Factor VIIa Injection

Brand(s)
Novoseven
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Novo Nordisk (2015-10-06)
Oldest Current Product
2008-04-30
License(s)
BLA
RxNORM
INJECTION\FACTOR VIIA
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COAGULATION FACTOR VIIA RECOMBINANT HUMAN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COAGULATION FACTOR VIIA RECOMBINANT HUMAN

product(s) by strength(s)

coagulation factor viia recombinant human 0.001 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001697010NovosevenBLANovo Nordisk2008-04-302015-08-31COAGULATION FACTOR VIIA RECOMBINANT HUMANINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103665ea65c32f-8518-4383-b621-17056c0eebc0
2001697050NovosevenBLANovo Nordisk2008-04-302015-10-31COAGULATION FACTOR VIIA RECOMBINANT HUMANINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103665ea65c32f-8518-4383-b621-17056c0eebc0
3001697201NovosevenBLANovo Nordisk2012-10-29103665ea65c32f-8518-4383-b621-17056c0eebc0
4001697208NovosevenBLANovo Nordisk2012-10-29103665ea65c32f-8518-4383-b621-17056c0eebc0

application(s)

#idtitleapprovedtradenamesfda division
1103665Coagulation Factor VIIa (Recombinant) Application1999-03-25NovoSeven, NovoSeven RTCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ea65c32f-8518-4383-b621-17056c0eebc0 (view SPL)These highlights do not include all the information needed to use NovoSeven RT safely and effectively. See full prescribing information for NovoSeven RT. NovoSeven RT, Coagulation Factor VIIa (Recombinant)For Intravenous Use Only. Lyophilized Powder for Solution for Injection Initial U.S. Approval: 1999otherPlasma DerivativeNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-10-0615001697010, 001697050, 001697201, 001697208, 001697020, 001697040, 001697202, 001697205

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