ANDA 212410, held by Ingenus Pharms LLC. Dofetilide.
As of Nov 13, 2026, ANDA 212410 (Dofetilide), held by Ingenus Pharms LLC, was first approved by FDA on Dec 27, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 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
