APPLICATION
ANDA071644
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-01
LATEST ACTION
2019-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
Approval history
2019-07-22Labeling · Supplement 11 · standardAP
2016-05-09Labeling · Supplement 10 · standardAP
1991-10-18Manufacturing (CMC) · Supplement 8AP
1991-10-18Manufacturing (CMC) · Supplement 6AP
1991-10-18Manufacturing (CMC) · Supplement 7AP
1991-06-12Manufacturing (CMC) · Supplement 3AP
1989-09-19Bioequivalence · Supplement 5AP
1988-06-17Manufacturing (CMC) · Supplement 2AP
1988-06-17Manufacturing (CMC) · Supplement 1AP
1988-02-01OriginalAP
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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