ANDA 78729, held by Teva Pharms. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 78729 (Arsenic Trioxide), held by Teva Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2008 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arsenic Trioxide10ML ยท injectable; injection | Arsenic Trioxide | 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