Flublok Quadrivalent Northern Hemisphere is a Intramuscular Injection in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen; Influenza A Virus A/tasmania/503/2020 (h3n2) Recombinant Hemagglutinin Antigen; Influenza B Virus B/washington/02/2019 Recombinant Hemagglutinin Antigen; Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen.
Product ID | 49281-721_638284a4-c749-45cf-b72b-0b586ba4a8e9 |
NDC | 49281-721 |
Product Type | Vaccine |
Proprietary Name | Flublok Quadrivalent Northern Hemisphere |
Generic Name | Influenza A Virus A/wisconsin/588/2019 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/tasmania/503/2020 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/washington/02/2019 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen |
Dosage Form | Injection |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2021-07-02 |
Marketing End Date | 2022-06-30 |
Marketing Category | BLA / |
Application Number | BLA125285 |
Labeler Name | Sanofi Pasteur Inc. |
Substance Name | INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN |
Active Ingredient Strength | 45 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
NDC Exclude Flag | N |
Marketing Start Date | 2021-07-02 |
Marketing End Date | 2022-06-30 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
49281-720 | Flublok Quadrivalent Northern Hemisphere | INFLUENZA A VIRUS A/HAWAII/70/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/MINNESOTA/41/2019 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN |
49281-721 | Flublok Quadrivalent Northern Hemisphere | INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN |
49281-722 | Flublok Quadrivalent Northern Hemisphere | INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN |