FDA.reportPublic FDA data

Application 125521

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

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

NDC Listings For This Application#

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