Thiotepa is a Intracavitary; Intravenous; Intravesical Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Thiotepa.
| Product ID | 65219-029_a1ce70f8-1f22-4771-b51a-2e9b12876558 | 
| NDC | 65219-029 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Thiotepa | 
| Generic Name | Thiotepa | 
| Dosage Form | Injection, Powder, Lyophilized, For Solution | 
| Route of Administration | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL | 
| Marketing Start Date | 2022-04-11 | 
| Marketing Category | ANDA / | 
| Application Number | ANDA214222 | 
| Labeler Name | Fresenius Kabi USA, LLC | 
| Substance Name | THIOTEPA | 
| Active Ingredient Strength | 100 mg/1 | 
| Pharm Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] | 
| NDC Exclude Flag | N | 
| Listing Certified Through | 2023-12-31 | 
| Marketing Start Date | 2022-04-11 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| NDC | Brand Name | Generic Name | 
|---|---|---|
| 0143-9309 | Thiotepa | Thiotepa | 
| 0143-9565 | Thiotepa | Thiotepa | 
| 25021-246 | Thiotepa | Thiotepa | 
| 43598-171 | Thiotepa | Thiotepa | 
| 43598-650 | Thiotepa | Thiotepa | 
| 54879-014 | Thiotepa | Thiotepa | 
| 65219-029 | Thiotepa | Thiotepa | 
| 68083-446 | Thiotepa | Thiotepa | 
| 68083-503 | Thiotepa | Thiotepa | 
| 69539-123 | Thiotepa | Thiotepa | 
| 69539-124 | Thiotepa | Thiotepa | 
| 70860-220 | Thiotepa | thiotepa | 
| 72205-045 | Thiotepa | Thiotepa | 
| 72205-046 | Thiotepa | Thiotepa | 
| 53964-001 | TEPADINA | THIOTEPA | 
| 53964-002 | TEPADINA | THIOTEPA | 
| 70121-1630 | TEPADINA | THIOTEPA | 
| 70121-1631 | TEPADINA | THIOTEPA | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() THIOTEPA  73471323  not registered Dead/Abandoned  | 
        AMERICAN CYANAMID COMPANY  1984-03-21  |