AUROBINDO PHARMA LTD FDA Approval ANDA 216531

ANDA 216531

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216531

Application Sponsors

ANDA 216531AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0AMBRISENTANAMBRISENTAN
002TABLET;ORAL10MG0AMBRISENTANAMBRISENTAN

FDA Submissions

UNKNOWN; ORIG1AP2022-07-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216531
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-21
        )

)

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