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
Plegridy	125499	001	351(a)	peginterferon beta-1a	Injection	Subcutaneous	125MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	002	351(a)	peginterferon beta-1a	Injection	Subcutaneous	63MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	003	351(a)	peginterferon beta-1a	Injection	Subcutaneous	94MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	004	351(a)	peginterferon beta-1a	Injection	Subcutaneous, Intramuscular	125MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	005	351(a)	peginterferon beta-1a	Injection	Subcutaneous	63MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	006	351(a)	peginterferon beta-1a	Injection	Subcutaneous	94MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Somavert	021106	004	351(a)	pegvisomant	For Injection	Subcutaneous	25MG	Single-Dose Vial	2014/07/31	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Somavert	021106	005	351(a)	pegvisomant	For Injection	Subcutaneous	30MG	Single-Dose Vial	2014/07/31	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Ruconest	125495	001	351(a)	C1 Esterase Inhibitor (Recombinant)	For Injection	Intravenous	2100IU	Single-Dose Vial	2014/07/16	Pharming Americas BV	Rx	Licensed		N/A
Octagam	125062	006	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10% 20G	Single-Use Bottle	2014/07/11	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
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

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	-