APPLICATION
ANDA202252
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-26
LATEST ACTION
2021-11-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 130MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 43MG · CAPSULE · ORAL
Approval history
2021-11-16Labeling · Supplement 9 · standardAP
2019-12-09Labeling · Supplement 6 · standardAP
2019-12-09Labeling · Supplement 4 · standardAP
2019-12-09Labeling · Supplement 7 · standardAP
2019-12-09Labeling · Supplement 5 · standardAP
2013-07-26OriginalAP
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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