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FDA ANDA · ANDA209950

FENOFIBRATE

Sponsor: AMNEAL

APPLICATION
ANDA209950
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-19
LATEST ACTION
2021-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FENOFIBRATEPrescription
FENOFIBRATE 54MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 160MG · TABLET · ORAL

Approval history

2021-06-03Labeling · Supplement 4 · standardAP
2019-10-25Labeling · Supplement 2 · standardAP
2019-10-25Labeling · Supplement 3 · standardAP
2019-10-25Labeling · Supplement 1 · standardAP
2018-03-19UNKNOWN · Original · standardAP
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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