Fenofibric Acid

ANDA 201573, held by Ph Health. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 201573 (Fenofibric Acid), held by Ph Health, was first approved by FDA on Jul 18, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 18, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 18, 2013	Original application	Approved	Label Letter

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Oct 29, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jul 6, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jul 18, 2013	Original application	Approved	Label Letter

Identifiers

Application: ANDA 201573
Drugs@FDA: Overview at FDA
Company: PH Health

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