FDA.reportPublic FDA data

Application 761140

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIABNIRITUXIMAB-ARRXINJECTABLE;INJECTION100MG/10ML(10MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-224Riabnirituximab-arrxAmgen IncBLACurrent
55513-224Riabnirituximab-arrxAmgen IncBLACurrent
55513-326Riabnirituximab-arrxAmgen IncBLACurrent
55513-326Riabnirituximab-arrxAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82523SUPPL 2025-06-10
82521SUPPL 2025-06-10
82515SUPPL 2025-06-10
71220SUPPL2022-06-06
71217SUPPL2022-06-06
71216SUPPL2022-06-06
65984ORIG2021-01-26
65646ORIG2020-12-21
65614ORIG2020-12-17
65613ORIG2020-12-17