HISUN PHARM HANGZHOU FDA Approval ANDA 207843

ANDA 207843

HISUN PHARM HANGZHOU

FDA Drug Application

Application #207843

Application Sponsors

ANDA 207843HISUN PHARM HANGZHOU

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL20MG0TELMISARTANTELMISARTAN
002TABLET;ORAL40MG0TELMISARTANTELMISARTAN
003TABLET;ORAL80MG0TELMISARTANTELMISARTAN

FDA Submissions

UNKNOWN; ORIG1AP2019-02-19STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

HISUN PHARM HANGZHOU
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207843
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-19
        )

)

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