APPLICATION
ANDA204598
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-12
LATEST ACTION
2025-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 48MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 145MG · TABLET · ORAL
Approval history
2025-08-28Labeling · Supplement 11 · standardAP
2023-03-27Labeling · Supplement 6 · standardAP
2016-07-12UNKNOWN · OriginalAP
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.
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