Application 761358

Type: BLA
Sponsor: CELLTRION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYMFENTRA	INFLIXIMAB-DYYB	INJECTABLE;INJECTION	120MG/ML	No	No

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80000	ORIG	2024-10-28
78159	SUPPL	2024-04-19
78158	SUPPL	2024-04-19
75915	ORIG	2023-10-24
75914	ORIG	2023-10-24
75899	ORIG	2023-10-24