APPLICATION
ANDA210606
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-17
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
2021-05-14Labeling · Supplement 3 · standardAP
2019-09-23Labeling · Supplement 1 · standardAP
2019-09-23Labeling · Supplement 2 · standardAP
2018-08-17UNKNOWN · Original · 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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