For severe hypertriglyceridemia. ANDA 200750, held by Chartwell Rx. Choline Fenofibrate.
As of Nov 14, 2026, ANDA 200750 (Fenofibric Acid), held by Chartwell Rx, was first approved by FDA on Dec 4, 2013, with 6 approved supplements and 0 published complete response letters.
Fenofibric acid delayed-release capsule is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: Reduce TG in patients with severe hypertriglyceridemia. Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia. Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsule did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 4, 2013 | Original application | Approved | None posted |
| Fenofibric AcidEQ 45MG FENOFIBRIC ACID · capsule, delayed release;oral | Choline Fenofibrate | Rx |
| Fenofibric AcidEQ 135MG FENOFIBRIC ACID · capsule, delayed release;oral | Choline Fenofibrate | Rx |
| Nov 29, 2021 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 19, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 6, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 4, 2013 | 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
