Application 125276

Type: BLA
Sponsor: GENENTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTEMRA	TOCILIZUMAB	INJECTABLE; INJECTION	80MG/4ML	No	No
002	ACTEMRA	TOCILIZUMAB	INJECTABLE; INJECTION	200MG/10ML	No	No
003	ACTEMRA	TOCILIZUMAB	INJECTABLE; INJECTION	400MG/20ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-135	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-136	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current
50242-137	ACTEMRA	tocilizumab	Genentech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84390	SUPPL	2025-12-12
84385	SUPPL	2025-12-11
83089	SUPPL	2025-08-12
83072	SUPPL	2025-08-11
83071	SUPPL	2025-08-11
80555	SUPPL	2024-12-11
79698	SUPPL	2024-09-23
79697	SUPPL	2024-09-23
79675	SUPPL	2024-09-23
79671	SUPPL	2024-09-20
72994	SUPPL	2022-12-22
72991	SUPPL	2022-12-22
72990	SUPPL	2022-12-22
70323	SUPPL	2022-03-01
70322	SUPPL	2022-03-01
70306	SUPPL	2022-03-01
69085	SUPPL	2021-10-25
67006	SUPPL	2021-04-07
66685	SUPPL	2021-03-09
66680	SUPPL	2021-03-09
66568	SUPPL	2021-03-08
63358	SUPPL	2020-06-01
63345	SUPPL	2020-05-29
63342	SUPPL	2020-05-29
59039	SUPPL	2019-06-12
59038	SUPPL	2019-06-12
59027	SUPPL	2019-06-12
58327	SUPPL	2019-04-15
58326	SUPPL	2019-04-15
58305	SUPPL	2019-04-12
58303	SUPPL	2019-04-12
56988	SUPPL	2018-12-21
56519	SUPPL	2018-11-20
56514	SUPPL	2018-11-20
55485	SUPPL	2018-09-14
55463	SUPPL	2018-09-13
54268	SUPPL	2018-05-21
54261	SUPPL	2018-05-21
54198	SUPPL	2018-05-16
54172	SUPPL	2018-05-14
53665	SUPPL	2018-04-13
53484	SUPPL	2018-03-28
53106	SUPPL	2018-03-22
52647	SUPPL	2018-02-14
50616	SUPPL	2017-12-06
49638	SUPPL	2017-08-31
49591	SUPPL	2017-08-30
48511	SUPPL	2017-05-24
48510	SUPPL	2017-05-24
47824	SUPPL	2017-04-03
47806	SUPPL	2017-03-31
45389	SUPPL	2016-09-27
45400	SUPPL	2016-09-26
31893	SUPPL	2015-08-21
9665	SUPPL	2014-11-14
31892	SUPPL	2013-10-22
18842	SUPPL	2013-10-21
9664	SUPPL	2013-07-05
18841	SUPPL	2013-05-01
9663	SUPPL	2013-05-01
22796	SUPPL	2012-12-28
39892	SUPPL	2012-10-15
31891	SUPPL	2012-10-15
31890	SUPPL	2012-08-15
18840	SUPPL	2012-08-15
9662	SUPPL	2012-06-22
31889	SUPPL	2011-05-26
31888	SUPPL	2011-05-26
18839	SUPPL	2011-04-18
18838	SUPPL	2011-04-18
39891	SUPPL	2011-01-11
18837	SUPPL	2011-01-11
18836	SUPPL	2011-01-11
31887	SUPPL	2011-01-07
31886	SUPPL	2011-01-07
24360	ORIG	2010-03-09
22795	ORIG	2010-03-09
31885	ORIG	2010-01-26
18835	ORIG	2010-01-12
66829	ORIG	1900-01-01
66828	SUPPL	1900-01-01
66827	SUPPL	1900-01-01
53424	ORIG	1900-01-01
53423	ORIG	1900-01-01
53421	ORIG	1900-01-01

Application 125276

Related Records#

Application Products#

NDC Listings For This Application#

Documents#