VIIV HLTHCARE FDA Approval NDA 212887

NDA 212887

VIIV HLTHCARE

FDA Drug Application

Application #212887

Documents

Letter2021-01-22
Label2021-02-12

Application Sponsors

NDA 212887VIIV HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET, FILM COATED30MG0VOCABRIACABOTEGRAVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-01-21PRIORITY

Submissions Property Types

ORIG1Null33

CDER Filings

VIIV HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212887
            [companyName] => VIIV HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VOCABRIA","activeIngredients":"CABOTEGRAVIR","strength":"30MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212887Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)

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