NDA 022083

NOVARTIS

FDA Drug Application

Application #022083

Documents

• Letter: 2010-08-31
• Letter: 2012-09-05
• Letter: 2013-07-01
• Label: 2007-07-09
• Label: 2010-09-07
• Label: 2012-09-06
• Label: 2015-02-05
• Letter: 2015-02-05
• Label: 2013-07-11
• Review: 2009-05-28
• Review: 2016-11-02
• Letter: 2016-11-03
• Label: 2016-11-04
• Label: 2018-12-19
• Letter: 2018-12-21

Application Sponsors

NDA 022083

NOVARTIS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 005

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	4.6MG/24HR	1	EXELON	RIVASTIGMINE
002	FILM, EXTENDED RELEASE;TRANSDERMAL	9.5MG/24HR	1	EXELON	RIVASTIGMINE
005	FILM, EXTENDED RELEASE;TRANSDERMAL	13.3MG/24HR	1	EXELON	RIVASTIGMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-07-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2010-08-27	UNKNOWN
EFFICACY; Efficacy	SUPPL	16	AP	2012-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2013-03-13	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2013-06-27	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-06-24	STANDARD
LABELING; Labeling	SUPPL	23	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-12-18	STANDARD

Submissions Property Types

SUPPL	8	Null	6
SUPPL	16	Null	15
SUPPL	18	Null	0
SUPPL	19	Null	15
SUPPL	20	Null	6
SUPPL	21	Null	0
SUPPL	23	Null	15
SUPPL	26	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
005	Prescription	AB

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22083
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXELON","activeIngredients":"RIVASTIGMINE","strength":"4.6MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"EXELON","activeIngredients":"RIVASTIGMINE","strength":"9.5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"EXELON","activeIngredients":"RIVASTIGMINE","strength":"13.3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/18\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022083s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022083s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022083s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2013","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022083s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2012","submission":"SUPPL-16","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022083s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2010","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022083s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022083lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXELON","submission":"RIVASTIGMINE","actionType":"4.6MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXELON","submission":"RIVASTIGMINE","actionType":"9.5MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EXELON","submission":"RIVASTIGMINE","actionType":"13.3MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-18
        )

)