Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 204189, held by Cadila. Gemfibrozil.
As of Nov 13, 2026, ANDA 204189 (Gemfibrozil), held by Cadila, was first approved by FDA on Aug 28, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Gemfibrozil tablets, USP 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil600MG · tablet;oral | Gemfibrozil | Discontinued |
| Dec 10, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 28, 2018 | Original application | Approved | None posted |
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
