| NDC Code | 70461-320-03 |
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| Package Description | 10 SYRINGE, GLASS in 1 CARTON (70461-320-03) > .5 mL in 1 SYRINGE, GLASS (70461-320-04) |
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| Product NDC | 70461-320 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Flucelvax Quadrivalent |
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| Proprietary Name Suffix | (pre-filled Syringe) |
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| Non-Proprietary Name | Influenza A Virus A/nebraska/14/2019 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/delaware/39/2019 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/darwin/7/2019 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 | 20200702 |
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| End Marketing Date | 20210731 |
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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/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/DARWIN/7/2019 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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