AUROBINDO PHARMA LTD FDA Approval ANDA 216481

ANDA 216481

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216481

Application Sponsors

ANDA 216481AUROBINDO PHARMA LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

001TABLET;ORAL200MG0ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE
002TABLET;ORAL400MG0ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE
003TABLET;ORAL600MG0ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE

FDA Submissions

UNKNOWN; ORIG1TA2022-10-21STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216481
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ESLICARBAZEPINE ACETATE","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-21
        )

)

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