ACCORD HLTHCARE FDA Approval ANDA 207477

ANDA 207477

ACCORD HLTHCARE

FDA Drug Application

Application #207477

Application Sponsors

ANDA 207477ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-01-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207477
            [companyName] => ACCORD HLTHCARE
            [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":"01\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-04
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.