Gemfibrozil

ANDA 78207, held by Impax Pharms. Gemfibrozil.

As of Nov 13, 2026, ANDA 78207 (Gemfibrozil), held by Impax Pharms, was first approved by FDA on Jun 1, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2007
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 1, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 12, 2022	Supplement 6Labeling · Standard review	Approved	None posted
May 26, 2010	Supplement 2Labeling	Approved	None posted
Sep 28, 2009	Supplement 3Labeling	Approved	None posted
Jun 1, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78207
Drugs@FDA: Overview at FDA
Company: Impax Pharms

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