APPLICATION
ANDA212562
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-23
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
FENOFIBRIC ACIDPrescription
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
FENOFIBRIC ACIDPrescription
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2026-07-13Labeling · Supplement 4 · standardAP
2022-01-03Labeling · Supplement 1 · standardAP
2020-12-23UNKNOWN · 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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