ALLERGAN FDA Approval NDA 202513

NDA 202513

ALLERGAN

FDA Drug Application

Application #202513

Documents

Letter2011-12-14
Letter2015-07-13
Label2015-07-13
Letter2013-01-11
Label2011-12-13
Label2013-01-11
Review2012-06-26
Summary Review2012-06-26

Application Sponsors

NDA 202513ALLERGAN

Marketing Status

Discontinued001

Application Products

001GEL, METERED;TRANSDERMAL3%1GELNIQUE 3%OXYBUTYNIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2011-12-07STANDARD
LABELING; LabelingSUPPL3AP2013-01-09STANDARD
LABELING; LabelingSUPPL5AP2015-07-10STANDARD

Submissions Property Types

ORIG1Null40
SUPPL3Null15
SUPPL5Null15

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
        )

)

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