FDA.reportPublic FDA data

Application 761032

Type
BLA
Sponsor
VALEANT LUXEMBOURG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILIQBRODALUMABINJECTABLE;INJECTION210MG/1.5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent
0187-0004SiliqBrodalumabBausch Health Americas Inc.BLACurrent
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent
0187-0004SiliqBrodalumabValeant Pharmaceuticals North America LLCBLACurrent
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent
0187-0004SiliqBrodalumabBausch Health US LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85872SUPPL 2026-05-11
85279SUPPL 2026-03-06
85212SUPPL 2026-03-03
85285SUPPL 2026-02-27
79385SUPPL 2024-08-13
79379SUPPL 2024-08-13
78988SUPPL 2024-07-08
78977SUPPL 2024-07-05
76281ORIG 2023-11-03
74803SUPPL 2023-07-20
71315SUPPL2022-06-15
65969SUPPL2021-01-25
55937SUPPL2018-10-15
52126SUPPL2018-01-30
48689SUPPL2017-06-09
47731ORIG2017-03-28
47443ORIG2017-03-03
47228ORIG2017-02-16
47227ORIG2017-02-16
47226ORIG2017-02-15