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-Massachusetts-2-2012-like virus Prefilled Syringe

Brand(s)
Flucelvax 2013-2014 Formula, Flucelvax 2014-2015 Formula, Fluvirin 2013-2014 Formula, Fluvirin 2014-2015 Formula
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Catalent Belgium Sa (2015-01-27)
Oldest Current Product
2013-09-15
License(s)
BLA
RxNORM
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-MASSACHUSETTS-2-2012-LIKE VIRUS
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED)
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
INTRAMUSCULAR\INJECTION, SUSPENSION\INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED): INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED)

product(s) by strength(s)

0.5 ml influenza a virus vaccine, a-california-7-2009 (h1n1)-like virus 0.03 mg/ml / influenza a virus vaccine, a-victoria-361-2011 (h3n2)-like virus 0.03 mg/ml / influenza b virus vaccine, b-massachusetts-2-2012-like virus 0.03 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1438350004Fluvirin 2014-2015 FormulaBLACatalent Belgium Sa2013-09-15INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION1038370d8c11b7-12a1-6b60-e054-00144ff8d46c
2625770613Flucelvax 2014-2015 FormulaBLANovartis Vaccines And Diagnostics, Inc.2014-07-01INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION125408cb063bf0-4aaf-4733-a950-9ab5229ea137
3764200481Fluvirin 2013-2014 FormulaBLAAsclemed Usa, Inc.2013-09-1510383734b5dd28-d095-4690-93e8-c1d2a6efaf63

application(s)

#idtitleapprovedfda division
1103837Influenza Virus VaccineFluVirin Application1988-08-12CBER
2125408Influenza Virus VaccineFlucelvax Application2012-11-20CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1030dfb30-589d-4335-85fe-d609644088e0 (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 Virus Vaccine) Suspension for Intramuscular Injection2013-2014 FormulaInitial U.S. Approval: 2012otherVaccineNovartis Vaccines And Diagnostics GmbhMANUFACTURE2013-08-162638510612
20d8c11b7-12a1-6b60-e054-00144ff8d46c (view SPL)FluvirinotherVaccineCatalent Belgium Sa2015-01-271438350004
334b5dd28-d095-4690-93e8-c1d2a6efaf63 (view SPL)These highlights do not include all the information needed to use FLUVIRIN (Influenza Virus Vaccine) safely and effectively. See full prescribing information for FLUVIRIN.FLUVIRIN (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula Initial U.S. Approval: 1988otherVaccineAsclemed Usa, Inc.MANUFACTURE, REPACK2013-08-271764200481
499438059-7dce-4b6d-929c-e924a83cd865 (view SPL)These highlights do not include all the information needed to use FLUVIRIN (Influenza Virus Vaccine) safely and effectively. See full prescribing information for FLUVIRIN.FLUVIRIN (Influenza Virus Vaccine)Suspension for Intramuscular Injection2013-2014 FormulaInitial U.S. Approval: 1988otherVaccineAsclemed Usa, Inc.REPACK2014-08-071764200491
5cb063bf0-4aaf-4733-a950-9ab5229ea137 (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 Injection2014-2015 FormulaInitial U.S. Approval: 2012otherVaccineNovartis Vaccines And Diagnostics, Inc.MANUFACTURE2014-03-261625770613

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