761434 — OTSUKA PHARM CO LTD

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

761434

BLA OTSUKA PHARM CO LTD

Products

#	Drug Name	Active Ingredient	Form	Strength	Marketing Status	TE Codes	Ref Drug	Ref Std
001	VOYXACT	SIBEPRENLIMAB-SZSI	INJECTABLE;INJECTION	400MG/2ML(200MG/ML)	Prescription

Submissions

Type	#	Status	Date	Class	Review Priority	Notes
ORIG	1	AP	2025-11-25	TYPE 1	PRIORITY

Documents (latest 100)

Date	Type	Submission	Title / Link
2025-12-22	Review	ORIG-1	0
2025-11-28	Letter	ORIG-1	0
2025-11-25	Label	ORIG-1	0

Change History (all loads)

Date	Table	Change	Key
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761434", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761434", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761434", "ProductNo": "001"}
2026-07-12	submissions	INSERT	{"ApplNo": "761434", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12	products	INSERT	{"ApplNo": "761434", "ProductNo": "001"}
2026-07-12	applications	INSERT	{"ApplNo": "761434"}