NDC Code | 49281-336-15 |
Package Description | 10 VIAL, MULTI-DOSE in 1 PACKAGE (49281-336-15) > 5 mL in 1 VIAL, MULTI-DOSE (49281-336-78) |
Product NDC | 49281-336 |
Product Type Name | VACCINE |
Proprietary Name | Fluzone Quadrivalent Southern Hemisphere |
Non-Proprietary Name | Influenza A Virus A/brisbane/02/2018 Ivr-190 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/south Australia/34/2019 Ivr-197 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated) |
Dosage Form | INJECTION, SUSPENSION |
Usage | INTRAMUSCULAR |
Start Marketing Date | 20190930 |
End Marketing Date | 20201231 |
Marketing Category Name | BLA |
Application Number | BLA103914 |
Manufacturer | Sanofi Pasteur Inc. |
Substance Name | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Strength | 15; 15; 15; 15 |
Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |