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As of Nov 14, 2026, ANDA 209580 (Busulfan), held by Amneal, was first approved by FDA on Dec 18, 2017, with 3 approved supplements and 0 published complete response letters.
First approved: Dec 18, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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).
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
