tirofiban Injectable Solution

Brand(s)
Aggrastat
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medicure International Inc (2015-04-30)
Oldest Current Product
1998-05-14
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\TIROFIBAN
FDAOB
INJECTION\INJECTION\TIROFIBAN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\TIROFIBAN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\TIROFIBAN

product(s) by strength(s)

tirofiban 0.05 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1252080002AggrastatNDAMedicure International Inc1998-05-14TIROFIBAN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA020913fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA020912AGGRASTATTrueMEDICURE INTERNATIONAL INC1998-05-14p5965581
p6136794
p5972967
p5978698
p5733919
p6770660
NDA020912_001
2NDA020913AGGRASTATMEDICURE INTERNATIONAL INC1998-05-14p5965581
p6136794
p5972967
p5978698
p5733919
p6770660
NDA020913_001, NDA020913_002, NDA020913_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020912_001discontinuedTIROFIBAN HYDROCHLORIDE (EQ 12.5MG BASE/50ML)INJECTIONFalse1998-05-14AGGRASTAT
2NDA020913_001discontinuedTIROFIBAN HYDROCHLORIDE (EQ 25MG BASE/500ML)INJECTIONFalse1998-05-14AGGRASTAT
3NDA020913_002RXTIROFIBAN HYDROCHLORIDE (EQ 5MG BASE/100ML)INJECTIONFalse2002-05-17AGGRASTAT
4NDA020913_003RXTIROFIBAN HYDROCHLORIDE (EQ 12.5MG BASE/250ML)INJECTIONTrue2000-04-20AGGRASTAT

patent(s)

#idexpiration dateapplication(s)
1p5733919 (view patent)2016-10-23NDA020912, NDA020913
2p5965581 (view patent)2016-10-23NDA020912, NDA020913
3p5972967 (view patent)2016-10-23NDA020912, NDA020913
4p5978698 (view patent)2017-10-08NDA020912, NDA020913
5p6136794 (view patent)2019-01-29NDA020912, NDA020913
6p6770660 (view patent)2023-05-01NDA020912, NDA020913

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f (view SPL)These highlights do not include all the information needed to use AGGRASTAT (tirofiban hydrochloride) safely and effectively. See full prescribing information for AGGRASTATAGGRASTAT (tirofiban hydrochloride) injection, for intravenous use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMedicure International Incanalysis, label, manufacture, pack2015-04-308252080002

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