ANDA 210739, held by Amneal. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 210739 (Arsenic Trioxide), held by Amneal, was first approved by FDA on Jan 25, 2021, with 0 approved supplements and 0 published complete response letters.
Arsenic trioxide injection is an arsenical indicated: For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 1.2 Relapsed or Refractory APL Arsenic trioxide injection is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2021 | Original application | Approved | None posted |
| Arsenic Trioxide1MG/ML · injectable;injection | Arsenic Trioxide | Rx |
| Arsenic Trioxide2MG/ML · injectable;injection | Arsenic Trioxide | Rx |
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
