APPLICATION
ANDA073515
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-22
LATEST ACTION
1999-03-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
KETOPROFENDiscontinued
KETOPROFEN 25MG · CAPSULE · ORAL
Approval history
1999-03-26Manufacturing (CMC) · Supplement 12AP
1998-07-14Manufacturing (CMC) · Supplement 11AP
1998-03-17Labeling · Supplement 8AP
1997-12-10Manufacturing (CMC) · Supplement 10AP
1997-05-13Manufacturing (CMC) · Supplement 9AP
1997-03-14Manufacturing (CMC) · Supplement 7AP
1997-03-14Manufacturing (CMC) · Supplement 6AP
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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