ANDA 203713

DEXCEL PHARMA

FDA Drug Application

Application #203713

Application Sponsors

ANDA 203713

DEXCEL PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

23MG

0

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-19
LABELING; Labeling	SUPPL	3	AP	2019-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DEXCEL PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203713
            [companyName] => DEXCEL PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/20\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-20
        )

)