ANDA 208519, held by Strides Pharma Intl. Dofetilide.
As of Nov 13, 2026, ANDA 208519 (Dofetilide), held by Strides Pharma Intl, was first approved by FDA on Oct 9, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2018 | 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
