AGGRASTAT از شرکت MEDICURE

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AGGRASTAT از شرکت MEDICURE

New Drug Application (NDA): 020913

Company: MEDICURE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued

None

No No
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription

None

Yes No
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription

AP

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 3 – New Dosage Form

PRIORITY

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20913ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20913.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2020 SUPPL-28

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020913Orig1s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020913Orig1s028ltr.pdf

05/16/2019 SUPPL-26 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020912Orig1s027,%20020913Orig1s026ltr.pdf

09/07/2016 SUPPL-22 Manufacturing (CMC)

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf

06/16/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/21/2015 SUPPL-18 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

06/06/2012 SUPPL-17 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

03/05/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/17/2002 SUPPL-10 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf

06/17/2002 SUPPL-9 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf

07/24/2002 SUPPL-8 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-7 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-6 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf

04/20/2000 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
12/11/2020 SUPPL-28

Manufacturing (CMC)

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020913Orig1s028lbl.pdf
05/16/2019 SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf
09/07/2016 SUPPL-22

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-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf
06/06/2012 SUPPL-17

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/1998/20913lbl.pdf

AGGRASTAT

SOLUTION;INTRAVENOUS; EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AGGRASTAT TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 020913 MEDICURE
TIROFIBAN HYDROCHLORIDE TIROFIBAN HYDROCHLORIDE EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 206888 GLAND PHARMA LTD
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