Hepatitis A Vaccine (Inactivated) Strain HM175 Injection

Brand(s)
Havrix
Category(s)
other
SPL Type(s)
Vaccine
Oldest Current Product
2007-04-13
License(s)
BLA
RxNORM
INJECTION\HEPATITIS A VACCINE (INACTIVATED) STRAIN HM175
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)

product(s) by strength(s)

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1550453841HavrixBLADispensing Solutions, Inc.2007-04-13HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION58160082610347563d283dd-e857-4c0e-b1fa-9e9d9b8717a8
2682588912HavrixBLADispensing Solutions, Inc.2007-04-13HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)INTRAMUSCULARINJECTION, SUSPENSION581600826103475135ff1b4-c21f-4df1-97be-9475680e9e44

application(s)

#idtitleapprovedfda division
1103475Hepatitis A Vaccine InactivatedHavrix Application1995-02-22CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1135ff1b4-c21f-4df1-97be-9475680e9e44 (view SPL)These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX.HAVRIX (Hepatitis A Vaccine)Suspension for Intramuscular InjectionInitial U.S. Approval: 1995otherVaccineDispensing Solutions, Inc.relabel, repack2013-11-071682588912
263d283dd-e857-4c0e-b1fa-9e9d9b8717a8 (view SPL)These highlights do not include all the information needed to use HAVRIX safely and effectively. See full prescribing information for HAVRIX.HAVRIX (Hepatitis A Vaccine)Suspension for Intramuscular InjectionInitial U.S. Approval: 1995otherVaccineDispensing Solutions, Inc.relabel, repack2011-10-071550453841

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