Fluad Purple Book BLA 125510

BLA number: 125510
Proprietary names: Fluad, Fluad,Fluad Quadrivalent
Proper names: Influenza Vaccine, Adjuvanted
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	Fluad	Influenza Vaccine, Adjuvanted	351(a)	45UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	Licensed	2015-11-24
002	Fluad,Fluad Quadrivalent	Influenza Vaccine, Adjuvanted	351(a)	60UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2020-02-21

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
70461-025	FLUAD	INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)	Seqirus, Inc.	current
70461-018	FLUAD	Influenza Vaccine, Adjuvanted	Seqirus, Inc.	legacy
70461-019	FLUAD	Influenza Vaccine, Adjuvanted	Seqirus, Inc.	legacy
70461-020	FLUAD	influenza vaccine, adjuvanted	Seqirus, Inc.	legacy
70461-120	FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Seqirus, Inc.	legacy
70461-121	FLUAD QUADRIVALENT	influenza vaccine, adjuvanted	Seqirus, Inc.	legacy
70461-122	FLUAD QUADRIVALENT	INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED)	Seqirus, Inc.	legacy
70461-026	FLUAD	INFLUENZA A VIRUS A/Missouri/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)		openFDA

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
FLUAD - Seqirus, Inc. \| Seqirus Inc	Seqirus, Inc. \| Seqirus Inc	2026-07-06
FLUAD - Seqirus, Inc. \| Seqirus Inc	Seqirus, Inc. \| Seqirus Inc	2025-07-01
FLUAD QUADRIVALENT - Seqirus, Inc.	Seqirus, Inc.	2021-07-07
FLUAD QUADRIVALENT - Seqirus, Inc.	Seqirus, Inc.	2020-11-03
FLUAD	Seqirus, Inc.	2019-06-10

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2023-06-01	U	001	Fluad	351(a)	Disc	Seqirus Inc.
2021-05-01	U	001	Fluad	351(a)	Rx	Seqirus Inc.
2021-05-01	U	002	Fluad,Fluad Quadrivalent	351(a)	Rx	Seqirus Inc.
2021-01-01	U	002	Fluad,Fluad Quadrivalent	351(a)	Rx	Seqirus Inc.
2020-08-01	N	001	Fluad,Fluad Quadrivalent	351(a)	Rx	Seqirus Inc.
2020-08-01	N	002	Fluad,Fluad Quadrivalent	351(a)	Rx	Seqirus Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2023-06-01	001	Fluad	351(a)	Disc	Licensed	2015-11-24
2021-01-01	001	Fluad	351(a)	Rx	Licensed	2015-11-24
2020-08-01	001	Fluad,Fluad Quadrivalent	351(a)	Rx	Licensed	2020-02-21
2020-08-01	002	Fluad,Fluad Quadrivalent	351(a)	Rx	Licensed	2020-02-21