ANDA 205095, held by Sciegen Pharms. Rufinamide.
As of Nov 14, 2026, ANDA 205095 (Rufinamide), held by Sciegen Pharms, was first approved by FDA on May 16, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2016 | Original application | Approved |
| Rufinamide200MG · tablet;oral | Rufinamide | Rx |
| Rufinamide400MG · tablet;oral | Rufinamide | Rx |
| Mar 10, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 16, 2016 | Original application | Approved |
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
