ASTELLAS FDA Approval NDA 021518

NDA 021518

ASTELLAS

FDA Drug Application

Application #021518

Documents

Letter2007-07-24
Letter2008-11-21
Letter2010-07-14
Letter2011-03-14
Letter2012-07-17
Letter2012-08-06
Letter2013-04-01
Letter2013-10-11
Label2004-12-03
Label2007-07-16
Label2008-02-14
Label2010-07-01
Letter2004-12-02
Letter2008-02-14
Letter2008-10-30
Letter2012-06-12
Letter2012-01-19
Label2008-11-19
Label2011-03-11
Label2012-06-11
Label2012-01-23
Label2012-07-25
Label2012-08-06
Label2013-04-01
Label2013-10-17
Review2005-02-08
Pediatric Medical Review2017-07-20
Pediatric Clinical Pharmacology Review2017-07-20
Pediatric Statistical Review2017-07-20
Pediatric Written Request2017-07-20
Pediatric Amendment 12017-07-20
Pediatric Amendment 22017-07-20
Pediatric Amendment 32017-07-20
Label2019-05-01
Letter2019-05-02
Label2020-05-27
Letter2020-05-28
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01

Application Sponsors

NDA 021518ASTELLAS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG1VESICARESOLIFENACIN SUCCINATE
002TABLET;ORAL10MG1VESICARESOLIFENACIN SUCCINATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2004-11-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2007-04-24N/A
LABELING; LabelingSUPPL3AP2007-07-12STANDARD
LABELING; LabelingSUPPL4AP2008-02-08STANDARD
LABELING; LabelingSUPPL6AP2008-10-29STANDARD
LABELING; LabelingSUPPL7AP2008-11-18STANDARD
LABELING; LabelingSUPPL8AP2010-07-12STANDARD
LABELING; LabelingSUPPL10AP2011-03-10UNKNOWN
LABELING; LabelingSUPPL11AP2012-06-07STANDARD
LABELING; LabelingSUPPL12AP2012-01-17STANDARD
LABELING; LabelingSUPPL13AP2012-07-13STANDARD
LABELING; LabelingSUPPL14AP2012-08-03STANDARD
LABELING; LabelingSUPPL15AP2013-03-29STANDARD
LABELING; LabelingSUPPL16AP2013-10-09STANDARD
LABELING; LabelingSUPPL17AP2020-05-26STANDARD
LABELING; LabelingSUPPL18AP2019-04-30STANDARD

Submissions Property Types

SUPPL8Null6
SUPPL10Null7
SUPPL11Null15
SUPPL12Null6
SUPPL13Null6
SUPPL14Null7
SUPPL15Null7
SUPPL16Null15
SUPPL17Null6
SUPPL18Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ASTELLAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21518
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VESICARE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VESICARE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021518s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021518s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2013","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021518s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2013","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021518s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2012","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021518s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021518S013lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021518s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021518s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021518s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2010","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021518s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021518s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2008","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021518s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2007","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021518s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21518lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VESICARE","submission":"SOLIFENACIN SUCCINATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VESICARE","submission":"SOLIFENACIN SUCCINATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-26
        )

)
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