761498 — CELLTRION INC

Data as of 2026-07-12 — 788,886 rows loaded

761498

BLA CELLTRION INC

Products

#	Drug Name	Active Ingredient	Form	Strength	Marketing Status	TE Codes	Ref Drug	Ref Std
001	AVTOZMA	TOCILIZUMAB-ANOH	INJECTABLE;IV (INFUSION)	80MG/4ML(20MG/ML)	Prescription
002	AVTOZMA	TOCILIZUMAB-ANOH	INJECTABLE;IV (INFUSION)	200MG/10ML(20MG/ML)	Prescription
003	AVTOZMA	TOCILIZUMAB-ANOH	INJECTABLE;IV (INFUSION)	400MG/20ML(20MG/ML)	Prescription
004	AVTOZMA	TOCILIZUMAB-ANOH	INJECTABLE;SUBCUTANEOUS	162MG/20ML(20MG/ML)	Prescription

Submissions

Type	#	Status	Date	Class	Review Priority	Notes
ORIG	1	AP	2026-01-21	UNKNOWN	STANDARD

Documents (latest 100)

Date	Type	Submission	Title / Link
2026-02-12	Review	ORIG-1	0
2026-01-22	Letter	ORIG-1	0
2026-01-21	Label	ORIG-1	0
2026-01-21	Medication Guide	ORIG-1	0

Change History (all loads)

Date	Table	Change	Key
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761498", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761498", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761498", "ProductNo": "004"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761498", "ProductNo": "003"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761498", "ProductNo": "002"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761498", "ProductNo": "001"}
2026-07-12	submissions	INSERT	{"ApplNo": "761498", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12	products	INSERT	{"ApplNo": "761498", "ProductNo": "004"}
2026-07-12	products	INSERT	{"ApplNo": "761498", "ProductNo": "003"}
2026-07-12	products	INSERT	{"ApplNo": "761498", "ProductNo": "002"}
2026-07-12	products	INSERT	{"ApplNo": "761498", "ProductNo": "001"}
2026-07-12	applications	INSERT	{"ApplNo": "761498"}