FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus, Inc.. The primary component is Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/north Carolina/04/2016 (h3n2) Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/iowa/06/2017 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/singapore/inftt-16-0610/2016 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated).
| Product ID | 70461-418_517e03e0-dd10-491b-8524-9fba6e679515 |
| NDC | 70461-418 |
| Product Type | Vaccine |
| Proprietary Name | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) |
| Generic Name | Influenza A Virus A/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/north Carolina/04/2016 (h3n2) Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/iowa/06/2017 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Hemagglutinin Antigen (mdck Cell Derived, Propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2016-05-23 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125408 |
| Labeler Name | Seqirus, Inc. |
| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2016-05-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA125408 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-23 |
| Marketing End Date | 2019-07-31 |
| Marketing Category | BLA |
| Application Number | BLA125408 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-23 |
| Marketing End Date | 2019-07-31 |
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70461-418 | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-419 | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) |
| 70461-420 | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) |
| 70461-318 | FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |