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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215256
Company: NOVO

Medication Guide

Products on NDA 215256

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WEGOVY	SEMAGLUTIDE	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
WEGOVY	SEMAGLUTIDE	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
WEGOVY	SEMAGLUTIDE	1MG/0.5ML (1MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
WEGOVY	SEMAGLUTIDE	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
WEGOVY	SEMAGLUTIDE	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215256

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2021	ORIG-1	Approval		PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215256Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2024	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s011ltr.pdf
07/21/2023	SUPPL-7	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s007ltr.pdf
02/14/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s006ltr.pdf
12/23/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215256Orig1s005ltr.pdf
08/24/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf

Labels for NDA 215256

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2024	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf
07/21/2023	SUPPL-7	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf
02/14/2023	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf
02/14/2023	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf
12/23/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf
08/24/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf
06/04/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf

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