Fenofibric Acid

ANDA 208705, held by Alembic. Choline Fenofibrate.

As of Nov 14, 2026, ANDA 208705 (Fenofibric Acid), held by Alembic, was first approved by FDA on May 12, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: May 12, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenofibric acid delayed-release capsules indicated as adjunctive therapy to diet:

to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).
to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use
Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 12, 2017	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 6 submissions, including labeling and manufacturing supplements


Mar 11, 2026	Supplement 22Labeling · Standard review	Approved	None posted
Mar 11, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Sep 19, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Sep 19, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Sep 19, 2019	Supplement 11Labeling · Standard review	Approved	None posted
May 12, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208705
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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