APPLICATION
ANDA071668
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-18
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 800MG · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 18 · standardAP
1994-05-11Manufacturing (CMC) · Supplement 15AP
1992-01-31Labeling · Supplement 14AP
1989-12-07Bioequivalence · Supplement 13AP
1989-02-01Labeling · Supplement 9AP
1988-07-05Manufacturing (CMC) · Supplement 7AP
1988-01-11Manufacturing (CMC) · Supplement 4AP
1988-01-11Manufacturing (CMC) · Supplement 5AP
1987-10-06Manufacturing (CMC) · Supplement 2AP
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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