Reduces elevated sitosterol and campesterol levels. ANDA 209234, held by Alkem Labs Ltd. Ezetimibe.
As of Nov 13, 2026, ANDA 209234 (Ezetimibe), held by Alkem Labs Ltd, was first approved by FDA on Dec 21, 2017, with 4 approved supplements and 0 published complete response letters.
Ezetimibe Tablets 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 |
|---|---|---|---|
| Dec 21, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG · tablet;oral | Ezetimibe | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 17, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 16, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 21, 2018 | Supplement 1Manufacturing | Approved | None posted |
| Dec 21, 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
