ASTELLAS FDA Approval NDA 209529

NDA 209529

ASTELLAS

FDA Drug Application

Application #209529

Documents

Label2020-05-27
Letter2020-05-28
Review2020-07-22

Application Sponsors

NDA 209529ASTELLAS

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL5MG/5ML(1MG/ML)2VESICARE LSSOLIFENACIN SUCCINATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-05-26PRIORITY

Submissions Property Types

ORIG1Null26

CDER Filings

ASTELLAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209529
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VESICARE LS","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG\/5ML(1MG\/ML)","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209529s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209529s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209529Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-26
        )

)

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