Application 761235

Type: BLA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FARICIMAB	VABYSMO	INJECTABLE; INTRAVITREAL	120MG/ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-096	VABYSMO	Faricimab	Genentech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85678	SUPPL	2026-04-14
85670	SUPPL	2026-04-10
79109	SUPPL	2024-07-17
79054	SUPPL	2024-07-12
75979	SUPPL	2023-10-27
75962	SUPPL	2023-10-27
73327	SUPPL	2023-01-30
73315	SUPPL	2023-01-30
70274	ORIG	2022-02-28
70038	ORIG	2022-02-01
70002	ORIG	2022-01-31