← FDA DRUG APPROVALS

FDA ANDA · ANDA207796

FENOFIBRIC ACID

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA207796
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-08
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

FENOFIBRIC ACIDDiscontinued
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL
FENOFIBRIC ACIDDiscontinued
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2026-07-13Labeling · Supplement 3 · standardAP
2024-02-08UNKNOWN · Original · standardAP
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 →