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
Erbitux	125084	002	351(a)	cetuximab	Injection	Intravenous	200MG/100ML (2MG/ML)	Single-Dose Vial	2007/03/28	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Octagam	125062	005	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5% 25G	Single-Use Bottle	2007/03/26	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Benefix	103677	004	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	2000IU/ML	Single-Dose Vial	2007/03/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Soliris	125166	001	351(a)	eculizumab	Injection	Intravenous	300MG/30ML (10MG/ML)	Single-Dose Vial	2007/03/16	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Enbrel	103795	004	351(a)	etanercept	Injection	Subcutaneous	25MG/0.5ML	Pre-Filled Syringe	2007/02/01	Immunex Corporation	Rx	Licensed	N/A	N/A
Saizen	019764	005	351(a)	somatropin	For Injection	Subcutaneous	4MG	Single-Dose Vial	2007/01/16	EMD Serono, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	005	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	20G/400ML	Single-Dose Vial	2006/12/21	Instituto Grifols, S.A.	Rx	Licensed		N/A
	125154	001	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/250ML	Single-Use Bottle	2006/10/17	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
	125154	002	351(a)	Albumin (Human)	Injection	Intravenous	5G/100ML	Single-Use Bottle	2006/10/17	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
	125154	004	351(a)	Albumin (Human)	Injection	Intravenous	25G/100ML	Single-Use Bottle	2006/10/17	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
	125154	005	351(a)	Albumin (Human)	Injection	Intravenous	25G/500ML	Single-Use Bottle	2006/10/17	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
	125154	007	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Use Bottle	2006/10/17	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Flulaval, Flulaval Quadrivalent	125163	001	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Multi-Dose Vial	2006/10/05	ID Biomedical Corporation of Quebec	Rx	Licensed		N/A
Vectibix	125147	001	351(a)	panitumumab	Injection	Intravenous	100MG/5ML (20MG/ML)	Single-Dose Vial	2006/09/27	Amgen Inc.	Rx	Licensed	N/A	N/A
Vectibix	125147	002	351(a)	panitumumab	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2006/09/27	Amgen Inc.	Rx	Licensed	N/A	N/A
Vectibix	125147	003	351(a)	panitumumab	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2006/09/27	Amgen Inc.	Disc	Licensed	N/A	N/A
Tisseel	103980	002	351(a)	Fibrin Sealant (Tisseel)	Solution	Topical	86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin	Pre-Filled Syringe	2006/07/27	Baxter Healthcare Corporation	Rx	Licensed		N/A
Elaprase	125151	001	351(a)	idursulfase	Injection	Intravenous	6MG/3ML (2MG/ML)	Single-Dose Vial	2006/07/24	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Lucentis	125156	001	351(a)	ranibizumab	Injection	Intravitreal	10MG/ML (0.5MG/0.05ML)	Single-Dose Vial	2006/06/30	Genentech, Inc.	Disc*	Licensed	N/A	N/A
Aranesp	103951	033	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	25MCG/0.42ML	Autoinjector	2006/06/29	Amgen Inc.	Disc	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	-