Reduces elevated sitosterol and campesterol levels. ANDA 209838, held by Aurobindo Pharma. Ezetimibe.
As of Nov 13, 2026, ANDA 209838 (Ezetimibe), held by Aurobindo Pharma, was first approved by FDA on Aug 25, 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 |
|---|---|---|---|
| Aug 25, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG · tablet;oral | Ezetimibe | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 17, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 25, 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
