APPLICATION
ANDA071999
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-03
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 23 · standardAP
2021-04-28Labeling · Supplement 21 · standardAP
2019-07-22Labeling · Supplement 20 · standardAP
2016-05-09Labeling · Supplement 19 · standardAP
2016-01-22Labeling · Supplement 18 · standardAP
1998-02-25Manufacturing (CMC) · Supplement 17AP
1998-02-05Manufacturing (CMC) · Supplement 16AP
1994-05-05Manufacturing (CMC) · Supplement 15AP
1991-10-31Manufacturing (CMC) · Supplement 10AP
1991-10-31Labeling · Supplement 11AP
1991-10-10Labeling · Supplement 12AP
1991-04-24Labeling · Supplement 9AP
1990-01-31Manufacturing (CMC) · Supplement 8AP
1988-06-21Manufacturing (CMC) · Supplement 3AP
1988-06-21Manufacturing (CMC) · Supplement 4AP
1988-06-21Manufacturing (CMC) · Supplement 2AP
1988-04-04Labeling · Supplement 1AP
1987-12-03OriginalAP
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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