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
Xyntha, Xyntha Solofuse	125264	002	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	2000IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	003	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	1000IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	004	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	1000IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	005	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	250IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	006	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	250IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	007	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	500IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	008	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	500IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Accretropin	021538	001	351(a)	somatropin	Injection	Subcutaneous	5MG/ML	Multi-Dose Vial	2008/01/23	Emergent Biosolutions Canada Inc.	Disc	Voluntarily Revoked	N/A	N/A
Recothrom	125248	001	351(a)	Thrombin topical (Recombinant)	For Solution	Topical	5000IU	Single-Dose Vial	2008/01/17	Baxter Healthcare Corporation	Rx	Licensed		N/A
Omnitrope	021426	003	351(a)	somatropin	Injection	Subcutaneous	5MG/1.5ML	Multi-Dose Cartridge	2008/01/16	Sandoz Inc.	Rx	Licensed	N/A	N/A
Nutropin AQ	020522	003	351(a)	somatropin	Injection	Subcutaneous	5MG/2ML	Autoinjector	2008/01/03	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Nutropin AQ	020522	004	351(a)	somatropin	Injection	Subcutaneous	20MG/2ML	Autoinjector	2008/01/03	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Nutropin AQ	020522	005	351(a)	somatropin	Injection	Subcutaneous	10MG/2ML	Autoinjector	2008/01/03	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Nutropin AQ	020522	006	351(a)	somatropin	Injection	Subcutaneous	20MG/2ML	Multi-Dose Cartridge	2008/01/03	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Mircera	125164	002	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	50MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	003	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	75MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	004	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	100MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	006	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	150MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	007	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	200MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	Licensed	N/A	N/A
Mircera	125164	008	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	250MCG/0.3ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Rx	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	-