Gemfibrozil

ANDA 78599, held by Hikma Pharms. Gemfibrozil.

As of Nov 13, 2026, ANDA 78599 (Gemfibrozil), held by Hikma Pharms, was first approved by FDA on Aug 16, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 16, 2010
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
Aug 16, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 28, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Jun 22, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Nov 9, 2010	Supplement 2Labeling	Approved	None posted
Aug 16, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78599
Drugs@FDA: Overview at FDA
Company: Hikma Pharmaceuticals

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