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FDA ANDA · ANDA074411

FLURBIPROFEN

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074411
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-31
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLURBIPROFENDiscontinued
FLURBIPROFEN 50MG · TABLET · ORAL
FLURBIPROFENDiscontinued
FLURBIPROFEN 100MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 11AP
2002-03-12Manufacturing (CMC) · Supplement 9AP
2002-03-12Manufacturing (CMC) · Supplement 10AP
2000-12-20Manufacturing (CMC) · Supplement 7AP
2000-12-20Manufacturing (CMC) · Supplement 5AP
2000-12-20Manufacturing (CMC) · Supplement 8AP
2000-12-20Manufacturing (CMC) · Supplement 6AP
2000-01-28Manufacturing (CMC) · Supplement 4AP
1999-11-23Manufacturing (CMC) · Supplement 3AP
1998-12-09Manufacturing (CMC) · Supplement 2AP
1997-05-30Manufacturing (CMC) · Supplement 1AP
1995-05-31OriginalAP
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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