APPLICATION
ANDA074431
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-31
LATEST ACTION
2010-11-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLURBIPROFENPrescription
FLURBIPROFEN 100MG · TABLET · ORAL
Approval history
2010-11-29Labeling · Supplement 17AP
2006-04-25Labeling · Supplement 15AP
2006-03-13Labeling · Supplement 14AP
2001-08-30Manufacturing (CMC) · Supplement 9AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
1998-08-27Manufacturing (CMC) · Supplement 7AP
1998-03-09Manufacturing (CMC) · Supplement 6AP
1997-04-07Manufacturing (CMC) · Supplement 5AP
1997-04-07Manufacturing (CMC) · Supplement 3AP
1997-04-07Manufacturing (CMC) · Supplement 4AP
1996-10-21Manufacturing (CMC) · Supplement 2AP
1996-02-22Manufacturing (CMC) · Supplement 1AP
1995-05-31OriginalAP
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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