Gemfibrozil

Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 77836, held by Invagen Pharms. Gemfibrozil.

As of Nov 13, 2026, ANDA 77836 (Gemfibrozil), held by Invagen Pharms, was first approved by FDA on Jul 27, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 27, 2006
Supplements approved: 7
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: 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 2,000 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 1,000 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 8 submissions below

Date	Submission	Status	Documents
Jul 27, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil600MG · tablet;oral	Gemfibrozil	Rx

All 8 submissions, including labeling and manufacturing supplements


Aug 17, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Nov 26, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Oct 2, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Oct 2, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Jan 21, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Nov 23, 2010	Supplement 4Labeling	Approved	None posted
Jan 11, 2010	Supplement 3Labeling	Approved	None posted
Jul 27, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77836
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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