ANDA 217509, held by Teva Pharmaceuticals USA, Inc.. Binimetinib.
As of Nov 15, 2026, ANDA 217509 (Binimetinib), held by Teva Pharmaceuticals USA, Inc., was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 2024 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Binimetinib15MG ยท tablet | Binimetinib | 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
