APPLICATION
ANDA075679
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-20
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription
Products
KETOPROFENDiscontinued
KETOPROFEN 100MG · CAPSULE, EXTENDED RELEASE · ORAL
KETOPROFENPrescription
KETOPROFEN 200MG · CAPSULE, EXTENDED RELEASE · ORAL
KETOPROFENDiscontinued
KETOPROFEN 150MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 19 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2016-05-09Labeling · Supplement 7 · standardAP
2008-01-08Labeling · Supplement 4AP
2006-07-03Labeling · Supplement 2AP
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.