Application 125433

Type: BLA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMPONI ARIA	GOLIMUMAB	INJECTABLE; INJECTION	50MG/4ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-350	SIMPONI ARIA	golimumab	Janssen Biotech, Inc.	BLA	Current
57894-350	SIMPONI ARIA	golimumab	Janssen Biotech, Inc.	BLA	Current
57894-350	SIMPONI ARIA	golimumab	Janssen Biotech, Inc.	BLA	Current
57894-350	SIMPONI ARIA	golimumab	Janssen Biotech, Inc.	BLA	Current
57894-350	SIMPONI ARIA	golimumab	Janssen Biotech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82825	SUPPL	2025-07-14
82795	SUPPL	2025-07-11
82003	SUPPL	2025-04-25
66108	SUPPL	2021-02-05
66107	SUPPL	2021-02-05
66071	SUPPL	2021-02-03
64771	SUPPL	2020-10-01
64770	SUPPL	2020-10-01
64761	SUPPL	2020-09-30
64760	SUPPL	2020-09-30
60110	SUPPL	2019-09-25
60099	SUPPL	2019-09-25
60098	SUPPL	2019-09-24
53725	SUPPL	2018-04-18
52550	SUPPL	2018-02-09
52534	SUPPL	2018-02-09
52533	SUPPL	2018-02-09
50169	SUPPL	2017-10-24
50168	SUPPL	2017-10-24
50137	SUPPL	2017-10-23
50136	SUPPL	2017-10-23
47059	SUPPL	2017-01-31
47063	SUPPL	2017-01-30
45152	SUPPL	2016-08-19
45105	SUPPL	2016-08-19
39970	SUPPL	2016-05-03
9759	SUPPL	2016-04-27
31972	SUPPL	2016-02-24
39971	SUPPL	2016-02-23
39969	SUPPL	2016-01-12
31971	SUPPL	2016-01-11
9758	SUPPL	2015-08-10
39968	SUPPL	2015-08-06
9757	SUPPL	2014-12-24
31970	SUPPL	2014-02-13
18916	SUPPL	2014-02-12
9756	SUPPL	2014-02-11
39967	SUPPL	2014-02-06
43330	ORIG	2013-09-30
9755	ORIG	2013-07-26
18915	ORIG	2013-07-22