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-Wisconsin-1-2010-like virus Prefilled Syringe

Brand(s)
Fluvirin 2012-2013 Formula
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Asclemed Usa, Inc. (2013-05-30)
Oldest Current Product
2013-05-30
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-WISCONSIN-1-2010-LIKE VIRUS

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-wisconsin-1-2010-like virus 0.03 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1764200471Fluvirin 2012-2013 FormulaBLAAsclemed Usa, Inc.2013-05-30103837dcff7edc-ce0a-421b-bcfa-7a407966d8fe

application(s)

#idtitleapprovedfda division
1103837Influenza Virus VaccineFluVirin Application1988-08-12CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1dcff7edc-ce0a-421b-bcfa-7a407966d8fe (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 Injection2012-2013 FormulaInitial U.S. Approval: 1988otherVaccineAsclemed Usa, Inc.LABEL, MANUFACTURE, REPACK2013-05-302764200471

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