APPLICATION
ANDA200913
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-25
LATEST ACTION
2021-11-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
FENOFIBRIC ACIDDiscontinued
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
FENOFIBRIC ACIDDiscontinued
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2021-11-16Labeling · Supplement 7 · standardAP
2019-09-19Labeling · Supplement 6 · standardAP
2019-09-19Labeling · Supplement 5 · standardAP
2015-07-06Labeling · Supplement 2 · 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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