ANDA 210281

JIANGXI BOYA SEEHOT

FDA Drug Application

Application #210281

Application Sponsors

ANDA 210281

JIANGXI BOYA SEEHOT

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	2019-05-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-01-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

JIANGXI BOYA SEEHOT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210281
            [companyName] => JIANGXI BOYA SEEHOT
            [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":"01\/14\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-14
        )

)