ANDA 210148, held by Accord Hlthcare Inc. Busulfan.
As of Nov 14, 2026, ANDA 210148 (Busulfan), held by Accord Hlthcare Inc, was first approved by FDA on Feb 22, 2019, with 2 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 |
|---|---|---|---|
| Feb 22, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Busulfan6MG/ML · injectable;injection | Busulfan | Rx |
| Jul 22, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 10, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 22, 2019 | 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
