NDA 202211

ALLERGAN

FDA Drug Application

Application #202211

Documents

• Label: 2013-11-12
• Review: 2013-11-05
• Summary Review: 2013-11-05
• Letter: 2013-01-30
• Letter: 2016-03-04
• Label: 2016-03-04

Application Sponsors

NDA 202211

ALLERGAN

Marketing Status

• Over-the-counter: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

3.9MG/24HR

1

OXYTROL FOR WOMEN

OXYBUTYNIN

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch	ORIG	1	AP	2013-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-05-15	N/A
LABELING; Labeling	SUPPL	4	AP	2016-03-03	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202211
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTROL FOR WOMEN","activeIngredients":"OXYBUTYNIN","strength":"3.9MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/03\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202211Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202211Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 8 - Partial Rx to OTC Switch","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202211Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202211Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/202211_oxytrol_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/202211Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/03\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202211Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202211Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/15\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/16\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-03-03
        )

)