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] |