AUROBINDO PHARMA FDA Approval ANDA 216796

ANDA 216796

AUROBINDO PHARMA

FDA Drug Application

Application #216796

Application Sponsors

ANDA 216796AUROBINDO PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.35MG0EMZAHHNORETHINDRONE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2

CDER Filings

AUROBINDO PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216796
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMZAHH","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-06
        )

)

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