← FDA DRUG APPROVALS

FDA NDA · NDA021612

LIPOFEN

fenofibrate

Sponsor: CIPHER PHARMS INC

APPLICATION
NDA021612
TYPE
NDA
ORIGINAL APPROVAL
2006-01-11
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

LIPOFEN · ReferenceDiscontinued
FENOFIBRATE 100MG · CAPSULE · ORAL
LIPOFEN · ReferencePrescription
FENOFIBRATE 150MG · CAPSULE · ORAL
LIPOFEN · ReferencePrescription
FENOFIBRATE 50MG · CAPSULE · ORAL

Approval history

2025-06-06Labeling · Supplement 26 · standard — Label ↗AP
2021-06-03Labeling · Supplement 24 · 901 required — Label ↗AP
2019-05-15Labeling · Supplement 20 · 901 required — Letter ↗AP
2018-11-06Labeling · Supplement 17 · standard — Label ↗AP
2018-05-18Labeling · Supplement 18 · 901 required — Letter ↗AP
2015-12-23Manufacturing (CMC) · Supplement 16 · standardAP
2013-01-18Manufacturing (CMC) · Supplement 14 · standard — Label ↗AP
2013-01-18Labeling · Supplement 15 · standard — Letter ↗AP
2013-01-18Manufacturing (CMC) · Supplement 13 · standardAP
2011-10-31Labeling · Supplement 7 · standard — Letter ↗AP
2008-12-12Labeling · Supplement 4 · standard — Letter ↗AP
2008-12-12Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2006-01-11Type 3 - New Dosage Form · Original · standard — Review ↗AP
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.

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