APPLICATION
ANDA075270
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-24
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
KETOPROFENDiscontinued
KETOPROFEN 150MG · CAPSULE, EXTENDED RELEASE · ORAL
KETOPROFENDiscontinued
KETOPROFEN 200MG · CAPSULE, EXTENDED RELEASE · ORAL
KETOPROFENDiscontinued
KETOPROFEN 100MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2016-05-09Labeling · Supplement 13 · standardAP
2008-02-21Labeling · Supplement 10AP
2006-09-22Labeling · Supplement 8AP
2006-07-03Labeling · Supplement 7AP
2002-12-24Manufacturing (CMC) · Supplement 3AP
2002-09-20Manufacturing (CMC) · Supplement 2AP
2000-02-04Manufacturing (CMC) · Supplement 1AP
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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