Application 215974

Type: NDA
Sponsor: GILEAD SCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUNLENCA	LENACAPAVIR	TABLET;ORAL	300MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-3001	Sunlenca	LENACAPAVIR SODIUM	Gilead Sciences	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85379	SUPPL	2026-03-16
80435	SUPPL	2024-11-26
80421	SUPPL	2024-11-26
80216	SUPPL	2024-11-14
80212	SUPPL	2024-11-14
79138	SUPPL	2024-07-22
79117	SUPPL	2024-07-18
73384	ORIG	2023-02-06
73029	ORIG	2022-12-23
73005	ORIG	2022-12-22