An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215383s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215383Orig1s006ltr.pdf

Labels for NDA 215383

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

Top