APPLICATION
ANDA071232
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 20 · standardAP
2021-04-28Labeling · Supplement 19 · standardAP
2019-07-22Labeling · Supplement 18 · standardAP
2016-05-09Labeling · Supplement 17 · standardAP
1997-12-05Manufacturing (CMC) · Supplement 16AP
1997-02-24Manufacturing (CMC) · Supplement 15AP
1995-06-22Manufacturing (CMC) · Supplement 14AP
1994-04-07Manufacturing (CMC) · Supplement 11AP
1994-01-12Manufacturing (CMC) · Supplement 13AP
1992-12-14Manufacturing (CMC) · Supplement 10AP
1992-06-02Labeling · Supplement 12AP
1990-11-29Manufacturing (CMC) · Supplement 9AP
1989-06-28Labeling · Supplement 8AP
1989-01-13Manufacturing (CMC) · Supplement 5AP
1989-01-13Manufacturing (CMC) · Supplement 3AP
1988-12-30Labeling · Supplement 6AP
1988-10-11Labeling · Supplement 4AP
1987-08-27Manufacturing (CMC) · Supplement 2AP
1987-07-17Manufacturing (CMC) · Supplement 1AP
1986-10-22OriginalAP
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.