Application 761064

Type: BLA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RITUXAN HYCELA	RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)	SOLUTION;SUBCUTANEOUS	1400MG and 23400UNITS/11.7ML	No	No
002	RITUXAN HYCELA	RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)	SOLUTION;SUBCUTANEOUS	1600MG and 26800UNITS/13.4ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-108	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current
50242-109	Rituxan Hycela	rituximab and hyaluronidase	Genentech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67777	SUPPL	2021-06-14
67771	SUPPL	2021-06-11
67770	SUPPL	2021-06-11
62841	SUPPL	2020-05-06
62840	SUPPL	2020-05-06
62839	SUPPL	2020-05-06
62838	SUPPL	2020-05-06
62835	SUPPL	2020-05-06
62834	SUPPL	2020-05-06
61392	SUPPL	2019-12-23
61349	SUPPL	2019-12-19
61348	SUPPL	2019-12-19
55872	ORIG	2018-10-11
48827	ORIG	2017-06-26
48801	SUPPL	2017-06-22
48800	SUPPL	2017-06-22

Application 761064

Related Records#

Application Products#

NDC Listings For This Application#

Documents#