NDA 021627

ALLERGAN

FDA Drug Application

Application #021627

Documents

• Letter: 2005-04-19
• Letter: 2006-04-21
• Label: 2014-08-12
• Letter: 2006-10-13
• Letter: 2013-10-25
• Letter: 2014-08-12
• Label: 2005-04-19
• Label: 2013-10-25
• Review: 2006-10-18

Application Sponsors

NDA 021627

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

2MG/ML

1

NAMENDA

MEMANTINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-04-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2006-04-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2014-07-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-08-11	STANDARD

Submissions Property Types

SUPPL	8	Null	6
SUPPL	11	Null	0
SUPPL	12	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21627
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAMENDA","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/11\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021627s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021487s010s012s014,021627s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021627lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAMENDA","submission":"MEMANTINE HYDROCHLORIDE","actionType":"2MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-08-11
        )

)