Gemfibrozil

ANDA 74256, held by Teva. Gemfibrozil.

As of Nov 13, 2026, ANDA 74256 (Gemfibrozil), held by Teva, was first approved by FDA on Oct 31, 1993, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1993
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Oct 31, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Sep 18, 2017	Supplement 43Labeling · Standard review	Approved	None posted
Oct 3, 2016	Supplement 41Labeling · Standard review	Approved	None posted
Apr 29, 2015	Supplement 39Labeling · Standard review	Approved	None posted
Apr 29, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Feb 28, 2011	Supplement 32Labeling	Approved	None posted
Jan 12, 2010	Supplement 31Labeling	Approved	None posted
Mar 26, 2009	Supplement 28Labeling	Approved	None posted
Jan 6, 2005	Supplement 24Labeling	Approved	None posted
Apr 11, 2002	Supplement 19Labeling	Approved	None posted
Jul 7, 2000	Supplement 15Manufacturing	Approved	None posted
Jan 10, 2000	Supplement 16Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 18Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 17Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 8Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 7Manufacturing	Approved	None posted
Jan 8, 1999	Supplement 6Manufacturing	Approved	None posted
May 28, 1998	Supplement 5Manufacturing	Approved	None posted
Nov 7, 1997	Supplement 4Manufacturing	Approved	None posted
Dec 18, 1996	Supplement 3Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 2Manufacturing	Approved	None posted
Feb 28, 1996	Supplement 1Manufacturing	Approved	None posted
Oct 31, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74256
Drugs@FDA: Overview at FDA
Company: Teva 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