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FDA ANDA · ANDA071333
IBUPROFEN PAIN RELEIVER/ FEVER REDUCER
ibuprofen
Sponsor: AMNEAL PHARMS NY
APPLICATION
ANDA071333
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-17
LATEST ACTION
2012-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2012-04-25Manufacturing (CMC) · Supplement 44AP
2011-05-08Labeling · Supplement 45AP
2008-08-21Labeling · Supplement 39AP
2006-05-09Labeling · Supplement 33AP
2005-11-16Labeling · Supplement 32AP
2002-10-22Labeling · Supplement 26AP
2001-09-25Manufacturing (CMC) · Supplement 25AP
2001-03-13Labeling · Supplement 24AP
2000-12-04Manufacturing (CMC) · Supplement 23AP
2000-07-25Manufacturing (CMC) · Supplement 13AP
2000-07-25Manufacturing (CMC) · Supplement 14AP
2000-07-25Manufacturing (CMC) · Supplement 12AP
2000-07-25Labeling · Supplement 15AP
2000-04-12Manufacturing (CMC) · Supplement 22AP
2000-04-12Manufacturing (CMC) · Supplement 19AP
2000-04-12Manufacturing (CMC) · Supplement 21AP
1999-09-24Manufacturing (CMC) · Supplement 17AP
1999-09-13Labeling · Supplement 20AP
1999-02-11Manufacturing (CMC) · Supplement 16AP
1998-01-20Manufacturing (CMC) · Supplement 8AP
1997-07-24Manufacturing (CMC) · Supplement 10AP
1994-11-22Labeling · Supplement 9AP
1988-07-26Manufacturing (CMC) · Supplement 7AP
1988-04-05Manufacturing (CMC) · Supplement 4AP
1988-04-05Manufacturing (CMC) · Supplement 5AP
1988-04-05Manufacturing (CMC) · Supplement 6AP
1988-02-17Manufacturing (CMC) · Supplement 2AP
1987-10-08Manufacturing (CMC) · Supplement 3AP
1987-06-24Manufacturing (CMC) · Supplement 1AP
1987-02-17OriginalAP
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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