Fenofibrate

As of Nov 14, 2026, ANDA 76520 (Fenofibrate), held by Mylan, was first approved by FDA on Dec 29, 2005, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2005
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 29, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Fenofibrate54MG · tablet;oral	Fenofibrate	Discontinued
Fenofibrate107MG · tablet;oral	Fenofibrate	Discontinued
Fenofibrate160MG · tablet;oral	Fenofibrate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Jun 3, 2021	Supplement 21Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Feb 14, 2011	Supplement 6Labeling	Approved	None posted
Nov 22, 2010	Supplement 5Labeling	Approved	None posted
Sep 2, 2010	Supplement 4Labeling	Approved	None posted
May 3, 2010	Supplement 3Manufacturing	Approved	None posted
Oct 25, 2007	Supplement 1Manufacturing	Approved	None posted
Oct 25, 2007	Supplement 2Labeling	Approved	None posted
Dec 29, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76520
Drugs@FDA: Overview at FDA
Company: Mylan

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