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
Strensiq	125513	004	351(a)	asfotase alfa	Injection	Subcutaneous	80MG/0.8ML	Single-Dose Vial	2015/10/23	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Coagadex	125506	001	351(a)	Coagulation Factor X (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2015/10/20	Bio Products Laboratory Limited	Rx	Licensed		N/A
Coagadex	125506	002	351(a)	Coagulation Factor X (Human)	For Injection	Intravenous	250IU	Single-Dose Vial	2015/10/20	Bio Products Laboratory Limited	Rx	Licensed		N/A
Praxbind	761025	001	351(a)	idarucizumab	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	2015/10/16	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Ryzodeg 70/30	203313	001	351(a)	insulin degludec and insulin aspart	Injection	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNIT/3ML (30UNITS/ML)	Autoinjector	2015/09/25	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Tresiba	203314	001	351(a)	insulin degludec	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2015/09/25	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Tresiba	203314	002	351(a)	insulin degludec	Injection	Subcutaneous	600UNITS/3ML (200UNITS/ML)	Autoinjector	2015/09/25	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Nuwiq	125555	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Vial	2015/09/04	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Nuwiq	125555	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Vial	2015/09/04	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Nuwiq	125555	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	2015/09/04	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Nuwiq	125555	004	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2015/09/04	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Repatha	125522	001	351(a)	evolocumab	Injection	Subcutaneous	140MG/ML	Pre-Filled Syringe	2015/08/27	Amgen Inc.	Rx	Licensed	N/A	N/A
Repatha	125522	002	351(a)	evolocumab	Injection	Subcutaneous	140MG/ML	Autoinjector	2015/08/27	Amgen Inc.	Disc	Licensed	N/A	N/A
Praluent	125559	001	351(a)	alirocumab	Injection	Subcutaneous	75MG/ML	Autoinjector	2015/07/24	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Praluent	125559	002	351(a)	alirocumab	Injection	Subcutaneous	150MG/ML	Autoinjector	2015/07/24	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Praluent	125559	003	351(a)	alirocumab	Injection	Subcutaneous	75MG/ML	Pre-Filled Syringe	2015/07/24	Regeneron Pharmaceuticals, Inc.	Disc	Licensed	N/A	N/A
Praluent	125559	004	351(a)	alirocumab	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2015/07/24	Regeneron Pharmaceuticals, Inc.	Disc	Licensed	N/A	N/A
Humalog	205747	001	351(a)	insulin lispro	Injection	Subcutaneous	600UNITS/3ML (200UNITS/ML)	Autoinjector	2015/05/26	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Anavip	125488	001	351(a)	Crotalidae Immune F(ab')2 (Equine)	For Injection	Intravenous	MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL	Single-Dose Vial	2015/05/06	Rare Disease Therapeutics, Inc. (RDT)	Rx	Licensed		N/A
Raplixa	125523	001	351(a)	Fibrin Sealant (Human)	Powder	Topical	0.5G	Vial	2015/04/30	Mallinckrodt Pharma IP Trading DAC	Disc	Voluntarily Revoked

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	-