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)

#	id	brand	category	labeler	first marketed	application	spl
1	001697013	Tretten	BLA	Novo Nordisk	2013-12-23	125398	8664978e-1814-4930-aca5-97a24455f6df

factor xiii, human 1 unt injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	application	spl
1	638330518	Corifact	BLA	Csl Behring Gmbh	2011-02-17	125385	96f1b658-01b0-43a7-9aba-693271389a78

application(s)

#	id	title	approved	tradenames	fda division
1	125385	Factor XIII Concentrate (Human) Application	2011-02-17	Corifact	CBER
2	125398	Coagulation Factor XIII A Subunit (Recombinant) Application	2013-12-23	TRETTEN	CBER

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	8664978e-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: 2013	other	Plasma Derivative	Novo Nordisk	MANUFACTURE	2014-04-30	2	001697013
2	96f1b658-01b0-43a7-9aba-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: 2011	other	Plasma Derivative	Csl Behring Gmbh	MANUFACTURE	2015-09-30	7	638330518

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