Application 761331

Type: BLA
Sponsor: AMGEN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WEZLANA	USTEKINUMAB-AUUB	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	130MG/26ML	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85959	SUPPL	2026-05-19
85946	SUPPL	2026-05-18
85907	SUPPL	2026-05-13
83549	SUPPL	2025-09-26
83548	SUPPL	2025-09-26
80771	SUPPL	2024-12-27
80767	SUPPL	2024-12-27
77412	ORIG	2024-02-07
76881	ORIG	2023-12-18
76019	ORIG	2023-11-01
76018	ORIG	2023-11-01