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FDA NDA · NDA021647

VIOXX

Sponsor: MERCK

APPLICATION
NDA021647
TYPE
NDA
ORIGINAL APPROVAL
2004-03-26
LATEST ACTION
2004-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VIOXXDiscontinued
ROFECOXIB 50MG · TABLET · ORAL
VIOXXDiscontinued
ROFECOXIB 12.5MG · TABLET · ORAL
VIOXXDiscontinued
ROFECOXIB 25MG · TABLET · ORAL

Approval history

2004-03-26Type 6 - New Indication (no longer used) · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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