APPLICATION
ANDA076433
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-13
LATEST ACTION
2013-08-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FENOFIBRATEPrescription
FENOFIBRATE 54MG · TABLET · ORAL
FENOFIBRATEPrescription
FENOFIBRATE 160MG · TABLET · ORAL
Approval history
2013-08-06Labeling · Supplement 6 · standardAP
2011-05-08Labeling · Supplement 4AP
2010-04-30Labeling · Supplement 3AP
2010-01-04Labeling · Supplement 2AP
2005-05-13OriginalAP
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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