FDA.reportPublic FDA data

Application 125521

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125521Taltzixekizumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TALTZIXEKIZUMABINJECTABLE;INJECTION80MG/MLNoNo

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
TALTZIXEKIZUMABEli Lilly and Companyac96658a-d7dc-4c7c-8928-2adcdf4318b22026-01-22Warnings, Adverse reactionsExact identifier
application number: BLA125521
ndc (product): 0002-7724
ndc (product): 0002-1445

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-1445TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent
0002-7724TALTZixekizumabEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79461SUPPL 2024-08-22
79454SUPPL 2024-08-21
77777SUPPL 2024-03-11
77759SUPPL 2024-03-08
75450SUPPL 2023-09-14
71657SUPPL2022-07-28
71656SUPPL2022-07-28
71652SUPPL2022-07-28
66737SUPPL2021-03-11
66735SUPPL2021-03-11
63392SUPPL2020-06-02
63391SUPPL2020-06-02
63381SUPPL2020-06-02
62353SUPPL2020-03-27
62352SUPPL2020-03-27
62351SUPPL2020-03-27
59904SUPPL2019-09-04
59846SUPPL2019-08-27
54266SUPPL2018-05-21
54259SUPPL2018-05-21
53792SUPPL2018-04-23
53783SUPPL2018-04-23
53058SUPPL2018-03-20
50593SUPPL2017-12-04
50580SUPPL2017-12-01
48921SUPPL2017-07-06
48915SUPPL2017-07-05
43336ORIG2016-05-03
24378ORIG2016-05-03
23469ORIG2016-03-30
9776ORIG2016-03-24
39986ORIG2016-03-23
63084SUPPL1900-01-01