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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 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 April 23, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/1979 CORTONE
NDA #007750		 SUPPL-11 CORTISONE ACETATE MERCK Labeling Approval
08/01/1979 PHOSPHOLINE IODIDE
NDA #011963		 SUPPL-17 ECHOTHIOPHATE IODIDE FERA PHARMS LLC Labeling Approval
08/01/1979 PERIACTIN
NDA #013220		 SUPPL-25 CYPROHEPTADINE HYDROCHLORIDE MERCK Labeling Approval
08/01/1979 ALUPENT
NDA #016402		 SUPPL-14 METAPROTERENOL SULFATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
08/01/1979 HYDERGINE
NDA #017993		 SUPPL-2 ERGOLOID MESYLATES NOVARTIS Manufacturing (CMC) Approval
08/01/1979 MANDOL
NDA #050504		 SUPPL-35 CEFAMANDOLE NAFATE LILLY Efficacy Approval
08/01/1979 MANDOL
NDA #050504		 SUPPL-37 CEFAMANDOLE NAFATE LILLY Labeling Approval
08/02/1979 APRESOLINE
NDA #008303		 SUPPL-42 HYDRALAZINE HYDROCHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/02/1979 DELATESTRYL
NDA #009165		 SUPPL-9 TESTOSTERONE ENANTHATE ENDO PHARMS Efficacy Approval
08/02/1979 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-36 MANNITOL BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016673		 SUPPL-51 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-51 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016678		 SUPPL-42 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-41 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #016682		 SUPPL-40 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016683		 SUPPL-39 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
NDA #016687		 SUPPL-39 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
NDA #016689		 SUPPL-42 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
NDA #016692		 SUPPL-38 SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 RINGER'S IN PLASTIC CONTAINER
NDA #016693		 SUPPL-39 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #016694		 SUPPL-40 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
NDA #016695		 SUPPL-40 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016696		 SUPPL-39 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #016697		 SUPPL-39 DEXTROSE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-5 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-5 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-4 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017390		 SUPPL-4 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE R IN PLASTIC CONTAINER
NDA #017438		 SUPPL-4 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017451		 SUPPL-5 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-5 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-2 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-4 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-4 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-4 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
NDA #017634		 SUPPL-4 DEXTROSE; POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
NDA #017648		 SUPPL-5 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-5 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-5 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
NDA #017648		 SUPPL-5 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
NDA #017648		 SUPPL-5 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018008		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018016		 SUPPL-5 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
NDA #018037		 SUPPL-5 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/02/1979 TOTACILLIN
ANDA #062212		 ORIG-1 AMPICILLIN/AMPICILLIN TRIHYDRATE GLAXOSMITHKLINE Approval
08/02/1979 AMOXIL
ANDA #062216		 ORIG-1 AMOXICILLIN US ANTIBIOTICS Approval
08/03/1979 CYSTOGRAFIN
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 CYSTOGRAFIN DILUTE
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 DIATRIZOATE MEGLUMINE
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 RENO-30
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 RENO-60
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 RENO-DIP
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE BRACCO Manufacturing (CMC) Approval
08/03/1979 RENOGRAFIN-60
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Manufacturing (CMC) Approval
08/03/1979 RENOGRAFIN-76
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Manufacturing (CMC) Approval
08/03/1979 RENOVIST
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Manufacturing (CMC) Approval
08/03/1979 RENOVIST II
NDA #010040		 SUPPL-108 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Manufacturing (CMC) Approval
08/03/1979 CYTOXAN
NDA #012141		 SUPPL-59 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/03/1979 CYTOXAN
NDA #012142		 SUPPL-44 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/03/1979 CYTOXAN (LYOPHILIZED)
NDA #012142		 SUPPL-44 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/03/1979 LYOPHILIZED CYTOXAN
NDA #012142		 SUPPL-44 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/03/1979 SLOW-K
NDA #017476		 SUPPL-19 POTASSIUM CHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/03/1979 SLOW-K
NDA #017476		 SUPPL-20 POTASSIUM CHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/03/1979 SLOW-K
NDA #017476		 SUPPL-21 POTASSIUM CHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/03/1979 MPI STANNOUS DIPHOSPHONATE
NDA #017667		 SUPPL-3 TECHNETIUM TC-99M ETIDRONATE KIT GE HEALTHCARE Labeling Approval
08/03/1979 ORETON
ANDA #080281		 ORIG-1 METHYLTESTOSTERONE SCHERING Approval
08/03/1979 TOLBUTAMIDE
ANDA #086141		 ORIG-1 TOLBUTAMIDE ALRA Approval
08/03/1979 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #086513		 ORIG-1 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE MYLAN Approval
08/06/1979 BUTAZOLIDIN
NDA #008319		 SUPPL-64 PHENYLBUTAZONE NOVARTIS Labeling Approval
08/06/1979 HYDROCORTONE
NDA #008506		 SUPPL-11 HYDROCORTISONE MERCK Labeling Approval
08/06/1979 ARISTOCORT
NDA #011161		 SUPPL-40 TRIAMCINOLONE ASTELLAS Manufacturing (CMC) Approval
08/06/1979 DEXACORT
NDA #013413		 SUPPL-14 DEXAMETHASONE SODIUM PHOSPHATE UCB INC Labeling Approval
08/06/1979 DEXACORT
NDA #014242		 SUPPL-16 DEXAMETHASONE SODIUM PHOSPHATE UCB INC Labeling Approval
08/06/1979 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016733		 SUPPL-21 SODIUM CHLORIDE B BRAUN Labeling Approval
08/06/1979 CLINORIL
NDA #017911		 SUPPL-4 SULINDAC MERCK Labeling Approval
08/06/1979 RINGER'S IN PLASTIC CONTAINER
NDA #018156		 ORIG-1 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Type 5 - New Formulation or New Manufacturer Approval
08/06/1979 ACETIC ACID 0.25% IN PLASTIC CONTAINER
NDA #018161		 ORIG-1 ACETIC ACID, GLACIAL B BRAUN Type 5 - New Formulation or New Manufacturer Approval
08/07/1979 DYRENIUM
NDA #013174		 SUPPL-39 TRIAMTERENE CONCORDIA Labeling Approval
08/07/1979 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-25 MANNITOL BAXTER HLTHCARE Labeling Approval
08/07/1979 BRICANYL
NDA #017466		 SUPPL-9 TERBUTALINE SULFATE SANOFI AVENTIS US Labeling Approval
08/07/1979 LOPRESSOR
NDA #017963		 SUPPL-5 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
08/07/1979 LIDOCAINE HYDROCHLORIDE
ANDA #086283		 ORIG-1 LIDOCAINE HYDROCHLORIDE INTL MEDICATION Approval
08/08/1979 PHENERGAN
NDA #008857		 SUPPL-7 PROMETHAZINE HYDROCHLORIDE WYETH AYERST Labeling Approval
08/08/1979 PHENERGAN
NDA #008857		 SUPPL-8 PROMETHAZINE HYDROCHLORIDE WYETH AYERST Manufacturing (CMC) Approval
08/08/1979 DORIDEN
NDA #009519		 SUPPL-10 GLUTETHIMIDE SANOFI AVENTIS US Labeling Approval
08/08/1979 HYDELTRA-TBA
NDA #010562		 SUPPL-14 PREDNISOLONE TEBUTATE MERCK Labeling Approval
08/08/1979 HYDELTRA-TBA
NDA #010562		 SUPPL-15 PREDNISOLONE TEBUTATE MERCK Labeling Approval
08/08/1979 HYDELTRA-TBA
NDA #010562		 SUPPL-16 PREDNISOLONE TEBUTATE MERCK Labeling Approval
08/08/1979 TANDEARIL
NDA #012542		 SUPPL-48 OXYPHENBUTAZONE NOVARTIS Manufacturing (CMC) Approval
08/08/1979 NEURAMATE
NDA #014359		 SUPPL-42 MEPROBAMATE HALSEY Labeling Approval
08/08/1979 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-6 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Labeling Approval
08/08/1979 INDOCIN
NDA #016059		 SUPPL-39 INDOMETHACIN ZYLA LIFE SCIENCES Labeling Approval
08/08/1979 DECADRON-LA
NDA #016675		 SUPPL-12 DEXAMETHASONE ACETATE MERCK Labeling Approval
08/08/1979 NORMOSOL-R IN PLASTIC CONTAINER
NDA #017586		 SUPPL-32 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE ICU MEDICAL INC Labeling Approval
08/08/1979 CLINORIL
NDA #017911		 SUPPL-3 SULINDAC MERCK Labeling Approval
08/08/1979 CLINORIL
NDA #017911		 SUPPL-7 SULINDAC MERCK Manufacturing (CMC) Approval
08/09/1979 FML
NDA #016851		 SUPPL-26 FLUOROMETHOLONE ABBVIE Manufacturing (CMC) Approval
08/10/1979 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-6 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/10/1979 PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017390		 SUPPL-6 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/13/1979 URECHOLINE
NDA #006536		 SUPPL-20 BETHANECHOL CHLORIDE ODYSSEY PHARMS Labeling Approval
08/13/1979 SYNALAR
NDA #012787		 SUPPL-37 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
08/13/1979 QUIDE
NDA #013615		 SUPPL-29 PIPERACETAZINE DOW PHARM Labeling Approval
08/13/1979 SYNALAR
NDA #013960		 SUPPL-28 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
08/13/1979 SYNALAR
NDA #015296		 SUPPL-32 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
08/13/1979 SYNALAR-HP
NDA #016161		 SUPPL-24 FLUOCINOLONE ACETONIDE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
08/13/1979 LIDEX
NDA #016908		 SUPPL-28 FLUOCINONIDE ALVOGEN Manufacturing (CMC) Approval
08/13/1979 LIDEX-E
NDA #016908		 SUPPL-28 FLUOCINONIDE ALVOGEN Manufacturing (CMC) Approval
08/13/1979 LIDEX
NDA #016909		 SUPPL-23 FLUOCINONIDE ALVOGEN Manufacturing (CMC) Approval
08/13/1979 FLUOCINONIDE
NDA #017373		 SUPPL-12 FLUOCINONIDE ALVOGEN Manufacturing (CMC) Approval
08/13/1979 INFED
NDA #017441		 SUPPL-105 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-106 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-107 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-108 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-109 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-110 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/13/1979 INFED
NDA #017441		 SUPPL-111 FERRIC OXYHYDROXIDE ALLERGAN Labeling Approval
08/14/1979 CLISTIN
NDA #008955		 SUPPL-6 CARBINOXAMINE MALEATE MCNEIL Labeling Approval
08/14/1979 CLISTIN
NDA #008955		 SUPPL-7 CARBINOXAMINE MALEATE MCNEIL Manufacturing (CMC) Approval
08/14/1979 SODIUM PERTECHNETATE TC 99M
NDA #017725		 SUPPL-2 TECHNETIUM TC-99M SODIUM PERTECHNETATE MALLINCKRODT Labeling Approval
08/14/1979 CLINORIL
NDA #017911		 SUPPL-1 SULINDAC MERCK Manufacturing (CMC) Approval
08/15/1979 CORTONE
NDA #007110		 SUPPL-9 CORTISONE ACETATE MERCK Labeling Approval
08/15/1979 HYDROCORTONE
NDA #008228		 SUPPL-13 HYDROCORTISONE ACETATE MERCK Labeling Approval
08/15/1979 HYDROCORTONE
NDA #008506		 SUPPL-10 HYDROCORTISONE MERCK Labeling Approval
08/15/1979 HYDELTRA-TBA
NDA #010562		 SUPPL-18 PREDNISOLONE TEBUTATE MERCK Labeling Approval
08/15/1979 DECADRON
NDA #011664		 SUPPL-31 DEXAMETHASONE MERCK Labeling Approval
08/15/1979 DECADRON
NDA #012071		 SUPPL-26 DEXAMETHASONE SODIUM PHOSPHATE MERCK Labeling Approval
08/15/1979 DECADRON
NDA #012376		 SUPPL-17 DEXAMETHASONE MERCK Labeling Approval
08/15/1979 DEXACORT
NDA #013413		 SUPPL-15 DEXAMETHASONE SODIUM PHOSPHATE UCB INC Labeling Approval
08/15/1979 ORTHO-NOVUM 1/50 28
NDA #016709		 SUPPL-81 MESTRANOL; NORETHINDRONE ORTHO MCNEIL JANSSEN Labeling Approval
08/15/1979 LIMBITROL
NDA #016949		 SUPPL-10 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Manufacturing (CMC) Approval
08/15/1979 LIMBITROL DS
NDA #016949		 SUPPL-10 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Manufacturing (CMC) Approval
08/15/1979 MICRONOR
NDA #016954		 SUPPL-47 NORETHINDRONE JANSSEN PHARMS Labeling Approval
08/15/1979 PROGESTERONE
NDA #017362		 SUPPL-51 PROGESTERONE ACTAVIS LABS UT INC Labeling Approval
08/15/1979 DANTRIUM
NDA #017443		 SUPPL-20 DANTROLENE SODIUM PAR STERILE PRODUCTS Manufacturing (CMC) Approval
08/15/1979 DANTRIUM
NDA #017443		 SUPPL-21 DANTROLENE SODIUM PAR STERILE PRODUCTS Manufacturing (CMC) Approval
08/15/1979 MODICON 21
NDA #017488		 SUPPL-59 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Labeling Approval
08/15/1979 MODICON 21
NDA #017488		 SUPPL-62 ETHINYL ESTRADIOL; NORETHINDRONE ORTHO MCNEIL PHARM Labeling Approval
08/15/1979 MODICON 28
NDA #017735		 SUPPL-37 ETHINYL ESTRADIOL; NORETHINDRONE JANSSEN PHARMS Labeling Approval
08/15/1979 DEPO-ESTRADIOL
ANDA #085470		 ORIG-1 ESTRADIOL CYPIONATE PFIZER Approval
08/15/1979 DIETHYLPROPION HYDROCHLORIDE
ANDA #085741		 ORIG-1 DIETHYLPROPION HYDROCHLORIDE WATSON LABS Approval
08/16/1979 DILANTIN-125
NDA #008762		 SUPPL-13 PHENYTOIN VIATRIS Labeling Approval
08/16/1979 DILANTIN-30
NDA #008762		 SUPPL-13 PHENYTOIN VIATRIS Labeling Approval
08/16/1979 MIOCHOL
NDA #016211		 SUPPL-9 ACETYLCHOLINE CHLORIDE NOVARTIS Manufacturing (CMC) Approval
08/16/1979 MOBAN
NDA #017111		 SUPPL-28 MOLINDONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/16/1979 INTRALIPID 10%
NDA #017643		 SUPPL-23 SOYBEAN OIL FRESENIUS Labeling Approval
08/17/1979 DEXACORT
NDA #014242		 SUPPL-18 DEXAMETHASONE SODIUM PHOSPHATE UCB INC Labeling Approval
08/17/1979 SORBITOL 3.3% IN PLASTIC CONTAINER
NDA #016741		 SUPPL-3 SORBITOL B BRAUN Labeling Approval
08/17/1979 RESECTISOL IN PLASTIC CONTAINER
NDA #016772		 SUPPL-3 MANNITOL B BRAUN Labeling Approval
08/17/1979 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018096		 ORIG-1 DEXTROSE; SODIUM CHLORIDE HOSPIRA Type 5 - New Formulation or New Manufacturer Approval
08/20/1979 ORETICYL 25
NDA #012148		 SUPPL-8 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/20/1979 ORETICYL 25
NDA #012148		 SUPPL-10 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/20/1979 ORETICYL 50
NDA #012148		 SUPPL-8 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/20/1979 ORETICYL 50
NDA #012148		 SUPPL-10 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/20/1979 ORETICYL FORTE
NDA #012148		 SUPPL-8 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/20/1979 ORETICYL FORTE
NDA #012148		 SUPPL-10 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
08/21/1979 CORTISONE ACETATE
NDA #009458		 SUPPL-60 CORTISONE ACETATE IMPAX LABS Labeling Approval
08/21/1979 CORTISONE ACETATE
NDA #009458		 SUPPL-61 CORTISONE ACETATE IMPAX LABS Labeling Approval
08/21/1979 CORTISONE ACETATE
NDA #009458		 SUPPL-62 CORTISONE ACETATE IMPAX LABS Labeling Approval
08/21/1979 CORTISONE ACETATE
NDA #009458		 SUPPL-63 CORTISONE ACETATE IMPAX LABS Labeling Approval
08/21/1979 CORTISONE ACETATE
NDA #009458		 SUPPL-65 CORTISONE ACETATE IMPAX LABS Labeling Approval
08/21/1979 COMPAZINE
NDA #010571		 SUPPL-58 PROCHLORPERAZINE MALEATE GLAXOSMITHKLINE Labeling Approval
08/21/1979 COMPAZINE
NDA #010742		 SUPPL-31 PROCHLORPERAZINE EDISYLATE GLAXOSMITHKLINE Labeling Approval
08/21/1979 COMPAZINE
NDA #011000		 SUPPL-46 PROCHLORPERAZINE MALEATE GLAXOSMITHKLINE Labeling Approval
08/21/1979 COMPAZINE
NDA #011127		 SUPPL-28 PROCHLORPERAZINE GLAXOSMITHKLINE Labeling Approval
08/21/1979 COMPAZINE
NDA #011188		 SUPPL-22 PROCHLORPERAZINE EDISYLATE GLAXOSMITHKLINE Labeling Approval
08/21/1979 COMPAZINE
NDA #011276		 SUPPL-23 PROCHLORPERAZINE EDISYLATE GLAXOSMITHKLINE Labeling Approval
08/21/1979 KENACORT
NDA #011283		 SUPPL-40 TRIAMCINOLONE DELCOR ASSET CORP Manufacturing (CMC) Approval
08/21/1979 KENALOG-10
NDA #012041		 SUPPL-19 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
08/21/1979 KENALOG IN ORABASE
NDA #012097		 SUPPL-14 TRIAMCINOLONE ACETONIDE DELCOR ASSET CORP Manufacturing (CMC) Approval
08/21/1979 KENACORT
NDA #012515		 SUPPL-17 TRIAMCINOLONE DIACETATE DELCOR ASSET CORP Manufacturing (CMC) Approval
08/21/1979 KENALOG-40
NDA #014901		 SUPPL-19 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
08/21/1979 KENALOG-80
NDA #014901		 SUPPL-19 TRIAMCINOLONE ACETONIDE APOTHECON Manufacturing (CMC) Approval
08/21/1979 LASIX
NDA #016363		 SUPPL-20 FUROSEMIDE SANOFI AVENTIS US Manufacturing (CMC) Approval
08/21/1979 MOTRIN
NDA #017463		 SUPPL-24 IBUPROFEN MCNEIL CONSUMER Labeling Approval
08/21/1979 MOTRIN
NDA #017463		 SUPPL-40 IBUPROFEN MCNEIL CONSUMER Efficacy Approval
08/21/1979 RIMACTANE
NDA #050429		 SUPPL-59 RIFAMPIN OXFORD PHARMS Manufacturing (CMC) Approval
08/22/1979 GALLIUM CITRATE GA 67
NDA #017700		 SUPPL-2 GALLIUM CITRATE GA-67 GE HEALTHCARE Labeling Approval
08/22/1979 ERYTHROCIN
NDA #050182		 SUPPL-70 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
08/22/1979 TOPICYCLINE
NDA #050493		 SUPPL-19 TETRACYCLINE HYDROCHLORIDE SHIRE Manufacturing (CMC) Approval
08/23/1979 PROGESTERONE
NDA #017362		 SUPPL-52 PROGESTERONE ACTAVIS LABS UT INC Labeling Approval
08/23/1979 PROGESTERONE
NDA #017362		 SUPPL-53 PROGESTERONE ACTAVIS LABS UT INC Labeling Approval
08/24/1979 COLBENEMID
NDA #012383		 SUPPL-16 COLCHICINE; PROBENECID MERCK Labeling Approval
08/24/1979 LINCOCIN
NDA #050317		 SUPPL-149 LINCOMYCIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
08/24/1979 HYDROXYZINE
ANDA #085551		 ORIG-1 HYDROXYZINE HYDROCHLORIDE BAXTER HLTHCARE Approval
08/24/1979 HYDROXYZINE HYDROCHLORIDE
ANDA #085551		 ORIG-1 HYDROXYZINE HYDROCHLORIDE BAXTER HLTHCARE Approval
08/26/1979 DECADRON
NDA #011984		 SUPPL-17 DEXAMETHASONE SODIUM PHOSPHATE MERCK Labeling Approval
08/27/1979 QUINAGLUTE
NDA #016647		 SUPPL-13 QUINIDINE GLUCONATE BAYER HLTHCARE Manufacturing (CMC) Approval
08/27/1979 QUINAGLUTE
NDA #016647		 SUPPL-14 QUINIDINE GLUCONATE BAYER HLTHCARE Manufacturing (CMC) Approval
08/27/1979 PRONESTYL
NDA #017371		 SUPPL-16 PROCAINAMIDE HYDROCHLORIDE APOTHECON Manufacturing (CMC) Approval
08/27/1979 CHLOROPTIC
NDA #050091		 SUPPL-29 CHLORAMPHENICOL ALLERGAN Manufacturing (CMC) Approval
08/27/1979 ERYTHROCIN
NDA #050182		 SUPPL-71 ERYTHROMYCIN LACTOBIONATE HOSPIRA Manufacturing (CMC) Approval
08/27/1979 TOTACILLIN
ANDA #062223		 ORIG-1 AMPICILLIN/AMPICILLIN TRIHYDRATE GLAXOSMITHKLINE Approval
08/28/1979 TESSALON
NDA #011210		 SUPPL-20 BENZONATATE PFIZER Manufacturing (CMC) Approval
08/28/1979 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #017521		 ORIG-1 DEXTROSE BAXTER HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 OVCON-35
NDA #017716		 SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT LLC Manufacturing (CMC) Approval
08/28/1979 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #018080		 ORIG-1 DEXTROSE ICU MEDICAL INC Type 5 - New Formulation or New Manufacturer Approval
08/28/1979 DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
NDA #018256		 ORIG-1 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Approval
08/28/1979 ACHROMYCIN
NDA #050273		 SUPPL-26 TETRACYCLINE HYDROCHLORIDE LEDERLE Manufacturing (CMC) Approval
08/29/1979 XYLOCAINE
NDA #006488		 SUPPL-21 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/29/1979 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-21 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/29/1979 XYLOCAINE 4% PRESERVATIVE FREE
NDA #010417		 SUPPL-4 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/29/1979 XYLOCAINE 5% W/ GLUCOSE 7.5%
NDA #010496		 SUPPL-7 LIDOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 CITANEST
NDA #014763		 SUPPL-15 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 CITANEST FORTE
NDA #014763		 SUPPL-15 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 CITANEST PLAIN
NDA #014763		 SUPPL-15 PRILOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 XYLOCAINE 1.5% W/ DEXTROSE 7.5%
NDA #016297		 SUPPL-6 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/29/1979 DIPROSONE
NDA #017691		 SUPPL-6 BETAMETHASONE DIPROPIONATE SCHERING Manufacturing (CMC) Approval
08/29/1979 DURANEST
NDA #017751		 SUPPL-1 EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 DURANEST
NDA #017751		 SUPPL-1 EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 DURANEST
NDA #017751		 SUPPL-1 ETIDOCAINE HYDROCHLORIDE ASTRAZENECA Labeling Approval
08/29/1979 CIS-MDP
NDA #018124		 ORIG-1 TECHNETIUM TC-99M MEDRONATE KIT SUN PHARM INDS INC Type 5 - New Formulation or New Manufacturer Approval
08/29/1979 OVCON-35
NDA #018127		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE WARNER CHILCOTT Manufacturing (CMC) Approval
08/29/1979 QUINIDINE SULFATE
ANDA #087011		 ORIG-1 QUINIDINE SULFATE DAVA PHARMS INC Approval
08/30/1979 DIAMOX
NDA #008943		 SUPPL-26 ACETAZOLAMIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
08/30/1979 SERENTIL
NDA #016774		 SUPPL-34 MESORIDAZINE BESYLATE NOVARTIS Manufacturing (CMC) Approval
08/30/1979 SERENTIL
NDA #016775		 SUPPL-7 MESORIDAZINE BESYLATE NOVARTIS Manufacturing (CMC) Approval
08/30/1979 DEXEDRINE
NDA #017078		 SUPPL-9 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
08/31/1979 NEPHRAMINE 5.4%
NDA #017766		 SUPPL-4 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
08/31/1979 NEPHRAMINE 5.4%
NDA #017766		 SUPPL-5 AMINO ACIDS B BRAUN Labeling Approval
08/31/1979 COLY-MYCIN M
NDA #050108		 SUPPL-16 COLISTIMETHATE SODIUM PAR STERILE PRODUCTS Labeling Approval
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