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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019937
Company: ASTELLAS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOCARD ADENOSINE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
02/23/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.
11/06/2009 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019937s024ltr.pdf
07/14/2005 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf
09/21/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/01/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
11/02/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
04/20/1999 SUPPL-15 Labeling

Label is not available on this site.
02/13/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
07/29/1996 SUPPL-13 Labeling

Label is not available on this site.
12/27/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
02/09/1996 SUPPL-11 Labeling

Label is not available on this site.
06/26/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
06/09/1995 SUPPL-9 Labeling

Label is not available on this site.
10/27/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
06/11/1992 SUPPL-7 Labeling

Label is not available on this site.
11/15/1990 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/1990 SUPPL-4 Labeling

Label is not available on this site.
04/25/1994 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/10/1990 SUPPL-2 Labeling

Label is not available on this site.
12/04/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/06/2009 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf
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