Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
December 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 October 21, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
12/06/1995 INVIRASE
NDA #020628
SAQUINAVIR MESYLATE Type 1 - New Molecular Entity Priority HOFFMANN LA ROCHE
12/08/1995 ZYRTEC ALLERGY
NDA #019835
CETIRIZINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard J AND J CONSUMER INC
12/08/1995 ZYRTEC HIVES RELIEF
NDA #019835
CETIRIZINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard J AND J CONSUMER INC
12/08/1995 ETHYOL
NDA #020221
AMIFOSTINE Type 1 - New Molecular Entity Priority CLINIGEN
12/12/1995 RILUTEK
NDA #020599
RILUZOLE Type 1 - New Molecular Entity Priority COVIS PHARMA BV
12/15/1995 VALTREX
NDA #020550
VALACYCLOVIR HYDROCHLORIDE Type 6 - New Indication (no longer used) Priority GLAXOSMITHKLINE
12/15/1995 NIMBEX
NDA #020551
CISATRACURIUM BESYLATE Type 2 - New Active Ingredient Standard ABBVIE
12/15/1995 NIMBEX PRESERVATIVE FREE
NDA #020551
CISATRACURIUM BESYLATE Type 2 - New Active Ingredient Standard ABBVIE
12/19/1995 RETROVIR
NDA #020518
ZIDOVUDINE Type 3 - New Dosage Form Standard VIIV HLTHCARE
12/19/1995 ZANTAC 75
NDA #020520
RANITIDINE HYDROCHLORIDE Type 3 - New Dosage Form Standard SANOFI US
12/20/1995 CEDAX
NDA #050685
CEFTIBUTEN DIHYDRATE Type 1 - New Molecular Entity Standard SI PHARMS
12/20/1995 CEDAX
NDA #050686
CEFTIBUTEN DIHYDRATE Type 3 - New Dosage Form Standard SI PHARMS
12/21/1995 OXILAN-300
NDA #020316
IOXILAN Type 1 - New Molecular Entity Standard GUERBET
12/21/1995 OXILAN-350
NDA #020316
IOXILAN Type 1 - New Molecular Entity Standard GUERBET
12/21/1995 FEMSTAT 3
NDA #020421
BUTOCONAZOLE NITRATE Type 3 - New Dosage Form Standard BAYER
12/21/1995 IONTOCAINE
NDA #020530
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard IOMED
12/22/1995 LUPRON DEPOT
NDA #020517
LEUPROLIDE ACETATE Type 3 - New Dosage Form Standard ABBVIE ENDOCRINE INC
12/27/1995 PHOTOFRIN
NDA #020451
PORFIMER SODIUM Type 1 - New Molecular Entity Priority PINNACLE BIOLGS
12/27/1995 ARIMIDEX
NDA #020541
ANASTROZOLE Type 1 - New Molecular Entity Standard ANI PHARMS INC
12/28/1995 CORVERT
NDA #020491
IBUTILIDE FUMARATE Type 1 - New Molecular Entity Standard PHARMACIA AND UPJOHN
12/29/1995 RENOVA
NDA #019963
TRETINOIN Type 3 - New Dosage Form Standard VALEANT PHARMS NORTH
12/29/1995 NUTROPIN AQ
BLA #020522
SOMATROPIN GENENTECH
12/29/1995 NUTROPIN AQ NUSPIN
BLA #020522
SOMATROPIN GENENTECH
12/29/1995 NUTROPIN AQ PEN
BLA #020522
SOMATROPIN GENENTECH

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