APPLICATION
ANDA070985
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-02
LATEST ACTION
2017-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2017-07-31Labeling · Supplement 25 · standardAP
2001-06-08Manufacturing (CMC) · Supplement 22AP
2001-06-08Labeling · Supplement 23AP
1998-12-09Manufacturing (CMC) · Supplement 21AP
1997-01-14Manufacturing (CMC) · Supplement 19AP
1996-08-28Labeling · Supplement 18AP
1996-08-28Manufacturing (CMC) · Supplement 17AP
1996-05-13Manufacturing (CMC) · Supplement 12AP
1994-07-15Manufacturing (CMC) · Supplement 13AP
1994-04-19Manufacturing (CMC) · Supplement 11AP
1989-03-03Manufacturing (CMC) · Supplement 8AP
1989-03-03Manufacturing (CMC) · Supplement 7AP
1988-02-04Manufacturing (CMC) · Supplement 5AP
1988-02-04Manufacturing (CMC) · Supplement 2AP
1987-10-02OriginalAP
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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