Fenofibrate (Micronized)

ANDA 75753, held by Rhodes Pharms. Fenofibrate.

As of Nov 14, 2026, ANDA 75753 (Fenofibrate (Micronized)), held by Rhodes Pharms, was first approved by FDA on Apr 9, 2002, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 9, 2002
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 9, 2002	Original application	Approved	Letter

Products

3 strengths and forms


Fenofibrate (Micronized)67MG · capsule;oral	Fenofibrate	Discontinued
Fenofibrate (Micronized)134MG · capsule;oral	Fenofibrate	Discontinued
Fenofibrate (Micronized)200MG · capsule;oral	Fenofibrate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jun 3, 2021	Supplement 13Labeling · Standard review	Approved	None posted
May 15, 2019	Supplement 10Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 9Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Feb 7, 2012	Supplement 5Labeling	Approved	Label
Jul 31, 2003	Supplement 3Labeling	Approved	None posted
Jul 31, 2003	Supplement 2Labeling	Approved	None posted
Sep 3, 2002	Supplement 1Manufacturing	Approved	None posted
Apr 9, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75753
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