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
Bioclate (Armour), Recombinate	103375	004	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1500IU	Single-Dose Vial	2010/03/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	005	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2010/03/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Hizentra	125350	001	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	2G/10ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	002	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	1G/5ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	003	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	10G/50ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	004	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	4G/20ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Norditropin	021148	008	351(a)	somatropin	Injection	Subcutaneous	5MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Norditropin	021148	009	351(a)	somatropin	Injection	Subcutaneous	10MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Norditropin	021148	010	351(a)	somatropin	Injection	Subcutaneous	15MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
VPRIV	022575	001	351(a)	velaglucerase alfa	For Injection	Intravenous	400UNITS	Single-Dose Vial	2010/02/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
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

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	-