ANDA 073695

COLGATE PALMOLIVE CO

FDA Drug Application

Application #073695

Documents

• Review: 2003-08-27

Application Sponsors

ANDA 073695

COLGATE PALMOLIVE CO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;DENTAL

0.12%

0

PERIOGARD

CHLORHEXIDINE GLUCONATE

FDA Submissions

	ORIG	1	AP	1994-01-14
LABELING; Labeling	SUPPL	4	AP	1996-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-07-08
LABELING; Labeling	SUPPL	11	AP	1997-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-11-15
LABELING; Labeling	SUPPL	14	AP	1999-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-07-01
LABELING; Labeling	SUPPL	20	AP	2009-01-14

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0

TE Codes

001

Prescription

AT

CDER Filings

COLGATE PALMOLIVE CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73695
            [companyName] => COLGATE PALMOLIVE CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERIOGARD","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"0.12%","dosageForm":"SOLUTION;DENTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PERIOGARD","submission":"CHLORHEXIDINE GLUCONATE","actionType":"0.12%","submissionClassification":"SOLUTION;DENTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)