AUROBINDO PHARMA LTD FDA Approval ANDA 214651

ANDA 214651

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214651

Application Sponsors

ANDA 214651AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL7MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL14MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL21MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORAL28MG0MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214651
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"7MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"14MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"21MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEMANTINE HYDROCHLORIDE","activeIngredients":"MEMANTINE HYDROCHLORIDE","strength":"28MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-09
        )

)

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