← FDA DRUG APPROVALS

FDA ANDA · ANDA207564

FENOFIBRATE (MICRONIZED)

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA207564
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-19
LATEST ACTION
2021-06-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FENOFIBRATE (MICRONIZED)Discontinued
FENOFIBRATE 200MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Discontinued
FENOFIBRATE 67MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Discontinued
FENOFIBRATE 134MG · CAPSULE · ORAL

Approval history

2021-06-03Labeling · Supplement 2 · standardAP
2019-09-19Labeling · Supplement 1 · standardAP
2019-04-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →