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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215383
Company: MERCK SHARP DOHME

Medication Guide

Products on NDA 215383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WELIREG	BELZUTIFAN	40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215383Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215383Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2026	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215383Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215383Orig1s015ltr.pdf
05/14/2025	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215383Orig1s012ltr.pdf
04/15/2025	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s010s011lbl..pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215383Orig1s010; s011ltr.pdf
04/15/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s010s011lbl..pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215383Orig1s010; s011ltr.pdf
02/26/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215383Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215383Orig1s007ltr.pdf
12/14/2023	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215383s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215383Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/215383Orig1s006.pdf

Labels for NDA 215383

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2026	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215383Orig1s015lbl.pdf
05/14/2025	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s012lbl.pdf
04/15/2025	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s010s011lbl..pdf
04/15/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s010s011lbl..pdf
02/26/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215383Orig1s007lbl.pdf
12/14/2023	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215383s006lbl.pdf
08/13/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf

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