NDA 20920, held by Scios LLC. Nesiritide.
As of Nov 13, 2026, NDA 20920 (Natrecor), held by Scios LLC, was first approved by FDA on Aug 10, 2001, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2001 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Natrecor1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for solution;intravenous | Nesiritide | DiscontinuedReference drug |
| Jan 9, 2019 | Supplement 36Labeling · Standard review | Approved | |
| Jul 31, 2015 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jul 29, 2014 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Apr 23, 2013 | Supplement 33Labeling · Standard review | Approved | |
| Nov 9, 2012 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jul 6, 2012 | Supplement 31Labeling · Standard review | Approved | |
| Jun 12, 2009 | Supplement 23Labeling · Standard review | Approved | |
| Mar 28, 2007 | Supplement 14Manufacturing | Approved | None posted |
| Dec 27, 2006 | Supplement 11Manufacturing | Approved | None posted |
| Nov 30, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Apr 29, 2005 | Supplement 6Labeling · Standard review | Approved | |
| Apr 20, 2005 | Supplement 8Labeling · Standard review | Approved | |
| Jul 2, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Aug 10, 2001 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
