ANDA 205269

HISUN PHARM HANGZHOU

FDA Drug Application

Application #205269

Application Sponsors

ANDA 205269

HISUN PHARM HANGZHOU

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE
002	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205269
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/30\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-30
        )

)