APPLICATION
ANDA070079
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-24
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 39 · standardAP
2021-04-30Labeling · Supplement 38 · standardAP
2019-07-22Labeling · Supplement 37 · standardAP
2016-05-09Labeling · Supplement 36 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 35AP
1994-12-23Manufacturing (CMC) · Supplement 34AP
1994-10-11Manufacturing (CMC) · Supplement 33AP
1992-04-03Manufacturing (CMC) · Supplement 30AP
1992-04-03Manufacturing (CMC) · Supplement 32AP
1991-09-11Manufacturing (CMC) · Supplement 29AP
1991-09-11Manufacturing (CMC) · Supplement 28AP
1991-08-20Manufacturing (CMC) · Supplement 12AP
1991-08-12Labeling · Supplement 27AP
1989-09-13Labeling · Supplement 26AP
1989-05-17Labeling · Supplement 25AP
1989-02-02Labeling · Supplement 24AP
1988-12-16Manufacturing (CMC) · Supplement 23AP
1988-09-20Labeling · Supplement 22AP
1988-03-04Manufacturing (CMC) · Supplement 21AP
1988-03-04Manufacturing (CMC) · Supplement 18AP
1987-03-27Manufacturing (CMC) · Supplement 17AP
1985-12-07Manufacturing (CMC) · Supplement 6AP
1985-12-06Manufacturing (CMC) · Supplement 5AP
1985-12-06Manufacturing (CMC) · Supplement 8AP
1985-12-06Manufacturing (CMC) · Supplement 4AP
1985-09-16Manufacturing (CMC) · Supplement 2AP
1985-09-16Manufacturing (CMC) · Supplement 1AP
1985-07-24OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.