POLYGEN PHARMS FDA Approval ANDA 210587

ANDA 210587

POLYGEN PHARMS

FDA Drug Application

Application #210587

Application Sponsors

ANDA 210587POLYGEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
002TABLET;ORAL10MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

POLYGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210587
            [companyName] => POLYGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-11
        )

)

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