Data / Drug companies / Thiotepa
Thiotepa: 8 companies and 17 products in the FDA NDC directory
Thiotepa is listed in the FDA National Drug Code Directory by 8 companies, with 17 products in commercial distribution. 13 of the products (76.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; injection, powder, for solution, and the newest product started marketing on April 18, 2025.
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- Companies listing it
- 8
- Products
- 17
- Generic (ANDA) products
- 13 (76.5%)
- Application numbers
- 8
- Routes
- Intracavitary, Intravenous, Intravesical
- Brand names
- Tepadina
- openFDA record search
- api.fda.gov
Companies that list thiotepa
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 4 | injection, powder, for solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | April 18, 2025 |
| Hikma Pharmaceuticals USA Inc. | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 29, 2023 |
| Dr. Reddy's Laboratories Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 1, 2022 |
| Gland Pharma Limited | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 3, 2022 |
| Meitheal Pharmaceuticals Inc. | 2 | injection, powder, for solution | Generic drugs (ANDA) | December 26, 2023 |
| Novadoz Pharmaceuticals LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | February 1, 2020 |
| Fresenius Kabi USA, LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 11, 2022 |
| Sagent Pharmaceuticals | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | June 15, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 13 | 76.5% |
| Injection, powder, for solution | 4 | 23.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 13 | 76.5% |
| New drug applications (NDA) | 4 | 23.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Alkylating Drug | 17 |
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.