Reduces elevated sitosterol and campesterol levels. ANDA 208803, held by Amneal Pharms Co. Ezetimibe.
As of Nov 13, 2026, ANDA 208803 (Ezetimibe), held by Amneal Pharms Co, was first approved by FDA on Jun 12, 2017, with 2 approved supplements and 0 published complete response letters.
Ezetimibe tablets are 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 |
|---|---|---|---|
| Jun 12, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG · tablet;oral | Ezetimibe | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 16, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 12, 2017 | 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
