APPLICATION
ANDA070908
TYPE
ANDA
ORIGINAL APPROVAL
1986-09-26
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 26AP
1995-04-10Manufacturing (CMC) · Supplement 10AP
1994-12-23Manufacturing (CMC) · Supplement 25AP
1994-10-11Manufacturing (CMC) · Supplement 24AP
1993-05-18Labeling · Supplement 22AP
1993-05-18Labeling · Supplement 23AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1992-03-12Labeling · Supplement 17AP
1989-01-26Manufacturing (CMC) · Supplement 13AP
1988-02-23Manufacturing (CMC) · Supplement 7AP
1988-02-22Manufacturing (CMC) · Supplement 8AP
1987-03-31Manufacturing (CMC) · Supplement 3AP
1987-03-31Manufacturing (CMC) · Supplement 4AP
1986-12-17Manufacturing (CMC) · Supplement 1AP
1986-11-05Manufacturing (CMC) · Supplement 2AP
1986-09-26OriginalAP
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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