| Product NDC: | 55390-030 |
| Proprietary Name: | Thiotepa |
| Non Proprietary Name: | Thiotepa |
| Active Ingredient(s): | 15 mg/1.5mL & nbsp; Thiotepa |
| Administration Route(s): | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55390-030 |
| Labeler Name: | Bedford Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075547 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20010601 |
| Package NDC: | 55390-030-10 |
| Package Description: | 1 VIAL in 1 BOX, UNIT-DOSE (55390-030-10) > 1.5 mL in 1 VIAL |
| NDC Code | 55390-030-10 |
| Proprietary Name | Thiotepa |
| Package Description | 1 VIAL in 1 BOX, UNIT-DOSE (55390-030-10) > 1.5 mL in 1 VIAL |
| Product NDC | 55390-030 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Thiotepa |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
| Start Marketing Date | 20010601 |
| Marketing Category Name | ANDA |
| Labeler Name | Bedford Laboratories |
| Substance Name | THIOTEPA |
| Strength Number | 15 |
| Strength Unit | mg/1.5mL |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |