Application 761338

Type: BLA
Sponsor: CELLTRION, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STEQEYMA	USTEKINUMAB-STBA	INJECTABLE;SUBCUTANEOUS	45MG/0.5ML	No	No
002	STEQEYMA	USTEKINUMAB-STBA	INJECTABLE;SUBCUTANEOUS	90MG/ML	No	No
003	STEQEYMA	USTEKINUMAB-STBA	INJECTABLE;INTRAVENOUS	130MG/26ML	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84452	SUPPL	2025-12-18
84420	SUPPL	2025-12-15
83933	ORIG	2025-10-27
83932	ORIG	2025-10-27
82671	SUPPL	2025-06-27
82669	SUPPL	2025-06-27
82575	SUPPL	2025-06-13
82150	ORIG	2025-05-05
82123	SUPPL	2025-05-01
82273	ORIG	2025-04-30
82038	SUPPL	2025-04-29
80619	ORIG	2024-12-18
80612	ORIG	2024-12-18