Fenofibric Acid

ANDA 210469, held by Twi Pharms. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 210469 (Fenofibric Acid), held by Twi Pharms, was first approved by FDA on Jul 5, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 5, 2019
Review: Standard
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
Jul 5, 2019	Original application	Approved	None posted

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 2 submissions, including labeling and manufacturing supplements


Oct 24, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jul 5, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210469
Drugs@FDA: Overview at FDA
Company: TWi 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