| NDC Code | 49281-403-65 |
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| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-403-65) / .5 mL in 1 SYRINGE, GLASS (49281-403-88) |
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| Product NDC | 49281-403 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone High-dose |
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| Non-Proprietary Name | Influenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20180629 |
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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/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) |
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| Strength | 60; 60; 60 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
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