ANDA 215102, held by Eugia Pharma. Busulfan.
As of Nov 14, 2026, ANDA 215102 (Busulfan), held by Eugia Pharma, was first approved by FDA on Jun 25, 2024, with 0 approved supplements and 0 published complete response letters.
Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Busulfan6MG/ML · injectable;injection | Busulfan | Discontinued |
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
