NDA 019028

3M

FDA Drug Application

Application #019028

Documents

• Letter: 2013-01-22
• Label: 2013-01-22
• Label: 2013-01-14
• Letter: 2010-10-04

Application Sponsors

NDA 019028

3M

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;DENTAL

0.12%

1

PERIDEX

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1986-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-01-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-08-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-12-04	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1997-01-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	1997-01-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	1997-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-11-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-06-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-06-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2007-08-08	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2010-09-28	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2013-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2013-04-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2013-01-16	PRIORITY

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	7
SUPPL	21	Null	0
SUPPL	22	Null	0

TE Codes

001

Prescription

AT

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19028
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERIDEX","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"0.12%","dosageForm":"SOLUTION;DENTAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/16\/2013","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019028s022lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"01\/16\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019028s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PERIDEX","submission":"CHLORHEXIDINE GLUCONATE","actionType":"0.12%","submissionClassification":"SOLUTION;DENTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-01-16
        )

)