ADENOSCAN از شرکت ASTELLAS

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

ADENOSCAN از شرکت ASTELLAS

New Drug Application (NDA): 020059

Company: ASTELLAS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSCAN ADENOSINE 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued

None

Yes No
ADENOSCAN ADENOSINE 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INTRAVENOUS Discontinued

None

Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/1995 ORIG-1 Approval

Type 6 – New Indication (no longer used)

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2014 SUPPL-18 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf

08/20/2014 SUPPL-17 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf

01/03/2014 SUPPL-16 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s016ltr.pdf

12/09/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/06/2009 SUPPL-14 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020059s014ltr.pdf

07/14/2005 SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf

02/01/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/31/2001 SUPPL-7 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20059s7ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-059S007_Adenoscan.pdf

10/26/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/10/1997 SUPPL-4 Labeling

Label is not available on this site.

01/07/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/26/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2014 SUPPL-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf
08/20/2014 SUPPL-17

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf
01/03/2014 SUPPL-16

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf
11/06/2009 SUPPL-14

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf
08/31/2001 SUPPL-7

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf
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