← FDA DRUG APPROVALS

FDA NDA · NDA021042

VIOXX

Sponsor: MERCK

APPLICATION
NDA021042
TYPE
NDA
ORIGINAL APPROVAL
1999-05-20
LATEST ACTION
2016-05-09
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

2016-05-09Labeling · Supplement 33 · standard — Letter ↗AP
2004-09-14Labeling · Supplement 28 · standard — Review ↗AP
2004-08-19Efficacy · Supplement 26 · priority — Letter ↗AP
2003-12-16Labeling · Supplement 23 · standard — Review ↗AP
2003-12-16Labeling · Supplement 24 · standard — Review ↗AP
2003-08-06Efficacy · Supplement 18 · standard — Letter ↗AP
2003-06-27Labeling · Supplement 21 · standard — Letter ↗AP
2003-06-27Labeling · Supplement 22 · standard — Review ↗AP
2003-06-27Labeling · Supplement 20 · standard — Review ↗AP
2003-05-19Labeling · Supplement 17 · standard — Review ↗AP
2002-06-25Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
2002-04-11Efficacy · Supplement 7 · standard — Letter ↗AP
2002-04-11Labeling · Supplement 13 · standard — Review ↗AP
2002-04-11Labeling · Supplement 8 · standard — Label ↗AP
2002-04-11Labeling · Supplement 14 · standard — Letter ↗AP
2002-04-11Efficacy · Supplement 12 · standard — Letter ↗AP
2002-04-11Labeling · Supplement 10 · standard — Review ↗AP
2002-04-06Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2001-06-13Manufacturing (CMC) · Supplement 11 · priority — Review ↗AP
2001-01-10Manufacturing (CMC) · Supplement 9 · priority — Letter ↗AP
2000-08-10Manufacturing (CMC) · Supplement 6 · priorityAP
2000-03-17Labeling · Supplement 3 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 4 · priority — Review ↗AP
2000-02-25Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
1999-10-28Labeling · Supplement 2 · standard — Review ↗AP
1999-05-20Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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