Product NDC: | 55390-451 |
Proprietary Name: | Mitomycin |
Non Proprietary Name: | Mitomycin |
Active Ingredient(s): | 10 mg/20mL & nbsp; Mitomycin |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55390-451 |
Labeler Name: | Bedford Laboratories |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA064117 |
Marketing Category: | ANDA |
Start Marketing Date: | 20010928 |
Package NDC: | 55390-451-01 |
Package Description: | 1 VIAL in 1 BOX, UNIT-DOSE (55390-451-01) > 10 mL in 1 VIAL |
NDC Code | 55390-451-01 |
Proprietary Name | Mitomycin |
Package Description | 1 VIAL in 1 BOX, UNIT-DOSE (55390-451-01) > 10 mL in 1 VIAL |
Product NDC | 55390-451 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Mitomycin |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20010928 |
Marketing Category Name | ANDA |
Labeler Name | Bedford Laboratories |
Substance Name | MITOMYCIN |
Strength Number | 10 |
Strength Unit | mg/20mL |
Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |