| NDC Code | 53964-002-01 |
|---|
| Package Description | 1 VIAL, GLASS in 1 BOX (53964-002-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
|---|
| Product NDC | 53964-002 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Tepadina |
|---|
| Non-Proprietary Name | Thiotepa |
|---|
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
|---|
| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
|---|
| Start Marketing Date | 20170126 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA208264 |
|---|
| Manufacturer | ADIENNE SA |
|---|
| Substance Name | THIOTEPA |
|---|
| Strength | 100 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
|---|