Fenofibric Acid

ANDA 200913, held by Pharmobedient. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 200913 (Fenofibric Acid), held by Pharmobedient, was first approved by FDA on Mar 25, 2013, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2013
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 25, 2013	Original application	Approved	Letter

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 16, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Sep 19, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 19, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jul 6, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Mar 25, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 200913
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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