APPLICATION
ANDA071448
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-18
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 20 · standardAP
2021-04-30Labeling · Supplement 19 · standardAP
2019-07-22Labeling · Supplement 18 · standardAP
2016-05-09Labeling · Supplement 17 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 16AP
1994-12-23Manufacturing (CMC) · Supplement 15AP
1994-10-11Manufacturing (CMC) · Supplement 14AP
1992-04-03Manufacturing (CMC) · Supplement 13AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1991-08-12Labeling · Supplement 10AP
1989-09-20Labeling · Supplement 8AP
1989-07-12Labeling · Supplement 7AP
1988-12-16Manufacturing (CMC) · Supplement 6AP
1988-05-11Manufacturing (CMC) · Supplement 3AP
1988-05-11Manufacturing (CMC) · Supplement 4AP
1987-03-25Manufacturing (CMC) · Supplement 1AP
1987-02-18OriginalAP
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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