MSN FDA Approval ANDA 214815

ANDA 214815

MSN

FDA Drug Application

Application #214815

Application Sponsors

ANDA 214815MSN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL250MG0LEVETIRACETAMLEVETIRACETAM
002TABLET;ORAL500MG0LEVETIRACETAMLEVETIRACETAM
003TABLET;ORAL750MG0LEVETIRACETAMLEVETIRACETAM
004TABLET;ORAL1GM0LEVETIRACETAMLEVETIRACETAM

FDA Submissions

UNKNOWN; ORIG1AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214815
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-07
        )

)

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