AUROBINDO PHARMA LTD FDA Approval ANDA 209407

ANDA 209407

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209407

Application Sponsors

ANDA 209407AUROBINDO PHARMA LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-283MG;0.03MG0ZUMANDIMINEDROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2018-03-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209407
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZUMANDIMINE","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-26
        )

)

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