Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214410
Company: GENENTECH INC
Company: GENENTECH INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XOFLUZA | BALOXAVIR MARBOXIL | 2MG/ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
08/11/2022 | ORIG-2 | Approval | Efficacy | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214410Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214410Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214410Orig2s000TOC.cfm | |
11/23/2020 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
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/2020/214410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/01/2024 | SUPPL-6 | 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-5 | 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 | |
09/27/2021 | SUPPL-1 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214410Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/01/2024 | SUPPL-6 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf | |
06/15/2023 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf | |
08/11/2022 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214410Orig2s000lbl.pdf | |
11/23/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf |