APPLICATION
ANDA072299
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-01
LATEST ACTION
2006-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2006-03-31Labeling · Supplement 14AP
2004-09-29Labeling · Supplement 12AP
1999-12-01Labeling · Supplement 10AP
1996-07-24Manufacturing (CMC) · Supplement 8AP
1996-07-23Manufacturing (CMC) · Supplement 9AP
1994-06-28Manufacturing (CMC) · Supplement 7AP
1993-08-24Manufacturing (CMC) · Supplement 6AP
1991-09-23Manufacturing (CMC) · Supplement 1AP
1991-09-23Manufacturing (CMC) · Supplement 2AP
1991-09-23Manufacturing (CMC) · Supplement 3AP
1989-12-12Bioequivalence · Supplement 4AP
1988-07-01OriginalAP
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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