CELLTRION FDA Approval ANDA 090073

ANDA 090073

CELLTRION

FDA Drug Application

Application #090073

Documents

Letter2016-02-18

Application Sponsors

ANDA 090073CELLTRION

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

ORIG1AP2015-09-04

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CELLTRION
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90073
            [companyName] => CELLTRION
            [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":"MEMANTINE HYDROCHLORIDE","submission":"MEMANTINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MEMANTINE HYDROCHLORIDE","submission":"MEMANTINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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