FDA ANDA · ANDA212598
FENOFIBRIC ACID
Sponsor: AUROBINDO PHARMA LTD
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APPLICATION
ANDA212598
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-25
LATEST ACTION
2026-10-08
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
2026-10-08Labeling · Supplement 6 · standardAP
2023-09-20Labeling · Supplement 3 · standardAP
2019-07-25UNKNOWN · Original · standardAP
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