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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213051
Company: NOVO

Medication Guide

Products on NDA 213051

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYBELSUS	SEMAGLUTIDE	3MG	TABLET;ORAL	Prescription	None	Yes	No
RYBELSUS	SEMAGLUTIDE	7MG	TABLET;ORAL	Prescription	None	Yes	No
RYBELSUS	SEMAGLUTIDE	14MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213051

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2019	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213051Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2024	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s018ltr.pdf
01/12/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213051Orig1s012ltr.pdf
06/10/2022	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213051Orig1s011ltr.pdf
04/30/2021	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf
01/16/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000, 213051Orig1s001ltr.pdf

Labels for NDA 213051

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/24/2024	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf
01/12/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf
06/10/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf
06/10/2022	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf
04/30/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf
04/30/2021	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf
01/16/2020	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
01/16/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
09/20/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf

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