Gemfibrozil

ANDA 75034, held by Apotex. Gemfibrozil.

As of Nov 13, 2026, ANDA 75034 (Gemfibrozil), held by Apotex, was first approved by FDA on Jul 20, 1998, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1998
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 20, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Apr 30, 2021	Supplement 31Labeling · Standard review	Approved	None posted
Feb 19, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Sep 18, 2017	Supplement 28Labeling · Standard review	Approved	None posted
Oct 3, 2016	Supplement 27Labeling · Standard review	Approved	None posted
May 8, 2015	Supplement 25Labeling · Standard review	Approved	None posted
May 8, 2015	Supplement 26Labeling · Standard review	Approved	None posted
Mar 14, 2011	Supplement 24Labeling	Approved	None posted
Nov 22, 2010	Supplement 23Labeling	Approved	None posted
Dec 21, 2006	Supplement 15Labeling	Approved	None posted
Nov 4, 2005	Supplement 11Labeling	Approved	None posted
Aug 1, 2005	Supplement 12Labeling	Approved	None posted
Mar 25, 2002	Supplement 3Labeling	Approved	None posted
Jan 31, 2002	Supplement 2Manufacturing	Approved	None posted
Jul 26, 2001	Supplement 1Labeling	Approved	None posted
Jul 20, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75034
Drugs@FDA: Overview at FDA
Company: Apotex

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