NDC 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)

AFLURIA QUADRIVALENT is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Pty Ltd. The primary component is 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); Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated).

Product ID33332-318_0e9dddc2-f132-4357-ad4f-0307408a2130
NDC33332-318
Product TypeVaccine
Proprietary NameAFLURIA QUADRIVALENT
Generic NameInfluenza 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)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2016-09-28
Marketing CategoryBLA / BLA
Application NumberBLA125254
Labeler NameSeqirus Pty Ltd
Substance NameINFLUENZA 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); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED)
Active Ingredient Strength15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33332-318-01

10 SYRINGE, GLASS in 1 CARTON (33332-318-01) > .5 mL in 1 SYRINGE, GLASS (33332-318-02)
Marketing Start Date2016-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33332-318-02 [33332031802]

AFLURIA QUADRIVALENT INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125254
Product TypeVACCINE
Billing UnitML
Marketing Start Date2016-09-28
Marketing End Date2019-11-01

NDC 33332-318-01 [33332031801]

AFLURIA QUADRIVALENT INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125254
Product TypeVACCINE
Billing UnitML
Marketing Start Date2016-09-28
Marketing End Date2019-11-01

Drug Details

Active Ingredients

IngredientStrength
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED)15 ug/.5mL

NDC Crossover Matching brand name "AFLURIA QUADRIVALENT" or generic name "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)"

NDCBrand NameGeneric Name
33332-219Afluria QuadrivalentINFLUENZA 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)
33332-220Afluria QuadrivalentINFLUENZA 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)
33332-221Afluria QuadrivalentINFLUENZA 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)
33332-318AFLURIA QUADRIVALENTINFLUENZA 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)
33332-319Afluria QuadrivalentINFLUENZA 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)
33332-320Afluria QuadrivalentINFLUENZA 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)
33332-321Afluria QuadrivalentINFLUENZA 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)
33332-322Afluria QuadrivalentINFLUENZA 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)
33332-418AFLURIA QUADRIVALENTINFLUENZA 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)
33332-419Afluria QuadrivalentINFLUENZA 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)
33332-420Afluria QuadrivalentINFLUENZA 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)
33332-421Afluria QuadrivalentINFLUENZA 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)
33332-422Afluria QuadrivalentINFLUENZA 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)

Trademark Results [AFLURIA QUADRIVALENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFLURIA QUADRIVALENT
AFLURIA QUADRIVALENT
87684481 5676287 Live/Registered
CSL Limited
2017-11-14

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