| 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: |
|
