Application 103795

Type: BLA
Sponsor: IMMUNEX

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103795	Enbrel	etanercept	351(a)	Disc	2026-06-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENBREL	ETANERCEPT	VIAL; SUBCUTANEOUS	25MG/VIAL	No	No
002	ENBREL	ETANERCEPT	SYRINGE	50MG/ML	No	No

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ENBREL	ETANERCEPT	Immunex Corporation	a002b40c-097d-47a5-957f-7a7b1807af7f	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103795 ndc (product): 58406-055 ndc (product): 58406-425 ndc (product): 58406-010 ndc (product): 58406-044 ndc (product): 58406-021 ndc (product): 58406-032

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 147 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3531	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
50090-3531	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
50090-3531	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
50090-4490	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
50090-4590	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
50090-4590	ENBREL	etanercept	A-S Medication Solutions	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-010	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-021	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-032	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-044	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-055	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-425	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-435	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-435	ENBREL	etanercept	Immunex Corporation	BLA	Current
58406-435	ENBREL	etanercept	Immunex Corporation	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84961	SUPPL	2026-02-06
84894	SUPPL	2026-02-03
84962	SUPPL	2026-01-30
84384	SUPPL	2025-12-11
82616	SUPPL	2025-06-20
82613	SUPPL	2025-06-20
79613	SUPPL	2024-09-16
79588	SUPPL	2024-09-16
79170	SUPPL	2024-07-24
79169	SUPPL	2024-07-24
79168	SUPPL	2024-07-24
79156	SUPPL	2024-07-23
79155	SUPPL	2024-07-23
79154	SUPPL	2024-07-23
75857	SUPPL	2023-10-19
75843	SUPPL	2023-10-19
74480	SUPPL	2023-06-13
74472	SUPPL	2023-06-12
71828	SUPPL	2022-08-17
71824	SUPPL	2022-08-17
71419	SUPPL	2022-06-21
71371	SUPPL	2022-06-21
66442	SUPPL	2021-03-02
66419	SUPPL	2021-03-01
62082	SUPPL	2020-03-09
62081	SUPPL	2020-03-09
62059	SUPPL	2020-03-06
62058	SUPPL	2020-03-06
57722	SUPPL	2019-02-21
55886	SUPPL	2018-10-11
55806	SUPPL	2018-10-04
55805	SUPPL	2018-10-04
55510	SUPPL	2018-09-18
54369	SUPPL	2018-05-29
54368	SUPPL	2018-05-29
54367	SUPPL	2018-05-29
54359	SUPPL	2018-05-29
54358	SUPPL	2018-05-29
50510	SUPPL	2017-11-27
49993	SUPPL	2017-10-10
49777	SUPPL	2017-09-19
49737	SUPPL	2017-09-15
48986	SUPPL	2017-07-14
48953	SUPPL	2017-07-12
45839	SUPPL	2016-11-15
45854	SUPPL	2016-11-08
31688	SUPPL	2015-03-26
18669	SUPPL	2015-03-26
18668	SUPPL	2015-03-24
18667	SUPPL	2013-11-22
9485	SUPPL	2013-11-18
39726	SUPPL	2012-12-14
9484	SUPPL	2012-12-13
39725	SUPPL	2012-12-05
9483	SUPPL	2012-12-05
44423	ORIG	2011-12-20
9482	SUPPL	2011-09-13
9480	SUPPL	2011-01-27
39724	SUPPL	2011-01-11
31687	SUPPL	2010-11-04
31686	SUPPL	2010-10-19
9481	SUPPL	2010-08-02
9479	SUPPL	2010-06-29
9478	SUPPL	2010-06-29
9477	SUPPL	2010-06-29
31685	SUPPL	2009-12-03
9476	SUPPL	2008-09-09
39723	SUPPL	2008-09-08
24172	ORIG	2008-09-04
22757	SUPPL	2008-07-31
22755	SUPPL	2008-07-31
39722	SUPPL	2008-05-29
9475	SUPPL	2007-03-15
18666	SUPPL	2007-03-14
18665	SUPPL	2006-08-31
43288	SUPPL	2005-12-06
18664	SUPPL	2005-08-08
9474	SUPPL	2005-08-08
31684	SUPPL	2005-07-21
18663	SUPPL	2005-07-21
18662	SUPPL	2005-06-07
9473	SUPPL	2005-06-07
22756	SUPPL	2004-12-07
31683	SUPPL	2004-11-08
18661	SUPPL	2004-11-08
31682	SUPPL	2004-10-26
39721	SUPPL	2004-10-21
43573	SUPPL	2004-09-22
43287	SUPPL	2004-09-22
39720	SUPPL	2004-09-22
39719	ORIG	2004-09-22
31677	SUPPL	2004-09-22
31676	SUPPL	2004-09-22
31675	SUPPL	2004-09-22
31674	ORIG	2004-09-22
22754	SUPPL	2004-09-22
22753	ORIG	2004-09-22
18659	SUPPL	2004-09-22
18658	SUPPL	2004-09-22
18657	SUPPL	2004-09-22