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
Yervoy	125377	002	351(a)	ipilimumab	Injection	Intravenous	200MG/40ML (5MG/ML)	Single-Dose Vial	2011/03/25	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
	125296	001	351(a)	Adenovirus Type 4 and Type 7 Vaccine, Live, Oral	Tablet	Oral	4.5LOG 10TCID	Bottle	2011/03/16	Teva Women's Health, Inc.	Rx	Licensed		N/A
Benlysta	125370	001	351(a)	belimumab	For Injection	Intravenous	120MG	Single-Dose Vial	2011/03/09	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Benlysta	125370	002	351(a)	belimumab	For Injection	Intravenous	400MG	Single-Dose Vial	2011/03/09	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Corifact	125385	001	351(a)	Factor XIII Concentrate (Human)	For Injection	Intravenous	1000-1600IU	Single-Dose Vial	2011/02/17	CSL Behring GmbH	Rx	Licensed		N/A
Thrombin-Jmi, Thrombocoll	102865	002	351(a)	Thrombin, Topical (Bovine)	Powder	Topical	5,000IU	Vial	2011/02/10	GenTrac, Inc.	Rx	Licensed		N/A
Wilate	125251	001	351(a)	von Willebrand Factor/Coagulation Factor VIII Complex (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2010/12/20	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Wilate	125251	002	351(a)	von Willebrand Factor/Coagulation Factor VIII Complex (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	2010/12/20	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Xgeva	125320	003	351(a)	denosumab	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2010/11/18	Amgen Inc.	Rx	Licensed	N/A	N/A
Egrifta	022505	001	351(a)	tesamorelin	For Injection	Subcutaneous	1MG	Single-Dose Vial	2010/11/10	Theratechnologies Inc.	Disc	Licensed	N/A	N/A
Krystexxa	125293	001	351(a)	pegloticase	Injection	Intravenous	8MG/ML	Single-Dose Vial	2010/09/14	Horizon Therapeutics Ireland DAC	Rx	Licensed	N/A	N/A
Novoseven, Novoseven Rt	103665	007	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	8.0MG	Single-Dose Vial	2010/08/06	Novo Nordisk Inc.	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	009	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	3000IU	Pre-Filled Syringe	2010/08/06	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xeomin	125360	001	351(a)	incobotulinumtoxinA	For Injection	Intramuscular, Intraglandular	50UNITS	Single-Dose Vial	2010/07/30	Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Xeomin	125360	002	351(a)	incobotulinumtoxinA	For Injection	Intramuscular, Intraglandular	100UNITS	Single-Dose Vial	2010/07/30	Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	006	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5G/50ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	007	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10G/100ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	008	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	20G/200ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Glassia	125325	001	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	1G	Single-Dose Vial	2010/07/01	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Prolia	125320	001	351(a)	denosumab	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2010/06/01	Amgen 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	-