factor IX Injection

Brand(s)
Alphanine SD, Ixinity, Mononine, Rixubis
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Cangene Biopharma Inc. (2015-09-24)
Oldest Current Product
1990-12-31
License(s)
BLA
RxNORM
INJECTION\FACTOR IX
SPL Active
INTRAVENOUS\POWDER\COAGULATION FACTOR IX RECOMBINANT HUMAN
SPL Moiety
INTRAVENOUS\POWDER\COAGULATION FACTOR IX RECOMBINANT HUMAN

product(s) by strength(s)

coagulation factor ix (recombinant human) 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009443026RixubisBLABaxter Healthcare Corporation2013-06-26125446f5070a92-96b8-476a-a2dc-18b22d95e5e0
2009443032RixubisBLABaxter Healthcare Corporation2013-06-26125446f5070a92-96b8-476a-a2dc-18b22d95e5e0
3009443034RixubisBLABaxter Healthcare Corporation2013-06-26125446f5070a92-96b8-476a-a2dc-18b22d95e5e0
4532700270IxinityCangene Biopharma Inc.COAGULATION FACTOR IX RECOMBINANT HUMANINTRAVENOUSPOWDER1cae46d1-f463-488a-9e8b-3431ef1de1e4

factor ix, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1000536232MononineBLACsl Behring Llc1992-08-2010395716f35cdb-7a3b-481b-a25b-0a065aea2c9b
2685163601Alphanine SDBLAGrifols Usa, Llc1990-12-311032493e99052d-4442-4283-8915-c9a796c77008
3685163602Alphanine SDBLAGrifols Usa, Llc1990-12-311032493e99052d-4442-4283-8915-c9a796c77008

application(s)

#idtitleapprovedtradenamesfda division
1103249Coagulation Factor IX (Human) Application1990-12-31AlphaNine, AlphaNine HP, AlphaNine SDCBER
2103957Coagulation Factor IX (Human) Application1992-08-20MononineCBER
3125446Coagulation Factor IX (Recombinant) Application2013-06-26RIXUBISCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
116f35cdb-7a3b-481b-a25b-0a065aea2c9b (view SPL)Coagulation Factor IX (Human) Mononine Monoclonal Antibody PurifiedotherPlasma DerivativeCsl Behring LlcMANUFACTURE2013-07-2910000536232, 000536233
21cae46d1-f463-488a-9e8b-3431ef1de1e4 (view SPL)These highlights do not include all the information needed to use IXINITY safely and effectively. See full prescribing information for IXINITY.Initial U.S. Approval: 2015prescriptionHuman PrescriptionCangene Biopharma Inc.MANUFACTURE2015-09-242532700270, 532700271, 532700272
33e99052d-4442-4283-8915-c9a796c77008 (view SPL)Coagulation Factor IX (Human), AlphaNine SD Solvent Detergent Treated/Virus FilteredotherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2014-03-1810685163601, 685163602, 685163603
4f5070a92-96b8-476a-a2dc-18b22d95e5e0 (view SPL)These highlights do not include all the information needed to use RIXUBIS safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)]For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 2013otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-01-172009443026, 009443032, 009443034, 009443028, 009443030

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