ANDA 216875

AUROBINDO PHARMA

FDA Drug Application

Application #216875

Application Sponsors

ANDA 216875

AUROBINDO PHARMA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

200MG/25MG

0

EMTRICITABINE; TENOFOVIR ALAFENAMIDE

EMTRICITABINE;TENOFOVIR ALAFENAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)