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
Toujeo	206538	002	351(a)	insulin glargine	Injection	Subcutaneous	900UNITS/3ML (300UNITS/ML)	Autoinjector	2018/03/26	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Lucentis	125156	004	351(a)	ranibizumab	Injection	Intravitreal	6MG/ML (0.3MG/0.05ML)	Pre-Filled Syringe	2018/03/20	Genentech, Inc.	Rx	Licensed	N/A	N/A
Ilumya	761067	001	351(a)	tildrakizumab-asmn	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2018/03/20	Sun Pharmaceutical Industries Limited	Rx	Licensed	N/A	N/A
Trogarzo	761065	001	351(a)	ibalizumab-uiyk	Injection	Intravenous	200MG/1.33ML (150MG/ML)	Single-Dose Vial	2018/03/06	Theratechnologies Inc.	Rx	Licensed	N/A	N/A
Luxturna	125610	001	351(a)	Voretigene Neparvovec	Injection	Intraocular	1.5X10 TO 11 ML	Single-Dose Vial	2017/12/19	Spark Therapeutics, Inc.	Rx	Licensed		N/A
Ixifi	761072	001	351(k) Biosimilar	infliximab-qbtx	For Injection	Intravenous	100MG	Single-Dose Vial	2017/12/13	Pfizer Ireland Pharmaceuticals	Disc	Licensed	infliximab	Remicade
Admelog	209196	001	351(a)	insulin lispro	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2017/12/11	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Admelog	209196	002	351(a)	insulin lispro	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2017/12/11	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Ogivri	761074	001	351(k) Biosimilar	trastuzumab-dkst	For Injection	Intravenous	420MG	Multi-Dose Vial	2017/12/01	Biocon Biologics Inc.	Rx	Licensed	trastuzumab	Herceptin
Hemlibra	761083	001	351(a)	emicizumab-kxwh	Injection	Subcutaneous	30MG/ML	Single-Dose Vial	2017/11/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Hemlibra	761083	002	351(a)	emicizumab-kxwh	Injection	Subcutaneous	60MG/0.4ML	Single-Dose Vial	2017/11/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Hemlibra	761083	003	351(a)	emicizumab-kxwh	Injection	Subcutaneous	105MG/0.7ML	Single-Dose Vial	2017/11/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Hemlibra	761083	004	351(a)	emicizumab-kxwh	Injection	Subcutaneous	150MG/ML	Single-Dose Vial	2017/11/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Mepsevii	761047	001	351(a)	vestronidase alfa-vjbk	Injection	Intravenous	10MG/5ML (2MG/ML)	Single-Dose Vial	2017/11/15	Ultragenyx Pharamceutical Inc.	Rx	Licensed	N/A	N/A
Fasenra	761070	001	351(a)	benralizumab	Injection	Subcutaneous	30MG/ML	Pre-Filled Syringe	2017/11/14	AstraZeneca AB	Rx	Licensed	N/A	N/A
Heplisav-B	125428	001	351(a)	Hepatitis B Vaccine (Recombinant), Adjuvanted	Injection	Intramuscular	20UG/.5ML	Single-Dose Vial	2017/11/09	Dynavax Technologies Corporation	Rx	Licensed		N/A
Vistaseal	125640	001	351(a)	Fibrin Sealant (Human)	Frozen	Topical	10ML	Pre-Filled Syringe	2017/11/01	Instituto Grifols, S.A.	Rx	Licensed		N/A
Vistaseal	125640	002	351(a)	Fibrin Sealant (Human)	Frozen	Topical	2ML	Pre-Filled Syringe	2017/11/01	Instituto Grifols, S.A.	Rx	Licensed		N/A
Vistaseal	125640	003	351(a)	Fibrin Sealant (Human)	Frozen	Topical	4ML	Pre-Filled Syringe	2017/11/01	Instituto Grifols, S.A.	Rx	Licensed		N/A
Vistaseal	125640	004	351(a)	Fibrin Sealant (Human)	Frozen	Topical	6ML	Pre-Filled Syringe	2017/11/01	Instituto Grifols, S.A.	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	-