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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 022161

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022161

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/2014/022161s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022161s011lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022161Orig1s011ltr_corrected.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

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

Therapeutic Equivalents for NDA 022161

LEXISCAN

SOLUTION;INTRAVENOUS; 0.4MG/5ML (0.08MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEXISCAN	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022161	ASTELLAS
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213236	ACCORD HLTHCARE
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207604	APOTEX
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217455	BAXTER HLTHCARE CORP
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213210	DR REDDYS
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216437	EUGIA PHARMA
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207320	GLAND PHARMA LTD
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215827	HIKMA
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214349	HOSPIRA
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214252	IMS LTD
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212806	MEITHEAL
REGADENOSON	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213856	MYLAN

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