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FDA ANDA · ANDA074448

FLURBIPROFEN

Sponsor: RISING

APPLICATION
ANDA074448
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-28
LATEST ACTION
2002-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-07-11Manufacturing (CMC) · Supplement 8AP
2002-04-19Manufacturing (CMC) · Supplement 7AP
2002-03-25Manufacturing (CMC) · Supplement 9AP
2001-07-27Manufacturing (CMC) · Supplement 6AP
2001-04-25Manufacturing (CMC) · Supplement 5AP
2001-04-25Manufacturing (CMC) · Supplement 4AP
2000-11-20Manufacturing (CMC) · Supplement 2AP
1999-05-13Labeling · Supplement 3AP
1999-05-13Manufacturing (CMC) · Supplement 1AP
1995-07-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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