| NDC Code | 49281-394-15 |
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| Package Description | 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-394-15) > 5 mL in 1 VIAL, MULTI-DOSE (49281-394-78) |
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| Product NDC | 49281-394 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluzone |
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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 Bx-51b Antigen (formaldehyde Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20140627 |
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| End Marketing Date | 20150630 |
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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 BX-51B ANTIGEN (FORMALDEHYDE 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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