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
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
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

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	-