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FDA ANDA · ANDA200264

FENOFIBRIC ACID

Sponsor: IMPAX LABS INC

APPLICATION
ANDA200264
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-07
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 4 · standardAP
2019-09-23Labeling · Supplement 2 · standardAP
2019-09-23Labeling · Supplement 3 · standardAP
2016-09-07Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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