ANDA 202114

CSPC OUYI

FDA Drug Application

Application #202114

Application Sponsors

ANDA 202114

CSPC OUYI

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-07-05
LABELING; Labeling	SUPPL	2	AP	2020-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202114
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-21
        )

)