ANDA 208328

AMNEAL PHARMS

FDA Drug Application

Application #208328

Documents

• Letter: 2017-01-31
• Label: 2017-01-31

Application Sponsors

ANDA 208328

AMNEAL PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG;14MG	0	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	10MG;28MG	0	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208328
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE","strength":"10MG;28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/27\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208328Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208328Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208328Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/09\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-09
        )

)