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
Pancreaze	022523	005	351(a)	pancrelipase	Capsule, Delayed Release	Oral	2,600USP UNITS; 8,800USP UNITS; 15,200USP UNITS		2014/03/07	VIVUS LLC	Rx	Licensed	N/A	N/A
Myalept	125390	001	351(a)	metreleptin	For Injection	Subcutaneous	11.3MG	Single-Dose Vial	2014/02/24	Chiesi Farmaceutici S.p.A.	Rx	Licensed	N/A	N/A
Vimizim	125460	001	351(a)	elosulfase alfa	Injection	Intravenous	5MG/5ML (1MG/ML)	Single-Dose Vial	2014/02/14	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Gammaplex	125329	004	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	20G/400ML	Single-Dose Vial	2014/02/07	Bio Products Laboratory Limited	Disc	Licensed	N/A	N/A
Tretten	125398	001	351(a)	Coagulation Factor XIII A-Subunit (Recombinant)	For Injection	Intravenous	2000 - 3125IU	Single-Dose Vial	2013/12/23	Novo Nordisk Inc.	Rx	Licensed		N/A
Kcentra	125421	002	351(a)	Prothrombin Complex Concentrate (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	2013/11/26	CSL Behring GmbH	Rx	Licensed		N/A
Arepanrix	125419	001	351(a)	Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	Injection	Intramuscular	0.5ML	Vial	2013/11/22	ID Biomedical Corporation of Quebec	Disc	Licensed		N/A
Humulin N	018781	003	351(a)	insulin isophane human	Injectable Suspension	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2013/11/07	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Humulin 70/30	019717	003	351(a)	insulin isophane human and insulin human	Injectable Suspension	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Autoinjector	2013/11/07	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Gazyva	125486	001	351(a)	obinutuzumab	Injection	Intravenous	1,000MG/40ML (25MG/ML)	Single-Dose Vial	2013/11/01	Genentech, Inc.	Rx	Licensed	N/A	N/A
Novolog	020986	005	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2013/10/31	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Levemir	021536	005	351(a)	insulin detemir	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2013/10/31	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Actemra	125472	001	351(a)	tocilizumab	Injection	Subcutaneous	162MG/0.9ML	Pre-Filled Syringe	2013/10/21	Genentech, Inc.	Rx	Licensed	N/A	N/A
Novoeight	125466	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	3000IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoeight	125466	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoeight	125466	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1500IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoeight	125466	004	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoeight	125466	005	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoeight	125466	006	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Single-Dose Vial	2013/10/15	Novo Nordisk Inc.	Rx	Licensed		N/A
Flulaval, Flulaval Quadrivalent	125163	004	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2013/09/27	ID Biomedical Corporation of Quebec	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	-