← FDA DRUG APPROVALS

FDA ANDA · ANDA072096

GOOD NEIGHBOR PHARMACY IBUPROFEN

ibuprofen

Sponsor: PERRIGO

APPLICATION
ANDA072096
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-08
LATEST ACTION
2023-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

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

Approval history

2023-05-11Manufacturing (CMC) · Supplement 111AP
2023-05-11Labeling · Supplement 103 · standardAP
2023-05-11Labeling · Supplement 115 · standardAP
2016-07-13Labeling · Supplement 99AP
2016-06-23Manufacturing (CMC) · Supplement 97 · unknownAP
2012-11-26Labeling · Supplement 76AP
2010-01-25Labeling · Supplement 72AP
2008-01-16Labeling · Supplement 70AP
2006-03-22Labeling · Supplement 63AP
2004-02-20Labeling · Supplement 33AP
2003-03-28Labeling · Supplement 44AP
2002-11-26Manufacturing (CMC) · Supplement 41AP
2002-11-26Manufacturing (CMC) · Supplement 42AP
2002-11-26Manufacturing (CMC) · Supplement 40AP
2001-09-12Labeling · Supplement 37AP
2001-08-21Manufacturing (CMC) · Supplement 35AP
2001-08-21Manufacturing (CMC) · Supplement 36AP
2001-06-19Manufacturing (CMC) · Supplement 32AP
2000-10-26Labeling · Supplement 34AP
2000-03-27Manufacturing (CMC) · Supplement 31AP
1999-10-01Manufacturing (CMC) · Supplement 30AP
1999-06-23Manufacturing (CMC) · Supplement 24AP
1999-06-23Manufacturing (CMC) · Supplement 25AP
1999-03-11Labeling · Supplement 29AP
1997-07-25Manufacturing (CMC) · Supplement 22AP
1997-07-25Manufacturing (CMC) · Supplement 21AP
1996-07-22Manufacturing (CMC) · Supplement 19AP
1996-07-15Labeling · Supplement 16AP
1996-07-15Labeling · Supplement 23AP
1996-03-22Manufacturing (CMC) · Supplement 20AP
1995-06-01Manufacturing (CMC) · Supplement 17AP
1995-04-06Manufacturing (CMC) · Supplement 15AP
1995-02-13Manufacturing (CMC) · Supplement 14AP
1994-07-11Manufacturing (CMC) · Supplement 13AP
1994-07-06Manufacturing (CMC) · Supplement 12AP
1994-01-11Manufacturing (CMC) · Supplement 10AP
1994-01-11Labeling · Supplement 11AP
1993-11-15Manufacturing (CMC) · Supplement 9AP
1993-02-11Manufacturing (CMC) · Supplement 5AP
1992-11-30Manufacturing (CMC) · Supplement 6AP
VIEW ON DRUGS@FDA ↗

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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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