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
Rebinyn	125611	003	351(a)	Coagulation Factor IX (Recombinant), GlycoPEGylated	For Injection	Intravenous	1000IU	Single-Dose Vial	2017/05/31	Novo Nordisk Inc.	Rx	Licensed		N/A
Zinbryta	761029	002	351(a)	daclizumab	Injection	Subcutaneous	150MG/ML	Autoinjector	2017/05/26	Biogen Inc.	Disc	Voluntarily Revoked	N/A	N/A
Kevzara	761037	001	351(a)	sarilumab	Injection	Subcutaneous	150MG/1.14ML	Pre-Filled Syringe	2017/05/22	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Kevzara	761037	002	351(a)	sarilumab	Injection	Subcutaneous	200MG/1.14ML	Pre-Filled Syringe	2017/05/22	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Imfinzi	761069	001	351(a)	durvalumab	Injection	Intravenous	500MG/10ML (50MG/ML)	Single-Dose Vial	2017/05/01	AstraZeneca UK Ltd	Rx	Licensed	N/A	N/A
Imfinzi	761069	002	351(a)	durvalumab	Injection	Intravenous	120MG/2.4ML (50MG/ML)	Single-Dose Vial	2017/05/01	AstraZeneca UK Ltd	Rx	Licensed	N/A	N/A
Humira	125057	010	351(a)	adalimumab	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2017/04/28	AbbVie Inc.	Rx	Licensed	N/A	N/A
Humira	125057	011	351(a)	adalimumab	Injection	Subcutaneous	10MG/0.1ML	Pre-Filled Syringe	2017/04/28	AbbVie Inc.	Rx	Licensed	N/A	N/A
Brineura	761052	001	351(a)	cerliponase alfa	Injection	Intraventricular	150MG/5ML (30MG/ML)	Single-Dose Vial	2017/04/27	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Humira	125057	009	351(a)	adalimumab	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2017/04/21	AbbVie Inc.	Rx	Licensed	N/A	N/A
Renflexis	761054	001	351(k) Biosimilar	infliximab-abda	For Injection	Intravenous	100MG	Single-Dose Vial	2017/04/21	Samsung Bioepis Co., Ltd.	Rx	Licensed	infliximab	Remicade
Afstyla	125591	006	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	2500IU	Single-Dose Vial	2017/03/31	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	007	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	1500IU	Single-Dose Vial	2017/03/31	CSL Behring Lengnau AG	Rx	Licensed		N/A
Orencia	125118	004	351(a)	abatacept	Injection	Subcutaneous	50MG/0.4ML	Pre-Filled Syringe	2017/03/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Orencia	125118	005	351(a)	abatacept	Injection	Subcutaneous	87.5MG/0.7ML	Pre-Filled Syringe	2017/03/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Ocrevus	761053	001	351(a)	ocrelizumab	Injection	Intravenous	300MG/10ML (30MG/ML)	Single-Dose Vial	2017/03/28	Genentech, Inc.	Rx	Licensed	N/A	N/A
Dupixent	761055	001	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2017/03/28	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Dupixent	761055	002	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2017/03/28	Regeneron Pharmaceuticals, Inc.	Disc	Licensed	N/A	N/A
Bavencio	761049	001	351(a)	avelumab	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2017/03/23	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Adynovate	125566	007	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	3000IU	Single-Dose Vial	2017/03/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		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	-