FDA ANDA · ANDA200264
FENOFIBRIC ACID
Sponsor: IMPAX LABS INC
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APPLICATION
ANDA200264
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-07
LATEST ACTION
2026-10-08
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
2026-10-08Labeling · Supplement 8 · standardAP
2021-11-29Labeling · Supplement 4 · standardAP
2019-09-23Labeling · Supplement 2 · standardAP
2019-09-23Labeling · Supplement 3 · standardAP
2016-09-07Not Applicable · OriginalAP
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