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
Amjevita	761024	004	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2023/04/06	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Xenpozyme	761261	002	351(a)	olipudase alfa-rpcp	For Injection	Intravenous	4MG	Single-Dose Vial	2023/03/31	Genzyme Corporation	Rx	Licensed	N/A	N/A
Skyrizi	761105	006	351(a)	risankizumab-rzaa	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2023/03/22	AbbVie Inc.	Rx	Licensed	N/A	N/A
Zynyz	761334	001	351(a)	retifanlimab-dlwr	Injection	Intravenous	500MG/20ML (25MG/ML)	Single-Dose Vial	2023/03/22	Incyte Corporation	Rx	Licensed	N/A	N/A
Hyrimoz	761071	004	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	005	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	006	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	007	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	008	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	009	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	10MG/0.1ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	010	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hemlibra	761083	005	351(a)	emicizumab-kxwh	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Single-Dose Vial	2023/03/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Udenyca	761039	002	351(k) Biosimilar	pegfilgrastim-cbqv	Injection	Subcutaneous	6MG/0.6ML	Autoinjector	2023/03/03	Accord BioPharma Inc.	Rx	Licensed	pegfilgrastim	Neulasta
M-M-R Ii	101069	002	351(a)	Measles, Mumps and Rubella Virus Vaccine Live	For Injection	Intramuscular	0.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Varivax	103552	002	351(a)	Varicella Virus Vaccine Live	For Injection	Intramuscular	NLT 1350PFU/.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Proquad	125108	002	351(a)	Measles, Mumps, Rubella and Varicella Virus Vaccine Live	For Injection	Intramuscular	0.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Yusimry	761216	002	351(k) Biosimilar	adalimumab-aqvh	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2023/02/27	Hong Kong King-Friend Industrial Company Limited	Rx	Licensed	adalimumab	Humira
ALTUVIIIO	125771	001	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	250IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed	N/A	N/A
ALTUVIIIO	125771	002	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	500IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed	N/A	N/A
ALTUVIIIO	125771	003	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	750IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed	N/A	N/A

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	-