MYLAN PHARMS INC FDA Approval ANDA 090650

ANDA 090650

MYLAN PHARMS INC

FDA Drug Application

Application #090650

Application Sponsors

ANDA 090650MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORAL1.25MG0RAMIPRILRAMIPRIL
002TABLET;ORAL2.5MG0RAMIPRILRAMIPRIL
003TABLET;ORAL5MG0RAMIPRILRAMIPRIL
004TABLET;ORAL10MG0RAMIPRILRAMIPRIL

FDA Submissions

ORIG1AP2011-06-30

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90650
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"1.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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