← FDA DRUG APPROVALS

FDA NDA · NDA019816

ORUVAIL

Sponsor: WYETH PHARMS INC

APPLICATION
NDA019816
TYPE
NDA
ORIGINAL APPROVAL
1993-09-24
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ORUVAIL · ReferenceDiscontinued
KETOPROFEN 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
ORUVAIL · ReferenceDiscontinued
KETOPROFEN 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
ORUVAIL · ReferenceDiscontinued
KETOPROFEN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2009-03-13Labeling · Supplement 8 · standardAP
2007-07-31Labeling · Supplement 11 · standard — Letter ↗AP
2006-01-18Labeling · Supplement 10 · standard — Label ↗AP
1997-08-05Labeling · Supplement 7 · standard — Review ↗AP
1996-03-21Manufacturing (CMC) · Supplement 5 · standardAP
1996-03-21Manufacturing (CMC) · Supplement 6 · standardAP
1996-03-21Manufacturing (CMC) · Supplement 4 · standardAP
1995-02-10Manufacturing (CMC) · Supplement 3 · standardAP
1995-02-08Manufacturing (CMC) · Supplement 1 · standardAP
1995-02-08Labeling · Supplement 2 · standardAP
1993-09-24Type 3 - New Dosage Form · Original · standardAP
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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