ANDA 211339, held by Beijing Sl Pharma Co Ltd. Febuxostat.
As of Nov 14, 2026, ANDA 211339 (Febuxostat), held by Beijing Sl Pharma Co Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2018 | Original application | Tentative approval | None posted |
| Febuxostat40MG · tablet;oral | Febuxostat | None (tentative approval) |
| Febuxostat80MG · tablet;oral | Febuxostat | None (tentative approval) |
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
