ANDA 202631

MACLEODS PHARMS LTD

FDA Drug Application

Application #202631

Application Sponsors

ANDA 202631

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

23MG

0

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-01-22
LABELING; Labeling	SUPPL	3	AP	2016-09-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-11-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	31
SUPPL	6	Null	7
SUPPL	11	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202631
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/08\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-11-08
        )

)