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
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
Shingrix	125614	001	351(a)	Zoster Vaccine Recombinant, Adjuvanted	Injection	Intramuscular	0.5ML	Single-Dose Vial	2017/10/20	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Yescarta	125643	001	351(a)	axicabtagene ciloleucel	Injection	Intravenous	2 × 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT	Bag	2017/10/18	Kite Pharma, Inc.	Rx	Licensed		N/A
Opdivo	125554	003	351(a)	nivolumab	Injection	Intravenous	240MG/24ML (10MG/ML)	Single-Dose Vial	2017/10/04	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Fiasp	208751	001	351(a)	insulin aspart	Injection	Intravenous, Subcutaneous	1000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2017/09/29	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Fiasp	208751	002	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2017/09/29	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Enbrel Mini	103795	005	351(a)	etanercept	Injection	Subcutaneous	50MG/ML	Single-Dose Cartridge	2017/09/14	Immunex Corporation	Rx	Licensed	N/A	N/A
Mvasi	761028	001	351(k) Biosimilar	bevacizumab-awwb	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2017/09/14	Amgen Inc.	Rx	Licensed	bevacizumab	Avastin
Mvasi	761028	002	351(k) Biosimilar	bevacizumab-awwb	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2017/09/14	Amgen Inc.	Rx	Licensed	bevacizumab	Avastin
prolastin,prolastin-c,prolastin-c liquid	103174	003	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	1000MG/20ML	Single-Dose Vial	2017/09/08	Grifols Therapeutics LLC	Rx	Licensed		N/A
Mylotarg	761060	001	351(a)	gemtuzumab ozogamicin	For Injection	Intravenous	4.5MG	Single-Dose Vial	2017/09/01	Wyeth Pharmaceuticals LLC	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	-