| NDC Code | 49281-379-50 |
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| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-379-50) / .7 mL in 1 SYRINGE, GLASS (49281-379-88) |
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| Product NDC | 49281-379 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone High-dose Quadrivalent Southern Hemisphere |
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| Non-Proprietary Name | Influenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (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) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20230213 |
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| End Marketing Date | 20231231 |
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| Marketing Category Name | BLA |
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| Application Number | BLA103914 |
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| Manufacturer | Sanofi Pasteur Inc. |
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| Substance Name | INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SYDNEY/5/2021 SAN-013 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
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| Strength | 60; 60; 60; 60 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
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