美国FDA生物制品紫皮书数据库（U.S. FDA Purple Book: Database of Licensed Biological Products）- 药物在线

商品名	申请号	产品号	BLA类型	非专利名称	剂型	给药途径	规格/剂量	产品形式	批准日期	申请人	市场状态	许可证状态	参考产品非专利名称	参考产品专利名称
Yartemlea	761152	001	351(a)	narsoplimab-wuug	Injection	Intravenous	370MG/2ML	Single-Dose Vial	2025/12/23	Omeros Corporation	Rx	Licensed	N/A	N/A
Lunsumio Velo	761263	003	351(a)	mosunetuzumab-axgb	Injection	Subcutaneous	5MG/0.5ML	Single-Dose Vial	2025/12/19	Genentech, Inc.	Rx	Licensed	N/A	N/A
Lunsumio Velo	761263	004	351(a)	mosunetuzumab-axgb	Injection	Subcutaneous	45MG/ML	Single-Dose Vial	2025/12/19	Genentech, Inc.	Rx	Licensed	N/A	N/A
Boncresa	761456	001	351(k) Interchangeable	denosumab-mobz	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/12/19	Amneal Pharmaceuticals LLC	Rx	Licensed	denosumab	Prolia
Oziltus	761457	001	351(k) Interchangeable	denosumab-mobz	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/12/19	Amneal Pharmaceuticals LLC	Rx	Licensed	denosumab	Xgeva
Nufymco	761473	001	351(k) Interchangeable	ranibizumab-leyk	Injection	Intravitreal	10MG/ML (0.5MG/0.05ML)	Single-Dose Vial	2025/12/18	Formycon AG	Rx	Licensed	ranibizumab	Lucentis
Nufymco	761473	002	351(k) Interchangeable	ranibizumab-leyk	Injection	Intravitreal	6MG/ML (0.3MG/0.05ML)	Single-Dose Vial	2025/12/18	Formycon AG	Rx	Licensed	ranibizumab	Lucentis
FESILTY	125833	001	351(a)	fibrinogen, human–chmt	For Injection	Intravenous	1G/50ML	Single-Dose Vial	2025/12/16	Grifols Therapeutics, LLC	Rx	Licensed	N/A	N/A
Exdensur	761458	001	351(a)	depemokimab-ulaa	Injection	Subcutaneous	100MG/ML	Autoinjector	2025/12/16	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Exdensur	761458	002	351(a)	depemokimab-ulaa	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2025/12/16	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Lerochol	761427	001	351(a)	lerodalcibep-liga	Injection	Subcutaneous	300MG/1.2ML (250MG/ML)	Pre-Filled Syringe	2025/12/12	LIB Therapeutics, Inc.	Rx	Licensed	N/A	N/A
waskyra	125846	001	351(a)	etuvetidigene autotemcel	Solution	Intravenous	1.9-11.4x10^6CD34+ CELLS/ML	Bag	2025/12/09	Fondazione Telethon Ets	Rx	Licensed	N/A	N/A
avance nerve graft	125816	001	351(a)	acellular nerve allograft-arwx	Implant	Implantation	1•LENGTHS: 15 MM, 30 MM, 50 MM, AND 70 MM •DIAMETERS: 1 TO 2 MM, 2 TO 3 MM, 3	Pouch	2025/12/03	Axogen Corporation	Rx	Licensed	N/A	N/A
Omlyclo	761399	003	351(k) Interchangeable	omalizumab-igec	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Pre-Filled Syringe	2025/12/01	CELLTRION, Inc.	Rx	Licensed	omalizumab	Xolair
Armlupeg	761212	001	351(k) Biosimilar	pegfilgrastim-unne	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2025/11/28	Lupin Limited (Biotech Division)	Rx	Licensed	pegfilgrastim	Neulasta
Voyxact	761434	001	351(a)	sibeprenlimab-szsi	Injection	Subcutaneous	400MG/2ML (200MG/ML)	Pre-Filled Syringe	2025/11/25	Otsuka Pharmaceutical Company, Ltd.	Rx	Licensed	N/A	N/A
ITVISMA	125856	001	351(a)	onasemnogene abeparvovec-brve	Injection	Intrathecal	4x10^13VG/ML	Single-Dose Vial	2025/11/24	Novartis Gene Therapies, Inc.	Rx	Licensed		N/A
Opdivo Qvantig	761381	002	351(a)	nivolumab and hyaluronidase-nvhy	Injection	Subcutaneous	300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2025/11/24	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Poherdy	761450	001	351(k) Interchangeable	pertuzumab-dpzb	Injection	Intravenous	420MG/14ML (30MG/ML)	Single-Dose Vial	2025/11/13	Shanghai Henlius Biotech, Inc.	Rx	Licensed	pertuzumab	Perjeta
Osvyrti	761424	001	351(k) Interchangeable	denosumab-desu	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/10/29	Accord BioPharma Inc.	Rx	Licensed	denosumab	Prolia

药品商品名或专利药名Proprietary (Brand) Name
药品通用名或非专利名称Nonproprietary (Proper) Name
药品申请号BLA Number
产品号Product Number
剂型Dosage Form
给药途径Route of Administration
产品形式Product Presentation
药品规格或剂量Strength
药品注册申请人Applicant
参考产品非专利名称Reference Product Proper Name
参考产品专利名称Reference Product Proprietary Name
BLA类型BLA Type
药品的市场状态Marketing Status
许可证号License Number
许可证状态Licensure
产品批准日期Approval Date	-