influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Prefilled Syringe

Brand(s)
Afluria 2015-2016, FluLaval Quadrivalent 2015-2016, Fluarix Quadrivalent 2015-2016, Flucelvax 2015-2016, Fluzone 2015-2016, Fluzone Quadrivalent 2015-2016
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Asclemed Usa, Inc. (2015-08-06)
Oldest Current Product
2011-07-15
License(s)
BLA
RxNORM
PREFILLED SYRINGE\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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
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)
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (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/BRISBANE/60/2008 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-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)
INTRAMUSCULAR\SUSPENSION\INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED): INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

product(s) by strength(s)

0.5 ml influenza a virus a/brisbane/10/2010 (h1n1) antigen 0.03 mg/ml / influenza a virus a/south australia/55/2014 (h3n2) antigen 0.03 mg/ml / influenza b virus b/utah/9/2014 antigen 0.03 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1764200510Flucelvax 2015-2016BLAAsclemed Usa, Inc.2014-07-011254083013074d-a5ac-494e-b641-769bd24fbd00

0.5 ml 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 prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1333320015Afluria 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

0.5 ml 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 prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1195150901FluLaval 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

0.25 ml 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 prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1492810515Fluzone Quadrivalent 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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION1039148213c229-a67a-4d3f-bd8f-b8729ae28472

0.1 ml influenza a virus a/california/7/2009 (h1n1) antigen 0.09 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 0.09 mg/ml / influenza b virus b/brisbane/60/2008 antigen 0.09 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.09 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1492810708Fluzone Quadrivalent 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/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION103914b013de0e-3634-4e01-91cd-7c7ce6ce8bb8

0.5 ml influenza a virus a/california/7/2009 (h1n1) antigen 0.12 mg/ml / influenza a virus a/switzerland/9715293/2013 (h3n2) antigen 0.12 mg/ml / influenza b virus b/phuket/3073/2013 antigen 0.12 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1492810397Fluzone 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, SUSPENSION1039147e55abca-701a-4142-9122-830118c5d115

0.5 ml influenza a virus a/christchurch/16/2010 (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 prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581600903Fluarix Quadrivalent 2015-2016BLAGlaxosmithkline Biologicals Sa2015-07-01INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARSUSPENSION125127ebeb1c66-deab-4358-a5c0-d4f58c8d8ae7

application(s)

#idtitleapprovedtradenamesfda division
1103914Influenza Virus VaccineFluzone; Fluzone High Dose; Fluzone Intradermal; Fluzone Quadrivalent Application1999-12-09CBER
2125127Influenza Virus VaccineFLUARIX FLUARIX Quadrivalent Application2005-08-31CBER
3125163Influenza Virus VaccineFluLaval; FluLaval Quadrivalent Application2006-10-05CBER
4125254Influenza Virus Vaccine Application2007-09-28AFLURIACBER
5125408Influenza Virus VaccineFlucelvax Application2012-11-20CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13013074d-a5ac-494e-b641-769bd24fbd00 (view SPL)These highlights do not include all the information needed to use FLUCELVAX safely and effectively. See full prescribing information for FLUCELVAX.FLUCELVAX (Influenza Vaccine) Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2012otherVaccineAsclemed Usa, Inc.REPACK2015-08-061764200510
27e55abca-701a-4142-9122-830118c5d115 (view SPL)These highlights do not include all the information needed to use Fluzone High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine)Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2009otherVaccineSanofi Pasteur Inc.MANUFACTURE2015-06-305492810397
38213c229-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.MANUFACTURE2015-07-231492810515, 492810415, 492810623influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injectable Suspension
49ba0bcf8-3a5d-462d-9025-08c8ffd1f2f0 (view SPL)These highlights do not include all the information needed to use FLUCELVAX safely and effectively. See full prescribing information for FLUCELVAX.FLUCELVAX (Influenza Vaccine) Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2012otherVaccineNovartis Vaccines And Diagnostics, Inc.MANUFACTURE2015-07-021625770614
5a9806027-8323-4abf-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 Quebec2015-06-303195150901, 195150891, 195150894, 195150898Influenza 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 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
influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injectable Suspension
6b013de0e-3634-4e01-91cd-7c7ce6ce8bb8 (view SPL)These highlights do not include all the information needed to use Fluzone Intradermal Quadrivalent safely and effectively. See full prescribing information for Fluzone Intradermal Quadrivalent. Fluzone Intradermal Quadrivalent (Influenza Vaccine) Suspension for Intradermal Injection 2015-2016 Formula Initial U.S. Approval (Fluzone Intradermal Quadrivalent): 2014otherVaccineSanofi Pasteur Inc.MANUFACTURE2015-06-014492810708
7bebf60e5-254d-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.MANUFACTURE2015-05-265333320015, 333320115influenza A virus (H1N1) antigen / influenza A virus (H3N2) antigen / influenza B virus antigen Injectable Suspension
8ebeb1c66-deab-4358-a5c0-d4f58c8d8ae7 (view SPL)These highlights do not include all the information needed to use FLUARIX QUADRIVALENT safely and effectively. See full prescribing information for FLUARIX QUADRIVALENT. FLUARIX QUADRIVALENT (Influenza Vaccine) Suspension for Intramuscular Injection2015-2016 FormulaInitial U.S. Approval: 2012otherVaccineGlaxosmithkline Biologicals Sa2015-06-305581600903

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