ANDA 209315, held by Ingenus Pharms LLC. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 209315 (Arsenic Trioxide), held by Ingenus Pharms LLC, 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 |
| Arsenic Trioxide1MG/ML · injectable;injection | Arsenic Trioxide | Rx |
| Arsenic Trioxide2MG/ML · injectable;injection | Arsenic Trioxide | Discontinued |
| Nov 12, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 15, 2020 | Supplement 2Labeling · 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
