factor XIII Injection

Brand(s)
Corifact, Tretten
Category(s)
other
SPL Type(s)
Plasma Derivative
Master SPL
Csl Behring Gmbh (2015-09-30)
Oldest Current Product
2011-02-17
License(s)
BLA
RxNORM
INJECTION\FACTOR XIII

product(s) by strength(s)

coagulation factor xiii a-subunit (recombinant) 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1001697013TrettenBLANovo Nordisk2013-12-231253988664978e-1814-4930-aca5-97a24455f6df

factor xiii, human 1 unt injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1638330518CorifactBLACsl Behring Gmbh2011-02-1712538596f1b658-01b0-43a7-9aba-693271389a78

application(s)

#idtitleapprovedtradenamesfda division
1125385Factor XIII Concentrate (Human) Application2011-02-17CorifactCBER
2125398Coagulation Factor XIII A Subunit (Recombinant) Application2013-12-23TRETTENCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18664978e-1814-4930-aca5-97a24455f6df (view SPL)These highlights do not include all the information needed to use TRETTEN safely and effectively. See full prescribing information for TRETTEN. TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant) For Intravenous Use. Lyophilized Powder for Solution for InjectionInitial U.S. Approval: 2013otherPlasma DerivativeNovo NordiskMANUFACTURE2014-04-302001697013
296f1b658-01b0-43a7-9aba-693271389a78 (view SPL)These highlights do not include all the information needed to use CORIFACT safely and effectively. See full prescribing information for CORIFACT. Corifact, Factor XIII Concentrate (Human) Lyophilized powder for solution for injection For intravenous use only. Initial U.S. Approval: 2011otherPlasma DerivativeCsl Behring GmbhMANUFACTURE2015-09-307638330518

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