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
Nucala	761122	002	351(a)	mepolizumab	Injection	Subcutaneous	100MG/ML	Autoinjector	2019/06/06	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Nucala	761122	003	351(a)	mepolizumab	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2019/06/06	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Emgality	761063	003	351(a)	galcanezumab-gnlm	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2019/06/04	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Zolgensma	125694	001	351(a)	onasemnogene abeparvovec-xioi	Injection	Intravenous	2x10^13VG/ML	Single-Dose Vial	2019/05/24	Novartis Gene Therapies, Inc.	Rx	Licensed		N/A
Herzuma	761091	002	351(k) Biosimilar	trastuzumab-pkrb	For injection	Intravenous	150MG	Single-Dose Vial	2019/05/16	CELLTRION, Inc.	Rx	Licensed	trastuzumab	Herceptin
Dengvaxia	125682	001	351(a)	Dengue Tetravalent Vaccine, Live	For Injection	Subcutaneous	4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50	Single-Dose Vial	2019/05/01	Sanofi Pasteur Inc.	Rx	Licensed		N/A
Eticovo	761066	001	351(k) Interchangeable	etanercept-ykro	Injection	Subcutaneous	50MG/ML	Pre-Filled Syringe	2019/04/25	Samsung Bioepis Co., Ltd.	Disc	Licensed	etanercept	Enbrel
Eticovo	761066	002	351(k) Interchangeable	etanercept-ykro	Injection	Subcutaneous	25MG/0.5ML	Pre-Filled Syringe	2019/04/25	Samsung Bioepis Co., Ltd.	Disc	Licensed	etanercept	Enbrel
Skyrizi	761105	001	351(a)	risankizumab-rzaa	Injection	Subcutaneous	75MG/0.83ML	Pre-Filled Syringe	2019/04/23	AbbVie Inc.	Disc	Licensed	N/A	N/A
Ogivri	761074	002	351(k) Biosimilar	trastuzumab-dkst	For Injection	Intravenous	150MG	Single-Dose Vial	2019/04/17	Biocon Biologics Inc.	Rx	Licensed	trastuzumab	Herceptin
Zemaira	125078	002	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	4000MG	Single-Dose Vial	2019/04/16	CSL Behring LLC	Rx	Licensed		N/A
Zemaira	125078	003	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	5000MG	Single-Dose Vial	2019/04/16	CSL Behring LLC	Rx	Licensed		N/A
Evenity	761062	001	351(a)	romosozumab-aqqg	Injection	Subcutaneous	105MG/1.17ML	Pre-Filled Syringe	2019/04/09	Amgen Inc.	Rx	Licensed	N/A	N/A
Asceniv	125590	001	351(a)	Immune Globulin Intravenous, Human-slra	Injection	Intravenous	5G/50ML	Single-Dose Vial	2019/04/01	ADMA Biologics, Inc.	Rx	Licensed		N/A
Cimzia	125160	002	351(a)	certolizumab pegol	Injection	Subcutaneous	200MG/ML	Pre-Filled Syringe	2019/03/28	UCB, Inc.	Rx	Licensed	N/A	N/A
Aimovig	761077	003	351(a)	erenumab-aooe	Injection	Subcutaneous	140MG/ML	Autoinjector	2019/03/11	Amgen Inc.	Rx	Licensed	N/A	N/A
Aimovig	761077	004	351(a)	erenumab-aooe	Injection	Subcutaneous	140MG/ML	Pre-Filled Syringe	2019/03/11	Amgen Inc.	Disc	Licensed	N/A	N/A
Trazimera	761081	001	351(k) Biosimilar	trastuzumab-qyyp	For Injection	Intravenous	420MG	Multi-Dose Vial	2019/03/11	Pfizer Ireland Pharmaceuticals	Rx	Licensed	trastuzumab	Herceptin
Tecentriq	761034	002	351(a)	atezolizumab	Injection	Intravenous	840MG/14ML (60MG/ML)	Single-Dose Vial	2019/03/08	Genentech, Inc.	Rx	Licensed	N/A	N/A
Herceptin Hylecta	761106	001	351(a)	trastuzumab and hyaluronidase-oysk	Injection	Subcutaneous	600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2019/02/28	Genentech, 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	-