TENSHI FDA Approval ANDA 212795

ANDA 212795

TENSHI

FDA Drug Application

Application #212795

Application Sponsors

ANDA 212795TENSHI

Marketing Status

Over-the-counter001

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL5MG0LORATADINELORATADINE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-18STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

TENSHI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212795
            [companyName] => TENSHI
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-18
        )

)

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