Fenofibrate (Micronized)

ANDA 201748, held by Sun Pharm Inds Ltd. Fenofibrate.

As of Nov 14, 2026, ANDA 201748 (Fenofibrate (Micronized)), held by Sun Pharm Inds Ltd, was first approved by FDA on Oct 31, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2014
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fenofibrate capsules, USP are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct 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 8 submissions below

Date	Submission	Status	Documents
Oct 31, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Fenofibrate (Micronized)43MG · capsule;oral	Fenofibrate	Discontinued
Fenofibrate (Micronized)130MG · capsule;oral	Fenofibrate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 29, 2026	Supplement 11Labeling · Standard review	Approved	None posted
May 22, 2025	Supplement 7Labeling · Standard review	Approved	None posted
May 22, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 31, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201748
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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