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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020912
Company: MEDICURE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE;INJECTION Discontinued None No No
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION;INJECTION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf
08/31/2016 SUPPL-24 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf
04/21/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf
10/10/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf
10/10/2013 SUPPL-19 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf
06/06/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf
07/09/1999 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf
05/14/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20912lbl.pdf
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