| NDC Code | 70461-422-10 |
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| Package Description | 1 VIAL, MULTI-DOSE in 1 CARTON (70461-422-10) / 5 mL in 1 VIAL, MULTI-DOSE (70461-422-11) |
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| Product NDC | 70461-422 |
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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/delaware/55/2019 Cvr-45 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 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 | 20220701 |
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| End Marketing Date | 20230731 |
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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/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/55/2019 CVR-45 (H1N1) 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/SINGAPORE/WUH4618/2021 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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