Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
November 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 July 11, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
11/17/1995 PREMPHASE 14/14
NDA #020527
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Type 3 - New Dosage Form Standard WYETH PHARMS
11/17/1995 PREMPRO
NDA #020527
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Type 3 - New Dosage Form Standard WYETH PHARMS
11/17/1995 EPIVIR
NDA #020564
LAMIVUDINE Type 1 - New Molecular Entity Priority VIIV HLTHCARE
11/17/1995 EPIVIR
NDA #020596
LAMIVUDINE Type 3 - New Dosage Form Priority VIIV HLTHCARE
11/17/1995 DOXIL (LIPOSOMAL)
NDA #050718
DOXORUBICIN HYDROCHLORIDE Type 3 - New Dosage Form Standard BAXTER HLTHCARE CORP
11/20/1995 ABELCET
NDA #050724
AMPHOTERICIN B Type 2 - New Active Ingredient Priority LEADIANT BIOSCI INC
11/22/1995 VESANOID
NDA #020438
TRETINOIN Type 3 - New Dosage Form Priority CHEPLAPHARM
11/30/1995 AMARYL
NDA #020496
GLIMEPIRIDE Type 1 - New Molecular Entity Standard SANOFI AVENTIS US

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