SANOFI AVENTIS US FDA Approval NDA 020165

NDA 020165

SANOFI AVENTIS US

FDA Drug Application

Application #020165

Documents

Letter2002-08-13
Letter2006-09-20
Letter2015-02-05
Letter2015-10-13
Label2007-04-19
Label2014-05-06
Label2015-02-17
Label2015-11-25
Label2016-05-06
Review2007-11-19
Letter2007-04-20
Letter2012-09-24
Letter2014-05-01
Letter2013-11-06
Letter2015-08-10
Letter2016-05-06
Label2006-09-18
Label2013-11-19
Label2015-08-10
Label2022-03-07
Letter2022-03-07

Application Sponsors

NDA 020165SANOFI AVENTIS US

Marketing Status

Over-the-counter004
Over-the-counter005
Over-the-counter006

Application Products

004FILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HR1NICODERM CQNICOTINE
005FILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HR1NICODERM CQNICOTINE
006FILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HR1NICODERM CQNICOTINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1991-11-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1992-07-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1992-07-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1992-08-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1993-07-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-07-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-01-23STANDARD
EFFICACY; EfficacySUPPL11AP1996-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1997-09-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1999-09-14STANDARD
LABELING; LabelingSUPPL16AP2000-02-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-02-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2000-09-21STANDARD
LABELING; LabelingSUPPL19AP2001-06-08STANDARD
LABELING; LabelingSUPPL20AP2002-08-13STANDARD
LABELING; LabelingSUPPL23AP2006-09-15STANDARD
LABELING; LabelingSUPPL24AP2007-04-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2014-02-20STANDARD
LABELING; LabelingSUPPL28AP2012-09-20STANDARD
LABELING; LabelingSUPPL29AP2014-04-30STANDARD
LABELING; LabelingSUPPL31AP2013-10-31STANDARD
LABELING; LabelingSUPPL34AP2015-02-03STANDARD
LABELING; LabelingSUPPL35AP2015-08-06STANDARD
LABELING; LabelingSUPPL36AP2015-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2015-10-26STANDARD
LABELING; LabelingSUPPL38AP2016-05-04STANDARD
LABELING; LabelingSUPPL47AP2022-03-04STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL9Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL17Null0
SUPPL18Null0
SUPPL26Null0
SUPPL28Null15
SUPPL29Null6
SUPPL31Null6
SUPPL34Null7
SUPPL35Null7
SUPPL36Null15
SUPPL37Null0
SUPPL38Null15
SUPPL47Null7

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20165
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICODERM CQ","activeIngredients":"NICOTINE","strength":"21MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NICODERM CQ","activeIngredients":"NICOTINE","strength":"14MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"NICODERM CQ","activeIngredients":"NICOTINE","strength":"7MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/04\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/20165Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2015","submission":"SUPPL-36","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020165Orig1s036lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2015","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020165Orig1s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020165Orig1s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020165Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020165Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020165Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2007","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020165s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2006","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020165s023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NICODERM CQ","submission":"NICOTINE","actionType":"21MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"NICODERM CQ","submission":"NICOTINE","actionType":"14MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"NICODERM CQ","submission":"NICOTINE","actionType":"7MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-04
        )

)
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