Fenofibric Acid

ANDA 212562, held by Yichang Humanwell. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 212562 (Fenofibric Acid), held by Yichang Humanwell, was first approved by FDA on Dec 23, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2020
Review: Standard
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
Dec 23, 2020	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 3 submissions, including labeling and manufacturing supplements


Jul 13, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Jan 3, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Dec 23, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212562
Drugs@FDA: Overview at FDA
Company: Yichang Humanwell Pharmaceutical

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