761444 — SHANGHAI HENLIUS BIOTECH

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

761444

BLA SHANGHAI HENLIUS BIOTECH

Products

#	Drug Name	Active Ingredient	Form	Strength	Marketing Status	TE Codes	Ref Drug	Ref Std
001	BILDYOS	DENOSUMAB-NXXP	INJECTABLE;INJECTION	60MG/ML	Prescription
002	BILPREVDA	DENOSUMAB-NXXP	INJECTABLE;INJECTION	120MG/1.7ML(70MG/ML)	Prescription

Submissions

Type	#	Status	Date	Class	Review Priority	Notes
ORIG	2	AP	2025-10-29	EFFICACY	STANDARD
ORIG	1	AP	2025-08-29	UNKNOWN	STANDARD

Documents (latest 100)

Date	Type	Submission	Title / Link
2025-12-15	Review	ORIG-2	0
2025-12-15	Review	ORIG-1	0
2025-11-21	Letter	ORIG-1	0
2025-11-21	Letter	ORIG-2	0
2025-10-31	Label	ORIG-2	0
2025-10-31	Medication Guide	ORIG-2	0
2025-10-07	Label	ORIG-1	0

Change History (all loads)

Date	Table	Change	Key
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "2", "ActionTypes_LookupID": "46"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761444", "ProductNo": "002"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761444", "ProductNo": "001"}
2026-07-12	submissions	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "2"}
2026-07-12	submissions	INSERT	{"ApplNo": "761444", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12	products	INSERT	{"ApplNo": "761444", "ProductNo": "002"}
2026-07-12	products	INSERT	{"ApplNo": "761444", "ProductNo": "001"}
2026-07-12	applications	INSERT	{"ApplNo": "761444"}