AUROBINDO PHARMA LTD FDA Approval ANDA 208355

ANDA 208355

AUROBINDO PHARMA LTD

FDA Drug Application

Application #208355

Application Sponsors

ANDA 208355AUROBINDO PHARMA LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL50MG0DOLUTEGRAVIR SODIUMDOLUTEGRAVIR SODIUM

FDA Submissions

UNKNOWN; ORIG1TA2016-09-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208355
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-19
        )

)

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