APPLICATION
ANDA211626
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-18
LATEST ACTION
2023-06-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
FENOFIBRIC ACIDPrescription
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
FENOFIBRIC ACIDPrescription
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2023-06-21Labeling · Supplement 2 · standardAP
2019-07-18UNKNOWN · 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.
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