ANDA 205406, held by Lupin. Febuxostat.
As of Nov 14, 2026, ANDA 205406 (Febuxostat), held by Lupin, was first approved by FDA on Jan 17, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 2024 | Original application | Approved | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | Discontinued |
| Febuxostat80MG · tablet;oral | Febuxostat | 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
