NDC Code | 70594-049-02 |
Package Description | 10 VIAL, GLASS in 1 CARTON (70594-049-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
Product NDC | 70594-049 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Polymyxin B |
Non-Proprietary Name | Polymyxin B Sulfate |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Usage | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
Start Marketing Date | 20181001 |
Marketing Category Name | ANDA |
Application Number | ANDA202766 |
Manufacturer | Xellia Pharmaceuticals USA LLC |
Substance Name | POLYMYXIN B SULFATE |
Strength | 500000 |
Strength Unit | [USP'U]/1 |
Pharmacy Classes | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |