ANDA 211423

CSPC OUYI

FDA Drug Application

Application #211423

Application Sponsors

ANDA 211423

CSPC OUYI

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
002	TABLET;ORAL	10MG	0	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211423
            [companyName] => RISING
            [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":"12\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/14\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-14
        )

)