Data / Drug companies / Sunitinib malate
Sunitinib malate: 9 companies and 36 products in the FDA NDC directory
Sunitinib malate is listed in the FDA National Drug Code Directory by 9 companies, with 36 products in commercial distribution. 32 of the products (88.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, and the newest product started marketing on February 14, 2025.
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- Companies listing it
- 9
- Products
- 36
- Generic (ANDA) products
- 32 (88.9%)
- Application numbers
- 8
- Routes
- Oral
- Brand names
- Sutent
- openFDA record search
- api.fda.gov
Companies that list sunitinib malate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Aurobindo Pharma Limited | 4 | capsule | Generic drugs (ANDA) | March 14, 2024 |
| AvKARE | 4 | capsule | Generic drugs (ANDA) | October 11, 2023 |
| Dr. Reddy's Laboratories Inc. | 4 | capsule | Generic drugs (ANDA) | November 30, 2022 |
| Mylan Pharmaceuticals Inc. | 4 | capsule | Generic drugs (ANDA) | January 4, 2022 |
| Novadoz Pharmaceuticals LLC | 4 | capsule | Generic drugs (ANDA) | February 14, 2025 |
| Novugen Pharma (USA) LLC | 4 | capsule | Generic drugs (ANDA) | May 1, 2024 |
| Pfizer Laboratories Div Pfizer Inc | 4 | capsule | New drug applications (NDA) | July 12, 2014 |
| Sun Pharmaceutical Industries, Inc. | 4 | capsule | Generic drugs (ANDA) | December 25, 2019 |
| Teva Pharmaceuticals USA, Inc. | 4 | capsule | Generic drugs (ANDA) | December 22, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 36 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 32 | 88.9% |
| New drug applications (NDA) | 4 | 11.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Kinase Inhibitor | 36 |
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.