| NDC Code | 70461-201-01 |
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| Package Description | 10 SYRINGE, GLASS in 1 CARTON (70461-201-01) > .5 mL in 1 SYRINGE, GLASS (70461-201-11) |
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| Product NDC | 70461-201 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Flucelvax Quadrivalent (prefilled Syringe) |
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| Non-Proprietary Name | A/singapore/gp1908/2015 Ivr-180 (h1n1) (an A/michigan/45/2015-like Virus), A/singapore/gp2050/2015 (h3n2) (an A/hong Kong/4801/2014 - Like Virus), B/utah/9/2014 (a B/phuket/3073/2013-like Virus), B/hong Kong/259/2010 (a B/brisbane/60/08-like Virus) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20170701 |
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| End Marketing Date | 20180630 |
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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/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (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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