COLGATE PALMOLIVE FDA Approval NDA 020231

Application #020231

Documents

Letter	2002-04-30
Letter	2002-12-06
Letter	2002-12-06
Letter	2003-10-16
Letter	2003-04-18
Letter	2003-12-02
Letter	2004-04-20
Letter	2005-02-03
Letter	2005-11-17
Letter	2006-09-20
Letter	2007-03-23
Letter	2007-09-25
Letter	2007-10-22
Letter	2008-01-09
Letter	2014-06-17
Letter	2016-03-29
Label	2014-08-05
Label	2014-08-05
Label	2016-04-11
Review	2008-09-25
Letter	2005-08-08
Letter	2006-04-25
Letter	2007-03-23
Letter	2007-11-19
Letter	2007-11-19
Letter	2007-09-25
Letter	2010-09-20
Letter	2009-02-23
Letter	2014-06-17
Label	2003-04-22
Label	2002-04-30
Label	2005-08-08
Label	2007-03-23
Label	2007-09-11

Application Sponsors

NDA 020231

COLGATE PALMOLIVE

Marketing Status

Discontinued

001

Application Products

001

PASTE;DENTAL

0.24%;0.3%

COLGATE TOTAL

SODIUM FLUORIDE; TRICLOSAN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-09-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-08-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2001-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2002-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2002-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2003-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2003-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2003-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2004-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2005-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2005-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2005-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2006-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2006-09-15	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2007-03-20	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2007-03-19	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2007-11-09	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2007-11-09	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2007-09-10	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2007-09-18	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2007-10-17	STANDARD
EFFICACY; Efficacy	SUPPL	58	AP	2010-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2007-12-03	N/A
LABELING; Labeling	SUPPL	64	AP	2009-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2013-04-12	STANDARD
LABELING; Labeling	SUPPL	72	AP	2014-06-11	STANDARD
LABELING; Labeling	SUPPL	73	AP	2014-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2015-12-21	STANDARD
LABELING; Labeling	SUPPL	75	AP	2016-03-24	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	37	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	6
SUPPL	60	Null	6
SUPPL	71	Null	0
SUPPL	72	Null	15
SUPPL	73	Null	15
SUPPL	74	Null	0
SUPPL	75	Null	6

CDER Filings

COLGATE PALMOLIVE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20231
            [companyName] => COLGATE PALMOLIVE
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLGATE TOTAL","activeIngredients":"SODIUM FLUORIDE; TRICLOSAN","strength":"0.24%;0.3%","dosageForm":"PASTE;DENTAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/24\/2016","submission":"SUPPL-75","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020231Orig1s075lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2014","submission":"SUPPL-73","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/11\/2014","submission":"SUPPL-72","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"09\/10\/2007","submission":"SUPPL-55","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020231s055lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2007","submission":"SUPPL-50","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020231s050lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2007","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020231s050lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2005","submission":"SUPPL-41","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020231s041lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2002","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20231s23.pdf\"}]","notes":""},{"actionDate":"08\/01\/2001","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20231s21lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COLGATE TOTAL","submission":"SODIUM FLUORIDE; TRICLOSAN","actionType":"0.24%;0.3%","submissionClassification":"PASTE;DENTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-03-24
        )

)

NDA 020231

COLGATE PALMOLIVE

FDA Drug Application

Application #020231

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

COLGATE PALMOLIVE