NDA 021351

ALLERGAN

FDA Drug Application

Application #021351

Documents

• Letter: 2006-07-13
• Letter: 2011-02-03
• Letter: 2012-10-12
• Letter: 2015-07-13
• Label: 2003-02-26
• Label: 2012-10-12
• Label: 2015-07-13
• Letter: 2003-03-10
• Letter: 2012-10-12
• Label: 2006-07-07
• Label: 2011-01-31
• Label: 2012-10-12
• Review: 2005-04-08
• Label: 2017-10-25
• Label: 2017-10-25
• Letter: 2017-10-30
• Letter: 2017-10-30

Application Sponsors

NDA 021351

ALLERGAN

Marketing Status

• Prescription: 002

Application Products

002

FILM, EXTENDED RELEASE;TRANSDERMAL

3.9MG/24HR

1

OXYTROL

OXYBUTYNIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-02-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2006-07-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2011-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-07-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2012-10-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2012-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2013-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-07-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-07-10	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-10-24	STANDARD
LABELING; Labeling	SUPPL	18	AP	2017-10-24	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	7	Null	0
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	6
SUPPL	17	Null	7
SUPPL	18	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21351
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTROL","activeIngredients":"OXYBUTYNIN","strength":"3.9MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/24\/2017","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021351s017s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021351s017s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021351s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021351s008s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021351s008s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021351s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021351s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021351lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXYTROL","submission":"OXYBUTYNIN","actionType":"3.9MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-10-24
        )

)