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As of Nov 14, 2026, ANDA 210448 (Busulfan), held by Apotex, was first approved by FDA on May 7, 2019, with 1 approved supplement and 0 published complete response letters.
First approved: May 7, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below
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
