| NDC Code | 83703-062-03 |
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| Package Description | 10 SYRINGE, GLASS in 1 CARTON (83703-062-03) / .5 mL in 1 SYRINGE, GLASS (83703-062-04) |
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| Product NDC | 83703-062 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Flucelvax |
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| Non-Proprietary Name | Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/sydney/1304/2022 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 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 | 20240701 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125408 |
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| Manufacturer | Bamboo US BidCo LLC |
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| Substance Name | INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SYDNEY/1304/2022 (H3N2) 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 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
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