Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/14/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20912lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20912ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2016 SUPPL-24 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf
04/21/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf
10/10/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf
10/10/2013 SUPPL-19 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020912Orig1s019,s020ltr.pdf
06/06/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf
02/28/2003 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20912slr013ltr.pdf
06/17/2002 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf
02/12/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/17/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/24/2002 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf
09/25/2001 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf
03/23/2001 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf
02/08/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/2000 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/2000 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf
06/09/1999 SUPPL-2 Labeling

Label is not available on this site.

07/09/1999 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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