANDA #085263
ORIG-1 THEOPHYLLINE KV PHARM Approval
07/13/1979 TRIPROLIDINE HYDROCHLORIDE
ANDA #085940
ORIG-1 TRIPROLIDINE HYDROCHLORIDE ALPHARMA US PHARMS Approval
07/16/1979 MACRODANTIN
NDA #016620
SUPPL-27 NITROFURANTOIN, MACROCRYSTALLINE ALVOGEN Manufacturing (CMC) Approval
07/16/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #017513
SUPPL-21 STERILE WATER FOR IRRIGATION ICU MEDICAL INC Manufacturing (CMC) Approval
07/16/1979 GYNE-LOTRIMIN
NDA #017717
SUPPL-5 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
07/16/1979 FLORONE
NDA #017741
SUPPL-3 DIFLORASONE DIACETATE PHARMACIA AND UPJOHN Labeling Approval
07/16/1979 PSORCON E
NDA #017994
SUPPL-5 DIFLORASONE DIACETATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/16/1979 PSORCON E
NDA #017994
SUPPL-6 DIFLORASONE DIACETATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/16/1979 PSORCON E
NDA #017994
SUPPL-7 DIFLORASONE DIACETATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/17/1979 DARVON COMPOUND
NDA #010996
SUPPL-29 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE XANODYNE PHARM Labeling Approval
07/17/1979 DARVON COMPOUND-65
NDA #010996
SUPPL-29 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE XANODYNE PHARM Labeling Approval
07/17/1979 DARVON W/ ASA
NDA #010996
SUPPL-29 ASPIRIN; PROPOXYPHENE HYDROCHLORIDE XANODYNE PHARM Labeling Approval
07/17/1979 KENACORT
NDA #011283
SUPPL-33 TRIAMCINOLONE DELCOR ASSET CORP Labeling Approval
07/17/1979 KENACORT
NDA #011283
SUPPL-37 TRIAMCINOLONE DELCOR ASSET CORP Manufacturing (CMC) Approval
07/17/1979 KENALOG-10
NDA #012041
SUPPL-17 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
07/17/1979 KENALOG IN ORABASE
NDA #012097
SUPPL-12 TRIAMCINOLONE ACETONIDE DELCOR ASSET CORP Manufacturing (CMC) Approval
07/17/1979 KENACORT
NDA #012515
SUPPL-15 TRIAMCINOLONE DIACETATE DELCOR ASSET CORP Manufacturing (CMC) Approval
07/17/1979 NEURAMATE
NDA #014359
SUPPL-41 MEPROBAMATE HALSEY Labeling Approval
07/17/1979 KENALOG-40
NDA #014901
SUPPL-17 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
07/17/1979 KENALOG-80
NDA #014901
SUPPL-17 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
07/17/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016366
SUPPL-46 SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/17/1979 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016367
SUPPL-58 DEXTROSE ICU MEDICAL INC Labeling Approval
07/17/1979 DARVOCET-N 100
NDA #017122
SUPPL-18 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE XANODYNE PHARM Labeling Approval
07/17/1979 DARVOCET-N 50
NDA #017122
SUPPL-18 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE XANODYNE PHARM Labeling Approval
07/17/1979 OSTEOSCAN
NDA #017454
SUPPL-15 TECHNETIUM TC-99M ETIDRONATE KIT MALLINCKRODT Manufacturing (CMC) Approval
07/17/1979 OSTEOSCAN
NDA #017454
SUPPL-16 TECHNETIUM TC-99M ETIDRONATE KIT MALLINCKRODT Manufacturing (CMC) Approval
07/17/1979 NAPROSYN
NDA #017581
SUPPL-17 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
07/17/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017585
SUPPL-35 DEXTROSE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/17/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
NDA #017606
SUPPL-36 DEXTROSE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/17/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017607
SUPPL-36 DEXTROSE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/17/1979 NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017609
SUPPL-33 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Labeling Approval
07/17/1979 NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017610
SUPPL-33 DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/17/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017799
SUPPL-25 DEXTROSE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
07/18/1979 NORINYL
NDA #013625
SUPPL-128 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL
NDA #013625
SUPPL-129 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL
NDA #013625
SUPPL-130 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL
NDA #013625
SUPPL-133 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 21-DAY
NDA #013625
SUPPL-128 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 21-DAY
NDA #013625
SUPPL-129 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 21-DAY
NDA #013625
SUPPL-130 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 21-DAY
NDA #013625
SUPPL-133 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 28-DAY
NDA #016659
SUPPL-79 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+50 28-DAY
NDA #016659
SUPPL-82 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+80 21-DAY
NDA #016724
SUPPL-77 MESTRANOL; NORETHINDRONE GD SEARLE LLC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+80 21-DAY
NDA #016724
SUPPL-80 MESTRANOL; NORETHINDRONE GD SEARLE LLC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+80 28-DAY
NDA #016725
SUPPL-75 MESTRANOL; NORETHINDRONE GD SEARLE LLC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+80 28-DAY
NDA #016725
SUPPL-78 MESTRANOL; NORETHINDRONE GD SEARLE LLC Manufacturing (CMC) Approval
07/18/1979 NOR-QD
NDA #017060
SUPPL-33 NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/18/1979 NOR-QD
NDA #017060
SUPPL-36 NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/18/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017514
SUPPL-25 SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+35 21-DAY
NDA #017565
SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+35 21-DAY
NDA #017565
SUPPL-26 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+35 28-DAY
NDA #017565
SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 NORINYL 1+35 28-DAY
NDA #017565
SUPPL-26 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 BREVICON 21-DAY
NDA #017566
SUPPL-38 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 BREVICON 21-DAY
NDA #017566
SUPPL-41 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #017633
SUPPL-10 GLYCINE HOSPIRA Manufacturing (CMC) Approval
07/18/1979 RINGER'S IN PLASTIC CONTAINER
NDA #017635
SUPPL-8 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/18/1979 SORBITOL-MANNITOL IN PLASTIC CONTAINER
NDA #017636
SUPPL-10 MANNITOL; SORBITOL HOSPIRA Manufacturing (CMC) Approval
07/18/1979 PHYSIOSOL IN PLASTIC CONTAINER
NDA #017637
SUPPL-12 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Manufacturing (CMC) Approval
07/18/1979 ACETIC ACID 0.25% IN PLASTIC CONTAINER
NDA #017656
SUPPL-10 ACETIC ACID, GLACIAL ICU MEDICAL INC Manufacturing (CMC) Approval
07/18/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017670
SUPPL-10 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/18/1979 BREVICON 28-DAY
NDA #017743
SUPPL-27 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 BREVICON 28-DAY
NDA #017743
SUPPL-30 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Manufacturing (CMC) Approval
07/18/1979 NORMINEST FE
NDA #017948
SUPPL-5 ETHINYL ESTRADIOL;NORETHINDRONE; FERROUS FUMARATE GD SEARLE LLC Manufacturing (CMC) Approval
07/19/1979 CAFERGOT
NDA #009000
SUPPL-3 CAFFEINE; ERGOTAMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
07/19/1979 NORPACE
NDA #017447
SUPPL-3 DISOPYRAMIDE PHOSPHATE GD SEARLE LLC Efficacy Approval
07/19/1979 ERYTHROCIN
NDA #050182
SUPPL-64 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
07/20/1979 ANTURANE
NDA #011556
SUPPL-33 SULFINPYRAZONE NOVARTIS Manufacturing (CMC) Approval
07/20/1979 ANTURANE
NDA #011556
SUPPL-34 SULFINPYRAZONE NOVARTIS Manufacturing (CMC) Approval
07/20/1979 LIBRIUM
NDA #012301
SUPPL-11 CHLORDIAZEPOXIDE HYDROCHLORIDE BAUSCH Labeling Approval
07/20/1979 VALIUM
NDA #016087
SUPPL-41 DIAZEPAM ROCHE Labeling Approval
07/20/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #016734
SUPPL-19 STERILE WATER FOR IRRIGATION B BRAUN Labeling Approval
07/20/1979 SORBITOL 3.3% IN PLASTIC CONTAINER
NDA #016741
SUPPL-6 SORBITOL B BRAUN Labeling Approval
07/20/1979 RESECTISOL IN PLASTIC CONTAINER
NDA #016772
SUPPL-5 MANNITOL B BRAUN Labeling Approval
07/20/1979 SODIUM PERTECHNETATE TC 99M
NDA #017471
SUPPL-9 TECHNETIUM TC-99M SODIUM PERTECHNETATE GE HEALTHCARE Manufacturing (CMC) Approval
07/20/1979 TIMOPTIC
NDA #018086
SUPPL-6 TIMOLOL MALEATE VALEANT PHARMS INTL Labeling Approval
07/20/1979 CLEOCIN HYDROCHLORIDE
NDA #050162
SUPPL-71 CLINDAMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/23/1979 DELTASONE
NDA #009986
SUPPL-45 PREDNISONE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/23/1979 PROVERA
NDA #011839
SUPPL-39 MEDROXYPROGESTERONE ACETATE PHARMACIA AND UPJOHN Efficacy Approval
07/23/1979 CELESTONE
NDA #012657
SUPPL-7 BETAMETHASONE SCHERING Manufacturing (CMC) Approval
07/23/1979 TALWIN 50
NDA #016732
SUPPL-42 PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
07/23/1979 COLESTID
NDA #017563
SUPPL-2 COLESTIPOL HYDROCHLORIDE PHARMACIA UPJOHN Manufacturing (CMC) Approval
07/23/1979 FLAVORED COLESTID
NDA #017563
SUPPL-2 COLESTIPOL HYDROCHLORIDE PHARMACIA UPJOHN Manufacturing (CMC) Approval
07/23/1979 GYNE-LOTRIMIN
NDA #017717
SUPPL-4 CLOTRIMAZOLE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
07/23/1979 TOPICORT
NDA #017856
SUPPL-4 DESOXIMETASONE TARO PHARM INDS LTD Manufacturing (CMC) Approval
07/23/1979 CLINORIL
NDA #017911
SUPPL-2 SULINDAC MERCK Manufacturing (CMC) Approval
07/24/1979 EQUANIL
NDA #010028
SUPPL-18 MEPROBAMATE WYETH AYERST Manufacturing (CMC) Approval
07/24/1979 ROBAXIN
NDA #011011
SUPPL-31 METHOCARBAMOL AUXILIUM PHARMS LLC Manufacturing (CMC) Approval
07/24/1979 ROBAXIN-750
NDA #011011
SUPPL-31 METHOCARBAMOL AUXILIUM PHARMS LLC Manufacturing (CMC) Approval
07/24/1979 ROBINUL
NDA #012827
SUPPL-20 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
07/24/1979 ROBINUL FORTE
NDA #012827
SUPPL-20 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
07/24/1979 8-HOUR BAYER
NDA #016030
SUPPL-21 ASPIRIN BAYER Manufacturing (CMC) Approval
07/24/1979 8-HOUR BAYER
NDA #016030
SUPPL-22 ASPIRIN BAYER Manufacturing (CMC) Approval
07/24/1979 MEASURIN
NDA #016030
SUPPL-21 ASPIRIN BAYER Manufacturing (CMC) Approval
07/24/1979 MEASURIN
NDA #016030
SUPPL-22 ASPIRIN BAYER Manufacturing (CMC) Approval
07/24/1979 QUINAGLUTE
NDA #016647
SUPPL-12 QUINIDINE GLUCONATE BAYER HLTHCARE Manufacturing (CMC) Approval
07/24/1979 ULTRA-TECHNEKOW FM
NDA #017243
SUPPL-6 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
07/24/1979 NOLVADEX
NDA #017970
SUPPL-2 TAMOXIFEN CITRATE ASTRAZENECA Manufacturing (CMC) Approval
07/25/1979 LEUCOVORIN CALCIUM
NDA #008107
SUPPL-19 LEUCOVORIN CALCIUM HOSPIRA Manufacturing (CMC) Approval
07/25/1979 BENDECTIN
NDA #010598
SUPPL-7 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
07/25/1979 SYNALAR
NDA #012787
SUPPL-36 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
07/25/1979 ALDOMET
NDA #013400
SUPPL-42 METHYLDOPA MERCK Labeling Approval
07/25/1979 ALDOMET
NDA #013400
SUPPL-48 METHYLDOPA MERCK Labeling Approval
07/25/1979 VALPIN 50
NDA #013428
SUPPL-27 ANISOTROPINE METHYLBROMIDE ENDO PHARMS Manufacturing (CMC) Approval
07/25/1979 HIBICLENS
NDA #017768
SUPPL-8 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Manufacturing (CMC) Approval
07/25/1979 RIFADIN
NDA #050420
SUPPL-54 RIFAMPIN SANOFI AVENTIS US Labeling Approval
07/25/1979 DEPO-TESTOSTERONE
ANDA #085635
ORIG-1 TESTOSTERONE CYPIONATE PHARMACIA AND UPJOHN Approval
07/25/1979 BUTALBITAL, ASPIRIN AND CAFFEINE
ANDA #086710
ORIG-1 ASPIRIN; BUTALBITAL; CAFFEINE ACTAVIS ELIZABETH Approval
07/26/1979 DEMEROL
NDA #005010
SUPPL-14 MEPERIDINE HYDROCHLORIDE US PHARM HOLDINGS Labeling Approval
07/26/1979 DECADRON
NDA #011664
SUPPL-24 DEXAMETHASONE MERCK Labeling Approval
07/26/1979 DECADRON
NDA #011664
SUPPL-27 DEXAMETHASONE MERCK Labeling Approval
07/26/1979 DECADRON
NDA #011664
SUPPL-28 DEXAMETHASONE MERCK Labeling Approval
07/26/1979 DECADRON
NDA #011664
SUPPL-29 DEXAMETHASONE MERCK Labeling Approval
07/26/1979 FLAGYL
NDA #012623
SUPPL-24 METRONIDAZOLE GD SEARLE LLC Labeling Approval
07/26/1979 MACRODANTIN
NDA #016620
SUPPL-25 NITROFURANTOIN, MACROCRYSTALLINE ALVOGEN Manufacturing (CMC) Approval
07/26/1979 SEPTRA
NDA #017376
SUPPL-21 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Efficacy Approval
07/26/1979 SEPTRA DS
NDA #017376
SUPPL-21 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Efficacy Approval
07/26/1979 BACTRIM
NDA #017377
SUPPL-23 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/26/1979 BACTRIM DS
NDA #017377
SUPPL-23 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/26/1979 BACTRIM
NDA #017560
SUPPL-12 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/26/1979 BACTRIM PEDIATRIC
NDA #017560
SUPPL-12 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/26/1979 SEPTRA
NDA #017598
SUPPL-10 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
07/26/1979 SEPTRA GRAPE
NDA #017598
SUPPL-10 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
07/26/1979 LO/OVRAL FE
NDA #018206
ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE CADENCE HEALTH Type 3 - New Dosage Form Approval
07/27/1979 KENALOG-40
NDA #014901
SUPPL-9 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
07/27/1979 KENALOG-80
NDA #014901
SUPPL-9 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
07/27/1979 BICILLIN C-R
NDA #050138
SUPPL-193 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
07/27/1979 BICILLIN C-R 900/300
NDA #050138
SUPPL-193 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
07/28/1979 CEFACLOR
ANDA #062205
ORIG-1 CEFACLOR CEPH INTL Approval
07/30/1979 ALDOMET
NDA #013401
SUPPL-23 METHYLDOPATE HYDROCHLORIDE MERCK Labeling Approval
07/30/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #017513
SUPPL-22 STERILE WATER FOR IRRIGATION ICU MEDICAL INC Manufacturing (CMC) Approval
07/30/1979 UNIPEN
NDA #050320
SUPPL-62 NAFCILLIN SODIUM WYETH AYERST Labeling Approval
07/30/1979 UNIPEN IN PLASTIC CONTAINER
NDA #050320
SUPPL-62 NAFCILLIN SODIUM WYETH AYERST Labeling Approval
07/31/1979 APRESOLINE
NDA #008303
SUPPL-43 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
07/31/1979 DIAMOX
NDA #008943
SUPPL-24 ACETAZOLAMIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/31/1979 SALUTENSIN
NDA #012359
SUPPL-16 HYDROFLUMETHIAZIDE; RESERPINE SHIRE Labeling Approval
07/31/1979 SALUTENSIN-DEMI
NDA #012359
SUPPL-16 HYDROFLUMETHIAZIDE; RESERPINE SHIRE Labeling Approval
07/31/1979 DELFEN
NDA #014349
SUPPL-19 NONOXYNOL-9 PERSONAL PRODS Manufacturing (CMC) Approval
07/31/1979 DELFEN
NDA #014349
SUPPL-20 NONOXYNOL-9 PERSONAL PRODS Manufacturing (CMC) Approval
07/31/1979 DELFEN
NDA #014349
SUPPL-21 NONOXYNOL-9 PERSONAL PRODS Manufacturing (CMC) Approval
07/31/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017514
SUPPL-26 SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/1979 OVCON-50
NDA #017576
SUPPL-17 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Manufacturing (CMC) Approval
07/31/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #017633
SUPPL-11 GLYCINE HOSPIRA Manufacturing (CMC) Approval
07/31/1979 RINGER'S IN PLASTIC CONTAINER
NDA #017635
SUPPL-9 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/1979 SORBITOL-MANNITOL IN PLASTIC CONTAINER
NDA #017636
SUPPL-11 MANNITOL; SORBITOL HOSPIRA Manufacturing (CMC) Approval
07/31/1979 PHYSIOSOL IN PLASTIC CONTAINER
NDA #017637
SUPPL-13 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/1979 ACETIC ACID 0.25% IN PLASTIC CONTAINER
NDA #017656
SUPPL-11 ACETIC ACID, GLACIAL ICU MEDICAL INC Manufacturing (CMC) Approval
07/31/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017670
SUPPL-11 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/31/1979 NOLVADEX
NDA #017970
SUPPL-3 TAMOXIFEN CITRATE ASTRAZENECA Labeling Approval
07/31/1979 INDERIDE-40/25
NDA #018031
SUPPL-1 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE WYETH PHARMS INC Manufacturing (CMC) Approval
07/31/1979 INDERIDE-80/25
NDA #018031
SUPPL-1 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE WYETH PHARMS INC Manufacturing (CMC) Approval
07/31/1979 OVCON-50
NDA #018128
SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Manufacturing (CMC) Approval

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