| NDC Code | 49281-399-65 |
|---|
| Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-399-65) > .5 mL in 1 SYRINGE, GLASS (49281-399-88) |
|---|
| Product NDC | 49281-399 |
|---|
| Product Type Name | VACCINE |
|---|
| Proprietary Name | Fluzone High-dose |
|---|
| Non-Proprietary Name | Influenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated) |
|---|
| Dosage Form | INJECTION, SUSPENSION |
|---|
| Usage | INTRAMUSCULAR |
|---|
| Start Marketing Date | 20160701 |
|---|
| End Marketing Date | 20170630 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA103914 |
|---|
| Manufacturer | Sanofi Pasteur Inc. |
|---|
| Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
|---|
| Strength | 60; 60; 60 |
|---|
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
|---|