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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 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 24, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/1979 METHOTREXATE SODIUM
NDA #008085		 SUPPL-15 METHOTREXATE SODIUM STRIDES PHARMA Manufacturing (CMC) Approval
05/01/1979 IODOTOPE
NDA #010929		 SUPPL-25 SODIUM IODIDE I-131 BRACCO Manufacturing (CMC) Approval
05/01/1979 MANNITOL 10%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 15%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 20%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 5%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
NDA #016080		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/01/1979 DALMANE
NDA #016721		 SUPPL-44 FLURAZEPAM HYDROCHLORIDE VALEANT PHARM INTL Manufacturing (CMC) Approval
05/01/1979 XENON XE 133
NDA #017256		 SUPPL-6 XENON XE-133 GE HEALTHCARE Labeling Approval
05/01/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #017513		 SUPPL-18 STERILE WATER FOR IRRIGATION ICU MEDICAL INC Manufacturing (CMC) Approval
05/01/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017514		 SUPPL-21 SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/01/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #017633		 SUPPL-9 GLYCINE HOSPIRA Manufacturing (CMC) Approval
05/01/1979 RINGER'S IN PLASTIC CONTAINER
NDA #017635		 SUPPL-5 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/01/1979 SORBITOL-MANNITOL IN PLASTIC CONTAINER
NDA #017636		 SUPPL-9 MANNITOL; SORBITOL HOSPIRA Manufacturing (CMC) Approval
05/01/1979 ACETIC ACID 0.25% IN PLASTIC CONTAINER
NDA #017656		 SUPPL-7 ACETIC ACID, GLACIAL ICU MEDICAL INC Manufacturing (CMC) Approval
05/01/1979 RIFADIN
NDA #050420		 SUPPL-53 RIFAMPIN SANOFI AVENTIS US Labeling Approval
05/02/1979 MANNITOL 20%
NDA #014738		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
05/02/1979 NAPROSYN
NDA #017581		 SUPPL-5 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
05/02/1979 NAPROSYN
NDA #017581		 SUPPL-6 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 10%
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 10% (PH6)
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 5%
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 7%
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 7% (PH6)
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 8.5%
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 8.5% (PH6)
NDA #017673		 SUPPL-26 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 8.5% W/ ELECTROLYTES
NDA #017673		 SUPPL-26 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 8.5% W/ELECTROLYTES
NDA #017673		 SUPPL-26 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 3.5%
NDA #017789		 SUPPL-14 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 3.5% M
NDA #017789		 SUPPL-14 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 3.5% M
NDA #017789		 SUPPL-14 AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/02/1979 AMINOSYN 7% W/ ELECTROLYTES
NDA #017789		 SUPPL-14 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/03/1979 STELAZINE
NDA #011552		 SUPPL-71 TRIFLUOPERAZINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
05/03/1979 STOXIL
NDA #013934		 SUPPL-9 IDOXURIDINE GLAXOSMITHKLINE Labeling Approval
05/03/1979 INDERAL
NDA #016418		 SUPPL-32 PROPRANOLOL HYDROCHLORIDE WYETH PHARMS Manufacturing (CMC) Approval
05/03/1979 FLEXERIL
NDA #017821		 SUPPL-7 CYCLOBENZAPRINE HYDROCHLORIDE JANSSEN RES AND DEV Manufacturing (CMC) Approval
05/03/1979 DEPAKENE
NDA #018081		 SUPPL-1 VALPROIC ACID ABBVIE Labeling Approval
05/03/1979 DEPAKENE
NDA #018082		 SUPPL-1 VALPROIC ACID ABBVIE Labeling Approval
05/03/1979 TOPICYCLINE
NDA #050493		 SUPPL-18 TETRACYCLINE HYDROCHLORIDE SHIRE Manufacturing (CMC) Approval
05/04/1979 NATURETIN-10
NDA #012164		 SUPPL-19 BENDROFLUMETHIAZIDE APOTHECON Labeling Approval
05/04/1979 NATURETIN-2.5
NDA #012164		 SUPPL-19 BENDROFLUMETHIAZIDE APOTHECON Labeling Approval
05/04/1979 NATURETIN-5
NDA #012164		 SUPPL-19 BENDROFLUMETHIAZIDE APOTHECON Labeling Approval
05/04/1979 TARACTAN
NDA #016149		 SUPPL-20 CHLORPROTHIXENE ROCHE Manufacturing (CMC) Approval
05/04/1979 SLOW-K
NDA #017476		 SUPPL-22 POTASSIUM CHLORIDE NOVARTIS Manufacturing (CMC) Approval
05/04/1979 CEPHULAC
NDA #017657		 SUPPL-7 LACTULOSE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/04/1979 CALCIMAR
NDA #017769		 SUPPL-5 CALCITONIN SALMON SANOFI AVENTIS US Manufacturing (CMC) Approval
05/04/1979 ERYTHROCIN
NDA #050182		 SUPPL-65 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
05/07/1979 MODICON 21
NDA #017488		 SUPPL-60 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
05/07/1979 MODICON 28
NDA #017735		 SUPPL-38 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
05/07/1979 OSTEOLITE
NDA #017972		 SUPPL-2 TECHNETIUM TC-99M MEDRONATE KIT PHARMALUCENCE Labeling Approval
05/08/1979 TALWIN COMPOUND
NDA #016891		 SUPPL-3 ASPIRIN; PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/08/1979 TALWIN COMPOUND
NDA #016891		 SUPPL-6 ASPIRIN; PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/08/1979 TALWIN COMPOUND
NDA #016891		 SUPPL-7 ASPIRIN; PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/09/1979 NOVAMINE 11.4%
NDA #017957		 SUPPL-5 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
05/09/1979 NOVAMINE 15%
NDA #017957		 SUPPL-5 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
05/09/1979 NOVAMINE 8.5%
NDA #017957		 SUPPL-5 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
05/09/1979 VEINAMINE 8%
NDA #017957		 SUPPL-5 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE HOSPIRA INC Manufacturing (CMC) Approval
05/10/1979 COLBENEMID
NDA #012383		 SUPPL-15 COLCHICINE; PROBENECID MERCK Manufacturing (CMC) Approval
05/10/1979 ATROPEN
NDA #017106		 SUPPL-3 ATROPINE MMT Manufacturing (CMC) Approval
05/10/1979 MOBAN
NDA #017111		 SUPPL-26 MOLINDONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/10/1979 RENAMIN W/O ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 10% W/O ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 3.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 5.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 5.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 8.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/10/1979 TRAVASOL 8.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-10 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
05/11/1979 PHENYTOIN SODIUM
ANDA #085894		 ORIG-1 PHENYTOIN SODIUM WATSON LABS Approval
05/11/1979 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #086681		 ORIG-1 ACETAMINOPHEN; CODEINE PHOSPHATE PUREPAC PHARM Approval
05/11/1979 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #086683		 ORIG-1 ACETAMINOPHEN; CODEINE PHOSPHATE PUREPAC PHARM Approval
05/14/1979 BILOPAQUE
NDA #013731		 SUPPL-16 TYROPANOATE SODIUM GE HEALTHCARE Manufacturing (CMC) Approval
05/15/1979 METHERGINE
NDA #006035		 SUPPL-20 METHYLERGONOVINE MALEATE EDISON THERAPS LLC Efficacy Approval
05/15/1979 TOLECTIN
NDA #017628		 SUPPL-4 TOLMETIN SODIUM ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
05/15/1979 TOLECTIN 600
NDA #017628		 SUPPL-4 TOLMETIN SODIUM ORTHO MCNEIL JANSSEN Manufacturing (CMC) Approval
05/15/1979 STADOL
NDA #017857		 SUPPL-11 BUTORPHANOL TARTRATE APOTHECON Manufacturing (CMC) Approval
05/15/1979 STADOL PRESERVATIVE FREE
NDA #017857		 SUPPL-11 BUTORPHANOL TARTRATE APOTHECON Manufacturing (CMC) Approval
05/15/1979 NUBAIN
NDA #018024		 ORIG-1 NALBUPHINE HYDROCHLORIDE PAR PHARM INC Type 1 - New Molecular Entity Approval
05/15/1979 THYREL TRH
NDA #018087		 SUPPL-2 PROTIRELIN FERRING Manufacturing (CMC) Approval
05/15/1979 MINOCIN
NDA #050315		 SUPPL-53 MINOCYCLINE HYDROCHLORIDE TRIAX PHARMS Manufacturing (CMC) Approval
05/15/1979 ANCEF
NDA #050461		 SUPPL-101 CEFAZOLIN SODIUM GLAXOSMITHKLINE Manufacturing (CMC) Approval
05/15/1979 MANDOL
NDA #050504		 SUPPL-36 CEFAMANDOLE NAFATE LILLY Labeling Approval
05/15/1979 SLO-PHYLLIN
ANDA #085187		 ORIG-1 THEOPHYLLINE SANOFI AVENTIS US Approval
05/16/1979 OVULEN
NDA #016029		 SUPPL-49 ETHYNODIOL DIACETATE; MESTRANOL GD SEARLE LLC Manufacturing (CMC) Approval
05/16/1979 OVULEN-21
NDA #016029		 SUPPL-49 ETHYNODIOL DIACETATE; MESTRANOL GD SEARLE LLC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 10%
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 10%
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 10% (PH6)
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 10% (PH6)
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 5%
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 5%
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 7%
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 7%
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 7% (PH6)
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 7% (PH6)
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 8.5%
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 8.5%
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 8.5% (PH6)
NDA #017673		 SUPPL-24 AMINO ACIDS ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 8.5% (PH6)
NDA #017673		 SUPPL-25 AMINO ACIDS ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 8.5% W/ ELECTROLYTES
NDA #017673		 SUPPL-24 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 8.5% W/ ELECTROLYTES
NDA #017673		 SUPPL-25 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
05/16/1979 AMINOSYN 8.5% W/ELECTROLYTES
NDA #017673		 SUPPL-24 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ICU MEDICAL INC Manufacturing (CMC) Approval
05/16/1979 AMINOSYN 8.5% W/ELECTROLYTES
NDA #017673		 SUPPL-25 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ICU MEDICAL INC Labeling Approval
05/16/1979 LIPOSYN 10%
NDA #018203		 ORIG-1 SAFFLOWER OIL ABBOTT Type 1 - New Molecular Entity Approval
05/16/1979 DECLOMYCIN
NDA #050261		 SUPPL-87 DEMECLOCYCLINE HYDROCHLORIDE COREPHARMA Manufacturing (CMC) Approval
05/17/1979 PARLODEL
NDA #017962		 SUPPL-4 BROMOCRIPTINE MESYLATE SS PHARMA Manufacturing (CMC) Approval
05/18/1979 NEURAMATE
NDA #014359		 SUPPL-40 MEPROBAMATE HALSEY Labeling Approval
05/18/1979 MINITEC
NDA #017339		 SUPPL-15 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR BRACCO Manufacturing (CMC) Approval
05/18/1979 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-68 CLINDAMYCIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
05/21/1979 ATARAX
NDA #010392		 SUPPL-21 HYDROXYZINE HYDROCHLORIDE PFIZER Labeling Approval
05/21/1979 ATARAX
NDA #010485		 SUPPL-11 HYDROXYZINE HYDROCHLORIDE ROERIG Labeling Approval
05/21/1979 ROBAXIN
NDA #011011		 SUPPL-19 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
05/21/1979 ROBAXIN
NDA #011011		 SUPPL-20 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
05/21/1979 ROBAXIN
NDA #011011		 SUPPL-22 METHOCARBAMOL AUXILIUM PHARMS LLC Manufacturing (CMC) Approval
05/21/1979 ROBAXIN-750
NDA #011011		 SUPPL-19 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
05/21/1979 ROBAXIN-750
NDA #011011		 SUPPL-20 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
05/21/1979 ROBAXIN-750
NDA #011011		 SUPPL-22 METHOCARBAMOL AUXILIUM PHARMS LLC Manufacturing (CMC) Approval
05/21/1979 VISTARIL
NDA #011459		 SUPPL-23 HYDROXYZINE PAMOATE PFIZER Labeling Approval
05/21/1979 VISTARIL
NDA #011795		 SUPPL-11 HYDROXYZINE PAMOATE PFIZER Labeling Approval
05/21/1979 ERYTHROCIN
NDA #050182		 SUPPL-66 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
05/21/1979 ACHROMYCIN V
NDA #050263		 SUPPL-65 TETRACYCLINE HYDROCHLORIDE LEDERLE Labeling Approval
05/21/1979 KEFLET
NDA #050440		 SUPPL-34 CEPHALEXIN LILLY Labeling Approval
05/22/1979 OPTIMINE
NDA #017601		 SUPPL-1 AZATADINE MALEATE SCHERING Manufacturing (CMC) Approval
05/22/1979 FLORONE
NDA #017741		 SUPPL-5 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
05/22/1979 PSORCON E
NDA #017994		 SUPPL-4 DIFLORASONE DIACETATE PFIZER Manufacturing (CMC) Approval
05/22/1979 CHLOROPTIC
NDA #050091		 SUPPL-28 CHLORAMPHENICOL ALLERGAN Manufacturing (CMC) Approval
05/23/1979 IMODIUM
NDA #017694		 SUPPL-12 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
05/24/1979 CYTOXAN
NDA #012141		 SUPPL-58 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/24/1979 ECONOPRED
NDA #017468		 SUPPL-5 PREDNISOLONE ACETATE HARROW EYE Manufacturing (CMC) Approval
05/24/1979 OMNIPRED
NDA #017469		 SUPPL-8 PREDNISOLONE ACETATE SANDOZ Manufacturing (CMC) Approval
05/24/1979 DTIC-DOME
NDA #017575		 SUPPL-2 DACARBAZINE BAYER HLTHCARE Manufacturing (CMC) Approval
05/24/1979 NAPROSYN
NDA #017581		 SUPPL-10 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
05/24/1979 BRETHINE
NDA #017849		 SUPPL-7 TERBUTALINE SULFATE ANI PHARMS Labeling Approval
05/24/1979 BICILLIN C-R
NDA #050138		 SUPPL-192 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
05/24/1979 BICILLIN C-R 900/300
NDA #050138		 SUPPL-192 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
05/25/1979 ANTABUSE
NDA #007883		 SUPPL-12 DISULFIRAM TEVA WOMENS Manufacturing (CMC) Approval
05/29/1979 APRESOLINE
NDA #008303		 SUPPL-41 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
05/29/1979 PERIACTIN
NDA #013220		 SUPPL-24 CYPROHEPTADINE HYDROCHLORIDE MERCK Manufacturing (CMC) Approval
05/29/1979 URISPAS
NDA #016769		 SUPPL-24 FLAVOXATE HYDROCHLORIDE ORTHO MCNEIL JANSSEN Labeling Approval
05/29/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017427		 SUPPL-29 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/29/1979 STERILE WATER
NDA #017428		 SUPPL-26 STERILE WATER FOR IRRIGATION BAXTER HLTHCARE Manufacturing (CMC) Approval
05/29/1979 HEPARIN SODIUM
NDA #017651		 SUPPL-7 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
05/29/1979 HEPARIN SODIUM
NDA #017979		 SUPPL-2 HEPARIN SODIUM ABRAXIS PHARM Manufacturing (CMC) Approval
05/30/1979 CAFERGOT
NDA #006620		 SUPPL-17 CAFFEINE; ERGOTAMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
05/30/1979 MEDROL
NDA #011153		 SUPPL-40 METHYLPREDNISOLONE PFIZER Manufacturing (CMC) Approval
05/30/1979 COLBENEMID
NDA #012383		 SUPPL-12 COLCHICINE; PROBENECID MERCK Manufacturing (CMC) Approval
05/30/1979 TOLBUTAMIDE
NDA #012678		 SUPPL-19 TOLBUTAMIDE SANDOZ Labeling Approval
05/30/1979 TOLBUTAMIDE
NDA #012678		 SUPPL-20 TOLBUTAMIDE SANDOZ Labeling Approval
05/30/1979 TOLBUTAMIDE
NDA #012678		 SUPPL-21 TOLBUTAMIDE SANDOZ Labeling Approval
05/30/1979 TOLBUTAMIDE
NDA #012678		 SUPPL-22 TOLBUTAMIDE SANDOZ Labeling Approval
05/30/1979 TALWIN COMPOUND
NDA #016891		 SUPPL-8 ASPIRIN; PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
05/30/1979 PROGESTASERT
NDA #017553		 SUPPL-9 PROGESTERONE ALZA Manufacturing (CMC) Approval
05/30/1979 PROGESTASERT
NDA #017553		 SUPPL-10 PROGESTERONE ALZA Manufacturing (CMC) Approval
05/31/1979 D.H.E. 45
NDA #005929		 SUPPL-3 DIHYDROERGOTAMINE MESYLATE BAUSCH Manufacturing (CMC) Approval
05/31/1979 CAFERGOT
NDA #006620		 SUPPL-19 CAFFEINE; ERGOTAMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
05/31/1979 VALIUM
NDA #016087		 SUPPL-39 DIAZEPAM ROCHE Labeling Approval
05/31/1979 VALISONE
NDA #016322		 SUPPL-9 BETAMETHASONE VALERATE SCHERING Manufacturing (CMC) Approval
05/31/1979 TALWIN 50
NDA #016732		 SUPPL-41 PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
05/31/1979 VALISONE
NDA #016740		 SUPPL-8 BETAMETHASONE VALERATE SCHERING Manufacturing (CMC) Approval
05/31/1979 VALISONE
NDA #016932		 SUPPL-4 BETAMETHASONE VALERATE SCHERING Manufacturing (CMC) Approval
05/31/1979 TRANXENE
NDA #017105		 SUPPL-38 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
05/31/1979 TRANXENE SD
NDA #017105		 SUPPL-38 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
05/31/1979 FIORINAL
NDA #017534		 SUPPL-12 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
05/31/1979 FIORINAL
NDA #017534		 SUPPL-13 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
05/31/1979 FLEXERIL
NDA #017821		 SUPPL-8 CYCLOBENZAPRINE HYDROCHLORIDE JANSSEN RES AND DEV Labeling Approval
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