FDA.reportPublic FDA data

Application 761178

Type
BLA
Sponsor
BIOGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADUHELMADUCANUMAB-AVWAINJECTABLE;INJECTION170MG/1.7ML (100MG/ML)YesNo
002ADUHELMADUCANUMAB-AVWAINJECTABLE;INJECTION300MG/3ML (100MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64406-101AduhelmAducanumabBiogen Inc.BLACurrent
64406-101AduhelmAducanumabBiogen Inc.BLACurrent
64406-101AduhelmAducanumabBiogen Inc.BLACurrent
64406-102AduhelmAducanumabBiogen Inc.BLACurrent
64406-102AduhelmAducanumabBiogen Inc.BLACurrent
64406-102AduhelmAducanumabBiogen Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78968SUPPL 2024-07-02
75343SUPPL 2023-09-01
75342SUPPL 2023-09-01
75329SUPPL 2023-08-31
73432SUPPL 2023-02-09
73420SUPPL 2023-02-09
70957SUPPL2022-05-03
70869SUPPL2022-05-02
68032SUPPL2021-07-08
68027SUPPL2021-07-08
67862ORIG2021-06-22
67732ORIG2021-06-07
67731ORIG2021-06-07
67730ORIG2021-06-07