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
Ilaris	125319	001	351(a)	canakinumab	For Injection	Subcutaneous	150MG	Single-Dose Vial	2009/06/17	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Creon	020725	001	351(a)	pancrelipase	Capsule, Delayed Release	Oral	6,000USP UNITS; 19,000USP UNITS; 30,000USP UNITS		2009/04/30	AbbVie Inc.	Rx	Licensed	N/A	N/A
Creon	020725	002	351(a)	pancrelipase	Capsule, Delayed Release	Oral	12,000USP UNITS; 38,000USP UNITS; 60,000USP UNITS		2009/04/30	AbbVie Inc.	Rx	Licensed	N/A	N/A
Creon	020725	003	351(a)	pancrelipase	Capsule, Delayed Release	Oral	24,000USP UNITS; 76,000USP UNITS; 120,000USP UNITS		2009/04/30	AbbVie Inc.	Rx	Licensed	N/A	N/A
Dysport	125274	001	351(a)	abobotulinumtoxinA	For Injection	Intramuscular	300UNITS	Single-Dose Vial	2009/04/29	Ipsen Biopharm Limited	Rx	Licensed	N/A	N/A
Dysport	125274	002	351(a)	abobotulinumtoxinA	For Injection	Intramuscular	500UNITS	Single-Dose Vial	2009/04/29	Ipsen Biopharm Limited	Rx	Licensed	N/A	N/A
Simponi	125289	001	351(a)	golimumab	Injection	Subcutaneous	50MG/0.5ML	Autoinjector	2009/04/24	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Simponi	125289	002	351(a)	golimumab	Injection	Subcutaneous	50MG/0.5ML	Pre-Filled Syringe	2009/04/24	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Ixiaro	125280	001	351(a)	Japanese Encephalitis Vaccine, Inactivated, Adsorbed	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2009/03/30	Valneva Austria GmbH	Rx	Licensed		N/A
Norditropin	021148	007	351(a)	somatropin	Injection	Subcutaneous	30MG/3ML	Autoinjector	2009/03/10	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Apidra	021629	003	351(a)	insulin glulisine	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2009/02/24	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Atryn	125284	001	351(a)	Antithrombin (Recombinant)	For Injection	Intravenous	1750IU	Single-Dose Vial	2009/02/06	rEVO Biologics, Inc.	Disc	Voluntarily Revoked		N/A
Riastap	125317	001	351(a)	Fibrinogen Concentrate (Human)	For Injection	Intravenous	900-1300MG	Single-Dose Vial	2009/01/16	CSL Behring GmbH	Rx	Licensed		N/A
Cinryze	125267	001	351(a)	C1 Esterase Inhibitor (Human)	For Injection	Intravenous	500U	Single-Dose Vial	2008/10/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Novolog Mix 50/50	021810	001	351(a)	insulin aspart protamine and insulin aspart	Injectable Suspension	Subcutaneous	150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML)	Multi-Dose Cartridge	2008/08/26	Novo Nordisk Inc.	Disc	Voluntarily Revoked	N/A	N/A
Novolog Mix 50/50	021810	002	351(a)	insulin aspart protamine and insulin aspart	Injectable Suspension	Subcutaneous	150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML)	Autoinjector	2008/08/26	Novo Nordisk Inc.	Disc	Voluntarily Revoked	N/A	N/A
Omnitrope	021426	004	351(a)	somatropin	Injection	Subcutaneous	10MG/1.5ML	Multi-Dose Cartridge	2008/08/25	Sandoz Inc.	Rx	Licensed	N/A	N/A
Nplate	125268	001	351(a)	romiplostim	For Injection	Subcutaneous	250MCG	Single-Dose Vial	2008/08/22	Amgen Inc.	Rx	Licensed	N/A	N/A
Nplate	125268	002	351(a)	romiplostim	For Injection	Subcutaneous	500MCG	Single-Dose Vial	2008/08/22	Amgen Inc.	Rx	Licensed	N/A	N/A
Kinrix	125260	001	351(a)	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2008/06/24	GlaxoSmithKline Biologicals	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	-