Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020059
Company: ASTELLAS

• Other Important Information from FDA

Products on NDA 20059

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ADENOSCAN	ADENOSINE	60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
ADENOSCAN	ADENOSINE	90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Labels for NDA 020059

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