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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
September 1995

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 May 03, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
09/06/1995 DDAVP
NDA #019955		 DESMOPRESSIN ACETATE Type 3 - New Dosage Form Standard FERRING PHARMS INC
09/06/1995 PRECOSE
NDA #020482		 ACARBOSE Type 1 - New Molecular Entity Standard BAYER HLTHCARE
09/11/1995 TIAZAC
NDA #020401		 DILTIAZEM HYDROCHLORIDE Type 3 - New Dosage Form Standard BAUSCH
09/13/1995 AZELEX
NDA #020428		 AZELAIC ACID Type 1 - New Molecular Entity Standard ALMIRALL
09/14/1995 COREG
NDA #020297		 CARVEDILOL Type 1 - New Molecular Entity Standard WOODWARD
09/15/1995 PROPULSID
NDA #020398		 CISAPRIDE MONOHYDRATE Type 3 - New Dosage Form Standard JANSSEN PHARMS
09/18/1995 BACTROBAN
NDA #050703		 MUPIROCIN CALCIUM Type 2 - New Active Ingredient Standard GLAXOSMITHKLINE
09/20/1995 FLOLAN
NDA #020444		 EPOPROSTENOL SODIUM Type 1 - New Molecular Entity Priority GLAXOSMITHKLINE LLC
09/20/1995 METROCREAM
NDA #020531		 METRONIDAZOLE Type 3 - New Dosage Form Standard GALDERMA LABS LP
09/28/1995 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019971		 DEXTROSE Type 5 - New Formulation or New Manufacturer Standard DHL
09/29/1995 ANDRODERM
NDA #020489		 TESTOSTERONE Type 3 - New Dosage Form Standard ABBVIE
09/29/1995 FOSAMAX
NDA #020560		 ALENDRONATE SODIUM Type 1 - New Molecular Entity Priority ORGANON
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