NDC Code | 49281-224-65 |
Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-224-65) / .7 mL in 1 SYRINGE, GLASS (49281-224-88) |
Product NDC | 49281-224 |
Product Type Name | VACCINE |
Proprietary Name | Fluzone High-dose Quadrivalent Northern Hemisphere |
Non-Proprietary Name | Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/california/122/2022 San-022 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated) |
Dosage Form | INJECTION, SUSPENSION |
Usage | INTRAMUSCULAR |
Start Marketing Date | 20240701 |
End Marketing Date | 20250630 |
Marketing Category Name | BLA |
Application Number | BLA103914 |
Manufacturer | Sanofi Pasteur Inc. |
Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Strength | 60; 60; 60; 60 |
Strength Unit | ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL |