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
Crosseal, Evicel	125010	003	351(a)	Fibrin Sealant (Human)	Spray	Topical	2ML	Single-Dose Vial	2003/03/21	Omrix Biopharmaceuticals Ltd	Disc	Voluntarily Revoked		N/A
Amevive	125036	001	351(a)	alefacept	For Injection	Intravenous	7.5MG	Single-Dose Vial	2003/01/30	Astellas Pharma US, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Amevive	125036	002	351(a)	alefacept	For Injection	Intramuscular	15MG	Single-Dose Vial	2003/01/30	Astellas Pharma US, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Simulect	103764	002	351(a)	basiliximab	For Injection	Intravenous	10MG	Single-Dose Vial	2003/01/02	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Humira	125057	001	351(a)	adalimumab	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2002/12/31	AbbVie Inc.	Rx	Licensed	N/A	N/A
Humira	125057	002	351(a)	adalimumab	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2002/12/31	AbbVie Inc.	Rx	Licensed	N/A	N/A
Aralast, Aralast Np	125039	001	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	0.5G	Single-Dose Vial	2002/12/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Aralast, Aralast Np	125039	002	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	1.0G	Single-Dose Vial	2002/12/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Aranesp	103951	014	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	60MCG/0.3ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	015	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	100MCG/0.5ML	Pre-Filled Syringe	2002/12/17	Amgen Inc.	Disc	Licensed	N/A	N/A
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

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	-