NDC Code | 83289-101-02 |
Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (83289-101-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Product NDC | 83289-101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Exblifep |
Non-Proprietary Name | Cefepime Hydrochloride, Enmetazobactam |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20240228 |
Marketing Category Name | NDA |
Application Number | NDA216165 |
Manufacturer | Allecra Therapeutics SAS |
Substance Name | CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM |
Strength | 2; .5 |
Strength Unit | g/1; g/1 |
Pharmacy Classes | Cephalosporin Antibacterial [EPC], Cephalosporins [CS] |