Fenofibrate (Micronized)

ANDA 75868, held by Impax Labs. Fenofibrate.

As of Nov 14, 2026, ANDA 75868 (Fenofibrate (Micronized)), held by Impax Labs, was first approved by FDA on Oct 27, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2003
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 27, 2003	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 4 submissions, including labeling and manufacturing supplements


Jun 3, 2021	Supplement 23Labeling · Standard review	Approved	None posted
May 15, 2019	Supplement 20Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 19Labeling · Standard review	Approved	None posted
Oct 27, 2003	Original application	Approved	Letter

Identifiers

Application: ANDA 75868
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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