Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator

Brand(s)
Artiss, Tisseel
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Baxter Healthcare Corporation (2013-09-03)
Oldest Current Product
1998-05-01
License(s)
BLA
RxNORM
PREFILLED APPLICATOR\CALCIUM CHLORIDE:FIBRINOGEN:FIBRINOLYSIS INHIBITOR:THROMBIN
SPL Active
TOPICAL\SOLUTION\FIBRINOGEN HUMAN: HUMAN THROMBIN
SPL Moiety
TOPICAL\SOLUTION\FIBRINOGEN HUMAN: HUMAN THROMBIN

product(s) by strength(s)

calcium chloride 0.04 meq/ml / fibrinogen 106 mg/ml / fibrinolysis inhibitor 3750 unt/ml / thrombin (human) 6.5 unt/ml prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009448503ArtissBLABaxter Healthcare Corporation2009-03-19, 2011-01-11FIBRINOGEN HUMAN, HUMAN THROMBINTOPICALSOLUTION12526613f76667-ec2f-4fa7-a9e8-12502d8224db, 25fabd0d-0adc-465c-8bab-18ff45ba6186, bd90793f-a6db-4cc3-8336-20b22d37a5ec

4 ml calcium chloride 0.04 meq/ml / fibrinogen 106 mg/ml / fibrinolysis inhibitor 3750 unt/ml / thrombin (human) 625 unt/ml prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1009444211TisseelBLABaxter Healthcare Corporation1998-05-0110398060e8272e-2a7d-42a5-af4b-3dbf727dd68f, 7d7abda1-9b76-43b2-8f74-0e376d9fe264

10 ml calcium chloride 0.04 meq/ml / fibrinogen 106 mg/ml / fibrinolysis inhibitor 3750 unt/ml / thrombin (human) 625 unt/ml prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1009444212TisseelBLABaxter Healthcare Corporation1998-05-0110398060e8272e-2a7d-42a5-af4b-3dbf727dd68f, 7d7abda1-9b76-43b2-8f74-0e376d9fe264

application(s)

#idtitleapprovedtradenamesfda division
1103980Fibrin Sealant (Tisseel) Application1998-05-01TISSEELCBER
2125266Fibrin Sealant (Human) Application2008-03-19ARTISSCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
113f76667-ec2f-4fa7-a9e8-12502d8224db (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008prescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-12-2312009448503, 009444351Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution
225fabd0d-0adc-465c-8bab-18ff45ba6186 (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008prescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-12-2311009448503, 009444351Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution
360e8272e-2a7d-42a5-af4b-3dbf727dd68f (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-032009444211, 009444212, 009444210, 009444301, 009444302, 009444303, 009448402Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution
47d7abda1-9b76-43b2-8f74-0e376d9fe264 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-031009444211, 009444212, 009444210, 009444301, 009444302, 009444303, 009448402Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution
5bd90793f-a6db-4cc3-8336-20b22d37a5ec (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-08-2912009448503, 009444351Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution

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