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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
September 1986

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 23, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
09/08/1986 MAGNESIUM SULFATE
NDA #019316		 MAGNESIUM SULFATE Type 5 - New Formulation or New Manufacturer Standard FRESENIUS KABI USA
09/09/1986 PCE
NDA #050611		 ERYTHROMYCIN Type 3 - New Dosage Form Standard AZURITY
09/10/1986 ESTRADERM
NDA #019081		 ESTRADIOL Type 3 - New Dosage Form Standard NOVARTIS
09/18/1986 FERTINEX
NDA #019415		 UROFOLLITROPIN Type 2 - New Active Ingredient Standard SERONO
09/18/1986 METRODIN
NDA #019415		 UROFOLLITROPIN Type 2 - New Active Ingredient Standard SERONO
09/24/1986 ERYTHROCIN
NDA #050609		 ERYTHROMYCIN LACTOBIONATE Type 3 - New Dosage Form Standard HOSPIRA
09/25/1986 CALCIJEX
NDA #018874		 CALCITRIOL Type 3 - New Dosage Form Standard ABBVIE
09/29/1986 BUSPAR
NDA #018731		 BUSPIRONE HYDROCHLORIDE Type 1 - New Molecular Entity Priority BRISTOL MYERS SQUIBB
09/30/1986 TEGISON
NDA #019369		 ETRETINATE Type 1 - New Molecular Entity Priority ROCHE
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