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
Mircera	125164	010	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	50MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	011	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	100MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	012	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	200MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	013	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	300MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	014	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	400MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	015	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	600MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	016	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	1,000MCG/ML	Single-Dose Vial	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	017	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	400MCG/0.6ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	018	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	600MCG/0.6ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Mircera	125164	019	351(a)	methoxy polyethylene glycol-epoetin beta	Injection	Intravenous, Subcutaneous	800MCG/0.6ML	Pre-Filled Syringe	2007/11/14	Vifor (International) Inc.	Disc	Licensed	N/A	N/A
Afluria, Afluria Quadrivalent	125254	001	351(a)	Influenza Vaccine	Injection	Intramuscular	225UG	Multi-Dose Vial	2007/09/28	Seqirus Pty Ltd.	Rx	Licensed		N/A
Afluria, Afluria Quadrivalent	125254	002	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Syringe	2007/09/28	Seqirus Pty Ltd.	Rx	Licensed		N/A
	125154	003	351(a)	Albumin (Human)	Injection	Intravenous	10G/50ML	Single-Use Bottle	2007/09/27	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
	125154	006	351(a)	Albumin (Human)	Injection	Intravenous	20G/100ML	Single-Use Bottle	2007/09/27	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Humalog	020563	003	351(a)	insulin lispro	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2007/09/06	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Humalog Mix 75/25	021017	002	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML)	Autoinjector	2007/09/06	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Humalog Mix 50/50	021018	002	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML)	Autoinjector	2007/09/06	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Acam2000	125158	001	351(a)	Smallpox (Vaccinia) Vaccine, Live	Suspension	Percutaneous	1.0- 5.0 X 10^8 PFU/ML	Multi-Dose Vial	2007/08/31	Emergent Product Development Gaithersburg, Inc.	Rx	Licensed		N/A
Evithrom	125247	001	351(a)	Thrombin, Topical (Human)	Solution	Topical	2ML IU/ML	Single-Dose Vial	2007/08/27	Omrix Biopharmaceuticals Ltd	Disc	Licensed		N/A
Evithrom	125247	002	351(a)	Thrombin, Topical (Human)	Solution	Topical	20ML IU/ML	Single-Dose Vial	2007/08/27	Omrix Biopharmaceuticals Ltd	Disc	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	-