Gemfibrozil

Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 78012, held by Epic Pharma LLC. Gemfibrozil.

As of Nov 13, 2026, ANDA 78012 (Gemfibrozil), held by Epic Pharma LLC, was first approved by FDA on Mar 26, 2007, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 26, 2007
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Mar 26, 2007	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 30, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Dec 13, 2018	Supplement 17Labeling · Standard review	Approved	None posted
Sep 18, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Oct 3, 2016	Supplement 10Labeling · Standard review	Approved	None posted
May 14, 2015	Supplement 8Labeling · Standard review	Approved	None posted
May 14, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 6Manufacturing	Approved	None posted
Mar 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78012
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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