Gemfibrozil

ANDA 74615, held by Chartwell Rx. Gemfibrozil.

As of Nov 13, 2026, ANDA 74615 (Gemfibrozil), held by Chartwell Rx, was first approved by FDA on Sep 29, 1995, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1995
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
Sep 29, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 8, 2009	Supplement 7Labeling	Approved	None posted
Dec 12, 1997	Supplement 4Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 2Labeling	Approved	None posted
Feb 22, 1996	Supplement 1Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 3Manufacturing	Approved	None posted
Sep 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74615
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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