761449 — FRESENIUS KABI USA

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

761449

BLA FRESENIUS KABI USA

Products

#	Drug Name	Active Ingredient	Form	Strength	Marketing Status	TE Codes	Ref Drug	Ref Std
004	TYENNE	TOCILIZUMAB-AAZG	INJECTABLE;SUBCUTANEOUS	162MG/0.9ML	Prescription

Submissions

Type	#	Status	Date	Class	Review Priority	Notes
SUPPL	6	AP	2026-05-20	LABELING	STANDARD
SUPPL	1	AP	2025-05-12	LABELING	STANDARD
ORIG	1	AP	2025-03-14	UNKNOWN	STANDARD

Documents (latest 100)

Date	Type	Submission	Title / Link
2026-05-22	Medication Guide	SUPPL-6	0
2026-05-21	Label	SUPPL-6	0
2026-05-21	Letter	SUPPL-6	0
2026-05-07	Review	ORIG-1	0
2025-05-14	Letter	SUPPL-1	0
2025-05-12	Label	SUPPL-1	0
2025-03-18	Letter	ORIG-1	0
2025-03-17	Label	ORIG-1	0
2025-03-17	Medication Guide	ORIG-1	0

Change History (all loads)

Date	Table	Change	Key
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "19"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "18"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "19"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "18"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12	join_submission_action_types	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "14"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	submission_property_type	INSERT	{"ApplNo": "761449", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12	marketing_status	INSERT	{"ApplNo": "761449", "ProductNo": "004"}
2026-07-12	submissions	INSERT	{"ApplNo": "761449", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12	submissions	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12	submissions	INSERT	{"ApplNo": "761449", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12	products	INSERT	{"ApplNo": "761449", "ProductNo": "004"}
2026-07-12	applications	INSERT	{"ApplNo": "761449"}