APPLICATION
ANDA204475
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-23
LATEST ACTION
2022-01-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 40MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 120MG · TABLET · ORAL
Approval history
2022-01-04Labeling · Supplement 5 · standardAP
2022-01-04Labeling · Supplement 3 · standardAP
2022-01-04Labeling · Supplement 2 · standardAP
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.