APOTEX FDA Approval ANDA 211443

ANDA 211443

APOTEX

FDA Drug Application

Application #211443

Application Sponsors

ANDA 211443APOTEX

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL5MG0LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-13STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211443
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-13
        )

)

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