ABBVIE INC FDA Approval NDA 215110

NDA 215110

ABBVIE INC

FDA Drug Application

Application #215110

Documents

Letter2021-06-14
Label2021-06-24

Application Sponsors

NDA 215110ABBVIE INC

Marketing Status

Prescription001

Application Products

001TABLET; ORAL100MG;40MG1MAVYRETGLECAPREVIR; PIBRENTASVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-06-10PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

ABBVIE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215110
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAVYRET","activeIngredients":"GLECAPREVIR; PIBRENTASVIR","strength":"100MG;40MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-10
        )

)

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