Application 761285

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WEZLANAUSTEKINUMAB-AUUBINJECTABLE;INTRAVENOUS, SUBCUTANEOUS45MG/0.5MLNoNo
002WEZLANAUSTEKINUMAB-AUUBINJECTABLE;INTRAVENOUS, SUBCUTANEOUS90MG/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85958SUPPL 2026-05-19
85945SUPPL 2026-05-18
85906SUPPL 2026-05-13
83547SUPPL 2025-09-26
83534SUPPL 2025-09-26
80770SUPPL 2024-12-27
80765SUPPL 2024-12-27
77411ORIG 2024-02-07
76879ORIG 2023-12-18
76016ORIG 2023-11-01