BIONPHARMA INC FDA Approval ANDA 202538

ANDA 202538

BIONPHARMA INC

FDA Drug Application

Application #202538

Application Sponsors

ANDA 202538BIONPHARMA INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL10MG0LORATADINELORATADINE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-21

Submissions Property Types

ORIG1Null3

CDER Filings

BIONPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202538
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)

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