Application 103950

Type: BLA
Sponsor: BIOVITRUM AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KINERET	ANAKINRA	VIAL; SUBCUTANEOUS	10MIU/VIAL	No	No
002	KINERET	ANAKINRA	VIAL; SUBCUTANEOUS	18MIU/VIAL	No	No
003	KINERET	ANAKINRA	VIAL; SUBCUTANEOUS	25MIU/VIAL	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66658-234	Kineret	anakinra	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-234	Kineret	anakinra	Swedish Orphan Biovitrum AB (publ)	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83963	SUPPL	2025-10-28
83938	SUPPL	2025-10-28
79686	SUPPL	2024-09-23
79667	SUPPL	2024-09-20
65671	SUPPL	2020-12-22
65627	SUPPL	2020-12-21
54565	SUPPL	2018-06-14
54497	SUPPL	2018-06-11
18696	SUPPL	2016-05-23
9510	SUPPL	2016-05-20
39752	SUPPL	2013-10-25
9509	SUPPL	2013-10-25
18695	SUPPL	2012-12-28
9508	SUPPL	2012-12-28
39751	SUPPL	2011-09-30
22762	ORIG	2005-04-27
9507	SUPPL	2004-10-26
39750	SUPPL	2004-10-21
23081	SUPPL	2004-10-21
43574	ORIG	2004-03-17
31725	SUPPL	2004-03-17
31724	ORIG	2004-03-17
18694	SUPPL	2004-03-17
18693	ORIG	2004-03-17
31726	SUPPL	2003-11-06