Gemfibrozil

Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 79072, held by Northstar Hlthcare. Gemfibrozil.

As of Nov 13, 2026, ANDA 79072 (Gemfibrozil), held by Northstar Hlthcare, was first approved by FDA on Sep 13, 2010, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 13, 2010
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 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 9 submissions below

Date	Submission	Status	Documents
Sep 13, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Rx

All 9 submissions, including labeling and manufacturing supplements


Mar 8, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Dec 11, 2018	Supplement 12Labeling · Standard review	Approved	None posted
Dec 11, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Sep 28, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Sep 15, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Sep 15, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jan 7, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Feb 16, 2011	Supplement 1Labeling	Approved	None posted
Sep 13, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79072
Drugs@FDA: Overview at FDA
Company: Northstar Healthcare

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