| NDC Code | 49281-633-15 |
|---|
| Package Description | 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-633-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-633-78) |
|---|
| Product NDC | 49281-633 |
|---|
| Product Type Name | VACCINE |
|---|
| Proprietary Name | Fluzone Quadrivalent Northern Hemisphere |
|---|
| Non-Proprietary Name | Influenza A Virus A/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/2671/2019 Ivr-208 (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 | 20200702 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA103914 |
|---|
| Manufacturer | Sanofi Pasteur Inc. |
|---|
| Substance Name | INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (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 |
|---|