APPLICATION
ANDA071666
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-18
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 17 · standardAP
1994-05-11Manufacturing (CMC) · Supplement 14AP
1992-01-31Labeling · Supplement 13AP
1989-12-07Bioequivalence · Supplement 12AP
1989-02-01Labeling · Supplement 8AP
1988-07-05Manufacturing (CMC) · Supplement 5AP
1988-01-11Manufacturing (CMC) · Supplement 2AP
1988-01-11Manufacturing (CMC) · Supplement 3AP
1987-08-27Manufacturing (CMC) · Supplement 1AP
1987-06-18OriginalAP
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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