Application 125486

Type: BLA
Sponsor: GENENTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GAZYVA	OBINUTUZUMAB	INJECTABLE;INJECTION	1000MG/40ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current
50242-070	Gazyva	obinutuzumab	Genentech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84482	SUPPL	2025-12-22
84470	SUPPL	2025-12-19
83851	SUPPL	2025-10-21
83850	SUPPL	2025-10-21
83849	SUPPL	2025-10-21
83822	SUPPL	2025-10-20
83821	SUPPL	2025-10-20
71658	SUPPL	2022-07-28
71651	SUPPL	2022-07-28
71562	SUPPL	2022-07-15
71539	SUPPL	2022-07-13
70173	SUPPL	2022-02-15
70169	SUPPL	2022-02-15
62366	SUPPL	2020-03-30
62364	SUPPL	2020-03-30
50446	SUPPL	2017-11-17
50445	SUPPL	2017-11-17
50434	SUPPL	2017-11-16
50433	SUPPL	2017-11-16
9770	SUPPL	2016-02-29
39977	SUPPL	2016-02-26
18922	SUPPL	2015-10-06
9769	SUPPL	2015-09-25
31978	SUPPL	2014-12-31
39976	SUPPL	2014-07-01
9768	SUPPL	2014-07-01
22815	ORIG	2013-11-27
31977	ORIG	2013-11-06
44567	ORIG	2013-11-01
24375	ORIG	2013-11-01
18921	ORIG	2013-11-01