← FDA DRUG APPROVALS

FDA ANDA · ANDA202579

FENOFIBRATE (MICRONIZED)

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA202579
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-10
LATEST ACTION
2022-01-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

FENOFIBRATE (MICRONIZED)Discontinued
FENOFIBRATE 43MG · CAPSULE · ORAL
FENOFIBRATE (MICRONIZED)Discontinued
FENOFIBRATE 130MG · CAPSULE · ORAL

Approval history

2022-01-04Labeling · Supplement 7 · standardAP
2013-01-10UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →