ANDA 211223, held by Prinston. Dofetilide.
As of Nov 13, 2026, ANDA 211223 (Dofetilide), held by Prinston, was first approved by FDA on Dec 17, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2019 | 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
