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	2026-07-01

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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