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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022161
Company: ASTELLAS

Other Important Information from FDA

Products on NDA 22161

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	AP	Yes	Yes

Labels for NDA 022161

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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