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
Octagam	125062	007	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10% 5G	Single-Use Bottle	2014/07/11	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Octagam	125062	008	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10% 2G	Single-Use Bottle	2014/07/11	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Octagam	125062	009	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10% 10G	Single-Use Bottle	2014/07/11	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Afrezza	022472	001	351(a)	insulin human	Powder	Inhalation	4UNITS/INH	Single-Dose Cartridge	2014/06/27	Mannkind Corporation	Rx	Licensed	N/A	N/A
Afrezza	022472	002	351(a)	insulin human	Powder	Inhalation	8UNITS/INH	Single-Dose Cartridge	2014/06/27	Mannkind Corporation	Rx	Licensed	N/A	N/A
Alphanate	102475	005	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	2000IU	Single-Dose Vial	2014/06/26	Grifols Biologicals LLC	Rx	Licensed		N/A
Eloctate	125487	001	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	1500IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	002	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	1000IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	003	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	2000IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	004	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	3000IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	005	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	750IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	006	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	500IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	007	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	250IU	Single-Dose Vial	2014/06/06	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Evarrest	125392	003	351(a)	Fibrin Sealant Patch	Patch	Topical	55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 2x4 IN	Pouch	2014/05/27	Ethicon, Inc.	Rx	Licensed		N/A
Entyvio	125476	001	351(a)	vedolizumab	For Injection	Intravenous	300MG	Single-Dose Vial	2014/05/20	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Sylvant	125496	001	351(a)	siltuximab	For Injection	Intravenous	100MG	Single-Dose Vial	2014/04/23	Recordati Rare Diseases, Inc.	Rx	Licensed	N/A	N/A
Sylvant	125496	002	351(a)	siltuximab	For Injection	Intravenous	400MG	Single-Dose Vial	2014/04/23	Recordati Rare Diseases, Inc.	Rx	Licensed	N/A	N/A
Cyramza	125477	001	351(a)	ramucirumab	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2014/04/21	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Cyramza	125477	002	351(a)	ramucirumab	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2014/04/21	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Ragwitek	125478	001	351(a)	Short Ragweed Pollen Allergen Extract	Tablet	Sublingual	12 AMB A 1-UNITS/Tablet	Blister Pack	2014/04/17	ALK - Abello A/S	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	-