ANDA 206310

MACLEODS PHARMS LTD

FDA Drug Application

Application #206310

Application Sponsors

ANDA 206310

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

002	CAPSULE, EXTENDED RELEASE;ORAL	14MG	0	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	21MG	0	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	28MG	0	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-02-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206310
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-02-19
        )

)