Treats newly-diagnosed low-risk acute promyelocytic leukemia (APL). ANDA 206228, held by Zydus Pharms. Arsenic Trioxide.
As of Nov 15, 2026, ANDA 206228 (Arsenic Trioxide), held by Zydus Pharms, was first approved by FDA on Nov 13, 2018, with 2 approved supplements and 0 published complete response letters.
Arsenic trioxide injection is an arsenical indicated: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2018 | Original application | Approved | None posted |
| Arsenic Trioxide1MG/ML · injectable;injection | Arsenic Trioxide | Rx |
| Arsenic Trioxide2MG/ML · injectable;injection | Arsenic Trioxide | Rx |
| Jun 2, 2026 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 8, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 13, 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
