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COLGATE TOTAL از شرکت COLGATE PALMOLIVE

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COLGATE TOTAL از شرکت COLGATE PALMOLIVE

New Drug Application (NDA): 020231

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
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