Fenofibric Acid

ANDA 200920, held by Actavis Elizabeth. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 200920 (Fenofibric Acid), held by Actavis Elizabeth, was first approved by FDA on Oct 7, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 7, 2015
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 7, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Fenofibric AcidEQ 45MG FENOFIBRIC ACID · capsule, delayed release;oral	Choline Fenofibrate	Rx
Fenofibric AcidEQ 135MG FENOFIBRIC ACID · capsule, delayed release;oral	Choline Fenofibrate	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 30, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Oct 7, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 200920
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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