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)

#idbrandcategorylabelerfirst marketedapplicationspl
1000537201ZemairaBLACsl Behring Llc2003-07-081250780c3354b5-a1d8-4f98-ad55-2eafe4265c4e
2009442814AralastBLABaxter Healthcare Corporation2002-12-23125039a9a5b46e-04da-41bd-bb5f-c4936b664fef
3135330700ProlastinBLAGrifols1987-12-0210317491edab72-c889-470e-8315-1798b5548dca

application(s)

#idtitleapprovedtradenamesfda division
1103174Alpha-1-Proteinase Inhibitor (Human) Application1987-12-02Prolastin, Prolastin-CCBER
2125039Alpha-1-Proteinase Inhibitor (Human) Application2002-12-23Aralast, Aralast NPCBER
3125078Alpha-1-Proteinase Inhibitor (Human) Application2003-07-08ZemairaCBER
4125325Alpha-1-Proteinase Inhibitor (Human) Application2010-07-01GlassiaCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c3354b5-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: 2003otherPlasma DerivativeCsl Behring LlcMANUFACTURE2015-09-3016000537201
283473cbb-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 2010otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-03-2016009442884
391edab72-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: 1987otherPlasma DerivativeGrifolsMANUFACTURE2013-11-1313135330700, 135330701
4a9a5b46e-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: 2002otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2014-03-174009442814, 009442815

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