Thrombin Topical Solution

Brand(s)
Recothrom, Thrombin-JMI
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Pfizer Laboratories Div Pfizer Inc (2015-09-15)
Oldest Current Product
1995-02-24
License(s)
BLA
RxNORM
TOPICAL SOLUTION\THROMBIN
SPL Active
TOPICAL\POWDER, FOR SOLUTION\HUMAN THROMBIN
TOPICAL\SOLUTION\THROMBIN
SPL Moiety
TOPICAL\POWDER, FOR SOLUTION\THROMBIN
TOPICAL\SOLUTION\THROMBIN

product(s) by strength(s)

thrombin 1000 unt/ml topical solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1637130461BLAEthicon, Inc2009-09-19HUMAN THROMBINTOPICALPOWDER, FOR SOLUTION12524702edcd44-1c26-45f1-a75c-f1f639d1956e

thrombin 2000 unt/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930215Thrombin-JMIBLAPfizer Laboratories Div Pfizer Inc1995-02-24THROMBINTOPICALSOLUTION102865ba8fcebf-a924-488f-983d-088892761f0e

thrombin alfa 1000 unt/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)dose formapplicationspl
1284000105RecothromBLAZymogenetics, Inc.2008-01-292016-11-30THROMBIN ALFAKIT125248af304504-85af-87ba-edb6-9bf35985cba8
2652930006RecothromBLAThe Medicines Company2008-01-29THROMBIN ALFAKIT125248bcf44467-b1eb-479b-8866-a8ac2c780c22

application(s)

#idtitleapprovedtradenamesfda division
1102865Thrombin, Topical (Bovine) Application1986-02-03Thrombin-JMI, ThromboCollCBER
2125247Thrombin, Topical (Human) Application2007-08-27EvithromCBER
3125248Thrombin topical (Recombinant) Application2008-01-17RECOTHROMCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
102edcd44-1c26-45f1-a75c-f1f639d1956e (view SPL)These highlights do not include all the information needed to use EVITHROM safely and effectively. See full prescribing information for EVITHROM.EVITHROM, Thrombin, Topical (Human)For Topical Use Only, Lyophilized Powder for ReconstitutionInitial U.S. Approval: 2007prescriptionHuman PrescriptionEthicon, IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2009-09-133637130461
2af304504-85af-87ba-edb6-9bf35985cba8 (view SPL)These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM, Thrombin topical (Recombinant) Lyophilized Powder for Solution - For Topical Use Only Initial U.S. Approval: 2008otherPlasma DerivativeZymogenetics, Inc.2015-04-249284000105, 284000120
3ba8fcebf-a924-488f-983d-088892761f0e (view SPL)These highlights do not include all the information needed to use THROMBIN-JMI safely and effectively. See full prescribing information for THROMBIN-JMI. THROMBIN-JMI (Thrombin, Topical (Bovine) U.S.P.), Solution for topical use Initial U.S. Approval: 1986otherPlasma DerivativePfizer Laboratories Div Pfizer IncMANUFACTURE2015-09-1513607930215, 607930205, 607930217, 607930705Thrombin Nasal Spray
4bcf44467-b1eb-479b-8866-a8ac2c780c22 (view SPL)These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM, Thrombin topical (Recombinant) Lyophilized Powder for Solution - For Topical Use Only Initial U.S. Approval: 2008otherPlasma DerivativeThe Medicines CompanyANALYSIS, LABEL, MANUFACTURE, PACK2014-09-108652930006, 652930007

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