Trilipix

NDA 22224, held by Abbvie. Choline Fenofibrate.

As of Nov 14, 2026, NDA 22224 (Trilipix), held by Abbvie, was first approved by FDA on Dec 15, 2008, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2008
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 15, 2008	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


TrilipixEQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, delayed release;oral	Choline Fenofibrate	DiscontinuedReference drug
TrilipixEQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, delayed release;oral	Choline Fenofibrate	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jun 6, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 3, 2021	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 3, 2021	Supplement 17Labeling	Approved	Letter Label
Mar 28, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 7, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
May 18, 2018	Supplement 13Labeling	Approved	Label Letter
Nov 18, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 27, 2015	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 17, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 28, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 5, 2012	Supplement 7Manufacturing · Standard review	Approved	Letter Label
Sep 5, 2012	Supplement 8Labeling	Approved	Letter Label
Sep 30, 2011	Supplement 5Labeling	Approved	Letter Label
Sep 30, 2011	Supplement 6REMS	Approved	Letter Label
Mar 14, 2011	Supplement 4Labeling	Approved	Letter
Sep 14, 2010	Supplement 3Labeling	Approved	Label Letter
Dec 15, 2008	Original applicationNew active ingredient · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22224
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters