NDC Code | 0469-0420-99 |
Package Description | 10 CARTON in 1 CARTON (0469-0420-99) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) > 5 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 0469-0420 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Cresemba |
Non-Proprietary Name | Isavuconazonium Sulfate |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20150306 |
Marketing Category Name | NDA |
Application Number | NDA207501 |
Manufacturer | Astellas Pharma US, Inc. |
Substance Name | ISAVUCONAZONIUM SULFATE |
Strength | 40 |
Strength Unit | mg/mL |
Pharmacy Classes | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |