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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 May 23, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/02/1979 LASIX
NDA #016273		 SUPPL-34 FUROSEMIDE VALIDUS PHARMS 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 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 EVEREST LIFE SCI Approval
07/03/1979 DAPSONE
ANDA #086842		 ORIG-1 DAPSONE EVEREST LIFE SCI 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 ENDO OPERATIONS 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 HARROW EYE Labeling Approval
07/06/1979 MAXIDEX
NDA #013422		 SUPPL-11 DEXAMETHASONE HARROW EYE 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 AJENAT PHARMS Manufacturing (CMC) Approval
07/09/1979 TRANXENE SD
NDA #017105		 SUPPL-29 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS 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 PFIZER Labeling Approval
07/09/1979 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-70 CLINDAMYCIN HYDROCHLORIDE PFIZER 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 RISING Labeling Approval
07/13/1979 DIURIL
NDA #011145		 SUPPL-41 CHLOROTHIAZIDE SODIUM RISING 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 PFIZER 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 ALMATICA 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 PFIZER Labeling Approval
07/16/1979 PSORCON E
NDA #017994		 SUPPL-5 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
07/16/1979 PSORCON E
NDA #017994		 SUPPL-6 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
07/16/1979 PSORCON E
NDA #017994		 SUPPL-7 DIFLORASONE DIACETATE PFIZER 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 PFIZER 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 BAUSCH AND LOMB INC Labeling Approval
07/20/1979 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-71 CLINDAMYCIN HYDROCHLORIDE PFIZER 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 PFIZER 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 PFIZER Manufacturing (CMC) Approval
07/23/1979 FLAVORED COLESTID
NDA #017563		 SUPPL-2 COLESTIPOL HYDROCHLORIDE PFIZER 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 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 PFIZER 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 VALIDUS PHARMS 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 PFIZER Labeling Approval
07/26/1979 MACRODANTIN
NDA #016620		 SUPPL-25 NITROFURANTOIN, MACROCRYSTALLINE ALMATICA 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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