AVEO PHARMACEUTICALS INC FDA Approval NDA 212904

NDA 212904

AVEO PHARMACEUTICALS INC

FDA Drug Application

Application #212904

Documents

Letter2021-03-11
Label2021-03-29
Review2021-04-06

Application Sponsors

NDA 212904AVEO PHARMACEUTICALS INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL0.89MG2FOTIVDATIVOZANIB
002CAPSULE;ORAL1.34MG2FOTIVDATIVOZANIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-03-10STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

AVEO PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212904
            [companyName] => AVEO PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOTIVDA","activeIngredients":"TIVOZANIB","strength":"0.89MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"FOTIVDA","activeIngredients":"TIVOZANIB","strength":"1.34MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212904Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-10
        )

)

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