NDC Code | 71288-157-10 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Product NDC | 71288-157 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Thiotepa |
Non-Proprietary Name | Thiotepa |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
Start Marketing Date | 20231226 |
Marketing Category Name | ANDA |
Application Number | ANDA216037 |
Manufacturer | Meitheal Pharmaceuticals Inc |
Substance Name | THIOTEPA |
Strength | 100 |
Strength Unit | mg/1 |
Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |