Gemfibrozil

ANDA 74442, held by Watson Labs. Gemfibrozil.

As of Nov 13, 2026, ANDA 74442 (Gemfibrozil), held by Watson Labs, was first approved by FDA on Apr 28, 1995, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1995
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 28, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 21, 2004	Supplement 9Labeling	Approved	None posted
Aug 17, 1998	Supplement 8Manufacturing	Approved	None posted
Aug 17, 1998	Supplement 7Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 5Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 4Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 3Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 6Labeling	Approved	None posted
Jul 8, 1997	Supplement 2Manufacturing	Approved	None posted
Apr 10, 1996	Supplement 1Labeling	Approved	None posted
Apr 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74442
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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