ANDA 208672

MACLEODS PHARMS LTD

FDA Drug Application

Application #208672

Application Sponsors

ANDA 208672

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

CAPSULE, EXTENDED RELEASE;ORAL

10MG;28MG

0

DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-10-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208672
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/10\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-10
        )

)