Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020920
Company: SCIOS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NATRECOR NESIRITIDE RECOMBINANT 1.5MG/VIAL FOR SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/10/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20920lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20920ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-920_Natrecor.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2019 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020920s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020920Orig1s036ltr.pdf
07/31/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/29/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/23/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/20920s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020920Orig1s033ltr.pdf
11/09/2012 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/06/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020920s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020920s031ltr.pdf
06/12/2009 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020920s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020920s023ltr.pdf
03/28/2007 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/30/2006 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020920s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020920s012ltr.pdf
12/27/2006 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020920s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s008ltr.pdf
04/29/2005 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020920s006ltr.pdf
07/02/2004 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20920slr003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/09/2019 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020920s036lbl.pdf
04/23/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/20920s033lbl.pdf
07/06/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020920s031lbl.pdf
06/12/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020920s023lbl.pdf
11/30/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020920s012lbl.pdf
04/20/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020920s008lbl.pdf
08/10/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20920lbl.pdf

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