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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210854
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOFLUZA BALOXAVIR MARBOXIL 20MG TABLET;ORAL Discontinued None Yes No
XOFLUZA BALOXAVIR MARBOXIL 40MG TABLET;ORAL Prescription None Yes No
XOFLUZA BALOXAVIR MARBOXIL 80MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/24/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210854Orig1s000ltr_ReplacementLtr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210854Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2024 SUPPL-20 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s020; 214410Orig1s006ltr.pdf
06/15/2023 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210854Orig1s018;214410Orig1s005ltr.pdf
11/23/2020 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214410Orig1s000; 210854Orig1s004, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.cfm
08/11/2022 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210854Orig1s005, s009ltr.pdf
03/18/2021 SUPPL-8

Label is not available on this site.

08/11/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210854Orig1s005, s009ltr.pdf
11/23/2020 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214410Orig1s000; 210854Orig1s004, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.cfm
10/16/2019 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210854Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210854Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/01/2024 SUPPL-20 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf
06/15/2023 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf
08/11/2022 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf
08/11/2022 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf
11/23/2020 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf
11/23/2020 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf
10/16/2019 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf
10/24/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf
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