Haemophilus influenzae type b, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine Injection

Brand(s)
ActHIB, Hiberix
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2014-01-30)
Oldest Current Product
1993-03-30
License(s)
BLA
RxNORM
INJECTION\HAEMOPHILUS INFLUENZAE TYPE B, CAPSULAR POLYSACCHARIDE INACTIVATED TETANUS TOXOID CONJUGATE VACCINE
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
INTRAMUSCULAR\INJECTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
INTRAMUSCULAR\INJECTION\HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN

product(s) by strength(s)

0.5 ml haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810545ActHIBBLASanofi Pasteur Inc.1993-03-30HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGENINTRAMUSCULARINJECTION1039358143d01c-4911-40db-95b2-47f3ebea2a7d

0.5 ml haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1581600806HiberixBLAGlaxosmithkline Biologicals Sa2009-08-24HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGENINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION125347745ff8df-1618-4b76-9aa1-6f42752c0dda

application(s)

#idtitleapprovedfda division
1103935Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)ActHIB OmniHIB Application1993-03-30CBER
2125347Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Hiberix Application2009-08-19CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1745ff8df-1618-4b76-9aa1-6f42752c0dda (view SPL)These highlights do not include all the information needed to use HIBERIX safely and effectively. See full prescribing information for HIBERIX. HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]Solution for Intramuscular InjectionInitial U.S. Approval: 2009otherVaccineGlaxosmithkline Biologicals Sa2012-03-128581600806
28143d01c-4911-40db-95b2-47f3ebea2a7d (view SPL)Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIBotherVaccineSanofi Pasteur Inc.MANUFACTURE2014-01-305492810545

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