AUROBINDO PHARMA FDA Approval ANDA 216875

ANDA 216875

AUROBINDO PHARMA

FDA Drug Application

Application #216875

Application Sponsors

ANDA 216875AUROBINDO PHARMA

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL200MG/25MG0EMTRICITABINE; TENOFOVIR ALAFENAMIDEEMTRICITABINE;TENOFOVIR ALAFENAMIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-12-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AUROBINDO PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216875
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE; TENOFOVIR ALAFENAMIDE","activeIngredients":"EMTRICITABINE;TENOFOVIR ALAFENAMIDE","strength":"200MG\/25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-19
        )

)

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