| NDC Code | 0143-9309-01 |
|---|
| Package Description | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
|---|
| Product NDC | 0143-9309 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Thiotepa |
|---|
| Non-Proprietary Name | Thiotepa |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
|---|
| Start Marketing Date | 20010601 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA075547 |
|---|
| Manufacturer | Hikma Pharmaceuticals USA Inc. |
|---|
| Substance Name | THIOTEPA |
|---|
| Strength | 15 |
|---|
| Strength Unit | mg/1.5mL |
|---|
| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
|---|