ANDA 202790

MACLEODS PHARMS LTD

FDA Drug Application

Application #202790

Application Sponsors

ANDA 202790

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

2MG/ML

0

MEMANTINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2018-03-06	UNKNOWN

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7

TE Codes

001

Prescription

AA

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202790
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/06\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-06
        )

)