NDC Code | 70842-140-03 |
Package Description | 3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01) |
Product NDC | 70842-140 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Orbactiv |
Non-Proprietary Name | Oritavancin |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20140901 |
Marketing Category Name | NDA |
Application Number | NDA206334 |
Manufacturer | Melinta Therapeutics, LLC |
Substance Name | ORITAVANCIN |
Strength | 400 |
Strength Unit | mg/1 |
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] |