← FDA DRUG APPROVALS

FDA NDA · NDA021052

VIOXX

Sponsor: MERCK

APPLICATION
NDA021052
TYPE
NDA
ORIGINAL APPROVAL
1999-05-20
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

VIOXXDiscontinued
ROFECOXIB 25MG/5ML · SUSPENSION · ORAL
VIOXXDiscontinued
ROFECOXIB 12.5MG/5ML · SUSPENSION · ORAL

Approval history

2016-05-09Labeling · Supplement 24 · standard — Letter ↗AP
2004-09-14Labeling · Supplement 21 · standard — Letter ↗AP
2004-08-19Efficacy · Supplement 19 · priority — Review ↗AP
2003-12-16Labeling · Supplement 17 · standard — Review ↗AP
2003-08-06Efficacy · Supplement 12 · standard — Label ↗AP
2003-06-27Labeling · Supplement 16 · standard — Review ↗AP
2003-06-27Labeling · Supplement 14 · standard — Review ↗AP
2003-06-27Labeling · Supplement 15 · standard — Review ↗AP
2003-05-19Labeling · Supplement 11 · standard — Review ↗AP
2002-06-25Manufacturing (CMC) · Supplement 10 · priority — Review ↗AP
2002-04-11Labeling · Supplement 8 · standard — Letter ↗AP
2002-04-11Labeling · Supplement 6 · standard — Letter ↗AP
2002-04-11Efficacy · Supplement 4 · standard — Letter ↗AP
2002-04-11Labeling · Supplement 9 · standard — Label ↗AP
2002-04-11Efficacy · Supplement 7 · unknown — Label ↗AP
2002-04-11Labeling · Supplement 5 · standard — Review ↗AP
2000-03-17Labeling · Supplement 3 · standardAP
2000-03-02Manufacturing (CMC) · Supplement 2 · priorityAP
1999-10-28Labeling · Supplement 1 · standardAP
1999-05-20Type 3 - New Dosage Form · Original · priority — Label ↗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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