Reduces elevated sitosterol and campesterol levels. ANDA 215693, held by Orient Pharma. Ezetimibe.
As of Nov 13, 2026, ANDA 215693 (Ezetimibe), held by Orient Pharma, was first approved by FDA on Sep 13, 2022, with 2 approved supplements and 0 published complete response letters.
Ezetimibe tablet is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG · tablet;oral | Ezetimibe | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 2, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 13, 2022 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
