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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214410
Company: GENENTECH INC

Products on NDA 214410

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
XOFLUZA	BALOXAVIR MARBOXIL	30MG/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
XOFLUZA	BALOXAVIR MARBOXIL	40MG/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214410

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.html
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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2025	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210854Orig1s023,214410Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210854Orig1s023,214410Orig1s008ltr.pdf
12/19/2024	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s021;214410Orig1s007ltr.pdf
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

Labels for NDA 214410

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2025	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210854Orig1s023,214410Orig1s008lbl.pdf
12/19/2024	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf
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

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