Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 20MG | 1 | XOFLUZA | BALOXAVIR MARBOXIL |
| 002 | TABLET;ORAL | 40MG | 1 | XOFLUZA | BALOXAVIR MARBOXIL |
| 003 | TABLET;ORAL | 80MG | 1 | XOFLUZA | BALOXAVIR MARBOXIL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-10-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2020-11-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2022-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2021-03-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2022-08-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2020-11-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 15 |
CDER Filings
GENENTECH INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210854
[companyName] => GENENTECH INC
[docInserts] => ["",""]
[products] => [{"drugName":"XOFLUZA","activeIngredients":"BALOXAVIR MARBOXIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XOFLUZA","activeIngredients":"BALOXAVIR MARBOXIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/16\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210854s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210854s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210854s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210854Orig1s000ltr_ReplacementLtr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210854Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/16\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210854s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210854Orig1s001ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210854Orig1s001.pdf\"}]","notes":">"}]
[actionDate] => 2019-10-16
)
)