Label: FLUVIRIN- 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) injection, suspension

  • Category: LICENSED VACCINE BULK INTERMEDIATE LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated January 4, 2018

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  • INGREDIENTS AND APPEARANCE
    FLUVIRIN 
    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) injection, suspension
    Product Information
    Product Type LICENSED VACCINE BULK INTERMEDIATE Item Code (Source) NDC:43835-0019
    Route of Administration NOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3872LLC68G) (INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3872LLC68G) INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
    INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3S1ZBQ2B9I) (INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3S1ZBQ2B9I) INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
    INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: H41XP0E6G8) (INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:W3D48FDO26) INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug  in 0.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    THIMEROSAL (UNII: 2225PI3MOV)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43835-0019-1 40 in 1 BOX
    1 10 in 1 CARTON
    1 0.5 mL in 1 SYRINGE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    BLA BLA103837 09/15/2013
    Labeler - Catalent Belgium SA (370696762)
    Establishment
    Name Address ID/FEI Business Operations
    Catalent Belgium SA 370696762 manufacture(43835-0019) , analysis(43835-0019)
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