APPLICATION
ANDA075058
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLURBIPROFENDiscontinued
FLURBIPROFEN 100MG · TABLET · ORAL
FLURBIPROFENDiscontinued
FLURBIPROFEN 50MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2021-04-30Labeling · Supplement 14 · standardAP
2021-04-20Labeling · Supplement 13 · standardAP
2007-08-09Labeling · Supplement 7AP
2007-06-19Labeling · Supplement 6AP
2006-06-15Labeling · Supplement 3AP
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.