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
Tyruko	761322	001	351(k) Biosimilar	natalizumab-sztn	Injection	Intravenous	300MG/15ML (20MG/ML)	Single-Dose Vial	2023/08/24	Sandoz Inc.	Rx	Licensed	natalizumab	Tysabri
Veopoz	761339	001	351(a)	pozelimab-bbfg	Injection	Intravenous, Subcutaneous	400MG/2ML (200MG/ML)	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Eylea HD	761355	001	351(a)	aflibercept	Injection	Intravitreal	8MG/0.07ML	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	004	351(a)	omalizumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	005	351(a)	omalizumab	Injection	Subcutaneous	75MG/0.5ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	006	351(a)	omalizumab	Injection	Subcutaneous	150MG/ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	007	351(a)	omalizumab	Injection	Subcutaneous	300MG/2ML	Autoinjector	2023/08/17	Genentech, Inc.	Rx	Licensed	N/A	N/A
Amjevita	761024	009	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	005	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	006	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	007	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	008	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Elrexfio	761345	001	351(a)	elranatamab-bcmm	Injection	Subcutaneous	76MG/1.9ML (40MG/ML)	Single-Dose Vial	2023/08/14	Pfizer Inc.	Rx	Licensed	N/A	N/A
Elrexfio	761345	002	351(a)	elranatamab-bcmm	Injection	Subcutaneous	44MG/1.1ML (40MG/ML)	Single-Dose Vial	2023/08/14	Pfizer Inc.	Rx	Licensed	N/A	N/A
Talvey	761342	001	351(a)	talquetamab-tgvs	Injection	Subcutaneous	3MG/1.5ML (2MG/ML)	Single-Dose Vial	2023/08/09	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Talvey	761342	002	351(a)	talquetamab-tgvs	Injection	Subcutaneous	40MG/ML	Single-Dose Vial	2023/08/09	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Balfaxar	125776	001	351(a)	Prothrombin complex concentrate, human-lans	For Injection	Intravenous	500IU	Single-Dose Vial	2023/07/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed
Balfaxar	125776	002	351(a)	Prothrombin complex concentrate, human-lans	For Injection	Intravenous	1000IU	Single-Dose Vial	2023/07/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed
CYFENDUS	125761	001	351(a)	Anthrax Vaccine Adsorbed, Adjuvanted	Injection	Intramuscular	100UG/ML	Multi-Dose Vial	2023/07/20	Emergent Product Development Gaithersburg, Inc.	Rx	Licensed	N/A	N/A
Beyfortus	761328	001	351(a)	nirsevimab-alip	Injection	Intramuscular	50MG/0.5ML	Pre-Filled Syringe	2023/07/17	AstraZeneca AB	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	-