ANDA 205184, held by Pharmobedient. Busulfan.
As of Nov 14, 2026, ANDA 205184 (Busulfan), held by Pharmobedient, was first approved by FDA on Jul 13, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Busulfan6MG/ML · injectable;injection | Busulfan | Discontinued |
| Sep 5, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 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
