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FLUZONE QUADRIVALENT - 49281-413-50 - (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), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED))

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Drug Information of FLUZONE QUADRIVALENT

Product NDC: 49281-413
Proprietary Name: FLUZONE QUADRIVALENT
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), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient(s): 15; 15; 15; 15    ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL & nbsp;   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), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)
Administration Route(s): INTRAMUSCULAR
Dosage Form(s): INJECTION, SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of FLUZONE QUADRIVALENT

Product NDC: 49281-413
Labeler Name: Sanofi Pasteur Inc.
Product Type: VACCINE
FDA Application Number: BLA103914
Marketing Category: BLA
Start Marketing Date: 20130610

Package Information of FLUZONE QUADRIVALENT

Package NDC: 49281-413-50
Package Description: 10 SYRINGE, GLASS in 1 PACKAGE (49281-413-50) > .5 mL in 1 SYRINGE, GLASS (49281-413-88)

NDC Information of FLUZONE QUADRIVALENT

NDC Code 49281-413-50
Proprietary Name FLUZONE QUADRIVALENT
Package Description 10 SYRINGE, GLASS in 1 PACKAGE (49281-413-50) > .5 mL in 1 SYRINGE, GLASS (49281-413-88)
Product NDC 49281-413
Product Type Name VACCINE
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), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)
Dosage Form Name INJECTION, SUSPENSION
Route Name INTRAMUSCULAR
Start Marketing Date 20130610
Marketing Category Name BLA
Labeler Name Sanofi Pasteur Inc.
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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength Number 15; 15; 15; 15
Strength Unit ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmaceutical Classes

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