influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injectable Suspension

Brand(s)
Afluria 2015-2016, FluLaval Quadrivalent 2015-2016, Fluzone 2015-2016, Fluzone Quadrivalent 2015-2016
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2015-06-30)
Oldest Current Product
2011-07-15
License(s)
BLA
RxNORM
INJECTABLE SUSPENSION\INFLUENZA A VIRUS (H1N1) ANTIGEN:INFLUENZA A VIRUS (H3N2) ANTIGEN:INFLUENZA B VIRUS ANTIGEN
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED)
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED)
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)

product(s) by strength(s)

influenza a virus a/california/7/2009 (h1n1) antigen 0.03 mg/ml / influenza a virus a/south australia/55/2014 (h3n2) antigen 0.03 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.03 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1333320115Afluria 2015-2016BLABiocsl Pty Ltd.2011-07-15INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION125254bebf60e5-254d-4f84-8380-071908524ebd

influenza a virus a/california/7/2009 (h1n1) antigen 0.03 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 0.03 mg/ml / influenza b virus b/brisbane/60/2008 antigen 0.03 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.03 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1195150898FluLaval Quadrivalent 2015-2016BLAId Biomedical Corporation Of Quebec2015-07-01INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)INTRAMUSCULARSUSPENSION125163a9806027-8323-4abf-849f-46fb10984f13

influenza a virus a/california/7/2009 (h1n1) antigen 0.03 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 0.03 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.03 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1492810396Fluzone 2015-2016BLASanofi Pasteur Inc.2015-06-262016-06-30INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION1039140f809a23-0b85-4201-88ed-0851773bcdd8

application(s)

#idtitleapprovedtradenamesfda division
1103914Influenza Virus VaccineFluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent Application1999-12-09CBER
2125163Influenza Virus VaccineFluLaval; FluLaval Quadrivalent Application2006-10-05CBER
3125254Influenza Virus Vaccine Application2007-09-28AFLURIACBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10f809a23-0b85-4201-88ed-0851773bcdd8 (view SPL)These highlights do not include all the information needed to use Fluzone safely and effectively. See full prescribing information for Fluzone. Fluzone (Influenza Vaccine) Suspension for Intramuscular Injection 2015-2016 Formula Initial U.S. Approval 1980otherVaccineSanofi Pasteur Inc.MANUFACTURE2015-06-301492810396
28213c229-a67a-4d3f-bd8f-b8729ae28472 (view SPL)These highlights do not include all the information needed to use Fluzone Quadrivalent safely and effectively. See full prescribing information for Fluzone Quadrivalent. Fluzone Quadrivalent (Influenza Vaccine) Suspension for Intramuscular Injection 2015-2016 Formula Initial U.S. Approval (Fluzone Quadrivalent): 2013otherVaccineSanofi Pasteur Inc.MANUFACTURE2015-07-231492810415, 492810515, 492810623influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Prefilled Syringe
3a9806027-8323-4abf-849f-46fb10984f13 (view SPL)These highlights do not include all the information needed to use FLULAVAL QUADRIVALENT safely and effectively. See full prescribing information for FLULAVAL QUADRIVALENT. FLULAVAL QUADRIVALENT (Influenza Vaccine)Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2013otherVaccineId Biomedical Corporation Of Quebec2015-06-303195150898, 195150891, 195150894, 195150901Influenza A virus vaccine, A-California-7-2009 (H1N1)-like virus / Influenza A virus vaccine, A-Victoria-361-2011 (H3N2)-like virus / Influenza B virus vaccine, B-Brisbane-60-2008-like virus / Influenza B virus vaccine, B-Massachusetts-2-2012-like virus Injectable Suspension
influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Prefilled Syringe
Influenza A virus vaccine, A-California-7-2009 (H1N1)-like virus / Influenza A virus vaccine, A-Victoria-361-2011 (H3N2)-like virus / Influenza B virus vaccine, B-Brisbane-60-2008-like virus / Influenza B virus vaccine, B-Massachusetts-2-2012-like virus Prefilled Syringe
4bebf60e5-254d-4f84-8380-071908524ebd (view SPL)These highlights do not include all the information needed to use AFLURIA safely and effectively. See full prescribing information for AFLURIA. AFLURIA, Influenza VaccineSuspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2007otherVaccineBiocsl Pty Ltd.MANUFACTURE2015-05-265333320115, 333320015influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII