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FDA ANDA · ANDA074405

FLURBIPROFEN

Sponsor: TEVA

APPLICATION
ANDA074405
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-24
LATEST ACTION
1999-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1999-10-29Manufacturing (CMC) · Supplement 4AP
1998-06-25Manufacturing (CMC) · Supplement 3AP
1998-06-25Manufacturing (CMC) · Supplement 1AP
1998-06-25Manufacturing (CMC) · Supplement 2AP
1995-05-24OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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