alpha 1-Antitrypsin Injection

Brand(s): Aralast, Glassia, Prolastin, Zemaira
Category(s): other
SPL Type(s): Plasma Derivative
Master SPL: Csl Behring Llc (2015-09-30)
Oldest Current Product: 1987-12-02
License(s): BLA

RxNORM: INJECTION\ALPHA 1-ANTITRYPSIN

product(s) by strength(s)

alpha 1-proteinase inhibitor, human 1 mg injection

original product(s)(s)

#	id	brand	category	labeler	first marketed	application	spl
1	000537201	Zemaira	BLA	Csl Behring Llc	2003-07-08	125078	0c3354b5-a1d8-4f98-ad55-2eafe4265c4e
2	009442814	Aralast	BLA	Baxter Healthcare Corporation	2002-12-23	125039	a9a5b46e-04da-41bd-bb5f-c4936b664fef
3	135330700	Prolastin	BLA	Grifols	1987-12-02	103174	91edab72-c889-470e-8315-1798b5548dca

application(s)

#	id	title	approved	tradenames	fda division
1	103174	Alpha-1-Proteinase Inhibitor (Human) Application	1987-12-02	Prolastin, Prolastin-C	CBER
2	125039	Alpha-1-Proteinase Inhibitor (Human) Application	2002-12-23	Aralast, Aralast NP	CBER
3	125078	Alpha-1-Proteinase Inhibitor (Human) Application	2003-07-08	Zemaira	CBER
4	125325	Alpha-1-Proteinase Inhibitor (Human) Application	2010-07-01	Glassia	CBER

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	0c3354b5-a1d8-4f98-ad55-2eafe4265c4e (view SPL)	These highlights do not include all the information needed to use Zemaira safely and effectively. See full prescribing information for Zemaira. Zemaira, Alpha1-Proteinase Inhibitor (Human)For Intravenous Use. Lyophilized Powder for Reconstitution.Initial U.S. Approval: 2003	other	Plasma Derivative	Csl Behring Llc	MANUFACTURE	2015-09-30	16	000537201
2	83473cbb-48e4-42a2-81b6-4c851423da7b (view SPL)	These highlights do not include all the information needed to use GLASSIA safely and effectively. See full prescribing information for GLASSIA.GLASSIA (Alpha1-Proteinase Inhibitor (Human)) Injection Solution- For Intravenous Use OnlyInitial U.S. Approval: July 2010	other	Plasma Derivative	Baxter Healthcare Corporation	MANUFACTURE	2014-03-20	16	009442884
3	91edab72-c889-470e-8315-1798b5548dca (view SPL)	These highlights do not include all the information needed to use PROLASTIN-C safely and effectively. See full prescribing information for PROLASTIN-C. PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human])Lyophilized Powder for Solution for Injection For Intravenous UseInitial U.S. Approval: 1987	other	Plasma Derivative	Grifols	MANUFACTURE	2013-11-13	13	135330700, 135330701
4	a9a5b46e-04da-41bd-bb5f-c4936b664fef (view SPL)	These highlights do not include all the information needed to use ARALAST NP safely and effectively. See full prescribing information for ARALAST NP.ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]For Intravenous Use. Lyophilized Powder for Solution for Injection Initial U.S. Approval: 2002	other	Plasma Derivative	Baxter Healthcare Corporation	MANUFACTURE	2014-03-17	4	009442814, 009442815

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