AUROBINDO PHARMA LTD FDA Approval ANDA 214848

ANDA 214848

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214848

Application Sponsors

ANDA 214848AUROBINDO PHARMA LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002TABLET;ORAL100MG0BRIVARACETAMBRIVARACETAM

FDA Submissions

UNKNOWN; ORIG1TA2022-06-13STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214848
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/13\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-13
        )

)

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