NDA 021487

ALLERGAN

FDA Drug Application

Application #021487

Documents

• Letter: 2005-05-20
• Letter: 2006-10-13
• Letter: 2013-10-25
• Letter: 2013-10-25
• Label: 2003-10-20
• Label: 2013-10-25
• Label: 2013-10-25
• Letter: 2003-10-22
• Letter: 2004-09-29
• Letter: 2005-05-03
• Letter: 2006-04-21
• Letter: 2013-10-25
• Label: 2013-10-25
• Review: 2003-12-31
• Label: 2018-11-06
• Letter: 2018-11-14

Application Sponsors

NDA 021487

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	1	NAMENDA	MEMANTINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	1	NAMENDA	MEMANTINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2004-09-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2005-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2005-05-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-04-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-10-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-10-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	2013-10-24	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2013-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2015-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2016-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2016-05-18	STANDARD
LABELING; Labeling	SUPPL	25	AP	2018-11-02	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	6
SUPPL	12	Null	6
SUPPL	14	Null	15
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21487
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAMENDA","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"NAMENDA","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021487s025lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021487s010s012s014,021627s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2013","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021487s010s012s014,021627s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2013","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021487s010s012s014,021627s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021487lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAMENDA","submission":"MEMANTINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NAMENDA","submission":"MEMANTINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-02
        )

)