Application 125057

Type: BLA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HUMIRA	ADALIMUMAB	SYRINGE	40MG/0.8ML	No	No
002	HUMIRA	ADALIMUMAB	VIAL	40MG/0.8ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0067	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0124	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0243	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0554	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0616	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-0817	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-1539	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current
0074-2540	Humira	Adalimumab	AbbVie Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85138	SUPPL	2026-02-24
84663	SUPPL	2026-01-06
84615	SUPPL	2025-12-31
82896	SUPPL	2025-07-21
82895	SUPPL	2025-07-21
82885	SUPPL	2025-07-17
76387	SUPPL	2023-11-06
76380	SUPPL	2023-11-06
67005	SUPPL	2021-04-07
66364	SUPPL	2021-02-25
66363	SUPPL	2021-02-25
66360	SUPPL	2021-02-25
65660	SUPPL	2020-12-21
65659	SUPPL	2020-12-21
65658	SUPPL	2020-12-21
65657	SUPPL	2020-12-21
65642	SUPPL	2020-12-21
65641	SUPPL	2020-12-21
62136	SUPPL	2020-03-12
62131	SUPPL	2020-03-12
58982	SUPPL	2019-06-06
58921	SUPPL	2019-06-03
57260	SUPPL	2019-01-18
56660	SUPPL	2018-12-07
56643	SUPPL	2018-12-07
56010	SUPPL	2018-10-18
56009	SUPPL	2018-10-18
55968	SUPPL	2018-10-17
55788	SUPPL	2018-10-03
55769	SUPPL	2018-10-01
55103	SUPPL	2018-08-03
55096	SUPPL	2018-08-03
50831	SUPPL	2017-12-22
50830	SUPPL	2017-12-22
50712	SUPPL	2017-12-15
50170	SUPPL	2017-10-24
48417	SUPPL	2017-05-17
48416	SUPPL	2017-05-17
48202	SUPPL	2017-05-02
48176	SUPPL	2017-05-01
48116	SUPPL	2017-04-26
47765	SUPPL	2017-03-29
47741	SUPPL	2017-03-28
43300	SUPPL	2016-07-28
39811	SUPPL	2016-07-05
9576	SUPPL	2016-07-01
44790	SUPPL	2016-03-11
22775	SUPPL	2016-02-03
39810	SUPPL	2015-11-25
9575	SUPPL	2015-11-24
31796	SUPPL	2015-09-14
43297	SUPPL	2015-03-11
22773	SUPPL	2015-03-09
22772	SUPPL	2015-03-09
9571	SUPPL	2015-01-08
44990	SUPPL	2014-12-24
39809	SUPPL	2014-10-02
31795	SUPPL	2014-10-02
18756	SUPPL	2014-09-26
9573	SUPPL	2014-09-25
31794	SUPPL	2014-06-03
18757	SUPPL	2014-06-03
9574	SUPPL	2014-05-20
18758	SUPPL	2014-05-15
39808	SUPPL	2014-02-27
31793	SUPPL	2014-02-27
18755	SUPPL	2013-09-24
31792	SUPPL	2013-09-20
43298	SUPPL	2013-09-09
9572	SUPPL	2013-05-15
18753	SUPPL	2013-05-13
18754	SUPPL	2013-04-29
22774	SUPPL	2013-04-09
9566	SUPPL	2012-10-03
39806	SUPPL	2012-10-02
9570	SUPPL	2012-05-30
18752	SUPPL	2012-05-29
39807	SUPPL	2012-03-15
9569	SUPPL	2012-01-05
9568	SUPPL	2012-01-05
9567	SUPPL	2012-01-05
44425	ORIG	2011-12-20
31791	SUPPL	2011-09-13
31787	SUPPL	2011-03-25
18751	SUPPL	2011-03-04
9565	SUPPL	2010-10-19
31790	SUPPL	2010-08-03
31788	SUPPL	2010-06-17
39805	SUPPL	2010-02-23
31789	SUPPL	2009-12-03
43299	SUPPL	2009-03-24
24356	SUPPL	2009-03-24
39804	SUPPL	2008-03-27
31786	SUPPL	2008-02-26
18750	SUPPL	2008-02-26
31785	SUPPL	2008-01-25
39803	SUPPL	2007-09-07
31784	SUPPL	2007-09-07
9563	SUPPL	2007-08-01
18748	SUPPL	2007-07-31

Application 125057

Related Records#

Application Products#

NDC Listings For This Application#

Documents#