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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
November 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 April 25, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
11/08/2002 ACIPHEX
NDA #021456		 RABEPRAZOLE SODIUM Type 6 - New Indication (no longer used) Standard EISAI MEDCL RES
11/14/2002 MITOZYTREX
NDA #050763		 MITOMYCIN Type 3 - New Dosage Form Standard SUPERGEN
11/15/2002 ABILIFY
NDA #021436		 ARIPIPRAZOLE Type 1 - New Molecular Entity Standard OTSUKA
11/22/2002 ALINIA
NDA #021498		 NITAZOXANIDE Type 1 - New Molecular Entity Priority ROMARK
11/26/2002 FORTEO
NDA #021318		 TERIPARATIDE Type 3 - New Dosage Form Standard LILLY
11/26/2002 STRATTERA
NDA #021411		 ATOMOXETINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard LILLY
11/27/2002 LEXAPRO
NDA #021365		 ESCITALOPRAM OXALATE Type 3 - New Dosage Form Standard ABBVIE
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