AGGRASTAT از شرکت MEDICURE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AGGRASTAT از شرکت MEDICURE

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
05/16/2019 SUPPL-27 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, 020913Orig1s026ltr.pdf

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
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
بخوانید  BENYLIN از شرکت PARKE DAVIS
به بالای صفحه بردن