AUROBINDO PHARMA LTD FDA Approval ANDA 213652

ANDA 213652

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213652

Application Sponsors

ANDA 213652AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0LEFLUNOMIDELEFLUNOMIDE
002TABLET;ORAL20MG0LEFLUNOMIDELEFLUNOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213652
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-29
        )

)

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