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FDA ANDA · ANDA071163

IBUPROFEN

Sponsor: OHM

APPLICATION
ANDA071163
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-15
LATEST ACTION
2010-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2010-06-15Labeling · Supplement 54AP
2008-08-22Labeling · Supplement 53AP
2006-10-02Labeling · Supplement 52AP
2006-03-22Labeling · Supplement 48AP
2001-08-31Manufacturing (CMC) · Supplement 38AP
2001-08-16Manufacturing (CMC) · Supplement 39AP
2000-09-18Manufacturing (CMC) · Supplement 37AP
1999-07-08Labeling · Supplement 35AP
1998-11-18Labeling · Supplement 34AP
1997-10-06Labeling · Supplement 32AP
1994-08-05Manufacturing (CMC) · Supplement 31AP
1993-07-29Labeling · Supplement 30AP
1993-04-21Labeling · Supplement 26AP
1993-04-21Manufacturing (CMC) · Supplement 25AP
1992-11-02Labeling · Supplement 29AP
1992-09-21Manufacturing (CMC) · Supplement 28AP
1992-09-21Manufacturing (CMC) · Supplement 27AP
1991-11-21Labeling · Supplement 16AP
1991-11-21Manufacturing (CMC) · Supplement 14AP
1991-11-21Manufacturing (CMC) · Supplement 15AP
1990-04-17Manufacturing (CMC) · Supplement 20AP
1990-04-02Manufacturing (CMC) · Supplement 24AP
1989-06-22Labeling · Supplement 21AP
1989-05-31Manufacturing (CMC) · Supplement 13AP
1989-05-31Labeling · Supplement 12AP
1989-05-18Manufacturing (CMC) · Supplement 19AP
1988-11-22Manufacturing (CMC) · Supplement 18AP
1988-11-22Manufacturing (CMC) · Supplement 17AP
1988-06-03Manufacturing (CMC) · Supplement 11AP
1988-04-28Manufacturing (CMC) · Supplement 10AP
1988-04-28Manufacturing (CMC) · Supplement 9AP
1987-02-10Manufacturing (CMC) · Supplement 4AP
1986-12-09Manufacturing (CMC) · Supplement 5AP
1986-10-03Manufacturing (CMC) · Supplement 1AP
1986-10-03Manufacturing (CMC) · Supplement 2AP
1986-07-15OriginalAP
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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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