Fenofibrate

Treats severe hypertriglyceridemia. ANDA 76433, held by Rhodes Pharms. Fenofibrate.

As of Nov 14, 2026, ANDA 76433 (Fenofibrate), held by Rhodes Pharms, was first approved by FDA on May 13, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: May 13, 2005
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenofibrate Tablets, USP are 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 13, 2005	Original application	Approved	None posted

Products

2 strengths and forms


Fenofibrate54MG · tablet;oral	Fenofibrate	Rx
Fenofibrate160MG · tablet;oral	Fenofibrate	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 6, 2013	Supplement 6Labeling · Standard review	Approved	None posted
May 8, 2011	Supplement 4Labeling	Approved	None posted
Apr 30, 2010	Supplement 3Labeling	Approved	None posted
Jan 4, 2010	Supplement 2Labeling	Approved	None posted
May 13, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76433
Drugs@FDA: Overview at FDA
Company: Rhodes Pharmaceuticals

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