APPLICATION
ANDA207805
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-16
LATEST ACTION
2021-06-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 134MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 200MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Prescription
FENOFIBRATE 67MG · CAPSULE · ORAL
Approval history
2021-06-03Labeling · Supplement 16 · standardAP
2019-05-15Labeling · Supplement 8 · standardAP
2018-05-18Labeling · Supplement 6 · standardAP
2017-11-16UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.