Active ingredient
Busulfan
9 finished FDA listings contain Busulfan as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BUSULFAN
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 2 mg/1 · 6 mg/ml
- Brand names in FDA listings
- Myleran
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1828
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 009386 | WAYLIS THERAP | 1954-06-26 | 1 |
| ANDA 207050 | PHARMASCIENCE INC | 2017-03-24 | 2 |
| ANDA 209580 | AMNEAL | 2017-12-18 | 1 |
| ANDA 205672 | HOSPIRA | 2018-07-31 | 1 |
| ANDA 210148 | ACCORD HLTHCARE INC | 2019-02-22 | 1 |
| ANDA 212127 | MEITHEAL | 2020-10-23 | 2 |
| ANDA 215102 | EUGIA PHARMA | 2024-06-25 | 1 |
Official labeling on DailyMed
- BUSULFAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS] · version 7 · 2026-08-07
- MYLERAN (BUSULFAN) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC] · version 2 · 2025-01-10
- BUSULFAN INJECTION, SOLUTION [EUGIA US LLC] · version 1 · 2024-06-28
- BUSULFAN INJECTION [ACCORD HEALTHCARE, INC] · version 4 · 2024-01-08
- BUSULFAN INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 7 · 2023-12-28
- BUSULFAN INJECTION [PHARMASCIENCE INC.] · version 6 · 2022-05-20
- BUSULFAN INJECTION, SOLUTION [HOSPIRA, INC.] · version 9 · 2021-08-11
- BUSULFAN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 6 · 2021-06-16
- BUSULFAN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 1 · 2021-06-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.