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FDA NDA · NDA021341

BEXTRA

Sponsor: GD SEARLE

APPLICATION
NDA021341
TYPE
NDA
ORIGINAL APPROVAL
2001-11-16
LATEST ACTION
2004-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BEXTRADiscontinued
VALDECOXIB 20MG · TABLET · ORAL
BEXTRADiscontinued
VALDECOXIB 10MG · TABLET · ORAL

Approval history

2004-11-24Labeling · Supplement 6 · standard — Letter ↗AP
2004-04-23Efficacy · Supplement 3 · standard — Letter ↗AP
2002-11-01Labeling · Supplement 2 · standard — Review ↗AP
2001-11-16Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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