CIPLA FDA Approval ANDA 209839

ANDA 209839

CIPLA

FDA Drug Application

Application #209839

Application Sponsors

ANDA 209839CIPLA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE
002TABLET;ORAL10MG0SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2019-05-20STANDARD
LABELING; LabelingSUPPL4AP2020-11-24STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209839
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-20
        )

)

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