YAOPHARMA CO LTD FDA Approval ANDA 077514

ANDA 077514

YAOPHARMA CO LTD

FDA Drug Application

Application #077514

Documents

Other Important Information from FDA2008-07-01

Application Sponsors

ANDA 077514YAOPHARMA CO LTD

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

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

FDA Submissions

ORIG1AP2008-06-18

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77514
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"1.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAMIPRIL","activeIngredients":"RAMIPRIL","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"1.25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAMIPRIL","submission":"RAMIPRIL","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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