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| NATRECOR | NESIRITIDE | 1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| 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 |