ANDA 202410

HISUN PHARM HANGZHOU

FDA Drug Application

Application #202410

Application Sponsors

ANDA 202410

HISUN PHARM HANGZHOU

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

23MG

0

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-24

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202410
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/05\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-05
        )

)