APPLICATION
ANDA076635
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-31
LATEST ACTION
2021-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
FENOFIBRATEDiscontinued
FENOFIBRATE 160MG · TABLET · ORAL
FENOFIBRATEDiscontinued
FENOFIBRATE 54MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 107MG · TABLET · ORAL
Approval history
2021-06-03Labeling · Supplement 15 · standardAP
2020-10-13Labeling · Supplement 13 · standardAP
2020-10-13Labeling · Supplement 11 · standardAP
2020-10-13Labeling · Supplement 10 · standardAP
2018-05-18Labeling · Supplement 9 · 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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