Application 761354

Type
BLA
Sponsor
BIOGEN MA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TOFIDENCETOCILIZUMAB-BAVIINJECTABLE;INJECTION80MG/4MLNoNo
002TOFIDENCETOCILIZUMAB-BAVIINJECTABLE;INJECTION200MG/10MLNoNo
003TOFIDENCETOCILIZUMAB-BAVIINJECTABLE;INJECTION400MG/20MLNoNo

Documents

DocumentSubmission typeDate
81517SUPPL 2025-03-11
81516SUPPL 2025-03-11
81475SUPPL 2025-03-07
80527SUPPL 2024-12-05
80505SUPPL 2024-12-04
79161SUPPL 2024-07-24
79153SUPPL 2024-07-23
76519ORIG 2023-11-07
75655ORIG 2023-10-03
75629ORIG 2023-09-29