GENENTECH INC FDA Approval NDA 214410

NDA 214410

GENENTECH INC

FDA Drug Application

Application #214410

Documents

Label2020-11-25
Letter2020-11-25

Application Sponsors

NDA 214410GENENTECH INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL20MG2XOFLUZABALOXAVIR MARBOXIL
002TABLET;ORAL40MG2XOFLUZABALOXAVIR MARBOXIL
003SUSPENSION;ORAL40MG/20ML2XOFLUZABALOXAVIR MARBOXIL

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-11-23STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

GENENTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214410
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XOFLUZA","activeIngredients":"BALOXAVIR MARBOXIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"XOFLUZA","activeIngredients":"BALOXAVIR MARBOXIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"XOFLUZA","activeIngredients":"BALOXAVIR MARBOXIL","strength":"40MG\/20ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"11\/23\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214410s000,210854s004s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214410s000,210854s004s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-23
        )

)

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