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
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
Tenivac	103171	001	351(a)	Tetanus and Diphtheria Toxoids Adsorbed	Injection	Intramuscular	5LF,2LF/.5ML	Pre-Filled Syringe	2003/11/03	Sanofi Pasteur Limited	Rx	Licensed	N/A	N/A
Tenivac	103171	002	351(a)	Tetanus and Diphtheria Toxoids Adsorbed	Injection	Intramuscular	5LF,2LF/.5ML	Single-Dose Vial	2003/11/03	Sanofi Pasteur Limited	Rx	Licensed		N/A
Raptiva	125075	001	351(a)	efalizumab	Injection	Subcutaneous	125MG	Single-Dose Vial	2003/10/27	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
BabyBig	125034	001	351(a)	Botulism Immune Globulin Intravenous (Human)	For Injection	Intravenous	100MG	Single-Dose Vial	2003/10/23	California Department of Public Health (CDPH)	Rx	Licensed		N/A
Fabrazyme	103979	002	351(a)	agalsidase beta	For Injection	Intravenous	5MG	Single-Dose Vial	2003/10/10	Genzyme Corporation	Rx	Licensed	N/A	N/A
Gammaked, Gamunex-C	125046	001	351(a)	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	Injection	Intravenous	2.5G	Single-Use Bottle	2003/08/27	Grifols Therapeutics LLC	Rx	Licensed		N/A
Gammaked, Gamunex-C	125046	002	351(a)	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	Injection	Intravenous	5G	Single-Use Bottle	2003/08/27	Grifols Therapeutics LLC	Rx	Licensed		N/A
Gammaked, Gamunex-C	125046	003	351(a)	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	Injection	Intravenous	10G	Single-Use Bottle	2003/08/27	Grifols Therapeutics LLC	Rx	Licensed		N/A
Gammaked, Gamunex-C	125046	004	351(a)	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	Injection	Intravenous	1G	Bottle	2003/08/27	Grifols Therapeutics LLC	Rx	Licensed		N/A
Gammaked, Gamunex-C	125046	005	351(a)	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	Injection	Intravenous	20G	Single-Use Bottle	2003/08/27	Grifols Therapeutics LLC	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	-