APPLICATION
ANDA074035
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
KETOPROFENDiscontinued
KETOPROFEN 75MG · CAPSULE · ORAL
KETOPROFENDiscontinued
KETOPROFEN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2021-04-28Labeling · Supplement 15 · standardAP
2016-05-09Labeling · Supplement 13 · standardAP
2008-01-08Labeling · Supplement 9AP
2006-07-03Labeling · Supplement 6AP
2002-06-26Manufacturing (CMC) · Supplement 4AP
1998-02-20Labeling · Supplement 3AP
1998-02-05Manufacturing (CMC) · Supplement 2AP
1997-07-22Labeling · Supplement 1AP
1996-12-31OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.