Rho(D) Immune Globulin Injectable Solution

Brand(s)
WinRho SDF
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cangene Biopharma Inc. (2011-01-11)
Oldest Current Product
2004-03-31
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\RHO(D) IMMUNE GLOBULIN
SPL Active
INTRAMUSCULAR\LIQUID\HUMAN IMMUNOGLOBULIN G
SPL Moiety
INTRAMUSCULAR\LIQUID\HUMAN IMMUNOGLOBULIN G

product(s) by strength(s)

rho(d) immune globulin 0.227 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1532703100WinRho SDFBLACangene Biopharma Inc.2004-03-31HUMAN IMMUNOGLOBULIN GINTRAMUSCULARLIQUID103649a9f7654f-cf56-4aec-9e08-7c4b0dc54ff1

rho(d) immune globulin 0.231 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1532703000WinRho SDFBLACangene Biopharma Inc.2005-03-31HUMAN IMMUNOGLOBULIN GINTRAMUSCULARLIQUID103649a9f7654f-cf56-4aec-9e08-7c4b0dc54ff1

rho(d) immune globulin 0.24 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1532703120WinRho SDFBLACangene Biopharma Inc.2005-03-31HUMAN IMMUNOGLOBULIN GINTRAMUSCULARLIQUID103649a9f7654f-cf56-4aec-9e08-7c4b0dc54ff1

application(s)

#idtitleapprovedtradenamesfda division
1103649Rho(D) Immune Globulin Intravenous (Human) Application1995-03-24WinRho SD, WinRho SDF Liquid, WinRho SDF LyophilizedCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a9f7654f-cf56-4aec-9e08-7c4b0dc54ff1 (view SPL)These highlights do not include all the information needed to use WinRho SDF safely and effectively. See full prescribing information for WinRho SDF. Initial U.S. Approval: 1995prescriptionHuman PrescriptionCangene Biopharma Inc.MANUFACTURE2011-01-117532703000, 532703100, 532703120, 532703300, 532703500

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