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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 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 June 21, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/03/1979 MYAMBUTOL
NDA #016320		 SUPPL-37 ETHAMBUTOL HYDROCHLORIDE STI PHARMA LLC Manufacturing (CMC) Approval
04/03/1979 MYAMBUTOL
NDA #016320		 SUPPL-38 ETHAMBUTOL HYDROCHLORIDE STI PHARMA LLC Manufacturing (CMC) Approval
04/03/1979 ALUPENT
NDA #017571		 SUPPL-9 METAPROTERENOL SULFATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
04/03/1979 CAPITROL
NDA #017594		 SUPPL-2 CHLOROXINE WESTWOOD SQUIBB Manufacturing (CMC) Approval
04/03/1979 BRETHINE
NDA #017849		 SUPPL-8 TERBUTALINE SULFATE ANI PHARMS Manufacturing (CMC) Approval
04/03/1979 BRETHINE
NDA #017849		 SUPPL-9 TERBUTALINE SULFATE ANI PHARMS Manufacturing (CMC) Approval
04/03/1979 BRETHINE
NDA #017849		 SUPPL-10 TERBUTALINE SULFATE ANI PHARMS Manufacturing (CMC) Approval
04/03/1979 ALBAMYCIN
NDA #050339		 SUPPL-33 NOVOBIOCIN SODIUM PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
04/04/1979 MILTOWN
NDA #009698		 SUPPL-21 MEPROBAMATE MEDPOINTE PHARM HLC Manufacturing (CMC) Approval
04/04/1979 BIPHETAMINE 12.5
NDA #010093		 SUPPL-11 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Labeling Approval
04/04/1979 BIPHETAMINE 20
NDA #010093		 SUPPL-11 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Labeling Approval
04/04/1979 BIPHETAMINE 7.5
NDA #010093		 SUPPL-11 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Labeling Approval
04/04/1979 TRANCOPAL
NDA #011467		 SUPPL-9 CHLORMEZANONE SANOFI AVENTIS US Labeling Approval
04/04/1979 VALIUM
NDA #013263		 SUPPL-45 DIAZEPAM WAYLIS THERAP Manufacturing (CMC) Approval
04/04/1979 MEPROBAMATE
NDA #014474		 SUPPL-19 MEPROBAMATE STANLABS PHARM Labeling Approval
04/04/1979 CITANEST
NDA #014763		 SUPPL-14 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
04/04/1979 CITANEST FORTE
NDA #014763		 SUPPL-14 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
04/04/1979 CITANEST PLAIN
NDA #014763		 SUPPL-14 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
04/04/1979 SERENTIL
NDA #016774		 SUPPL-35 MESORIDAZINE BESYLATE NOVARTIS Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-13 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-16 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-13 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-16 BUPIVACAINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-13 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-16 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-13 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-16 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Manufacturing (CMC) Approval
04/04/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018090		 ORIG-1 SODIUM CHLORIDE ICU MEDICAL INC Type 5 - New Formulation or New Manufacturer Approval
04/04/1979 CECLOR
NDA #050521		 ORIG-1 CEFACLOR LILLY Type 1 - New Molecular Entity Approval
04/04/1979 CECLOR
NDA #050522		 ORIG-1 CEFACLOR LILLY Type 2 - New Active Ingredient Approval
04/04/1979 METHYLPHENIDATE HYDROCHLORIDE
ANDA #086428		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Approval
04/04/1979 METHYLPHENIDATE HYDROCHLORIDE
ANDA #086429		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Approval
04/05/1979 PRONESTYL
NDA #007335		 SUPPL-40 PROCAINAMIDE HYDROCHLORIDE APOTHECON Labeling Approval
04/05/1979 MEDROL
NDA #011153		 SUPPL-39 METHYLPREDNISOLONE PFIZER Manufacturing (CMC) Approval
04/05/1979 MEDROL
NDA #011153		 SUPPL-42 METHYLPREDNISOLONE PFIZER Manufacturing (CMC) Approval
04/05/1979 TRANCOPAL
NDA #011467		 SUPPL-10 CHLORMEZANONE SANOFI AVENTIS US Manufacturing (CMC) Approval
04/05/1979 MINITEC
NDA #017339		 SUPPL-17 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR BRACCO Labeling Approval
04/05/1979 IMODIUM
NDA #017694		 SUPPL-9 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
04/05/1979 IMODIUM
NDA #017694		 SUPPL-10 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
04/05/1979 TAGAMET
NDA #017939		 SUPPL-17 CIMETIDINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
04/05/1979 HYDERGINE
NDA #017993		 SUPPL-3 ERGOLOID MESYLATES NOVARTIS Manufacturing (CMC) Approval
04/05/1979 ERYTHROCIN
NDA #050182		 SUPPL-61 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
04/06/1979 ROBINUL
NDA #012827		 SUPPL-18 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
04/06/1979 ROBINUL FORTE
NDA #012827		 SUPPL-18 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
04/06/1979 RENESE
NDA #012845		 SUPPL-20 POLYTHIAZIDE PFIZER Manufacturing (CMC) Approval
04/06/1979 VANCERIL
NDA #017573		 SUPPL-4 BECLOMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
04/06/1979 TOLECTIN
NDA #017628		 SUPPL-8 TOLMETIN SODIUM ORTHO MCNEIL JANSSEN Efficacy Approval
04/06/1979 TOLECTIN 600
NDA #017628		 SUPPL-8 TOLMETIN SODIUM ORTHO MCNEIL JANSSEN Efficacy Approval
04/06/1979 CALCIMAR
NDA #017769		 SUPPL-4 CALCITONIN SALMON SANOFI AVENTIS US Manufacturing (CMC) Approval
04/06/1979 TIMOPTIC
NDA #018086		 SUPPL-4 TIMOLOL MALEATE BAUSCH AND LOMB INC Labeling Approval
04/09/1979 XYLOCAINE
NDA #006488		 SUPPL-17 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/09/1979 XYLOCAINE
NDA #006488		 SUPPL-18 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
04/09/1979 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-17 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
04/09/1979 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-18 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
04/09/1979 APRESOLINE
NDA #008303		 SUPPL-38 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
04/09/1979 APRESOLINE
NDA #008303		 SUPPL-39 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
04/09/1979 APRESOLINE
NDA #008303		 SUPPL-40 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
04/09/1979 CITANEST
NDA #014763		 SUPPL-13 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Manufacturing (CMC) Approval
04/09/1979 CITANEST FORTE
NDA #014763		 SUPPL-13 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE ASTRAZENECA Manufacturing (CMC) Approval
04/09/1979 CITANEST PLAIN
NDA #014763		 SUPPL-13 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Manufacturing (CMC) Approval
04/09/1979 VALIUM
NDA #016087		 SUPPL-38 DIAZEPAM ROCHE Manufacturing (CMC) Approval
04/09/1979 TALWIN
NDA #016194		 SUPPL-39 PENTAZOCINE LACTATE HOSPIRA Labeling Approval
04/09/1979 TEGRETOL
NDA #016608		 SUPPL-41 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
04/09/1979 INTRALIPID 10%
NDA #017643		 SUPPL-17 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
04/09/1979 INTRALIPID 10%
NDA #017643		 SUPPL-18 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
04/09/1979 NOVAMINE 11.4%
NDA #017957		 SUPPL-4 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/09/1979 NOVAMINE 15%
NDA #017957		 SUPPL-4 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/09/1979 NOVAMINE 8.5%
NDA #017957		 SUPPL-4 AMINO ACIDS HOSPIRA INC Manufacturing (CMC) Approval
04/09/1979 VEINAMINE 8%
NDA #017957		 SUPPL-4 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE HOSPIRA INC Manufacturing (CMC) Approval
04/09/1979 LOPRESSOR
NDA #017963		 SUPPL-2 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
04/09/1979 LOPRESSOR
NDA #017963		 SUPPL-3 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
04/10/1979 ORTHO-NOVUM 1/50 28
NDA #016709		 SUPPL-49 MESTRANOL; NORETHINDRONE ORTHO MCNEIL JANSSEN Labeling Approval
04/10/1979 WESTCORT
NDA #017950		 SUPPL-3 HYDROCORTISONE VALERATE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/10/1979 TROBICIN
NDA #050347		 SUPPL-35 SPECTINOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
04/10/1979 TROBICIN
NDA #050347		 SUPPL-36 SPECTINOMYCIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
04/10/1979 GRIS-PEG
NDA #050475		 SUPPL-25 GRISEOFULVIN, ULTRAMICROSIZE BAUSCH Manufacturing (CMC) Approval
04/10/1979 AK-PENTOLATE
ANDA #085555		 ORIG-1 CYCLOPENTOLATE HYDROCHLORIDE EPIC PHARMA LLC Approval
04/10/1979 TRIAMCINOLONE ACETONIDE
ANDA #086275		 ORIG-1 TRIAMCINOLONE ACETONIDE TARO Approval
04/10/1979 TRIAMCINOLONE ACETONIDE
ANDA #086276		 ORIG-1 TRIAMCINOLONE ACETONIDE TARO Approval
04/10/1979 TRIAMCINOLONE ACETONIDE
ANDA #086277		 ORIG-1 TRIAMCINOLONE ACETONIDE TARO Approval
04/10/1979 TOLBUTAMIDE
ANDA #086445		 ORIG-1 TOLBUTAMIDE MYLAN PHARMS INC Approval
04/10/1979 PREDNISONE
ANDA #086595		 ORIG-1 PREDNISONE MUTUAL PHARM Approval
04/10/1979 PREDNISONE
ANDA #086596		 ORIG-1 PREDNISONE SUN PHARM INDUSTRIES Approval
04/11/1979 TALWIN 50
NDA #016732		 SUPPL-39 PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
04/11/1979 FIORINAL
NDA #017534		 SUPPL-11 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
04/11/1979 HOMAPIN-10
ANDA #086308		 ORIG-1 HOMATROPINE METHYLBROMIDE MISSION PHARMA Approval
04/11/1979 HOMAPIN-5
ANDA #086309		 ORIG-1 HOMATROPINE METHYLBROMIDE MISSION PHARMA Approval
04/11/1979 EQUIPIN
ANDA #086310		 ORIG-1 HOMATROPINE METHYLBROMIDE MISSION PHARMA Approval
04/12/1979 ROBINUL
NDA #012827		 SUPPL-19 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
04/12/1979 ROBINUL FORTE
NDA #012827		 SUPPL-19 GLYCOPYRROLATE CASPER PHARMA LLC Labeling Approval
04/12/1979 HALDOL
NDA #015922		 SUPPL-13 HALOPERIDOL LACTATE ORTHO MCNEIL Manufacturing (CMC) Approval
04/12/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #016784		 SUPPL-5 GLYCINE B BRAUN Labeling Approval
04/12/1979 THYROLAR-0.25
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 THYROLAR-0.5
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 THYROLAR-1
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 THYROLAR-2
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 THYROLAR-3
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 THYROLAR-5
NDA #016807		 SUPPL-11 LIOTRIX (T4;T3) ALLERGAN Labeling Approval
04/12/1979 LORELCO
NDA #017535		 SUPPL-1 PROBUCOL SANOFI AVENTIS US Labeling Approval
04/12/1979 LORELCO
NDA #017535		 SUPPL-6 PROBUCOL SANOFI AVENTIS US Labeling Approval
04/12/1979 THALLOUS CHLORIDE TL 201
NDA #017806		 SUPPL-5 THALLOUS CHLORIDE TL-201 LANTHEUS MEDCL Manufacturing (CMC) Approval
04/12/1979 THEO-DUR
ANDA #085328		 ORIG-1 THEOPHYLLINE SCHERING Approval
04/13/1979 SOMA
NDA #011792		 SUPPL-20 CARISOPRODOL MYLAN SPECIALITY LP Manufacturing (CMC) Approval
04/13/1979 SYNALAR
NDA #012787		 SUPPL-34 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
04/13/1979 ARISTOSPAN
NDA #016466		 SUPPL-12 TRIAMCINOLONE HEXACETONIDE SANDOZ Labeling Approval
04/13/1979 DESONIDE
NDA #017426		 SUPPL-1 DESONIDE PADAGIS US Manufacturing (CMC) Approval
04/13/1979 PROSTIN F2 ALPHA
NDA #017434		 SUPPL-11 DINOPROST TROMETHAMINE PHARMACIA AND UPJOHN Labeling Approval
04/13/1979 VANCERIL
NDA #017573		 SUPPL-3 BECLOMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
04/13/1979 LIORESAL
NDA #017851		 SUPPL-6 BACLOFEN NOVARTIS Manufacturing (CMC) Approval
04/13/1979 ACEPHEN
NDA #018060		 SUPPL-21 ACETAMINOPHEN COSETTE Labeling Approval
04/13/1979 ERYTHROCIN
NDA #050182		 SUPPL-63 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
04/13/1979 RIMACTANE
NDA #050429		 SUPPL-58 RIFAMPIN OXFORD PHARMS Manufacturing (CMC) Approval
04/16/1979 ETHRANE
NDA #017087		 SUPPL-22 ENFLURANE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/16/1979 MOTRIN
NDA #017463		 SUPPL-41 IBUPROFEN MCNEIL CONSUMER Manufacturing (CMC) Approval
04/16/1979 PHENDIMETRAZINE TARTRATE
NDA #018074		 ORIG-1 PHENDIMETRAZINE TARTRATE VIRTUS Type 5 - New Formulation or New Manufacturer Approval
04/16/1979 RIFADIN
NDA #050420		 SUPPL-51 RIFAMPIN SANOFI AVENTIS US Manufacturing (CMC) Approval
04/16/1979 RIFADIN
NDA #050420		 SUPPL-52 RIFAMPIN SANOFI AVENTIS US Labeling Approval
04/17/1979 TRIPLE SULFAS
NDA #006920		 SUPPL-9 TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE) LEDERLE Manufacturing (CMC) Approval
04/17/1979 NYDRAZID
NDA #008662		 SUPPL-9 ISONIAZID SANDOZ Labeling Approval
04/17/1979 TRIAMCINOLONE ACETONIDE
NDA #011601		 SUPPL-34 TRIAMCINOLONE ACETONIDE MYLAN Labeling Approval
04/17/1979 ORAGRAFIN SODIUM
NDA #012967		 SUPPL-22 IPODATE SODIUM BRACCO Manufacturing (CMC) Approval
04/17/1979 HYPAQUE
NDA #016403		 SUPPL-30 DIATRIZOATE MEGLUMINE GE HEALTHCARE Manufacturing (CMC) Approval
04/17/1979 HYPAQUE-CYSTO
NDA #016403		 SUPPL-30 DIATRIZOATE MEGLUMINE GE HEALTHCARE Manufacturing (CMC) Approval
04/17/1979 DESONIDE
NDA #017010		 SUPPL-5 DESONIDE PADAGIS US Manufacturing (CMC) Approval
04/17/1979 SILVADENE
NDA #017381		 SUPPL-12 SILVER SULFADIAZINE KING PHARMS LLC Manufacturing (CMC) Approval
04/17/1979 COLESTID
NDA #017563		 SUPPL-3 COLESTIPOL HYDROCHLORIDE PFIZER Labeling Approval
04/17/1979 FLAVORED COLESTID
NDA #017563		 SUPPL-3 COLESTIPOL HYDROCHLORIDE PFIZER Labeling Approval
04/17/1979 HALOG
NDA #017824		 SUPPL-9 HALCINONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/18/1979 EXNA
NDA #012489		 SUPPL-11 BENZTHIAZIDE AH ROBINS INC Manufacturing (CMC) Approval
04/18/1979 EXNA
NDA #012489		 SUPPL-12 BENZTHIAZIDE AH ROBINS INC Manufacturing (CMC) Approval
04/18/1979 EXNA
NDA #012489		 SUPPL-13 BENZTHIAZIDE AH ROBINS INC Manufacturing (CMC) Approval
04/18/1979 PROLIXIN ENANTHATE
NDA #016110		 SUPPL-19 FLUPHENAZINE ENANTHATE APOTHECON Labeling Approval
04/18/1979 ARISTOSPAN
NDA #016466		 SUPPL-11 TRIAMCINOLONE HEXACETONIDE SANDOZ Labeling Approval
04/18/1979 ARISTOSPAN
NDA #016466		 SUPPL-13 TRIAMCINOLONE HEXACETONIDE SANDOZ Manufacturing (CMC) Approval
04/18/1979 SODIUM CHLORIDE
NDA #017013		 SUPPL-4 SODIUM CHLORIDE ABBOTT Labeling Approval
04/18/1979 BACTRIM
NDA #017377		 SUPPL-29 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/18/1979 BACTRIM DS
NDA #017377		 SUPPL-29 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
04/18/1979 HALOG
NDA #017823		 SUPPL-7 HALCINONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
04/18/1979 MYCIFRADIN
NDA #050285		 SUPPL-26 NEOMYCIN SULFATE PHARMACIA AND UPJOHN Labeling Approval
04/19/1979 COGENTIN
NDA #009193		 SUPPL-20 BENZTROPINE MESYLATE MERCK Labeling Approval
04/19/1979 VALMID
NDA #009750		 SUPPL-9 ETHINAMATE DISTA Labeling Approval
04/19/1979 COGENTIN
NDA #012015		 SUPPL-13 BENZTROPINE MESYLATE EPIC PHARMA LLC Labeling Approval
04/19/1979 FLAGYL
NDA #012623		 SUPPL-22 METRONIDAZOLE PFIZER Manufacturing (CMC) Approval
04/19/1979 DESONIDE
NDA #017010		 SUPPL-6 DESONIDE PADAGIS US Labeling Approval
04/19/1979 DESONIDE
NDA #017426		 SUPPL-2 DESONIDE PADAGIS US Labeling Approval
04/19/1979 THALLOUS CHLORIDE TL 201
NDA #017806		 SUPPL-6 THALLOUS CHLORIDE TL-201 LANTHEUS MEDCL Manufacturing (CMC) Approval
04/20/1979 TAVIST
NDA #017661		 SUPPL-15 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
04/20/1979 TAVIST
NDA #017661		 SUPPL-16 CLEMASTINE FUMARATE NOVARTIS Labeling Approval
04/20/1979 TAVIST-1
NDA #017661		 SUPPL-15 CLEMASTINE FUMARATE NOVARTIS Manufacturing (CMC) Approval
04/20/1979 TAVIST-1
NDA #017661		 SUPPL-16 CLEMASTINE FUMARATE NOVARTIS Labeling Approval
04/20/1979 KEFLET
NDA #050440		 SUPPL-33 CEPHALEXIN LILLY Manufacturing (CMC) Approval
04/23/1979 PROLIXIN
NDA #011751		 SUPPL-52 FLUPHENAZINE HYDROCHLORIDE APOTHECON Labeling Approval
04/23/1979 MUCOMYST
NDA #013601		 SUPPL-32 ACETYLCYSTEINE APOTHECON Manufacturing (CMC) Approval
04/23/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #017513		 SUPPL-20 STERILE WATER FOR IRRIGATION ICU MEDICAL INC Labeling Approval
04/23/1979 CEFACLOR
ANDA #062206		 ORIG-1 CEFACLOR FACTA FARMA Approval
04/23/1979 CYPROHEPTADINE HYDROCHLORIDE
ANDA #086678		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE MYLAN Approval
04/24/1979 ESKALITH
NDA #016860		 SUPPL-45 LITHIUM CARBONATE NOVEN THERAP Labeling Approval
04/24/1979 LOXITANE
NDA #017525		 SUPPL-16 LOXAPINE SUCCINATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
04/24/1979 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-67 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
04/25/1979 DELTASONE
NDA #009986		 SUPPL-44 PREDNISONE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
04/25/1979 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-24 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
04/25/1979 INTRALIPID 10%
NDA #017643		 SUPPL-13 SOYBEAN OIL FRESENIUS Manufacturing (CMC) Approval
04/25/1979 INTRALIPID 10%
NDA #017643		 SUPPL-14 SOYBEAN OIL FRESENIUS Labeling Approval
04/26/1979 TANDEARIL
NDA #012542		 SUPPL-40 OXYPHENBUTAZONE NOVARTIS Manufacturing (CMC) Approval
04/26/1979 TANDEARIL
NDA #012542		 SUPPL-43 OXYPHENBUTAZONE NOVARTIS Manufacturing (CMC) Approval
04/26/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016733		 SUPPL-19 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
04/26/1979 STERILE WATER IN PLASTIC CONTAINER
NDA #016734		 SUPPL-18 STERILE WATER FOR IRRIGATION B BRAUN Manufacturing (CMC) Approval
04/26/1979 SORBITOL 3.3% IN PLASTIC CONTAINER
NDA #016741		 SUPPL-4 SORBITOL B BRAUN Manufacturing (CMC) Approval
04/26/1979 RESECTISOL IN PLASTIC CONTAINER
NDA #016772		 SUPPL-4 MANNITOL B BRAUN Manufacturing (CMC) Approval
04/26/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #016784		 SUPPL-4 GLYCINE B BRAUN Manufacturing (CMC) Approval
04/26/1979 NORPACE
NDA #017447		 SUPPL-8 DISOPYRAMIDE PHOSPHATE PFIZER Manufacturing (CMC) Approval
04/26/1979 DRAXIMAGE MDP-10
NDA #018035		 SUPPL-3 TECHNETIUM TC-99M MEDRONATE JUBILANT Manufacturing (CMC) Approval
04/26/1979 DRAXIMAGE MDP-25
NDA #018035		 SUPPL-3 TECHNETIUM TC-99M MEDRONATE JUBILANT Manufacturing (CMC) Approval
04/26/1979 LINCOCIN
NDA #050316		 SUPPL-86 LINCOMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Labeling Approval
04/26/1979 DURICEF
NDA #050512		 SUPPL-24 CEFADROXIL/CEFADROXIL HEMIHYDRATE WARNER CHILCOTT Manufacturing (CMC) Approval
04/27/1979 TESLAC
NDA #016118		 SUPPL-13 TESTOLACTONE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/27/1979 TESLAC
NDA #016119		 SUPPL-18 TESTOLACTONE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
04/27/1979 RENAMIN W/O ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 10% W/O ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 3.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 5.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 5.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 8.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
04/27/1979 TRAVASOL 8.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-21 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
04/27/1979 LOPRESSOR
NDA #017963		 SUPPL-6 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
04/27/1979 LOPRESSOR
NDA #017963		 SUPPL-8 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
04/27/1979 LITHOBID
NDA #018027		 ORIG-1 LITHIUM CARBONATE ANI PHARMS Type 5 - New Formulation or New Manufacturer Approval
04/27/1979 ALBAMYCIN
NDA #050339		 SUPPL-34 NOVOBIOCIN SODIUM PHARMACIA AND UPJOHN Labeling Approval
04/30/1979 CYTOXAN
NDA #012141		 SUPPL-56 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/30/1979 MEPROBAMATE
NDA #014474		 SUPPL-18 MEPROBAMATE STANLABS PHARM Labeling Approval
04/30/1979 TALWIN 50
NDA #016732		 SUPPL-40 PENTAZOCINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
04/30/1979 TESULOID
NDA #016923		 SUPPL-9 TECHNETIUM TC-99M SULFUR COLLOID KIT BRACCO Labeling Approval
04/30/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017427		 SUPPL-27 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
04/30/1979 PHYSIOSOL IN PLASTIC CONTAINER
NDA #017637		 SUPPL-9 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Manufacturing (CMC) Approval
04/30/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017670		 SUPPL-8 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
04/30/1979 OSTEOLITE
NDA #017972		 SUPPL-5 TECHNETIUM TC-99M MEDRONATE KIT PHARMALUCENCE Manufacturing (CMC) Approval
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