AUROBINDO PHARMA FDA Approval ANDA 207585

ANDA 207585

AUROBINDO PHARMA

FDA Drug Application

Application #207585

Application Sponsors

ANDA 207585AUROBINDO PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.035MG;0.4MG0RHUZDAHETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AUROBINDO PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207585
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RHUZDAH","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;0.4MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-11
        )

)

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