ANDA 205385, held by Pharmobedient. Febuxostat.
As of Nov 14, 2026, ANDA 205385 (Febuxostat), held by Pharmobedient, was first approved by FDA on Jul 1, 2019, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2019 | Original application | Approved |
| Febuxostat40MG · tablet;oral | Febuxostat | Discontinued |
| Febuxostat80MG · tablet;oral | Febuxostat | Discontinued |
| Sep 16, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 1, 2019 | 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
