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] |