 
                        | Product NDC: | 0703-4686 | 
| Proprietary Name: | mitoXANTRONE | 
| Non Proprietary Name: | mitoXANTRONE | 
| Active Ingredient(s): | 2 mg/mL & nbsp; mitoXANTRONE | 
| Administration Route(s): | INTRAVENOUS | 
| Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0703-4686 | 
| Labeler Name: | Teva Parenteral Medicines, Inc | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA077356 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20060411 | 
| Package NDC: | 0703-4686-01 | 
| Package Description: | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4686-01) > 15 mL in 1 VIAL, MULTI-DOSE | 
| NDC Code | 0703-4686-01 | 
| Proprietary Name | mitoXANTRONE | 
| Package Description | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4686-01) > 15 mL in 1 VIAL, MULTI-DOSE | 
| Product NDC | 0703-4686 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | mitoXANTRONE | 
| Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE | 
| Route Name | INTRAVENOUS | 
| Start Marketing Date | 20060411 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Teva Parenteral Medicines, Inc | 
| Substance Name | MITOXANTRONE HYDROCHLORIDE | 
| Strength Number | 2 | 
| Strength Unit | mg/mL | 
| Pharmaceutical Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |