AUROBINDO PHARMA LTD FDA Approval ANDA 213557

ANDA 213557

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213557

Application Sponsors

ANDA 213557AUROBINDO PHARMA LTD

Marketing Status

Over-the-counter001

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL10MG0CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-11STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213557
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-11
        )

)

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