APPLICATION
ANDA202856
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-07
LATEST ACTION
2023-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 48MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 145MG · TABLET · ORAL
Approval history
2023-03-24Labeling · Supplement 10 · standardAP
2019-08-15Labeling · Supplement 9 · standardAP
2013-07-26Labeling · Supplement 3 · standardAP
2012-12-07UNKNOWN · OriginalAP
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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