NDC Code | 70842-225-01 |
Package Description | 1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL |
Product NDC | 70842-225 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Kimyrsa |
Non-Proprietary Name | Oritavancin Diphosphate |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20210323 |
Marketing Category Name | NDA |
Application Number | NDA214155 |
Manufacturer | Melinta Therapeutics, LLC |
Substance Name | ORITAVANCIN DIPHOSPHATE |
Strength | 1200 |
Strength Unit | mg/40mL |
Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS] |