| Product NDC: | 55390-084 |
| Proprietary Name: | Mitoxantrone |
| Non Proprietary Name: | Mitoxantrone hydrochloride |
| Active Ingredient(s): | 2 mg/mL & nbsp; Mitoxantrone hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55390-084 |
| Labeler Name: | Bedford Laboratories |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076611 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20060411 |
| Package NDC: | 55390-084-01 |
| Package Description: | 1 VIAL, MULTI-DOSE in 1 BOX (55390-084-01) > 12.5 mL in 1 VIAL, MULTI-DOSE |
| NDC Code | 55390-084-01 |
| Proprietary Name | Mitoxantrone |
| Package Description | 1 VIAL, MULTI-DOSE in 1 BOX (55390-084-01) > 12.5 mL in 1 VIAL, MULTI-DOSE |
| Product NDC | 55390-084 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mitoxantrone hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20060411 |
| Marketing Category Name | ANDA |
| Labeler Name | Bedford Laboratories |
| Substance Name | MITOXANTRONE |
| Strength Number | 2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |