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
VPRIV	022575	002	351(a)	velaglucerase alfa	For Injection	Intravenous	200UNITS	Single-Dose Vial	2010/02/26	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed	N/A	N/A
Prevnar 13	125324	001	351(a)	Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2010/02/24	Wyeth Pharmaceuticals LLC	Disc	Licensed		N/A
Menveo	125300	001	351(a)	Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2010/02/19	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Xiaflex	125338	001	351(a)	collagenase clostridium histolyticum	For Injection	Intralesional	0.9MG	Single-Dose Vial	2010/02/02	Auxilium Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Actemra	125276	001	351(a)	tocilizumab	Injection	Intravenous	80MG/4ML (20MG/ML)	Single-Dose Vial	2010/01/08	Genentech, Inc.	Rx	Licensed	N/A	N/A
Actemra	125276	002	351(a)	tocilizumab	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2010/01/08	Genentech, Inc.	Rx	Licensed	N/A	N/A
Actemra	125276	003	351(a)	tocilizumab	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2010/01/08	Genentech, Inc.	Rx	Licensed	N/A	N/A
Stelara	125261	003	351(a)	ustekinumab	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2009/12/30	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Stelara	125261	004	351(a)	ustekinumab	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2009/12/30	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	003	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	180 UG/.5ML	Pre-Filled Syringe	2009/12/23	Sanofi Pasteur Inc.	Rx	Licensed		N/A
Kalbitor	125277	001	351(a)	ecallantide	Injection	Subcutaneous	10MG/ML	Single-Dose Vial	2009/12/01	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Agriflu	125297	001	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	.05ML	Syringe	2009/11/27	Seqirus Inc.	Disc	Licensed		N/A
Flulaval, Flulaval Quadrivalent	125163	002	351(a)	Influenza Vaccine	Injection	Intramuscular	15UG/.5ML	Multi-Dose Vial	2009/11/10	ID Biomedical Corporation of Quebec	Disc	Licensed		N/A
Arzerra	125326	001	351(a)	ofatumumab	Injection	Intravenous	100MG/5ML	Single-Dose Vial	2009/10/26	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Cervarix	125259	001	351(a)	Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2009/10/16	GlaxoSmithKline Biologicals	Disc	Licensed		N/A
Berinert	125287	001	351(a)	C1 Esterase Inhibitor (Human)	For Injection	Intravenous	500U	Single-Dose Vial	2009/10/09	CSL Behring GmbH	Rx	Licensed		N/A
Privigen	125201	004	351(a)	Immune Globulin Intravenous (Human), 10% Liquid	Injection	Intravenous	2.5G	Single-Dose Vial	2009/10/02	CSL Behring AG	Rx	Licensed		N/A
Stelara	125261	001	351(a)	ustekinumab	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2009/09/25	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Stelara	125261	002	351(a)	ustekinumab	Injection	Subcutaneous	90MG/ML	Single-Dose Vial	2009/09/25	Janssen Biotech, Inc.	Disc	Licensed	N/A	N/A
Evithrom	125247	004	351(a)	Thrombin, Topical (Human)	For Injection	Topical	1600-2400IU/ML	Single-dose vial	2009/09/17	Omrix Biopharmaceuticals Ltd	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	-