APPLICATION
ANDA072169
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-11
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 14 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2019-07-22Labeling · Supplement 11 · standardAP
2016-05-09Labeling · Supplement 10 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 8AP
1989-04-26Manufacturing (CMC) · Supplement 5AP
1989-01-19Labeling · Supplement 6AP
1988-07-25Labeling · Supplement 3AP
1988-06-30Manufacturing (CMC) · Supplement 2AP
1988-04-07Labeling · Supplement 1AP
1987-12-11OriginalAP
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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