NDA 21312, held by Organon. Desloratadine.
As of Nov 15, 2026, NDA 21312 (Clarinex), held by Organon, was first approved by FDA on Jun 26, 2002, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Clarinex5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Desloratadine | DiscontinuedReference drug |
| Clarinex2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Desloratadine | DiscontinuedReference drug |
| Mar 15, 2019 | Supplement 20Labeling · Standard review | Approved | |
| Mar 1, 2019 | Supplement 18Labeling · Standard review | Approved | |
| Apr 23, 2014 | Supplement 15Labeling · Standard review | Approved | |
| Nov 14, 2012 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2010 | Supplement 11Labeling · Standard review | Approved | |
| Dec 14, 2006 | Supplement 9Labeling · Standard review | Approved | |
| Dec 14, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Dec 14, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Jul 14, 2005 | Supplement 7Manufacturing · Standard review | Approved | |
| Jan 29, 2004 | Supplement 4Labeling · Standard review | Approved | |
| Feb 6, 2003 | Supplement 2Labeling · Standard review | Approved | |
| Jun 26, 2002 | Original applicationNew dosage form · 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
