ANDA 202840

MACLEODS PHARMS LTD

FDA Drug Application

Application #202840

Documents

• Letter: 2014-08-29

Application Sponsors

ANDA 202840

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-13
LABELING; Labeling	SUPPL	9	AP	2019-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202840
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202840Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/28\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-28
        )

)