Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
October 2002

This report lists all applications approved for the first time during the selected month. It includes New Molecular Entities (NMEs) and new biologics. * It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history.* Not all biologics are in Drugs@FDA.

This report was produced on September 23, 2019.

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
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination
Meaning
Priority: Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies
Standard: Review designation assigned to applications for drugs that do not meet the priority review designation criteria

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