ANDA 214009, held by Chartwell Rx. Rufinamide.
As of Nov 14, 2026, ANDA 214009 (Rufinamide), held by Chartwell Rx, was first approved by FDA on Nov 7, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rufinamide40MG/ML ยท suspension;oral | Rufinamide | Rx |
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
