APPLICATION
ANDA090715
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-05
LATEST ACTION
2020-09-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOFIBRATEDiscontinued
FENOFIBRATE 48MG · TABLET · ORAL
FENOFIBRATEDiscontinued
FENOFIBRATE 145MG · TABLET · ORAL
Approval history
2020-09-01Labeling · Supplement 13 · standardAP
2015-10-06Labeling · Supplement 3 · standardAP
2012-04-05Supplement 5AP
2012-04-05OriginalAP
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.