Gemfibrozil

Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 74270, held by Chartwell Molecules. Gemfibrozil.

As of Nov 13, 2026, ANDA 74270 (Gemfibrozil), held by Chartwell Molecules, was first approved by FDA on Sep 27, 1993, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1993
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 27, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Rx

All 10 submissions, including labeling and manufacturing supplements


May 17, 2024	Supplement 19Manufacturing	Approved	None posted
Feb 1, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Oct 21, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Oct 3, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Feb 19, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Aug 29, 2005	Supplement 5Labeling	Approved	None posted
Apr 5, 1995	Supplement 1Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 3Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 2Manufacturing	Approved	None posted
Sep 27, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74270
Drugs@FDA: Overview at FDA
Company: Chartwell Molecules

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