| NDC Code | 43835-0019-1 |
|---|
| Package Description | 40 CARTON in 1 BOX (43835-0019-1) > 10 SYRINGE, GLASS in 1 CARTON > .5 mL in 1 SYRINGE, GLASS |
|---|
| Product NDC | 43835-0019 |
|---|
| Product Type Name | LICENSED VACCINE BULK INTERMEDIATE |
|---|
| Proprietary Name | Fluvirin |
|---|
| Non-Proprietary Name | A/singapore/gp1908/2015 Ivr-180 (an A/michigan/45/2015 (h1n1)pdm09-like Virus, A/hong Kong/4801/2014, Nymc X-263b (h3n2) (an A/hong Kong/4801/2014-like Virus), And B/brisbane/60/2008, Wild Type (a B/brisbane/60/2008-like Virus) |
|---|
| Dosage Form | INJECTION, SUSPENSION |
|---|
| Usage | NOT APPLICABLE |
|---|
| Start Marketing Date | 20130915 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA103837 |
|---|
| Manufacturer | Catalent Belgium SA |
|---|
| Substance Name | 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); INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) |
|---|
| Strength | 15; 15; 15 |
|---|
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
|---|