ANDA 219705, held by Sandoz Inc. Axitinib.
As of Nov 14, 2026, ANDA 219705 (Axitinib), held by Sandoz Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2025 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Axitinib1MG ยท tablet | Axitinib | 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