HETERO LABS LTD III FDA Approval ANDA 210409

ANDA 210409

HETERO LABS LTD III

FDA Drug Application

Application #210409

Application Sponsors

ANDA 210409HETERO LABS LTD III

Marketing Status

Over-the-counter001

Application Products

001SYRUP;ORAL1MG/ML0LORATADINELORATADINE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-07STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210409
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"1MG\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-07
        )

)

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