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
Alprolix	125444	005	351(a)	Coagulation Factor IX (Recombinant), Fc Fusion Protein	For Injection	Intravenous	250IU	Single-Dose Vial	2016/02/18	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
	125585	001	351(a)	HPC, Cord Blood	Injection	Intravenous	5X10^8 NUCLEATED CELLS CONTENT WITH 85% VIABILITY & 1.25X10^6 VIABLE CD34+ CELLS (PRE-CRYOPRESERVATION)	Bag	2016/01/28	Bloodworks	Rx	Licensed		N/A
Humulin R U-500	018780	002	351(a)	insulin human	Injection	Subcutaneous	1,500UNITS/3ML (500UNITS/ML)	Autoinjector	2015/12/29	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Ixinity	125426	004	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	2015/12/21	Medexus Pharma, Inc.	Disc	Licensed		N/A
Ixinity	125426	005	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	3000IU	Single-Dose Vial	2015/12/21	Medexus Pharma, Inc.	Rx	Licensed		N/A
Ixinity	125426	006	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2015/12/21	Medexus Pharma, Inc.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	017	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	15000IU	Vial	2015/12/18	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	018	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	15000IU	Vial	2015/12/18	Kamada Ltd.	Disc	Licensed		N/A
Basaglar	205692	001	351(a)	insulin glargine	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2015/12/16	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Kanuma	125561	001	351(a)	sebelipase alfa	Injection	Intravenous	20MG/10ML (2MG/ML)	Single-Dose Vial	2015/12/08	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Vonvendi	125577	001	351(a)	von Willebrand factor (Recombinant)	For Injection	Intravenous	1300IU	Single-Dose Vial	2015/12/08	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Vonvendi	125577	002	351(a)	von Willebrand factor (Recombinant)	For Injection	Intravenous	650IU	Single-Dose Vial	2015/12/08	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Empliciti	761035	001	351(a)	elotuzumab	For Injection	Intravenous	300MG	Single-Dose Vial	2015/11/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Empliciti	761035	002	351(a)	elotuzumab	For Injection	Intravenous	400MG	Single-Dose Vial	2015/11/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Fluad	125510	001	351(a)	Influenza Vaccine, Adjuvanted	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2015/11/24	Seqirus Inc.	Disc	Licensed		N/A
Portrazza	125547	001	351(a)	necitumumab	Injection	Intravenous	800MG/50ML (16MG/ML)	Single-Dose Vial	2015/11/24	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Humira	125057	006	351(a)	adalimumab	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2015/11/23	AbbVie Inc.	Rx	Licensed	N/A	N/A
Xeomin	125360	003	351(a)	incobotulinumtoxinA	For Injection	Intramuscular, Intraglandular	200UNITS	Single-Dose Vial	2015/11/20	Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Darzalex	761036	001	351(a)	daratumumab	Injection	Intravenous	100MG/5ML	Single-Dose Vial	2015/11/16	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Darzalex	761036	002	351(a)	daratumumab	Injection	Intravenous	400MG/20ML	Single-Dose Vial	2015/11/16	Janssen Biotech, 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	-