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
Kovaltry	125574	001	351(a)	Antihemophilic Factor (Recombinant), Full Length	For Injection	Intravenous	1000IU	Single-Dose Vial	2016/03/16	Bayer HealthCare LLC	Rx	Licensed		N/A
Kovaltry	125574	002	351(a)	Antihemophilic Factor (Recombinant), Full Length	For Injection	Intravenous	250IU	Single-Dose Vial	2016/03/16	Bayer HealthCare LLC	Rx	Licensed		N/A
Kovaltry	125574	003	351(a)	Antihemophilic Factor (Recombinant), Full Length	For Injection	Intravenous	2000IU	Single-Dose Vial	2016/03/16	Bayer HealthCare LLC	Rx	Licensed		N/A
Kovaltry	125574	004	351(a)	Antihemophilic Factor (Recombinant), Full Length	For Injection	Intravenous	3000IU	Single-Dose Vial	2016/03/16	Bayer HealthCare LLC	Rx	Licensed		N/A
Kovaltry	125574	005	351(a)	Antihemophilic Factor (Recombinant), Full Length	For Injection	Intravenous	500IU	Single-Dose Vial	2016/03/16	Bayer HealthCare LLC	Rx	Licensed		N/A
Humira	125057	007	351(a)	adalimumab	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2016/03/09	AbbVie Inc.	Rx	Licensed	N/A	N/A
Idelvion	125582	001	351(a)	Coagulation Factor IX (Recombinant), Albumin Fusion Protein	For Injection	Intravenous	500IU	Single-Dose Vial	2016/03/04	CSL Behring Lengnau AG	Rx	Licensed		N/A
Idelvion	125582	002	351(a)	Coagulation Factor IX (Recombinant), Albumin Fusion Protein	For Injection	Intravenous	1000IU	Single-Dose Vial	2016/03/04	CSL Behring Lengnau AG	Rx	Licensed		N/A
Idelvion	125582	003	351(a)	Coagulation Factor IX (Recombinant), Albumin Fusion Protein	For Injection	Intravenous	2000IU	Single-Dose Vial	2016/03/04	CSL Behring Lengnau AG	Rx	Licensed		N/A
Idelvion	125582	004	351(a)	Coagulation Factor IX (Recombinant), Albumin Fusion Protein	For Injection	Intravenous	250IU	Single-Dose Vial	2016/03/04	CSL Behring Lengnau AG	Rx	Licensed		N/A
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

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	-