| NDC Code | 49281-393-65 |
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| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-393-65) > .5 mL in 1 SYRINGE, GLASS (49281-393-88) |
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| Product NDC | 49281-393 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone High-dose |
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| Non-Proprietary Name | Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (formaldehyde Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20130628 |
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| End Marketing Date | 20140630 |
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| Marketing Category Name | BLA |
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| Application Number | BLA103914 |
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| Manufacturer | Sanofi Pasteur Inc. |
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| Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
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| Strength | 60; 60; 60 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
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