APPLICATION
ANDA071735
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-10
LATEST ACTION
2006-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2006-03-22Labeling · Supplement 19AP
1999-12-01Labeling · Supplement 17AP
1996-07-24Manufacturing (CMC) · Supplement 12AP
1996-07-23Manufacturing (CMC) · Supplement 16AP
1996-04-24Manufacturing (CMC) · Supplement 13AP
1996-04-24Manufacturing (CMC) · Supplement 14AP
1996-03-15Manufacturing (CMC) · Supplement 15AP
1994-09-30Manufacturing (CMC) · Supplement 11AP
1993-08-24Manufacturing (CMC) · Supplement 10AP
1991-08-27Manufacturing (CMC) · Supplement 5AP
1991-08-27Manufacturing (CMC) · Supplement 6AP
1990-01-23Bioequivalence · Supplement 8AP
1988-05-12Manufacturing (CMC) · Supplement 3AP
1988-05-12Manufacturing (CMC) · Supplement 1AP
1988-05-12Manufacturing (CMC) · Supplement 2AP
1987-09-10OriginalAP
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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