3M FDA Approval NDA 019028

NDA 019028

3M

FDA Drug Application

Application #019028

Documents

Letter2013-01-22
Label2013-01-22
Label2013-01-14
Letter2010-10-04

Application Sponsors

NDA 0190283M

Marketing Status

Prescription001

Application Products

001SOLUTION;DENTAL0.12%1PERIDEXCHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1986-08-13PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-01-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1992-08-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1992-12-04PRIORITY
LABELING; LabelingSUPPL7AP1997-01-08STANDARD
LABELING; LabelingSUPPL8AP1997-01-08STANDARD
LABELING; LabelingSUPPL9AP1997-01-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1997-11-21PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-06-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-06-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2007-08-08N/A
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2010-09-28PRIORITY
LABELING; LabelingSUPPL20AP2013-01-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2013-04-09PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2013-01-16PRIORITY

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL15Null0
SUPPL20Null7
SUPPL21Null0
SUPPL22Null0

TE Codes

001PrescriptionAT

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
        )

)

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