| Product NDC: | 66521-115 |
| Proprietary Name: | FLUVIRIN |
| Non Proprietary Name: | INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Active Ingredient(s): | 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL & nbsp; INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 66521-115 |
| Labeler Name: | Novartis Vaccines and Diagnostics Limited |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103837 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20120720 |
| Package NDC: | 66521-115-02 |
| Package Description: | 10 SYRINGE, GLASS in 1 CARTON (66521-115-02) > .5 mL in 1 SYRINGE, GLASS |
| NDC Code | 66521-115-02 |
| Proprietary Name | FLUVIRIN |
| Package Description | 10 SYRINGE, GLASS in 1 CARTON (66521-115-02) > .5 mL in 1 SYRINGE, GLASS |
| Product NDC | 66521-115 |
| Product Type Name | VACCINE |
| Non Proprietary Name | INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Dosage Form Name | INJECTION, SUSPENSION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20120720 |
| Marketing Category Name | BLA |
| Labeler Name | Novartis Vaccines and Diagnostics Limited |
| Substance Name | INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Strength Number | 15; 15; 15 |
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
| Pharmaceutical Classes |