Factor VIII / von Willebrand factor Injection

Brand(s)
Alphanate, Humate-P, Wilate
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Grifols Usa, Llc (2014-09-04)
Oldest Current Product
1986-05-01
License(s)
BLA
RxNORM
INJECTION\FACTOR VIII:VON WILLEBRAND FACTOR
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX
INTRAVENOUS\POWDER, FOR SOLUTION\ANTIHEMOPHILIC FACTOR HUMAN: VON WILLEBRAND FACTOR HUMAN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX
INTRAVENOUS\POWDER, FOR SOLUTION\ANTIHEMOPHILIC FACTOR HUMAN: VON WILLEBRAND FACTOR HUMAN

product(s) by strength(s)

factor viii, human 1 unt / von willebrand factor, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638330615Humate-PBLACsl Behring Gmbh1986-05-01HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103960c5f4b63b-8d8b-45b3-b530-2f1c32a1b852
2638330617Humate-PBLACsl Behring Gmbh1986-05-01HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103960c5f4b63b-8d8b-45b3-b530-2f1c32a1b852
3674670182WilateBLAOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2009-12-04ANTIHEMOPHILIC FACTOR HUMAN, VON WILLEBRAND FACTOR HUMANINTRAVENOUSPOWDER, FOR SOLUTION125251d0379e0c-bb51-554e-a58b-b2afa60019d4
4685164601AlphanateBLAGrifols Usa, Llc2007-01-311024755a7aea94-654c-4113-9014-c3137de0a931
5685164602AlphanateBLAGrifols Usa, Llc2007-01-311024755a7aea94-654c-4113-9014-c3137de0a931

application(s)

#idtitleapprovedtradenamesfda division
1102475Antihemophilic Factor/von Willebrand Factor Complex (Human) Application1978-08-15AlphanateCBER
2103960Antihemophilic Factor/von Willebrand Factor Complex (Human) Application1999-04-01Humate-PCBER
3125251von Willebrand Factor/Coagulation Factor VIII Complex (Human) Application2009-12-04WilateCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15a7aea94-654c-4113-9014-c3137de0a931 (view SPL)These highlights do not include all the information needed to use ALPHANATE safely and effectively. See full prescribing information for ALPHANATE. ALPHANATE (ANTIHEMEOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX [HUMAN])Lyophilized Powder for Solution for Intravenous InjectionInitial U.S. Approval: 1978otherPlasma DerivativeGrifols Usa, LlcMANUFACTURE2014-09-0412685164601, 685164602, 685164603, 685164604, 685164609
2c5f4b63b-8d8b-45b3-b530-2f1c32a1b852 (view SPL)These highlights do not include all the information needed to use Humate-P safely and effectively. See full prescribing information for Humate-P.Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]Lyophilized Powder for Reconstitution for Intravenous Use Only.Initial U.S. Approval: 1986otherPlasma DerivativeCsl Behring GmbhMANUFACTURE2014-05-058638330615, 638330617, 638330616
3d0379e0c-bb51-554e-a58b-b2afa60019d4 (view SPL)These highlights do not include all the information needed to use Wilate safely and effectively. See full prescribing information for Wilate. Wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human), Powder for Solution, for Intravenous Use Only. Initial U.S. Approval: 2009otherPlasma DerivativeOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2010-08-2012674670182

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