Fenofibrate

ANDA 76635, held by Sun Pharm Inds Ltd. Fenofibrate.

As of Nov 14, 2026, ANDA 76635 (Fenofibrate), held by Sun Pharm Inds Ltd, was first approved by FDA on Oct 31, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2005
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 31, 2005	Original application	Approved	Letter

Products

3 strengths and forms


Fenofibrate54MG · tablet;oral	Fenofibrate	Discontinued
Fenofibrate107MG · tablet;oral	Fenofibrate	Rx
Fenofibrate160MG · tablet;oral	Fenofibrate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 3, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 13Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 9Labeling · Standard review	Approved	None posted
Oct 31, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 76635
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