Drugs@FDA: FDA Approved Drug Products

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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ADENOSCAN ADENOSINE 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;IV (INFUSION) Discontinued None Yes No
ADENOSCAN ADENOSINE 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;IV (INFUSION) Discontinued None Yes No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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