Fibrinogen / Thrombin Transdermal Patch

Brand(s)
TachoSil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-07-20)
Oldest Current Product
2010-04-05
License(s)
BLA
RxNORM
TRANSDERMAL PATCH\FIBRINOGEN:THROMBIN
SPL Active
TOPICAL\PATCH\FIBRINOGEN HUMAN: HUMAN THROMBIN
SPL Moiety
TOPICAL\PATCH\FIBRINOGEN HUMAN: HUMAN THROMBIN

product(s) by strength(s)

fibrinogen 171 mg / thrombin 62.2 unt transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009448702TachoSilBLABaxter Healthcare Corporation2010-04-05FIBRINOGEN HUMAN, HUMAN THROMBINTOPICALPATCH1253515918e503-b457-48ab-b68b-243e29651d06

fibrinogen 337 mg / thrombin 123 unt transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009448701TachoSilBLABaxter Healthcare Corporation2010-04-05FIBRINOGEN HUMAN, HUMAN THROMBINTOPICALPATCH1253515918e503-b457-48ab-b68b-243e29651d06

fibrinogen 55.5 mg / thrombin 20.3 unt transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009448703TachoSilBLABaxter Healthcare Corporation2010-04-05FIBRINOGEN HUMAN, HUMAN THROMBINTOPICALPATCH1253515918e503-b457-48ab-b68b-243e29651d06

application(s)

#idtitleapprovedfda division
1125351Fibrin Sealant PatchTachoSil Application2010-04-05CBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15918e503-b457-48ab-b68b-243e29651d06 (view SPL)These highlights do not include all the information needed to use TACHOSIL safely and effectively. See full prescribing information for TACHOSIL.TACHOSIL Fibrin Sealant PatchAbsorbable Patch for Topical UseInitial U.S. Approval: 2010prescriptionHuman PrescriptionBaxter Healthcare Corporation2015-07-206009448701, 009448702, 009448703

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