Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent Purple Book BLA 103914

BLA number: 103914
Proprietary names: Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Proper names: Influenza Virus Vaccine
Applicant: Sanofi Vaccines US 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
001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	1999-12-09
002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Single-Dose Vial	Disc	Licensed	1999-12-09
003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	180 UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2009-12-23
004	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	27UG/0.1	Injection	Intradermal	Syringe	Disc	Licensed	2011-05-09
005	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2013-06-07
006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Single-Dose Vial	Disc	Licensed	2013-06-07
007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	60UG/.5ML	Injection	Intramuscular	Multi-Dose Vial	Rx	Licensed	2013-06-07
008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	36UG/.5ML	Injection	Intradermal	Pre-Filled Syringe	Disc	Licensed	2014-12-11
009	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	240UG/.7ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2019-11-04
010	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	Influenza Virus Vaccine	351(a)	45UG/.5ML	Injection	Intramuscular	Multi-Dose Vial	Rx	Licensed	2019-11-04

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
49281-016	FLUZONE HD TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Vaccines US Inc.	current
49281-125	FLUZONE HIGH DOSE NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	current
49281-226	Fluzone High-Dose Quadrivalent Northern Hemisphere	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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	current
49281-315	FLUZONE TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Vaccines US Inc.	current
49281-425	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Vaccines US Inc.	current
49281-541	Fluzone Quadrivalent Northern Hemisphere	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	current
49281-626	FLUZONE TIV SH 2026	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Vaccines US Inc.	current
49281-643	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Vaccines US Inc.	current
49281-926	Fluzone Quadrivalent Northern Hemisphere	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/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	current
63552-722	FLUZONE HIGH DOSE NORTHERN HEMISPHERE	influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)	Patheon Manufacturing Services LLC	current
83703-083	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Bamboo US BidCo LLC	current
49281-120	FLUZONE High-Dose Quadrivalent Northern Hemisphere	INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-121	FLUZONE High-Dose Quadrivalent Northern Hemisphere	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-122	FLUZONE High-Dose Quadrivalent Northern Hemisphere	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-181	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-182	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-320	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-321	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-322	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-336	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-337	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-339	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-403	FLUZONE High-Dose	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus) ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-405	FLUZONE High-Dose	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus) ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-418	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-419	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-420	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-421	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-422	FLUZONE QUADRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-518	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-519	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-520	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-521	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-629	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-631	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-633	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-635	FLUZONE QUADRIVALENT	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-637	FLUZONE QUADRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-650	INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE	INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED)	Sanofi Pasteur Inc.	legacy
49281-126	FLUZONE HIGH DOSE NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)		openFDA
49281-426	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)		openFDA
49281-645	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)		openFDA
83703-087	FLUZONE TRIVALENT NORTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)		openFDA

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
FLUZONE TRIVALENT NORTHERN HEMISPHERE - Bamboo US BidCo LLC	Bamboo US BidCo LLC	2026-07-01
FLUZONE TRIVALENT NORTHERN HEMISPHERE	Sanofi Vaccines US Inc.	2026-06-29
FLUZONE HIGH DOSE NORTHERN HEMISPHERE	Sanofi Vaccines US Inc. \| Patheon Manufacturing Services LLC	2026-06-26
FLUZONE TRIVALENT NORTHERN HEMISPHERE	Bamboo US BidCo LLC	2026-06-10
FLUZONE HD TIV SH 2026	Sanofi Vaccines US Inc.	2026-04-30
FLUZONE TIV SH 2026	Sanofi Vaccines US Inc.	2026-04-30
FLUZONE TRIVALENT NORTHERN HEMISPHERE	Sanofi Vaccines US Inc.	2026-03-25
FLUZONE TIV SH 2026	Sanofi Vaccines US Inc.	2026-03-19
FLUZONE HD TIV SH 2026	Sanofi Vaccines US Inc.	2026-02-26
FLUZONE TRIVALENT NORTHERN HEMISPHERE	Bamboo US BidCo LLC	2026-02-02
FLUZONE HIGH DOSE NORTHERN HEMISPHERE - Patheon Manufacturing Services LLC	Patheon Manufacturing Services LLC	2025-11-04
Fluzone Quadrivalent Northern Hemisphere	Sanofi Pasteur Inc.	2025-07-11
Fluzone High-Dose Quadrivalent Northern Hemisphere	Sanofi Pasteur Inc.	2025-07-11
FLUZONE HIGH DOSE NORTHERN HEMISPHERE	Sanofi Pasteur Inc.	2025-07-02
FLUZONE High-Dose	Sanofi Pasteur Inc.	2023-04-05
FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	Sanofi Pasteur Inc.	2020-10-07
INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE	Sanofi Pasteur Inc.	2009-09-24

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-05-01	U	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2026-05-01	U	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Vaccines US Inc.
2026-05-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2026-05-01	U	004	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Vaccines US Inc.
2026-05-01	U	005	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2026-05-01	U	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Vaccines US Inc.
2026-05-01	U	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2026-05-01	U	008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Vaccines US Inc.
2026-05-01	U	009	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2026-05-01	U	010	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Vaccines US Inc.
2024-08-01	U	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2024-08-01	U	010	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2024-02-01	U	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2024-02-01	U	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2024-02-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2024-02-01	U	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2023-07-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2023-07-01	U	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2023-07-01	U	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2023-07-01	U	008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2023-07-01	U	009	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2022-08-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2022-07-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2022-02-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2021-07-01	N	008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2021-05-01	U	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2021-05-01	U	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2021-05-01	U	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2021-05-01	U	004	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2021-05-01	U	005	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2021-05-01	U	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2021-05-01	U	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2020-08-01	R	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2020-08-01	R	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2020-08-01	R	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2020-08-01	R	004	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Sanofi Pasteur Inc.
2020-08-01	R	005	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2020-08-01	R	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.
2020-08-01	R	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Sanofi Pasteur Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2024-08-01	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	1999-12-09
2024-08-01	010	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2019-11-04
2024-02-01	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	1999-12-09
2024-02-01	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	1999-12-09
2024-02-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2009-12-23
2024-02-01	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2013-06-07
2023-07-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	2009-12-23
2023-07-01	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	2013-06-07
2023-07-01	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	2013-06-07
2023-07-01	008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	2014-12-11
2023-07-01	009	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2019-11-04
2022-07-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2009-12-23
2022-04-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	1909-12-23
2022-03-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2009-12-23
2021-07-01	008	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2019-11-04
2020-08-01	001	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	1999-12-09
2020-08-01	002	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	1999-12-09
2020-08-01	003	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	1909-12-23
2020-08-01	004	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Disc	Licensed	2011-05-09
2020-08-01	005	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2013-06-07
2020-08-01	006	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2013-06-07
2020-08-01	007	Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	351(a)	Rx	Licensed	2014-12-11

Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent Purple Book BLA 103914

Related Records#

Latest Known Product Presentations#

Published Patent List#

Related NDC Products#

Related DailyMed Labels#

Official Monthly Change Events#

Observed Product State History#