Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020231
Company: COLGATE PALMOLIVE
Company: COLGATE PALMOLIVE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLGATE TOTAL | SODIUM FLUORIDE; TRICLOSAN | 0.24%;0.3% | PASTE;DENTAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/11/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020231_total_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2016 | SUPPL-75 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020231Orig1s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020231Orig1s075ltr.pdf | |
| 12/21/2015 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2014 | SUPPL-73 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020231Orig1s072,s073ltr.pdf | |
| 06/11/2014 | SUPPL-72 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020231Orig1s072,s073ltr.pdf | |
| 04/12/2013 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/2009 | SUPPL-64 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020231s064ltr.pdf |
| 12/03/2007 | SUPPL-60 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s060ltr.pdf |
| 09/15/2010 | SUPPL-58 | Efficacy-Manufacturing Change With Clinical Data, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020231s058ltr.pdf |
| 10/17/2007 | SUPPL-57 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s057ltr.pdf |
| 09/18/2007 | SUPPL-56 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s056ltr.pdf |
| 09/10/2007 | SUPPL-55 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s055ltr.pdf | |
| 11/09/2007 | SUPPL-53 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s053ltr.pdf |
| 11/09/2007 | SUPPL-52 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s052ltr.pdf |
| 03/19/2007 | SUPPL-50 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s050ltr.pdf | |
| 03/20/2007 | SUPPL-47 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s047ltr.pdf |
| 09/15/2006 | SUPPL-46 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s046ltr.pdf |
| 04/21/2006 | SUPPL-43 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s043LTR.pdf |
| 11/10/2005 | SUPPL-42 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s042ltr.pdf |
| 08/03/2005 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020231s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s041ltr.pdf | |
| 02/02/2005 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20231s037ltr.pdf |
| 04/13/2004 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20231scf033ltr.pdf |
| 10/24/2003 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp032ltr.pdf |
| 04/10/2003 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scp029ltr.pdf |
| 10/09/2003 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20231scf028ltr.pdf |
| 12/06/2002 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scf027ltr.pdf |
| 12/06/2002 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231scp026ltr.pdf |
| 06/05/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/2002 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20231s23.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20231s023ltr.pdf | |
| 12/10/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/01/2001 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20231s21lbl.pdf | |
| 09/13/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/31/2000 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1999 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2016 | SUPPL-75 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020231Orig1s075lbl.pdf | |
| 06/11/2014 | SUPPL-73 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf | |
| 06/11/2014 | SUPPL-72 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf | |
| 09/10/2007 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s055lbl.pdf | |
| 03/19/2007 | SUPPL-50 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s050lbl.pdf | |
| 03/19/2007 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020231s050lbl.pdf | |
| 08/03/2005 | SUPPL-41 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020231s041lbl.pdf | |
| 04/30/2002 | SUPPL-23 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20231s23.pdf | |
| 08/01/2001 | SUPPL-21 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20231s21lbl.pdf |