APPLICATION
ANDA073516
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
KETOPROFENPrescription
KETOPROFEN 50MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 31 · standardAP
2021-04-28Labeling · Supplement 30 · standardAP
2016-05-09Labeling · Supplement 28 · standardAP
2006-11-29Labeling · Supplement 23AP
2006-03-08Labeling · Supplement 21AP
2001-10-24Manufacturing (CMC) · Supplement 16AP
2000-07-07Manufacturing (CMC) · Supplement 15AP
2000-01-14Manufacturing (CMC) · Supplement 14AP
1999-03-26Manufacturing (CMC) · Supplement 13AP
1998-07-14Manufacturing (CMC) · Supplement 12AP
1998-03-17Labeling · Supplement 9AP
1997-12-10Manufacturing (CMC) · Supplement 11AP
1997-05-13Manufacturing (CMC) · Supplement 10AP
1997-03-14Manufacturing (CMC) · Supplement 7AP
1997-03-14Manufacturing (CMC) · Supplement 8AP
1995-07-31Manufacturing (CMC) · Supplement 5AP
1995-02-16Manufacturing (CMC) · Supplement 3AP
1994-09-06Manufacturing (CMC) · Supplement 2AP
1994-07-15Manufacturing (CMC) · Supplement 1AP
1992-12-22OriginalAP
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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