Flucelvax, Flucelvax Quadrivalent Purple Book BLA 125408

BLA number: 125408
Proprietary names: Flucelvax, Flucelvax Quadrivalent
Proper names: Influenza Vaccine
Applicant: Seqirus Inc.
Center: CBER
First observed release: 2020-08-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	Voluntarily Revoked	2012-11-20
002	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	Licensed	2016-05-23
003	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Multi-Dose Vial	Disc	Licensed	2017-03-03
004	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Multi-Dose Vial	Disc	Licensed	2024-03-04
005	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2024-03-04

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
70461-555	Flucelvax	INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED),INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	current
70461-655	Flucelvax	INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	current
83703-084	Flucelvax	INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Bamboo US BidCo LLC	current
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)	Seqirus, Inc.	legacy
70461-319	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED, INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus, Inc.	legacy
70461-320	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
70461-321	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
70461-322	Flucelvax Quadrivalent	INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
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)	Seqirus, Inc.	legacy
70461-419	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED, INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus, Inc.	legacy
70461-420	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
70461-421	FLUCELVAX QUADRIVALENT	INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
70461-422	Flucelvax Quadrivalent	INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	Seqirus Inc.	legacy
76420-521	Medical Provider Single Use EZ Flu Shot 2018-2019	influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/singapore/gp2050/2015 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/utah/9/2014 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/hong kong/259/2010 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), Isopropyl Alcohol	Asclemed USA, Inc.	legacy
70461-656	Flucelvax	INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)		openFDA

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Flucelvax	Seqirus Inc.	2026-07-01
Flucelvax	Bamboo US BidCo LLC	2026-06-17
Flucelvax	Seqirus Inc.	2026-03-05
Flucelvax	Bamboo US BidCo LLC	2026-02-02
FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)	Seqirus Inc.	2021-10-21
FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)	Seqirus Inc.	2021-03-11
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)	Seqirus, Inc.	2019-09-19
Medical Provider Single Use EZ Flu Shot 2018-2019 - Asclemed USA, Inc.	Asclemed USA, Inc.	2018-08-31
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)	Seqirus, Inc.	2018-07-05

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-06-01	U	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2024-08-01	U	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2024-08-01	U	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2024-08-01	U	003	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2024-08-01	N	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2024-08-01	N	005	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2021-05-01	U	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2021-05-01	U	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2021-05-01	U	003	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2021-05-01	U	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2021-03-01	U	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2021-03-01	U	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2021-03-01	N	003	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2021-03-01	N	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Seqirus Inc.
2020-08-01	R	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.
2020-08-01	R	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Seqirus Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2026-06-01	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Licensed	2024-03-04
2024-08-01	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Licensed	2016-05-23
2024-08-01	003	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Licensed	2017-03-03
2024-08-01	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Licensed	2024-03-04
2024-08-01	005	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Licensed	2024-03-04
2021-03-01	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Voluntarily Revoked	2012-11-20
2021-03-01	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Voluntarily Revoked	2012-11-20
2021-03-01	003	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Licensed	2021-03-03
2021-03-01	004	Flucelvax, Flucelvax Quadrivalent	351(a)	Rx	Licensed	2021-03-26
2020-08-01	001	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Licensed	2012-11-20
2020-08-01	002	Flucelvax, Flucelvax Quadrivalent	351(a)	Disc	Licensed	2012-11-20