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FLUZONE High-Dose - 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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Field Value
NDC Code: 49281-393
Proprietary Name: FLUZONE High-Dose
Suffix:
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)
Dosage Form: INJECTION, SUSPENSION
Method: INTRAMUSCULAR
Original Marketing Date: 28-06-2013
End of Marketing: 30-06-2014
Category Name: BLA
Application Number: BLA103914
Labeler: 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/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Numerator Strength: 60; 60; 60
Active Ingredient Unit: ug/.5mL; ug/.5mL; ug/.5mL
Pharm Classes:
DEA Schedule: