FDA ANDA · ANDA211080
FENOFIBRATE
Sponsor: PRINSTON INC
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA211080
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-28
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 48MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 145MG · TABLET · ORAL
Approval history
2026-10-08Labeling · Supplement 3 · standardAP
2021-02-02Labeling · Supplement 1 · standardAP
2018-08-28UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →