ANDA 210018, held by Teva Pharms USA. Dofetilide.
As of Nov 13, 2026, ANDA 210018 (Dofetilide), held by Teva Pharms USA, was first approved by FDA on Apr 15, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dofetilide0.125MG · capsule;oral | Dofetilide | Discontinued |
| Dofetilide0.25MG · capsule;oral | Dofetilide | Discontinued |
| Dofetilide0.5MG · capsule;oral | Dofetilide | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
