| NDC Code | 49281-121-65 |
|---|
| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-121-65) / .7 mL in 1 SYRINGE, GLASS (49281-121-88) |
|---|
| Product NDC | 49281-121 |
|---|
| Product Type Name | VACCINE |
|---|
| Proprietary Name | Fluzone High-dose Quadrivalent Northern Hemisphere |
|---|
| Non-Proprietary Name | Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated) |
|---|
| Dosage Form | INJECTION, SUSPENSION |
|---|
| Usage | INTRAMUSCULAR |
|---|
| Start Marketing Date | 20210702 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA103914 |
|---|
| Manufacturer | Sanofi Pasteur Inc. |
|---|
| Substance Name | INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) |
|---|
| Strength | 60; 60; 60; 60 |
|---|
| Strength Unit | ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL |
|---|