| NDC Code | 43835-0020-1 |
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| Package Description | 40 CARTON in 1 BOX (43835-0020-1) > 10 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS (43835-0020-2) |
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| Product NDC | 43835-0020 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Fluvirin |
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| Non-Proprietary Name | A/singapore/gp1908/2015 Ivr-180 (an A/michigan/45/2015 (h1n1)pdm09-like Virus, A/hong Kong/4801/2014, Nymc X-263b (h3n2) (an A/hong Kong/4801/2014-like Virus), And B/brisbane/60/2008, Wild Type (a B/brisbane/60/2008-like Virus) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20170701 |
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| End Marketing Date | 20180630 |
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| Marketing Category Name | BLA |
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| Application Number | BLA103837 |
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| Manufacturer | Catalent Belgium SA |
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| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (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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| Pharmacy Classes | Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] |
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