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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020920
Company: SCIOS LLC

Products on NDA 020920

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NATRECOR	NESIRITIDE	1.5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020920

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

Labels for NDA 020920

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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