ANDA 215323, held by Somerset Theraps LLC. Dofetilide.
As of Nov 13, 2026, ANDA 215323 (Dofetilide), held by Somerset Theraps LLC, was first approved by FDA on Apr 14, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 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
