Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 203266, held by Cadila Pharms Ltd. Gemfibrozil.
As of Nov 13, 2026, ANDA 203266 (Gemfibrozil), held by Cadila Pharms Ltd, was first approved by FDA on Jun 17, 2016, with 3 approved supplements and 0 published complete response letters.
INDICATIONS & 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil600MG · tablet;oral | Gemfibrozil | Rx |
| Dec 10, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 13, 2018 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 11, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 17, 2016 | 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
