AUROBINDO PHARMA LTD FDA Approval ANDA 214849

ANDA 214849

AUROBINDO PHARMA LTD

FDA Drug Application

Application #214849

Application Sponsors

ANDA 214849AUROBINDO PHARMA LTD

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL300MG0URSODIOLURSODIOL

FDA Submissions

UNKNOWN; ORIG1AP2022-11-28STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214849
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-28
        )

)

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