Manages hyperuricemia. ANDA 213069, held by Sunshine. Febuxostat.
As of Nov 14, 2026, ANDA 213069 (Febuxostat), held by Sunshine, was first approved by FDA on Jun 2, 2020, with 1 approved supplement and 0 published complete response letters.
Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2020 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Rx |
| Febuxostat80MG · tablet;oral | Febuxostat | Rx |
| Jul 22, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 2, 2020 | Original application | Approved | None posted |
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
