Treats severe hypertriglyceridemia. NDA 21656, held by Abbvie. Fenofibrate.
As of Nov 14, 2026, NDA 21656 (Tricor), held by Abbvie, was first approved by FDA on Nov 5, 2004, with 14 approved supplements and 0 published complete response letters.
TRICOR is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For treatment of adult patients with severe hypertriglyceridemia. Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Tricor48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Tricor145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fenofibrate | DiscontinuedReference drug |
| Jun 6, 2025 | Supplement 32Labeling · Standard review | Approved | |
| Jun 3, 2021 | Supplement 31Labeling | Approved | |
| Jun 3, 2021 | Supplement 30Labeling · Standard review | Approved | |
| Mar 28, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Nov 6, 2018 | Supplement 27Labeling · Standard review | Approved | |
| May 18, 2018 | Supplement 26Labeling | Approved | |
| Apr 17, 2015 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 25, 2014 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 5, 2013 | Supplement 23Labeling · Standard review | Approved | |
| Sep 22, 2011 | Supplement 20Labeling | Approved | |
| Oct 20, 2010 | Supplement 19Labeling | Approved | |
| Apr 15, 2008 | Supplement 13Labeling · Standard review | Approved | |
| Sep 10, 2007 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 10, 2007 | Supplement 4Labeling · Standard review | Approved | |
| Nov 5, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
