NDA 206439

ALLERGAN

FDA Drug Application

Application #206439

Documents

• Letter: 2014-12-30
• Letter: 2016-07-19
• Label: 2016-07-21
• Summary Review: 2015-05-14
• Label: 2015-01-08
• Review: 2015-05-14

Application Sponsors

NDA 206439

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG;14MG	1	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	10MG;28MG	1	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	10MG;7MG	1	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
004	CAPSULE, EXTENDED RELEASE;ORAL	10MG;21MG	1	NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2014-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2016-07-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	3	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206439
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAMZARIC","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NAMZARIC","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NAMZARIC","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NAMZARIC","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/18\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206439s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206439lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206439lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206439Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206439Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206439Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/18\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206439s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206439Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/01\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-07-18
        )

)