Fenofibrate

Treats severe hypertriglyceridemia. ANDA 204019, held by Lupin. Fenofibrate.

As of Nov 14, 2026, ANDA 204019 (Fenofibrate), held by Lupin, was first approved by FDA on Aug 17, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 17, 2015
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenofibrate tablet USP 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.

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
Aug 17, 2015	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


Jun 3, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Oct 30, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Oct 30, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Oct 30, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Aug 17, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204019
Drugs@FDA: Overview at FDA
Company: Lupin

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