hepatitis B immune globulin Injection

Brand(s)
HepaGam B, Nabi-HB
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Cangene Biopharma Inc. (2012-01-13)
Oldest Current Product
2010-03-10
License(s)
BLA
RxNORM
INJECTION\HEPATITIS B IMMUNE GLOBULIN
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
INTRAMUSCULAR\INJECTION\HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
INTRAMUSCULAR\INJECTION\HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

product(s) by strength(s)

1 ml hepatitis b immune globulin 312 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1532700052HepaGam BBLACangene Biopharma Inc.2010-08-01HUMAN HEPATITIS B VIRUS IMMUNE GLOBULININTRAMUSCULARINJECTION, SOLUTION125035b3337f3e-fe90-4969-8fd1-4de8de6ef76c

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597304202Nabi-HBBLANabi Biopharmaceuticals2010-03-10HUMAN HEPATITIS B VIRUS IMMUNE GLOBULININTRAMUSCULARINJECTION99144217fda474-4e87-4ca4-b5f5-0df5978f83b7

5 ml hepatitis b immune globulin 312 unt/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1532700054HepaGam BBLACangene Biopharma Inc.2010-08-01HUMAN HEPATITIS B VIRUS IMMUNE GLOBULININTRAMUSCULARINJECTION, SOLUTION125035f8fd8297-4d47-4781-93ef-d0e6946fc55c

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597304203Nabi-HBBLANabi Biopharmaceuticals2010-03-12HUMAN HEPATITIS B VIRUS IMMUNE GLOBULININTRAMUSCULARINJECTION9914428847ff27-8bad-45fd-a9db-594e4f811803

application(s)

#idtitleapprovedtradenamesfda division
1125035Hepatitis B Immune Globulin (Human) Application2006-01-27HepaGam BCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117fda474-4e87-4ca4-b5f5-0df5978f83b7 (view SPL)Hepatitis B Immune Globulin (Human) Nabi-HB Solvent Detergent Treated and FilteredprescriptionHuman PrescriptionNabi Biopharmaceuticalsmanufacture2010-08-252597304202
28847ff27-8bad-45fd-a9db-594e4f811803 (view SPL)Hepatitis B Immune Globulin (Human) Nabi-HB Solvent Detergent Treated and FilteredprescriptionHuman PrescriptionNabi Biopharmaceuticalsmanufacture2010-08-252597304203
3b3337f3e-fe90-4969-8fd1-4de8de6ef76c (view SPL)These highlights do not include all the information needed to use HepaGam B safely and effectively. See full prescribing information for HepaGam B.HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. >312 IU/mL (Measured potency stamped on the vial label ) Initial U.S. Approval: 2006otherPlasma DerivativeCangene Biopharma Inc.MANUFACTURE2012-01-133532700052, 532700051
4f8fd8297-4d47-4781-93ef-d0e6946fc55c (view SPL)These highlights do not include all the information needed to use HepaGam B safely and effectively. See full prescribing information for HepaGam B. HepaGam B [Hepatitis B Immune Globulin Intravenous (Human)],Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. >312 IU/mL (Measured potency stamped on the vial label)Initial U.S. Approval: 2006prescriptionHuman PrescriptionCangene Biopharma Inc.MANUFACTURE2010-06-142532700054, 532700053

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