761428 — NOVO NORDISK INC

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

761428

BLA NOVO NORDISK INC

Products

#	Drug Name	Active Ingredient	Form	Strength	Marketing Status	TE Codes	Ref Drug	Ref Std
001	ALHEMO	CONCIZUMAB	SOLUTION; INJECTION	60MG/1.5ML (40MG/ML)	Prescription
002	ALHEMO	CONCIZUMAB	SOLUTION; INJECTION	150MG/1.5ML (100MG/ML)	Prescription
003	ALHEMO	CONCIZUMAB	SOLUTION; INJECTION	300MG/3ML (100MG/ML)	Prescription

Special Designations

Orphan (Sub 1)

Submissions

Type	#	Status	Date	Class	Review Priority	Notes
ORIG	1	AP	2025-07-31	TYPE 9- BLA	STANDARD

Documents (latest 100)

Date	Type	Submission	Title / Link
2025-08-01	Letter	ORIG-1	0
2025-08-01	Label	ORIG-1	0
2025-08-01	Medication Guide	ORIG-1	0

Change History (all loads)

Date	Table	Change	Key
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761428", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761428", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Orphan"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761428", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761428", "ProductNo": "003"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761428", "ProductNo": "002"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761428", "ProductNo": "001"}
2026-07-12	submissions	INSERT	{"ApplNo": "761428", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12	products	INSERT	{"ApplNo": "761428", "ProductNo": "003"}
2026-07-12	products	INSERT	{"ApplNo": "761428", "ProductNo": "002"}
2026-07-12	products	INSERT	{"ApplNo": "761428", "ProductNo": "001"}
2026-07-12	applications	INSERT	{"ApplNo": "761428"}