Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 December 05, 2021.

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 EGALET 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 ALLERGAN 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 HERITAGE PHARMS INC Manufacturing (CMC) Approval
08/15/1979 LIMBITROL DS
NDA #016949
SUPPL-10 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE HERITAGE PHARMS INC 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 UPJOHN Labeling Approval
08/16/1979 DILANTIN-30
NDA #008762
SUPPL-13 PHENYTOIN UPJOHN 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 ENDO PHARMS 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English