| NDC Code | 70461-200-01 |
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| Package Description | 10 SYRINGE, GLASS in 1 CARTON (70461-200-01) > .5 mL in 1 SYRINGE, GLASS (70461-200-11) |
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| Product NDC | 70461-200 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Flucelvax Quadrivalent |
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| Non-Proprietary Name | Influenza A Virus A/brisbane/10/2010 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/hong Kong/4801/2014 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/utah/9/2014 Antigen (mdck Cell Derived, Propiolactone Inactivated) And Influenza B Virus B/hong Kong/259/2010 Antigen (mdck Cell Derived, Propiolactone Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20160701 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125408 |
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| Manufacturer | Seqirus, Inc. |
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| Substance Name | INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
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| Strength | 15; 15; 15; 15 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
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