APPLICATION
ANDA072095
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-08
LATEST ACTION
2008-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TAB-PROFENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2008-01-16Labeling · Supplement 54AP
2006-03-31Labeling · Supplement 49AP
2004-02-20Labeling · Supplement 25AP
2004-01-09Labeling · Supplement 35AP
2001-09-12Labeling · Supplement 29AP
2001-08-21Manufacturing (CMC) · Supplement 28AP
2001-08-21Manufacturing (CMC) · Supplement 27AP
2000-10-26Labeling · Supplement 26AP
2000-03-27Manufacturing (CMC) · Supplement 24AP
1999-10-01Manufacturing (CMC) · Supplement 23AP
1999-03-11Labeling · Supplement 22AP
1997-07-25Manufacturing (CMC) · Supplement 19AP
1997-07-25Manufacturing (CMC) · Supplement 17AP
1996-07-22Manufacturing (CMC) · Supplement 15AP
1996-07-22Manufacturing (CMC) · Supplement 16AP
1996-07-22Manufacturing (CMC) · Supplement 14AP
1996-07-15Labeling · Supplement 20AP
1996-07-15Labeling · Supplement 12AP
1995-06-01Manufacturing (CMC) · Supplement 13AP
1995-04-06Manufacturing (CMC) · Supplement 11AP
1994-07-11Manufacturing (CMC) · Supplement 10AP
1993-02-11Manufacturing (CMC) · Supplement 6AP
1992-11-30Manufacturing (CMC) · Supplement 8AP
1992-11-30Manufacturing (CMC) · Supplement 9AP
1992-11-30Manufacturing (CMC) · Supplement 7AP
1992-03-18Manufacturing (CMC) · Supplement 5AP
1989-03-28Manufacturing (CMC) · Supplement 1AP
1987-12-08OriginalAP
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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