Gemfibrozil

ANDA 79239, held by Sun Pharm Inds Inc. Gemfibrozil.

As of Nov 13, 2026, ANDA 79239 (Gemfibrozil), held by Sun Pharm Inds Inc, was first approved by FDA on Dec 29, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 29, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 4, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Jun 4, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 27, 2011	Supplement 7Labeling	Approved	None posted
Dec 15, 2009	Supplement 4Labeling	Approved	None posted
Dec 29, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79239
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