NDA 21144, held by Sanofi Aventis US. Telithromycin.
As of Nov 14, 2026, NDA 21144 (Ketek), held by Sanofi Aventis US, was first approved by FDA on Apr 1, 2004, with 13 approved supplements and 0 published complete response letters.
| Feb 9, 2005 | Supplement 1Efficacy (new indication or use) | Approved | |
| Apr 1, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| Ketek400MG · tablet;oral | Telithromycin | Discontinued |
| Ketek300MG · tablet;oral | Telithromycin | Discontinued |
| Nov 4, 2015 | Supplement 19Labeling · Standard review | Approved | |
| Mar 9, 2015 | Supplement 18Labeling · Standard review | Approved | |
| Feb 26, 2014 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2013 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2011 | Supplement 15REMS | Approved | |
| Dec 8, 2010 | Supplement 13Labeling · Standard review | Approved | |
| Dec 8, 2010 | Supplement 14Labeling · Standard review | Approved | |
| Feb 12, 2007 | Supplement 12Labeling · Standard review | Approved | |
| Jun 29, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Nov 2, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Apr 8, 2005 | Supplement 5Manufacturing · Standard review | Approved | |
| Feb 9, 2005 | Supplement 1Efficacy (new indication or use) | Approved | |
| Feb 9, 2005 | Supplement 3Labeling · Standard review | Approved | |
| Apr 1, 2004 | 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
