NDA 20231, held by Colgate Palmolive. Sodium Fluoride; Triclosan.
As of Nov 13, 2026, NDA 20231 (Colgate Total), held by Colgate Palmolive, was first approved by FDA on Jul 11, 1997, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2010 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Jul 11, 1997 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Colgate Total0.24%;0.3% · paste;dental | Sodium Fluoride; Triclosan | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2016 | Supplement 75Labeling · Standard review | Approved | |
| Dec 21, 2015 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Jun 11, 2014 | Supplement 72Labeling · Standard review | Approved | |
| Jun 11, 2014 | Supplement 73Labeling · Standard review | Approved | |
| Apr 12, 2013 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Sep 15, 2010 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2009 | Supplement 64Labeling · Standard review | Approved | |
| Dec 3, 2007 | Supplement 60Manufacturing | Approved | |
| Nov 9, 2007 | Supplement 52Manufacturing | Approved | |
| Nov 9, 2007 | Supplement 53Manufacturing | Approved | |
| Oct 17, 2007 | Supplement 57Manufacturing · Standard review | Approved | |
| Sep 18, 2007 | Supplement 56Manufacturing | Approved | |
| Sep 10, 2007 | Supplement 55Manufacturing | Approved | |
| Mar 20, 2007 | Supplement 47Manufacturing | Approved | |
| Mar 19, 2007 | Supplement 50Manufacturing | Approved | |
| Sep 15, 2006 | Supplement 46Manufacturing | Approved | |
| Apr 21, 2006 | Supplement 43Manufacturing · Standard review | Approved | |
| Nov 10, 2005 | Supplement 42Manufacturing · Standard review | Approved | |
| Aug 3, 2005 | Supplement 41Manufacturing · Standard review | Approved | |
| Feb 2, 2005 | Supplement 37Manufacturing · Standard review | Approved | |
| Apr 13, 2004 | Supplement 33Manufacturing · Standard review | Approved | |
| Oct 24, 2003 | Supplement 32Manufacturing · Standard review | Approved | |
| Oct 9, 2003 | Supplement 28Manufacturing · Standard review | Approved | |
| Apr 10, 2003 | Supplement 29Manufacturing · Standard review | Approved | |
| Dec 6, 2002 | Supplement 27Manufacturing · Standard review | Approved | |
| Dec 6, 2002 | Supplement 26Manufacturing · Standard review | Approved | |
| Jun 5, 2002 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 7, 2002 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 30, 2002 | Supplement 23Manufacturing · Standard review | Approved | |
| Dec 10, 2001 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 13, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 1, 2001 | Supplement 21Manufacturing · Standard review | Approved | |
| Feb 8, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2000 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 12, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 31, 2000 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Feb 28, 2000 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1999 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1999 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1998 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 29, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1997 | Original applicationNew combination · 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
