APPLICATION
ANDA072098
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-08
LATEST ACTION
2001-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2001-09-12Labeling · Supplement 32AP
2001-08-21Manufacturing (CMC) · Supplement 30AP
2001-08-21Manufacturing (CMC) · Supplement 31AP
2000-10-26Labeling · Supplement 29AP
2000-03-27Manufacturing (CMC) · Supplement 27AP
1999-10-01Manufacturing (CMC) · Supplement 26AP
1999-08-16Manufacturing (CMC) · Supplement 23AP
1999-03-11Labeling · Supplement 25AP
1997-07-25Manufacturing (CMC) · Supplement 20AP
1997-07-25Manufacturing (CMC) · Supplement 19AP
1997-07-25Labeling · Supplement 21AP
1996-11-25Labeling · Supplement 14AP
1996-07-22Manufacturing (CMC) · Supplement 17AP
1996-03-22Manufacturing (CMC) · Supplement 18AP
1995-06-01Manufacturing (CMC) · Supplement 15AP
1995-04-06Manufacturing (CMC) · Supplement 13AP
1995-02-13Manufacturing (CMC) · Supplement 12AP
1994-07-11Manufacturing (CMC) · Supplement 11AP
1994-07-06Manufacturing (CMC) · Supplement 10AP
1994-01-26Manufacturing (CMC) · Supplement 8AP
1994-01-26Labeling · Supplement 9AP
1993-02-11Manufacturing (CMC) · Supplement 5AP
1992-11-30Manufacturing (CMC) · Supplement 7AP
1992-11-30Manufacturing (CMC) · Supplement 6AP
1992-11-30Manufacturing (CMC) · Supplement 4AP
1989-03-28Manufacturing (CMC) · Supplement 1AP
1987-12-08OriginalAP
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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