NDA 202513

ALLERGAN

FDA Drug Application

Application #202513

Documents

• Letter: 2011-12-14
• Letter: 2015-07-13
• Label: 2015-07-13
• Letter: 2013-01-11
• Label: 2011-12-13
• Label: 2013-01-11
• Review: 2012-06-26
• Summary Review: 2012-06-26

Application Sponsors

NDA 202513

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

GEL, METERED;TRANSDERMAL

3%

1

GELNIQUE 3%

OXYBUTYNIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2011-12-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2013-01-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-07-10	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	15
SUPPL	5	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202513
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"GELNIQUE 3%","activeIngredients":"OXYBUTYNIN","strength":"3%","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/10\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202513s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202513s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202513s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/07\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202513s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202513s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202513_anturol_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202513Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/10\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202513s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202513Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"01\/09\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202513s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202513Orig1s003ltr_replacement.pdf\"}]","notes":">"}]
            [actionDate] => 2015-07-10
        )

)