← FDA DRUG APPROVALS

FDA NDA · NDA021656

TRICOR

Sponsor: ABBVIE

APPLICATION
NDA021656
TYPE
NDA
ORIGINAL APPROVAL
2004-11-05
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRICOR · ReferenceDiscontinued
FENOFIBRATE 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRICOR · ReferenceDiscontinued
FENOFIBRATE 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-06-06Labeling · Supplement 32 · standard — Label ↗AP
2021-06-03Labeling · Supplement 30 · standard — Label ↗AP
2021-06-03Labeling · Supplement 31 · 901 required — Letter ↗AP
2019-03-28Labeling · Supplement 29 · standard — Letter ↗AP
2018-11-06Labeling · Supplement 27 · standard — Label ↗AP
2018-05-18Labeling · Supplement 26 · 901 required — Letter ↗AP
2015-04-17Manufacturing (CMC) · Supplement 25 · standardAP
2014-08-25Manufacturing (CMC) · Supplement 24 · standardAP
2013-02-05Labeling · Supplement 23 · standard — Label ↗AP
2011-09-22Labeling · Supplement 20 · unknown — Label ↗AP
2010-10-20Labeling · Supplement 19 · unknown — Letter ↗AP
2008-04-15Labeling · Supplement 13 · standard — Letter ↗AP
2007-09-10Labeling · Supplement 11 · standardAP
2007-09-10Labeling · Supplement 4 · standard — Letter ↗AP
2004-11-05Type 5 - New Formulation or New Manufacturer · 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.

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 →