← FDA DRUG APPROVALS

FDA NDA · NDA018766

ANSAID

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
NDA018766
TYPE
NDA
ORIGINAL APPROVAL
1988-10-31
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ANSAID · ReferenceDiscontinued
FLURBIPROFEN 50MG · TABLET · ORAL
ANSAID · ReferenceDiscontinued
FLURBIPROFEN 100MG · TABLET · ORAL

Approval history

2016-05-09Labeling · Supplement 20 · standard — Label ↗AP
2010-08-13Labeling · Supplement 15 · unknown — Letter ↗AP
2007-06-21Labeling · Supplement 14 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 13 · standard — Letter ↗AP
2001-10-30Labeling · Supplement 10 · standardAP
2001-10-30Labeling · Supplement 11 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 12 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 5 · standardAP
1994-03-25Manufacturing (CMC) · Supplement 8 · standardAP
1991-09-04Manufacturing (CMC) · Supplement 4 · standardAP
1989-09-06Manufacturing (CMC) · Supplement 2 · standardAP
1989-05-05Labeling · Supplement 1AP
1988-10-31Type 3 - New Dosage Form · Original · standardAP
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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