Application 761044

Type
BLA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STELARAUSTEKINUMABINJECTABLE;INJECTION130MG/26MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85701SUPPL 2026-04-20
85702SUPPL 2026-04-16
85694SUPPL 2026-04-16
84062SUPPL 2025-11-04
84050SUPPL 2025-11-04
82730SUPPL 2025-07-03
82692SUPPL 2025-06-30
81871SUPPL 2025-04-08
81810SUPPL 2025-04-02
80240SUPPL 2024-11-19
77901SUPPL 2024-03-21
77874SUPPL 2024-03-19
73702SUPPL 2023-03-07
73698SUPPL 2023-03-07
71677SUPPL2022-08-01
71676SUPPL2022-08-01
71673SUPPL2022-08-01
68781SUPPL2021-09-24
65593SUPPL2020-12-15
65581SUPPL2020-12-14
65580SUPPL2020-12-14
65467SUPPL2020-12-02
65459SUPPL2020-12-01
65458SUPPL2020-12-01
62547SUPPL2020-04-13
62546SUPPL2020-04-13
60840SUPPL2019-11-14
60839SUPPL2019-11-14
60808SUPPL2019-11-12
60598SUPPL2019-10-24
60608SUPPL2019-10-21
60607SUPPL2019-10-21
51048ORIG2018-01-12
45422ORIG2016-09-29
45480ORIG2016-09-26