ANDA 78724, held by Teva Pharms USA. Ezetimibe.
As of Nov 13, 2026, ANDA 78724 (Ezetimibe), held by Teva Pharms USA, was first approved by FDA on Jun 12, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG ยท tablet;oral | Ezetimibe | Discontinued |
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
