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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 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 10, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/1979 PREDNISONE
ANDA #086813		 ORIG-1 PREDNISONE WATSON LABS Approval
06/04/1979 CORTEF
NDA #009900		 SUPPL-16 HYDROCORTISONE CYPIONATE PHARMACIA AND UPJOHN Labeling Approval
06/04/1979 KENACORT
NDA #011283		 SUPPL-38 TRIAMCINOLONE DELCOR ASSET CORP Labeling Approval
06/04/1979 DESFERAL
NDA #016267		 SUPPL-11 DEFEROXAMINE MESYLATE NOVARTIS Efficacy Approval
06/04/1979 DESFERAL
NDA #016267		 SUPPL-12 DEFEROXAMINE MESYLATE NOVARTIS Labeling Approval
06/04/1979 RENAMIN W/O ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 10% W/O ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 3.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 5.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 5.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 8.5% W/ ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 TRAVASOL 8.5% W/O ELECTROLYTES
NDA #017493		 SUPPL-23 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
06/04/1979 OVCON-50
NDA #017576		 SUPPL-16 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Labeling Approval
06/04/1979 OVCON-35
NDA #017716		 SUPPL-17 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Labeling Approval
06/04/1979 OVCON-35
NDA #018127		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Labeling Approval
06/04/1979 OVCON-50
NDA #018128		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Labeling Approval
06/05/1979 TRANXENE
NDA #017105		 SUPPL-37 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/05/1979 TRANXENE SD
NDA #017105		 SUPPL-37 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/05/1979 BUTALBITAL, ASPIRIN AND CAFFEINE
ANDA #086162		 ORIG-1 ASPIRIN; BUTALBITAL; CAFFEINE HIKMA INTL PHARMS Approval
06/06/1979 PROVERA
NDA #011839		 SUPPL-35 MEDROXYPROGESTERONE ACETATE PFIZER Efficacy Approval
06/06/1979 IVADANTIN
NDA #012402		 SUPPL-15 NITROFURANTOIN SODIUM PROCTER AND GAMBLE Manufacturing (CMC) Approval
06/06/1979 IVADANTIN
NDA #012402		 SUPPL-16 NITROFURANTOIN SODIUM PROCTER AND GAMBLE Labeling Approval
06/06/1979 DEXEDRINE
NDA #017078		 SUPPL-7 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
06/07/1979 TRIDIONE
NDA #005856		 SUPPL-8 TRIMETHADIONE ABBVIE Manufacturing (CMC) Approval
06/07/1979 TOFRANIL-PM
NDA #017090		 SUPPL-35 IMIPRAMINE PAMOATE SPECGX LLC Manufacturing (CMC) Approval
06/07/1979 TOFRANIL-PM
NDA #017090		 SUPPL-36 IMIPRAMINE PAMOATE SPECGX LLC Manufacturing (CMC) Approval
06/07/1979 TRANXENE
NDA #017105		 SUPPL-34 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 TRANXENE
NDA #017105		 SUPPL-35 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 TRANXENE
NDA #017105		 SUPPL-36 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 TRANXENE SD
NDA #017105		 SUPPL-34 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 TRANXENE SD
NDA #017105		 SUPPL-35 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 TRANXENE SD
NDA #017105		 SUPPL-36 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
06/07/1979 NAPROSYN
NDA #017581		 SUPPL-12 NAPROXEN ATNAHS PHARMA US Manufacturing (CMC) Approval
06/07/1979 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #018046		 SUPPL-4 DEXTROSE B BRAUN Manufacturing (CMC) Approval
06/07/1979 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #018046		 SUPPL-5 DEXTROSE B BRAUN Labeling Approval
06/08/1979 CYSTOGRAFIN
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 CYSTOGRAFIN
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 CYSTOGRAFIN
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-30
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-30
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-30
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-60
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-60
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-60
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-DIP
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-DIP
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENO-DIP
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-60
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-60
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-60
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-76
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-76
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOGRAFIN-76
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST II
NDA #010040		 SUPPL-100 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST II
NDA #010040		 SUPPL-101 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 RENOVIST II
NDA #010040		 SUPPL-102 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/08/1979 HEXADROL
NDA #012675		 SUPPL-8 DEXAMETHASONE ASPEN GLOBAL INC Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016730		 SUPPL-11 DEXTROSE B BRAUN Manufacturing (CMC) Approval
06/08/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017464		 SUPPL-5 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017510		 SUPPL-6 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
06/08/1979 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018023		 SUPPL-6 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018026		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018030		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
NDA #018030		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #018030		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #018030		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018030		 SUPPL-5 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #018046		 SUPPL-6 DEXTROSE B BRAUN Manufacturing (CMC) Approval
06/08/1979 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018047		 SUPPL-4 DEXTROSE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
06/08/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018184		 ORIG-1 SODIUM CHLORIDE B BRAUN Approval
06/11/1979 INTROPIN
NDA #017395		 SUPPL-8 DOPAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/11/1979 INTROPIN
NDA #017395		 SUPPL-9 DOPAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/11/1979 INTROPIN
NDA #017395		 SUPPL-10 DOPAMINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/11/1979 NEBCIN
NDA #050519		 ORIG-1 TOBRAMYCIN SULFATE LILLY Type 3 - New Dosage Form Approval
06/12/1979 SURMONTIL
NDA #016792		 ORIG-1 TRIMIPRAMINE MALEATE ODYSSEY PHARMS Type 1 - New Molecular Entity Approval
06/12/1979 CARISOPRODOL
ANDA #086179		 ORIG-1 CARISOPRODOL WATSON LABS TEVA Approval
06/13/1979 NESACAINE
NDA #009435		 SUPPL-10 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/13/1979 NESACAINE-MPF
NDA #009435		 SUPPL-10 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/14/1979 MESANTOIN
NDA #006008		 SUPPL-25 MEPHENYTOIN NOVARTIS Manufacturing (CMC) Approval
06/14/1979 ISONIAZID
NDA #008428		 SUPPL-22 ISONIAZID PANRAY Manufacturing (CMC) Approval
06/14/1979 HYDERGINE
NDA #009087		 SUPPL-25 ERGOLOID MESYLATES NOVARTIS Manufacturing (CMC) Approval
06/14/1979 KEMADRIN
NDA #009818		 SUPPL-11 PROCYCLIDINE HYDROCHLORIDE MONARCH PHARMS Manufacturing (CMC) Approval
06/14/1979 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-2 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-2 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 SILVADENE
NDA #017381		 SUPPL-15 SILVER SULFADIAZINE KING PHARMS LLC Labeling Approval
06/14/1979 MONISTAT 7
NDA #017450		 SUPPL-13 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
06/14/1979 MONISTAT 7
NDA #017450		 SUPPL-14 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
06/14/1979 PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017451		 SUPPL-2 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-2 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 VANCERIL
NDA #017573		 SUPPL-2 BECLOMETHASONE DIPROPIONATE SCHERING Labeling Approval
06/14/1979 VANCERIL
NDA #017573		 SUPPL-5 BECLOMETHASONE DIPROPIONATE SCHERING Labeling Approval
06/14/1979 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
NDA #017648		 SUPPL-2 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-2 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-2 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-2 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
NDA #017648		 SUPPL-2 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 MELLARIL-S
NDA #017923		 SUPPL-4 THIORIDAZINE NOVARTIS Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 PAMELOR
NDA #018013		 SUPPL-3 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
06/14/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018016		 SUPPL-2 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
NDA #018037		 SUPPL-2 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/14/1979 ERYTHROMYCIN ESTOLATE
ANDA #062087		 ORIG-1 ERYTHROMYCIN ESTOLATE WATSON LABS Approval
06/15/1979 VANCERIL
NDA #017573		 SUPPL-7 BECLOMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
06/15/1979 PAMELOR
NDA #018012		 SUPPL-3 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Manufacturing (CMC) Approval
06/15/1979 INDERIDE-40/25
NDA #018031		 ORIG-1 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE WYETH PHARMS INC Type 4 - New Combination Approval
06/15/1979 INDERIDE-80/25
NDA #018031		 ORIG-1 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE WYETH PHARMS INC Type 4 - New Combination Approval
06/15/1979 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
NDA #018186		 ORIG-1 SODIUM LACTATE B BRAUN Approval
06/18/1979 CORTRIL
NDA #009176		 SUPPL-5 HYDROCORTISONE PFIZER GLOBAL Labeling Approval
06/18/1979 SOLU-CORTEF
NDA #009866		 SUPPL-43 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
06/18/1979 MUCOMYST
NDA #013601		 SUPPL-33 ACETYLCYSTEINE APOTHECON Manufacturing (CMC) Approval
06/18/1979 ALDOCLOR-150
NDA #016016		 SUPPL-35 CHLOROTHIAZIDE; METHYLDOPA MERCK Manufacturing (CMC) Approval
06/18/1979 ALDOCLOR-150
NDA #016016		 SUPPL-36 CHLOROTHIAZIDE; METHYLDOPA MERCK Manufacturing (CMC) Approval
06/18/1979 ALDOCLOR-250
NDA #016016		 SUPPL-35 CHLOROTHIAZIDE; METHYLDOPA MERCK Manufacturing (CMC) Approval
06/18/1979 ALDOCLOR-250
NDA #016016		 SUPPL-36 CHLOROTHIAZIDE; METHYLDOPA MERCK Manufacturing (CMC) Approval
06/18/1979 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-17 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/18/1979 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-17 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/18/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-17 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
06/18/1979 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-17 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
06/18/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #017633		 SUPPL-12 GLYCINE HOSPIRA Manufacturing (CMC) Approval
06/19/1979 CYTOXAN
NDA #012142		 SUPPL-43 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/19/1979 CYTOXAN (LYOPHILIZED)
NDA #012142		 SUPPL-43 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/19/1979 LYOPHILIZED CYTOXAN
NDA #012142		 SUPPL-43 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/19/1979 GLYCINE 1.5% IN PLASTIC CONTAINER
NDA #016784		 SUPPL-3 GLYCINE B BRAUN Labeling Approval
06/19/1979 MODICON 21
NDA #017488		 SUPPL-45 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
06/19/1979 ORTHO-NOVUM 1/35-21
NDA #017489		 SUPPL-40 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Manufacturing (CMC) Approval
06/19/1979 MODICON 28
NDA #017735		 SUPPL-23 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
06/19/1979 ORTHO-NOVUM 1/35-28
NDA #017919		 SUPPL-10 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Manufacturing (CMC) Approval
06/19/1979 ERYTHROCIN
NDA #050182		 SUPPL-67 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
06/20/1979 PERIACTIN
NDA #012649		 SUPPL-27 CYPROHEPTADINE HYDROCHLORIDE MERCK Labeling Approval
06/20/1979 MEGACE
NDA #016979		 SUPPL-15 MEGESTROL ACETATE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
06/20/1979 MOTRIN
NDA #017463		 SUPPL-42 IBUPROFEN MCNEIL CONSUMER Manufacturing (CMC) Approval
06/20/1979 DIPROSONE
NDA #017691		 SUPPL-5 BETAMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
06/20/1979 CHRONULAC
NDA #017884		 ORIG-1 LACTULOSE SANOFI AVENTIS US Type 5 - New Formulation or New Manufacturer Approval
06/20/1979 ERYTHROCIN
NDA #050182		 SUPPL-68 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
06/20/1979 LINCOCIN
NDA #050316		 SUPPL-87 LINCOMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
06/20/1979 LINCOCIN
NDA #050317		 SUPPL-148 LINCOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
06/21/1979 DIENESTROL
NDA #006110		 SUPPL-15 DIENESTROL ORTHO MCNEIL PHARM Efficacy Approval
06/21/1979 QUINIDEX
NDA #012796		 SUPPL-18 QUINIDINE SULFATE WYETH PHARMS INC Labeling Approval
06/21/1979 EDECRIN
NDA #016092		 SUPPL-15 ETHACRYNIC ACID BAUSCH Manufacturing (CMC) Approval
06/21/1979 EDECRIN
NDA #016093		 SUPPL-15 ETHACRYNATE SODIUM BAUSCH Manufacturing (CMC) Approval
06/21/1979 MICRONOR
NDA #016954		 SUPPL-39 NORETHINDRONE JANSSEN PHARMS REMS Approval
06/25/1979 LEVO-DROMORAN
NDA #008720		 SUPPL-9 LEVORPHANOL TARTRATE VALEANT PHARM INTL Manufacturing (CMC) Approval
06/25/1979 MEDIHALER ERGOTAMINE
NDA #012102		 SUPPL-5 ERGOTAMINE TARTRATE 3M Labeling Approval
06/25/1979 ISMELIN
NDA #012329		 SUPPL-42 GUANETHIDINE MONOSULFATE NOVARTIS Manufacturing (CMC) Approval
06/25/1979 ISMELIN
NDA #012329		 SUPPL-43 GUANETHIDINE MONOSULFATE NOVARTIS Manufacturing (CMC) Approval
06/25/1979 ISMELIN
NDA #012329		 SUPPL-44 GUANETHIDINE MONOSULFATE NOVARTIS Manufacturing (CMC) Approval
06/25/1979 LASIX
NDA #016363		 SUPPL-28 FUROSEMIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
06/25/1979 ALUPENT
NDA #017571		 SUPPL-10 METAPROTERENOL SULFATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
06/25/1979 DITROPAN
NDA #017577		 SUPPL-8 OXYBUTYNIN CHLORIDE JANSSEN PHARMS Labeling Approval
06/25/1979 IMODIUM
NDA #017694		 SUPPL-11 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
06/26/1979 SYNCURINE
NDA #006931		 SUPPL-3 DECAMETHONIUM BROMIDE GLAXOSMITHKLINE Manufacturing (CMC) Approval
06/26/1979 ACTHAR
NDA #007504		 SUPPL-15 CORTICOTROPIN SANOFI AVENTIS US Labeling Approval
06/26/1979 ACTHAR
NDA #007504		 SUPPL-16 CORTICOTROPIN SANOFI AVENTIS US Labeling Approval
06/26/1979 ACTHAR GEL
NDA #008372		 SUPPL-18 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL
NDA #008372		 SUPPL-20 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL
NDA #008372		 SUPPL-21 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL
NDA #008372		 SUPPL-22 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
06/26/1979 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-18 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-20 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-21 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
06/26/1979 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-22 CORTICOTROPIN MALLINCKRODT ARD Manufacturing (CMC) Approval
06/26/1979 CYSTOGRAFIN
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 RENO-30
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 RENO-60
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 RENO-DIP
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE BRACCO Labeling Approval
06/26/1979 RENOGRAFIN-60
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/26/1979 RENOGRAFIN-76
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/26/1979 RENOVIST
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/26/1979 RENOVIST II
NDA #010040		 SUPPL-93 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Labeling Approval
06/26/1979 SINOGRAFIN
NDA #011324		 SUPPL-20 DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE BRACCO Labeling Approval
06/26/1979 DIMETANE-TEN
NDA #011418		 SUPPL-14 BROMPHENIRAMINE MALEATE WYETH AYERST Manufacturing (CMC) Approval
06/26/1979 DIMETANE-TEN
NDA #011418		 SUPPL-15 BROMPHENIRAMINE MALEATE WYETH AYERST Labeling Approval
06/26/1979 CARBOCAINE
NDA #012250		 SUPPL-12 MEPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/26/1979 ALUPENT
NDA #015874		 SUPPL-20 METAPROTERENOL SULFATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
06/26/1979 VANCERIL
NDA #017573		 SUPPL-6 BECLOMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
06/26/1979 TECHNETIUM TC 99M MPI MDP
NDA #018141		 ORIG-1 TECHNETIUM TC-99M MEDRONATE KIT GE HEALTHCARE Type 5 - New Formulation or New Manufacturer Approval
06/26/1979 RIFADIN
NDA #050420		 SUPPL-49 RIFAMPIN SANOFI AVENTIS US Labeling Approval
06/26/1979 PENICILLIN G POTASSIUM
ANDA #060306		 ORIG-1 PENICILLIN G POTASSIUM TEVA Approval
06/27/1979 DEXEDRINE
NDA #017078		 SUPPL-8 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
06/28/1979 MEPHYTON
NDA #010104		 SUPPL-6 PHYTONADIONE BAUSCH Labeling Approval
06/28/1979 NUBAIN
NDA #018024		 SUPPL-1 NALBUPHINE HYDROCHLORIDE PAR PHARM INC Labeling Approval
06/28/1979 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018229		 ORIG-1 DEXTROSE; SODIUM CHLORIDE B BRAUN Type 5 - New Formulation or New Manufacturer Approval
06/28/1979 CLEOCIN HYDROCHLORIDE
NDA #050162		 SUPPL-64 CLINDAMYCIN HYDROCHLORIDE PFIZER Labeling Approval
06/29/1979 FURADANTIN
NDA #008693		 SUPPL-17 NITROFURANTOIN PROCTER AND GAMBLE Manufacturing (CMC) Approval
06/29/1979 ESIDRIX
NDA #011793		 SUPPL-45 HYDROCHLOROTHIAZIDE NOVARTIS Manufacturing (CMC) Approval
06/29/1979 ESIDRIX
NDA #011793		 SUPPL-46 HYDROCHLOROTHIAZIDE NOVARTIS Manufacturing (CMC) Approval
06/29/1979 ESIDRIX
NDA #011793		 SUPPL-47 HYDROCHLOROTHIAZIDE NOVARTIS Manufacturing (CMC) Approval
06/29/1979 DARVOCET-N 100
NDA #017122		 SUPPL-16 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE XANODYNE PHARM Manufacturing (CMC) Approval
06/29/1979 DARVOCET-N 50
NDA #017122		 SUPPL-16 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE XANODYNE PHARM Manufacturing (CMC) Approval
06/29/1979 MONISTAT 7
NDA #017450		 SUPPL-15 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
06/29/1979 SLOW-K
NDA #017476		 SUPPL-13 POTASSIUM CHLORIDE NOVARTIS Manufacturing (CMC) Approval
06/29/1979 TAGAMET
NDA #017920		 SUPPL-19 CIMETIDINE GLAXOSMITHKLINE Labeling Approval
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