AUROBINDO PHARMA LTD FDA Approval ANDA 211360

ANDA 211360

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211360

Application Sponsors

ANDA 211360AUROBINDO PHARMA LTD

Marketing Status

Over-the-counter001

Application Products

001TABLET, EXTENDED RELEASE;ORAL220MG;120MG0NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDENAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-01STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211360
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"220MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-01
        )

)

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