Afluria, Afluria Quadrivalent Purple Book BLA 125254

BLA number: 125254
Proprietary names: Afluria, Afluria Quadrivalent
Proper names: Influenza Vaccine
Applicant: Seqirus Pty Ltd.
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	Afluria, Afluria Quadrivalent	Influenza Vaccine	351(a)	225UG	Injection	Intramuscular	Multi-Dose Vial	Rx	Licensed	2007-09-28
002	Afluria, Afluria Quadrivalent	Influenza Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Syringe	Rx	Licensed	2007-09-28
003	Afluria, Afluria Quadrivalent	Influenza Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	Licensed	2016-08-26
004	Afluria, Afluria Quadrivalent	Influenza Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Multi-Dose Vial	Disc	Licensed	2016-08-26
005	Afluria, Afluria Quadrivalent	Influenza Vaccine	351(a)	30UG/.25ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	Licensed	2018-10-04

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
33332-025	Afluria	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	current
33332-125	Afluria	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	current
33332-015	AFLURIA	INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED)	bioCSL Pty Ltd.	legacy
33332-018	AFLURIA	INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd	legacy
33332-115	AFLURIA	INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED)	bioCSL Pty Ltd.	legacy
33332-118	AFLURIA	INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd	legacy
33332-219	Afluria Quadrivalent	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-220	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-221	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	legacy
33332-318	AFLURIA QUADRIVALENT	INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd	legacy
33332-319	Afluria Quadrivalent	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-320	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-321	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	legacy
33332-322	Afluria Quadrivalent	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	legacy
33332-418	AFLURIA QUADRIVALENT	INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd	legacy
33332-419	Afluria Quadrivalent	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-420	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus Pty Ltd.	legacy
33332-421	Afluria Quadrivalent	INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	legacy
33332-422	Afluria Quadrivalent	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)	Seqirus PTY LTD.	legacy

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Afluria	Seqirus PTY LTD. \| Seqirus Pty Ltd, Australia \| CSL Behring GmbH, Germany	2026-03-09
Afluria Quadrivalent	Seqirus PTY LTD. \| Seqirus Pty Ltd, Australia \| CSL Behring GmbH, Germany \| CSL behring LLC, US	2021-06-23
Afluria Quadrivalent	Seqirus Pty Ltd. \| Seqirus Pty Ltd, Australia \| CSL Behring GmbH, Germany \| CSL behring LLC, US	2020-08-27
Afluria Quadrivalent	Seqirus Pty Ltd.	2020-01-27
AFLURIA	Seqirus Pty Ltd \| CSL Behring GmbH \| CSL Behring LLC	2018-06-26
AFLURIA QUADRIVALENT	Seqirus Pty Ltd \| CSL Behring LLC \| CSL Behring GmbH	2018-06-26
AFLURIA	bioCSL Pty Ltd. \| CSL Behring GmbH \| CSL Behring LLC	2015-05-26

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2025-02-01	U	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2025-02-01	U	002	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2025-02-01	U	003	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2025-02-01	U	004	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2025-01-01	U	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2025-01-01	U	002	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2025-01-01	U	003	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2025-01-01	U	004	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2023-07-01	U	001	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2023-06-01	U	005	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2022-01-01	N	005	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2021-05-01	U	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2021-05-01	U	002	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2021-05-01	U	003	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2021-05-01	U	004	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2020-08-01	R	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2020-08-01	R	002	Afluria, Afluria Quadrivalent	351(a)	Disc	Seqirus Pty Ltd.
2020-08-01	R	003	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.
2020-08-01	R	004	Afluria, Afluria Quadrivalent	351(a)	Rx	Seqirus Pty Ltd.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2025-01-01	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2007-09-28
2025-01-01	002	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2007-09-28
2025-01-01	003	Afluria, Afluria Quadrivalent	351(a)	Disc	Licensed	2016-08-26
2025-01-01	004	Afluria, Afluria Quadrivalent	351(a)	Disc	Licensed	2016-08-26
2023-07-01	001	Afluria, Afluria Quadrivalent	351(a)	Disc	Licensed	2007-09-28
2023-06-01	005	Afluria, Afluria Quadrivalent	351(a)	Disc	Licensed	2018-10-04
2022-01-01	005	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2018-10-04
2020-08-01	001	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2007-09-28
2020-08-01	002	Afluria, Afluria Quadrivalent	351(a)	Disc	Licensed	2007-09-28
2020-08-01	003	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2016-08-26
2020-08-01	004	Afluria, Afluria Quadrivalent	351(a)	Rx	Licensed	2016-08-26