FDA.reportPublic FDA data

Application 125104

Type
BLA
Sponsor
BIOGEN IDEC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125104Tysabrinatalizumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYSABRINATALIZUMABVIAL; SINGLE-USE300MGNoNo

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
TYSABRINATALIZUMABBiogen Inc.c5fdde91-1989-4dd2-9129-4f3323ea29622025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125104
ndc (product): 64406-008

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent
64406-008TYSABRInatalizumabBiogen Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81664SUPPL 2025-03-21
81663SUPPL 2025-03-21
81637SUPPL 2025-03-19
75971SUPPL 2023-10-27
75970SUPPL 2023-10-27
75297SUPPL 2023-08-28
73980SUPPL 2023-04-12
73979SUPPL 2023-04-12
73975SUPPL 2023-04-12
73974SUPPL 2023-04-12
69560SUPPL2021-12-15
69559SUPPL2021-12-15
69558SUPPL2021-12-15
69548SUPPL2021-12-14
69547SUPPL2021-12-14
64887SUPPL2020-10-09
64853SUPPL2020-10-06
63608SUPPL2020-06-19
63621SUPPL2020-06-18
63620SUPPL2020-06-18
63619SUPPL2020-06-18
63618SUPPL2020-06-18
63609SUPPL2020-06-18
59605SUPPL2019-08-07
59581SUPPL2019-08-06
59580SUPPL2019-08-06
53777SUPPL2018-04-23
53776SUPPL2018-04-23
53754SUPPL2018-04-20
53753SUPPL2018-04-20
49492SUPPL2017-08-21
49438SUPPL2017-08-17
49437SUPPL2017-08-17
45526SUPPL2016-10-12
39845SUPPL2016-05-20
18792SUPPL2016-05-20
9611SUPPL2016-05-20
9610SUPPL2016-05-20
39844SUPPL2015-05-13
31833SUPPL2015-05-13
24357SUPPL2014-01-16
39843SUPPL2013-12-17
39842SUPPL2013-12-17
31832SUPPL2013-12-17
18791SUPPL2013-12-17
9609SUPPL2013-12-17
9608SUPPL2013-12-17
22784SUPPL2013-10-23
39841SUPPL2013-06-04
9607SUPPL2013-05-28
31831SUPPL2012-01-31
9606SUPPL2012-01-31
18790SUPPL2012-01-27
24083ORIG2012-01-18
39840SUPPL2011-09-27
18789SUPPL2011-04-07
18788SUPPL2011-04-07
39839SUPPL2009-09-16
9605SUPPL2008-11-03
9604SUPPL2008-11-03
18786SUPPL2008-10-31
9603SUPPL2008-01-23
39838SUPPL2008-01-15
39837SUPPL2006-06-06
31830SUPPL2006-06-06
22783ORIG2005-03-08
18785ORIG2004-11-24
9602ORIG2004-11-24
18787SUPPL2004-11-23