| NDC Code | 70461-002-01 |
|---|
| Package Description | 10 SYRINGE, GLASS in 1 CARTON (70461-002-01) > .5 mL in 1 SYRINGE, GLASS (70461-002-11) |
|---|
| Product NDC | 70461-002 |
|---|
| Product Type Name | VACCINE |
|---|
| Proprietary Name | Fluad |
|---|
| Non-Proprietary Name | A/singapore/gp1908/2015 Ivr-180 (h1n1) (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 | INTRAMUSCULAR |
|---|
| Start Marketing Date | 20170701 |
|---|
| End Marketing Date | 20180630 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA125510 |
|---|
| Manufacturer | Seqirus Inc. |
|---|
| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (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 | 15; 15; 15 |
|---|
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
|---|