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	016	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	150MCG/0.3ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	017	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	200MCG/0.4ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	018	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	300MCG/0.6ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	019	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	500MCG/1ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Pediarix	103907	001	351(a)	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2002/12/13	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Infasurf	020521	002	351(a)	calfactant	Suspension	Intratracheal	105MG/3ML (35MG/ML)	Single-Dose Vial	2002/12/12	ONY Biotech Inc.	Rx	Licensed	N/A	N/A
Pegasys	103964	001	351(a)	peginterferon alfa-2a	Injection	Subcutaneous	180MCG/ML	Single-Dose Vial	2002/10/16	pharmaand GmbH	Rx	Licensed	N/A	N/A
Helixate Fs, Kogenate, Kogenate Fs	103332	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	2002/08/20	Bayer HealthCare LLC	Disc	Licensed		N/A
Helixate Fs, Kogenate, Kogenate Fs	103332	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Single-Dose Vial	2002/08/20	Bayer HealthCare LLC	Disc	Licensed		N/A
Helixate Fs, Kogenate, Kogenate Fs	103332	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Single-Dose Vial	2002/08/20	Bayer HealthCare LLC	Disc	Licensed		N/A
Aranesp	103951	011	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	150MCG/0.75ML	Single-Dose Vial	2002/07/19	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	012	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	300MCG/1ML	Single-Dose Vial	2002/07/19	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	013	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	500MCG/1ML	Single-Dose Vial	2002/07/19	Amgen Inc.	Disc	Licensed	N/A	N/A
Elitek	103946	001	351(a)	rasburicase	For Injection	Intravenous	1.5MG	Single-Dose Vial	2002/07/12	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Daptacel	103666	001	351(a)	Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	Injection	Intramuscular	0.5ML	Single-Dose Vial	2002/05/14	Sanofi Pasteur Limited	Rx	Licensed		N/A
Bravelle	021289	001	351(a)	urofollitropin	For Injection	Subcutaneous, Intramuscular	75IU	Single-Dose Vial	2002/05/06	Ferring Pharmaceuticals Inc.	Disc	Voluntarily Revoked	N/A	N/A
Novolog Mix 70/30	021172	004	351(a)	insulin aspart protamine and insulin aspart	Injectable Suspension	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Autoinjector	2002/05/03	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Nutropin AQ	020522	002	351(a)	somatropin	Injection	Subcutaneous	10MG/2ML	Multi-Dose Cartridge	2002/04/22	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Rebif	103780	001	351(a)	interferon beta-1a	Injection	Subcutaneous	22MCG/0.5ML	Pre-Filled Syringe	2002/03/07	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Rebif	103780	002	351(a)	interferon beta-1a	Injection	Subcutaneous	44MCG/0.5ML	Pre-Filled Syringe	2002/03/07	EMD Serono, 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	-