Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 2002

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 February 27, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/07/2002 CHLORAPREP ONE-STEP SEPP
NDA #021555
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL Type 3 - New Dosage Form Standard BECTON DICKINSON CO
10/07/2002 CHLORAPREP SINGLE SWABSTICK
NDA #021555
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL Type 3 - New Dosage Form Standard BECTON DICKINSON CO
10/07/2002 CHLORAPREP TRIPLE SWABSTICK
NDA #021555
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL Type 3 - New Dosage Form Standard BECTON DICKINSON CO
10/08/2002 SUBUTEX
NDA #020732
BUPRENORPHINE HYDROCHLORIDE Type 3 - New Dosage Form Standard INDIVIOR INC
10/08/2002 SUBOXONE
NDA #020733
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Type 4 - New Combination Priority INDIVIOR INC
10/10/2002 AVANDAMET
NDA #021410
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Type 4 - New Combination Standard SB PHARMCO
10/16/2002 PEGASYS
BLA #103964
PEGINTERFERON ALFA-2A HOFFMAN-LA ROCHE
10/17/2002 DAYPRO ALTA
NDA #020776
OXAPROZIN POTASSIUM Type 2 - New Active Ingredient Standard GD SEARLE
10/17/2002 MENTAX-TC
NDA #021408
BUTENAFINE HYDROCHLORIDE Type 3 - New Dosage Form Standard MYLAN
10/18/2002 MIDOL LIQUID GELS
NDA #021472
IBUPROFEN Type 3 - New Dosage Form Standard BIONPHARMA INC
10/21/2002 METAGLIP
NDA #021460
GLIPIZIDE; METFORMIN HYDROCHLORIDE Type 4 - New Combination Standard BRISTOL MYERS SQUIBB
10/24/2002 THYRO-TABS
NDA #021116
LEVOTHYROXINE SODIUM Type 5 - New Formulation or New Manufacturer Standard ALVOGEN
10/25/2002 ZETIA
NDA #021445
EZETIMIBE Type 1 - New Molecular Entity Standard MSD INTL GMBH
10/31/2002 NICORETTE
NDA #021330
NICOTINE POLACRILEX Type 3 - New Dosage Form Standard GLAXOSMITHKLINE CONS
10/31/2002 TESTIM
NDA #021454
TESTOSTERONE Type 3 - New Dosage Form Standard AUXILIUM PHARMS LLC

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