| NDC Code | 49281-120-65 |
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| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-120-65) / .7 mL in 1 SYRINGE, GLASS (49281-120-88) |
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| Product NDC | 49281-120 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone High-dose Quadrivalent Northern Hemisphere |
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| 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) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20200702 |
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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/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) |
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| Strength | 60; 60; 60; 60 |
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| Strength Unit | ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL |
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