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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020059
Company: ASTELLAS

Other Important Information from FDA

Products on NDA 020059

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ADENOSCAN	ADENOSINE	60MG/20ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
ADENOSCAN	ADENOSINE	90MG/30ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020059

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.

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

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