APPLICATION
ANDA074647
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-01
LATEST ACTION
2000-07-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLURBIPROFENDiscontinued
FLURBIPROFEN 50MG · TABLET · ORAL
FLURBIPROFENDiscontinued
FLURBIPROFEN 100MG · TABLET · ORAL
Approval history
2000-07-07Manufacturing (CMC) · Supplement 1AP
1997-04-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.