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	006	351(a)	Coagulation Factor IX (Recombinant), Fc Fusion Protein	For Injection	Intravenous	4000IU	Single-Dose Vial	2016/07/14	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Repatha	125522	003	351(a)	evolocumab	Injection	Subcutaneous	420MG/3.5ML	Autoinjector	2016/07/08	Amgen Inc.	Disc	Licensed	N/A	N/A
Vaxchora	125597	001	351(a)	Cholera Vaccine, Live, Oral	Suspension	Oral	100ML	Packet	2016/06/10	Bavarian Nordic A/S	Rx	Licensed		N/A
Orencia	125118	003	351(a)	abatacept	Injection	Subcutaneous	125MG/ML	Autoinjector	2016/06/07	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Zinbryta	761029	001	351(a)	daclizumab	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2016/05/27	Biogen Inc.	Disc	Voluntarily Revoked	N/A	N/A
Afstyla	125591	001	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	3000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	002	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	1000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	003	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	250IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	004	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	2000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	005	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	500IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Flucelvax, Flucelvax Quadrivalent	125408	002	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2016/05/23	Seqirus Inc.	Disc	Licensed		N/A
Tecentriq	761034	001	351(a)	atezolizumab	Injection	Intravenous	1,200MG/20ML (60MG/ML)	Single-Dose Vial	2016/05/18	Genentech, Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	001	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	30MCG/0.3ML	Pre-Filled Syringe	2016/04/28	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	005	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	120MCG/0.3ML	Pre-Filled Syringe	2016/04/28	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	009	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	360MCG/0.6ML	Pre-Filled Syringe	2016/04/28	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Inflectra	125544	001	351(k) Biosimilar	infliximab-dyyb	For Injection	Intravenous	100MG	Single-Dose Vial	2016/04/05	CELLTRION, Inc.	Rx	Licensed	infliximab	Remicade
Cinqair	761033	001	351(a)	reslizumab	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2016/03/23	Teva Respiratory, LLC	Rx	Licensed	N/A	N/A
Taltz	125521	001	351(a)	ixekizumab	Injection	Subcutaneous	80MG/ML	Autoinjector	2016/03/22	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Taltz	125521	002	351(a)	ixekizumab	Injection	Subcutaneous	80MG/ML	Pre-Filled Syringe	2016/03/22	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Anthim	125509	001	351(a)	obiltoxaximab	Injection	Intravenous	600MG/6ML (100MG/ML)	Single-Dose Vial	2016/03/18	Elusys 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	-