NDA 214410

GENENTECH INC

FDA Drug Application

Application #214410

Documents

• Label: 2020-11-25
• Letter: 2020-11-25
• Review: 2021-02-03
• Letter: 2021-09-28
• Label: 2022-08-11
• Letter: 2022-08-12
• Review: 2022-10-03

Application Sponsors

NDA 214410

GENENTECH INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	20MG	2	XOFLUZA	BALOXAVIR MARBOXIL
002	TABLET;ORAL	40MG	2	XOFLUZA	BALOXAVIR MARBOXIL
003	SUSPENSION;ORAL	40MG/20ML	2	XOFLUZA	BALOXAVIR MARBOXIL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-11-23	STANDARD
EFFICACY; Efficacy	ORIG	2	AP	2022-08-11	STANDARD

Submissions Property Types

ORIG	1	Null	6
ORIG	2	Null	7

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
        )

)