Documents
Application Sponsors
NDA 020165 | SANOFI AVENTIS US | |
Marketing Status
Over-the-counter | 004 |
Over-the-counter | 005 |
Over-the-counter | 006 |
Application Products
004 | FILM, EXTENDED RELEASE;TRANSDERMAL | 21MG/24HR | 1 | NICODERM CQ | NICOTINE |
005 | FILM, EXTENDED RELEASE;TRANSDERMAL | 14MG/24HR | 1 | NICODERM CQ | NICOTINE |
006 | FILM, EXTENDED RELEASE;TRANSDERMAL | 7MG/24HR | 1 | NICODERM CQ | NICOTINE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1991-11-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-07-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-07-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1992-08-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-07-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-07-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-01-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 11 | AP | 1996-08-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-09-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-08-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-09-14 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2000-02-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-02-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2001-06-08 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2002-08-13 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2006-09-15 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2007-04-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2014-02-20 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2012-09-20 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2014-04-30 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2013-10-31 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2015-02-03 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2015-08-06 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2015-10-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2015-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2016-05-04 | STANDARD |
LABELING; Labeling | SUPPL | 47 | AP | 2022-03-04 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 28 | Null | 15 |
SUPPL | 29 | Null | 6 |
SUPPL | 31 | Null | 6 |
SUPPL | 34 | Null | 7 |
SUPPL | 35 | Null | 7 |
SUPPL | 36 | Null | 15 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 15 |
SUPPL | 47 | Null | 7 |
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
)
)