APPLICATION
ANDA070986
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-25
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 36 · standardAP
2021-04-28Labeling · Supplement 35 · standardAP
2019-07-22Labeling · Supplement 34 · standardAP
2016-05-09Labeling · Supplement 33 · standardAP
1998-03-13Manufacturing (CMC) · Supplement 32AP
1997-01-14Manufacturing (CMC) · Supplement 30AP
1994-07-15Manufacturing (CMC) · Supplement 27AP
1994-04-08Manufacturing (CMC) · Supplement 26AP
1992-01-10Labeling · Supplement 25AP
1991-06-11Labeling · Supplement 24AP
1989-03-02Manufacturing (CMC) · Supplement 19AP
1989-03-02Manufacturing (CMC) · Supplement 18AP
1989-02-21Labeling · Supplement 22AP
1988-12-30Labeling · Supplement 21AP
1988-11-22Manufacturing (CMC) · Supplement 20AP
1988-07-20Manufacturing (CMC) · Supplement 6AP
1988-07-01Labeling · Supplement 16AP
1988-02-10Manufacturing (CMC) · Supplement 12AP
1988-02-02Manufacturing (CMC) · Supplement 9AP
1987-09-22Manufacturing (CMC) · Supplement 10AP
1987-07-23Manufacturing (CMC) · Supplement 5AP
1986-10-17Manufacturing (CMC) · Supplement 3AP
1986-07-25OriginalAP
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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