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FDA NDA · NDA020429

ORUDIS KT

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APPLICATION
NDA020429
TYPE
NDA
ORIGINAL APPROVAL
1995-10-06
LATEST ACTION
2004-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ORUDIS KT · ReferenceDiscontinued
KETOPROFEN 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2004-09-10Labeling · Supplement 8 · standard — Letter ↗AP
2004-08-30Labeling · Supplement 7 · standard — Letter ↗AP
2002-02-20Manufacturing (CMC) · Supplement 5 · standardAP
2000-08-23Labeling · Supplement 4 · standardAP
1998-10-14Manufacturing (CMC) · Supplement 3 · standardAP
1995-12-26Labeling · Supplement 2 · standardAP
1995-11-03Labeling · Supplement 1 · standardAP
1995-10-06Type 3 - New Dosage Form · Original · standardAP
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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