NDC Code: |
49281-413 |
Proprietary Name: |
FLUZONE QUADRIVALENT |
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), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Dosage Form: |
INJECTION, SUSPENSION |
Method: |
INTRAMUSCULAR |
Original Marketing Date: |
10-06-2013 |
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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Active Numerator Strength: |
15; 15; 15; 15 |
Active Ingredient Unit: |
ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
Pharm Classes: |
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DEA Schedule: |
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