APPLICATION
ANDA200750
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-04
LATEST ACTION
2021-11-29
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
2021-11-29Labeling · Supplement 16 · standardAP
2019-09-19Labeling · Supplement 14 · standardAP
2019-09-19Labeling · Supplement 10 · standardAP
2019-09-19Labeling · Supplement 9 · standardAP
2019-09-19Labeling · Supplement 11 · standardAP
2015-07-06Labeling · Supplement 4 · standardAP
2013-12-04Not Applicable · 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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