NDA 215110

ABBVIE INC

FDA Drug Application

Application #215110

Documents

• Letter: 2021-06-14
• Label: 2021-06-24
• Letter: 2021-09-29
• Label: 2021-10-01
• Review: 2021-11-09

Application Sponsors

NDA 215110

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

100MG;40MG

1

MAVYRET

GLECAPREVIR; PIBRENTASVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-06-10

PRIORITY

Submissions Property Types

ORIG

1

Null

40

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
        )

)