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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
July 1996

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 September 20, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
07/03/1996 NICOTROL
NDA #020536		 NICOTINE Type 8 - Partial Rx to OTC Switch Standard MCNEIL CONS
07/03/1996 KADIAN
NDA #020616		 MORPHINE SULFATE Type 3 - New Dosage Form Standard ALLERGAN
07/03/1996 MORPHINE SULFATE
NDA #020631		 MORPHINE SULFATE Type 5 - New Formulation or New Manufacturer Standard SPECGX LLC
07/03/1996 MYOSCINT
BLA #103634		 IMCIROMAB PENTETATE CENTOCOR INC
07/12/1996 ULTIVA
NDA #020630		 REMIFENTANIL HYDROCHLORIDE Type 1 - New Molecular Entity Standard MYLAN INSTITUTIONAL
07/18/1996 ZITHROMAX
NDA #050711		 AZITHROMYCIN Type 3 - New Dosage Form Standard PFIZER
07/22/1996 DOVONEX
NDA #020554		 CALCIPOTRIENE Type 3 - New Dosage Form Standard LEO PHARMA AS
07/25/1996 ALLEGRA
NDA #020625		 FEXOFENADINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard CHATTEM SANOFI
07/29/1996 GYNE-LOTRIMIN 3
NDA #020525		 CLOTRIMAZOLE Type 8 - Partial Rx to OTC Switch Standard BAYER HEALTHCARE LLC
07/29/1996 GYNE-LOTRIMIN 3 COMBINATION PACK
NDA #020526		 CLOTRIMAZOLE Type 8 - Partial Rx to OTC Switch Standard BAYER HEALTHCARE LLC
07/31/1996 ESTRADIOL
NDA #020538		 ESTRADIOL Type 5 - New Formulation or New Manufacturer Standard SANDOZ
07/31/1996 VIVELLE-DOT
NDA #020538		 ESTRADIOL Type 5 - New Formulation or New Manufacturer Standard SANDOZ
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