NDC Code | 49281-116-25 |
Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-116-25) > .25 mL in 1 SYRINGE, GLASS (49281-116-00) |
Product NDC | 49281-116 |
Product Type Name | VACCINE |
Proprietary Name | Fluzone Quadrivalent Southern Hemisphere |
Non-Proprietary Name | Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated) |
Dosage Form | INJECTION, SUSPENSION |
Usage | INTRAMUSCULAR |
Start Marketing Date | 20160324 |
End Marketing Date | 20161231 |
Marketing Category Name | BLA |
Application Number | BLA103914 |
Manufacturer | Sanofi Pasteur Inc. |
Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Strength | 7.5; 7.5; 7.5; 7.5 |
Strength Unit | ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL |