Data / Drug companies / Busulfan
Busulfan: 8 companies and 9 products in the FDA NDC directory
Busulfan is listed in the FDA National Drug Code Directory by 8 companies, with 9 products in commercial distribution. 8 of the products (88.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection; tablet, film coated, and the newest product started marketing on June 25, 2024.
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- Companies listing it
- 8
- Products
- 9
- Generic (ANDA) products
- 8 (88.9%)
- Application numbers
- 7
- Routes
- Intravenous, Oral
- Brand names
- Myleran
- openFDA record search
- api.fda.gov
Companies that list busulfan
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 2 | injection, solution | Generic drugs (ANDA) | October 23, 2020 |
| Accord Healthcare Inc. | 1 | injection | Generic drugs (ANDA) | July 22, 2019 |
| Amneal Pharmaceuticals LLC | 1 | injection | Generic drugs (ANDA) | December 18, 2017 |
| Eugia US LLC | 1 | injection, solution | Generic drugs (ANDA) | June 25, 2024 |
| Hospira, Inc. | 1 | injection, solution | Generic drugs (ANDA) | February 28, 2019 |
| Pharmascience Inc. | 1 | injection | Generic drugs (ANDA) | May 19, 2017 |
| Sagent Pharmaceuticals | 1 | injection, solution, concentrate | Generic drugs (ANDA) | May 15, 2017 |
| Waylis Therapeutics LLC | 1 | tablet, film coated | New drug applications (NDA) | May 15, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 4 | 44.4% |
| Injection | 3 | 33.3% |
| Tablet, film coated | 1 | 11.1% |
| Injection, solution, concentrate | 1 | 11.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 8 | 88.9% |
| New drug applications (NDA) | 1 | 11.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Alkylating Drug | 9 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.