| Product NDC: | 10885-001 |
| Proprietary Name: | DaunoXome |
| Non Proprietary Name: | daunorubicin citrate |
| Active Ingredient(s): | 2 mg/mL & nbsp; daunorubicin citrate |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, LIPID COMPLEX |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 10885-001 |
| Labeler Name: | Galen US Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA050704 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120213 |
| Package NDC: | 10885-001-01 |
| Package Description: | 25 mL in 1 VIAL, SINGLE-USE (10885-001-01) |
| NDC Code | 10885-001-01 |
| Proprietary Name | DaunoXome |
| Package Description | 25 mL in 1 VIAL, SINGLE-USE (10885-001-01) |
| Product NDC | 10885-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | daunorubicin citrate |
| Dosage Form Name | INJECTION, LIPID COMPLEX |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20120213 |
| Marketing Category Name | NDA |
| Labeler Name | Galen US Inc |
| Substance Name | DAUNORUBICIN CITRATE |
| Strength Number | 2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] |