Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022161
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEXISCAN REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS 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
04/10/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022161s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022161s000_LexiscanTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022161s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022161Orig1s015ltr.pdf
01/17/2017 SUPPL-13 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022161s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022161Orig1s013ltr.pdf
09/19/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s012ltr.pdf
01/09/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf
09/30/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s009ltr.pdf
09/23/2011 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf
09/23/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf
09/23/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022161s006,s007,s008ltr.pdf
03/29/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/23/2009 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s004ltr.pdf
03/17/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022161s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022161s015lbl.pdf
01/17/2017 SUPPL-13 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022161s013lbl.pdf
09/19/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s012lbl.pdf
01/09/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf
01/09/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbl.pdf
09/30/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s009lbl.pdf
09/23/2011 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf
09/23/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf
09/23/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022161s006s007s008lbl.pdf
12/23/2009 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s004lbl.pdf
03/17/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022161s003lbl.pdf
04/10/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022161lbl.pdf

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