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
Rhophylac	125070	002	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	1500IU/ML	Pre-Filled Syringe	2004/02/12	CSL Behring AG	Rx	Licensed		N/A
Erbitux	125084	001	351(a)	cetuximab	Injection	Intravenous	100MG/50ML (2MG/ML)	Single-Dose Vial	2004/02/12	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Pegasys	103964	002	351(a)	peginterferon alfa-2a	Injection	Subcutaneous	180MCG/0.5ML	Pre-Filled Syringe	2004/01/07	pharmaand GmbH	Rx	Licensed	N/A	N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	001	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	0.5G/10ML	Single-Dose Vial	2003/12/15	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	002	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	2003/12/15	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	003	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5G/100ML	Single-Dose Vial	2003/12/15	Instituto Grifols, S.A.	Rx	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	004	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10G/200ML	Single-Dose Vial	2003/12/15	Instituto Grifols, S.A.	Rx	Licensed		N/A
Aranesp	103951	020	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	25MCG/0.42ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	021	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	25MCG/0.42ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	022	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	40MCG/0.4ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	023	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	40MCG/0.4ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	024	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	60MCG/0.3ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	025	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	100MCG/0.5ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	026	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	150MCG/0.3ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	027	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	200MCG/0.4ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	028	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	300MCG/0.6ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	029	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	500MCG/1ML	Pre-Filled Syringe	2003/12/12	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	030	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	150MCG/0.75ML	Single-Dose Vial	2003/12/12	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	031	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	300MCG/1ML	Single-Dose Vial	2003/12/12	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	032	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	500MCG/1ML	Single-Dose Vial	2003/12/12	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	-