Application 215383

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELIREG	BELZUTIFAN	TABLET;ORAL	40MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-5331	WELIREG	belzutifan	Merck Sharp & Dohme Corp.	NDA	Current
0006-5331	WELIREG	belzutifan	Merck Sharp & Dohme LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85859	SUPPL	2026-05-11
82302	SUPPL	2025-05-23
82243	SUPPL	2025-05-14
82242	SUPPL	2025-05-14
81961	SUPPL	2025-04-24
81960	SUPPL	2025-04-24
81932	SUPPL	2025-04-21
81931	SUPPL	2025-04-21
77633	SUPPL	2024-03-12
77630	SUPPL	2024-03-12
76857	SUPPL	2023-12-15
76841	SUPPL	2023-12-15
76840	SUPPL	2023-12-15
68566	ORIG	2021-09-10
68375	ORIG	2021-08-16
68366	ORIG	2021-08-13
68363	ORIG	2021-08-13