Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020920
Company: SCIOS LLC
Company: SCIOS LLC
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NATRECOR | NESIRITIDE | 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
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 |