ANDA 209780, held by Nexus. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 209780 (Arsenic Trioxide), held by Nexus, was first approved by FDA on Nov 15, 2018, with 2 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 |
|---|---|---|---|
| Nov 15, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arsenic Trioxide1MG/ML · injectable;injection | Arsenic Trioxide | Rx |
| Sep 24, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 27, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 15, 2018 | Original application | Approved | None posted |
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
