APPLICATION
ANDA208476
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-10
LATEST ACTION
2025-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 145MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 48MG · TABLET · ORAL
Approval history
2025-08-07Manufacturing (CMC) · Supplement 9 · unknownAP
2021-02-10UNKNOWN · 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.
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