APPLICATION
ANDA072004
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 800MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 18 · standardAP
2021-04-28Labeling · Supplement 17 · standardAP
2019-07-22Labeling · Supplement 16 · standardAP
2016-05-09Labeling · Supplement 15 · standardAP
1997-12-05Manufacturing (CMC) · Supplement 14AP
1997-02-24Manufacturing (CMC) · Supplement 13AP
1995-06-22Manufacturing (CMC) · Supplement 12AP
1994-04-07Manufacturing (CMC) · Supplement 9AP
1994-01-12Manufacturing (CMC) · Supplement 11AP
1992-12-14Manufacturing (CMC) · Supplement 8AP
1992-06-02Labeling · Supplement 10AP
1989-06-28Labeling · Supplement 7AP
1989-01-13Manufacturing (CMC) · Supplement 4AP
1989-01-13Manufacturing (CMC) · Supplement 2AP
1988-12-30Labeling · Supplement 5AP
1988-10-17Labeling · Supplement 3AP
1987-12-24Manufacturing (CMC) · Supplement 1AP
1987-11-18OriginalAP
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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