FDA.reportPublic FDA data

Application 103950

Type
BLA
Sponsor
BIOVITRUM AB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103950Kineretanakinra351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KINERETANAKINRAVIAL; SUBCUTANEOUS10MIU/VIALNoNo
002KINERETANAKINRAVIAL; SUBCUTANEOUS18MIU/VIALNoNo
003KINERETANAKINRAVIAL; SUBCUTANEOUS25MIU/VIALNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KineretANAKINRASwedish Orphan Biovitrum AB (publ)d9d74915-6606-4570-9c52-c4001d3177de2026-04-03Warnings, Adverse reactionsExact identifier
application number: BLA103950
ndc (product): 66658-234

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66658-234KineretanakinraSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-234KineretanakinraSwedish Orphan Biovitrum AB (publ)BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83963SUPPL 2025-10-28
83938SUPPL 2025-10-28
79686SUPPL 2024-09-23
79667SUPPL 2024-09-20
65671SUPPL2020-12-22
65627SUPPL2020-12-21
54565SUPPL2018-06-14
54497SUPPL2018-06-11
18696SUPPL2016-05-23
9510SUPPL2016-05-20
39752SUPPL2013-10-25
9509SUPPL2013-10-25
18695SUPPL2012-12-28
9508SUPPL2012-12-28
39751SUPPL2011-09-30
22762ORIG2005-04-27
9507SUPPL2004-10-26
39750SUPPL2004-10-21
23081SUPPL2004-10-21
43574ORIG2004-03-17
31725SUPPL2004-03-17
31724ORIG2004-03-17
18694SUPPL2004-03-17
18693ORIG2004-03-17
31726SUPPL2003-11-06