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FDA ANDA · ANDA074879

KETOPROFEN

Sponsor: ALKERMES GAINESVILLE

APPLICATION
ANDA074879
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-10
LATEST ACTION
2002-03-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

KETOPROFENDiscontinued
KETOPROFEN 200MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2002-03-18Manufacturing (CMC) · Supplement 7AP
2000-09-25Manufacturing (CMC) · Supplement 3AP
1998-09-18Manufacturing (CMC) · Supplement 2AP
1998-09-08Manufacturing (CMC) · Supplement 1AP
1997-12-10OriginalReviewAP
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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