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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
August 1976

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

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 16, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
08/02/1976 DEXEDRINE
NDA #017078		 DEXTROAMPHETAMINE SULFATE Type 5 - New Formulation or New Manufacturer Standard IMPAX LABS INC
08/04/1976 GLEOSTINE
NDA #017588		 LOMUSTINE Type 1 - New Molecular Entity Standard LATINA PHARMA
08/05/1976 TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT
NDA #017562		 TECHNETIUM TC-99M ETIDRONATE KIT Type 5 - New Formulation or New Manufacturer Standard GE HEALTHCARE
08/30/1976 DURANEST
NDA #017751		 EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard ASTRAZENECA
08/30/1976 DURANEST
NDA #017751		 EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard ASTRAZENECA
08/30/1976 DURANEST
NDA #017751		 ETIDOCAINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard ASTRAZENECA
08/30/1976 DURANEST
NDA #021384		 EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE DENTSPLY PHARM
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