APPLICATION
ANDA070045
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-24
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 31 · standardAP
2021-04-28Labeling · Supplement 29 · standardAP
2019-07-22Labeling · Supplement 28 · standardAP
2016-05-09Labeling · Supplement 27 · standardAP
2015-12-30Labeling · Supplement 26 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 25AP
1998-02-05Manufacturing (CMC) · Supplement 24AP
1994-05-05Manufacturing (CMC) · Supplement 23AP
1991-10-31Manufacturing (CMC) · Supplement 18AP
1991-10-31Labeling · Supplement 19AP
1991-10-10Labeling · Supplement 20AP
1991-06-04Labeling · Supplement 17AP
1990-01-31Manufacturing (CMC) · Supplement 16AP
1989-08-30Labeling · Supplement 15AP
1989-01-04Labeling · Supplement 13AP
1988-06-21Manufacturing (CMC) · Supplement 12AP
1988-05-13Manufacturing (CMC) · Supplement 8AP
1988-04-04Labeling · Supplement 9AP
1986-01-24Manufacturing (CMC) · Supplement 2AP
1986-01-24Manufacturing (CMC) · Supplement 3AP
1985-09-24OriginalAP
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.
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