FDA.reportPublic FDA data

Application 761067

Type
BLA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ILUMYATILDRAKIZUMAB-ASMNINJECTABLE;INJECTION100MG/1MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent
47335-177ILUMYAtildrakizumab-asmnSun Pharmaceutical Industries, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84451SUPPL 2025-12-18
84417SUPPL 2025-12-15
78072SUPPL 2024-04-04
78064SUPPL 2024-04-04
72981SUPPL2022-12-21
72962SUPPL2022-12-21
53824ORIG2018-04-26
53249ORIG2018-03-23
53248ORIG2018-03-23
53080ORIG2018-03-22