AUROBINDO PHARMA LTD FDA Approval ANDA 215672

ANDA 215672

AUROBINDO PHARMA LTD

FDA Drug Application

Application #215672

Application Sponsors

ANDA 215672AUROBINDO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001TABLET;ORAL2.5MG0PREDNISONEPREDNISONE
002TABLET;ORAL5MG0PREDNISONEPREDNISONE
003TABLET;ORAL10MG0PREDNISONEPREDNISONE
004TABLET;ORAL20MG0PREDNISONEPREDNISONE
005TABLET;ORAL50MG0PREDNISONEPREDNISONE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-28STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215672
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-28
        )

)

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