AUROBINDO PHARMA LTD FDA Approval ANDA 210740

ANDA 210740

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210740

Application Sponsors

ANDA 210740AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL0.125MG0DOFETILDEDOFETILIDE
002CAPSULE;ORAL0.25MG0DOFETILDEDOFETILIDE
003CAPSULE;ORAL0.5MG0DOFETILDEDOFETILIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-01-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210740
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOFETILDE","activeIngredients":"DOFETILIDE","strength":"0.125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILDE","activeIngredients":"DOFETILIDE","strength":"0.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILDE","activeIngredients":"DOFETILIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-22
        )

)

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