ANDA 210802, held by J Molner. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 210802 (Arsenic Trioxide), held by J Molner, was first approved by FDA on Nov 13, 2018, with 0 approved supplements and 0 published complete response letters.
Arsenic trioxide 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arsenic Trioxide1MG/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
