APPLICATION
ANDA211122
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-18
LATEST ACTION
2022-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 145MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 48MG · TABLET · ORAL
Approval history
2022-04-05Labeling · Supplement 3 · standardAP
2020-03-18UNKNOWN · Original · 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.