EPIC PHARMA LLC FDA Approval ANDA 077256

ANDA 077256

EPIC PHARMA LLC

FDA Drug Application

Application #077256

Documents

Other Important Information from FDA2007-06-18

Application Sponsors

ANDA 077256EPIC PHARMA LLC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL1MG0TRANDOLAPRILTRANDOLAPRIL
002TABLET;ORAL2MG0TRANDOLAPRILTRANDOLAPRIL
003TABLET;ORAL4MG0TRANDOLAPRILTRANDOLAPRIL

FDA Submissions

ORIG1AP2007-06-12

CDER Filings

EPIC PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77256
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRANDOLAPRIL","activeIngredients":"TRANDOLAPRIL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRANDOLAPRIL","submission":"TRANDOLAPRIL","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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