← FDA DRUG APPROVALS

FDA ANDA · ANDA072199

IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER

ibuprofen

Sponsor: AMNEAL PHARMS NY

APPLICATION
ANDA072199
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-23
LATEST ACTION
2015-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2015-08-03Manufacturing (CMC) · Supplement 39AP
2015-08-03Labeling · Supplement 41AP
2006-10-05Labeling · Supplement 28AP
2006-05-09Labeling · Supplement 29AP
2002-10-22Labeling · Supplement 22AP
2001-09-25Manufacturing (CMC) · Supplement 21AP
2001-05-21Labeling · Supplement 20AP
2001-03-13Labeling · Supplement 19AP
2000-12-06Manufacturing (CMC) · Supplement 18AP
2000-08-01Labeling · Supplement 10AP
2000-08-01Manufacturing (CMC) · Supplement 8AP
2000-08-01Manufacturing (CMC) · Supplement 9AP
2000-08-01Manufacturing (CMC) · Supplement 7AP
2000-04-12Manufacturing (CMC) · Supplement 17AP
2000-04-12Manufacturing (CMC) · Supplement 16AP
2000-04-12Manufacturing (CMC) · Supplement 14AP
1999-09-24Manufacturing (CMC) · Supplement 12AP
1999-09-15Labeling · Supplement 15AP
1999-02-11Manufacturing (CMC) · Supplement 11AP
1998-01-20Manufacturing (CMC) · Supplement 3AP
1997-07-24Manufacturing (CMC) · Supplement 5AP
1994-11-22Labeling · Supplement 4AP
1988-05-23OriginalAP
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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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