Treats severe hypertriglyceridemia. ANDA 208476, held by Bostal. Fenofibrate.
As of Nov 14, 2026, ANDA 208476 (Fenofibrate), held by Bostal, was first approved by FDA on Feb 10, 2021, with 2 approved supplements and 0 published complete response letters.
Fenofibrate tablets are peroxisome proliferator-activated receptors (PPARα) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For treatment of adult patients with severe hypertriglyceridemia. Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2021 | Original application | Approved | None posted |
| Fenofibrate48MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate145MG · tablet;oral | Fenofibrate | Rx |
| Aug 4, 2026 | Supplement 17Manufacturing | Approved | None posted |
| Aug 7, 2025 | Supplement 9Manufacturing | Approved | None posted |
| Feb 10, 2021 | 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
