Application 761331

Type
BLA
Sponsor
AMGEN INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001WEZLANAUSTEKINUMAB-AUUBINJECTABLE;INTRAVENOUS, SUBCUTANEOUS130MG/26MLNoNo

Documents

DocumentSubmission typeDate
85959SUPPL 2026-05-19
85946SUPPL 2026-05-18
85907SUPPL 2026-05-13
83549SUPPL 2025-09-26
83548SUPPL 2025-09-26
80771SUPPL 2024-12-27
80767SUPPL 2024-12-27
77412ORIG 2024-02-07
76881ORIG 2023-12-18
76019ORIG 2023-11-01
76018ORIG 2023-11-01