FDA ANDA · ANDA202252
FENOFIBRATE (MICRONIZED)
Sponsor: APOTEX
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APPLICATION
ANDA202252
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-26
LATEST ACTION
2026-10-06
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
2026-10-06Labeling · Supplement 14 · standardAP
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
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