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
Levemir	021536	004	351(a)	insulin detemir	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2005/06/16	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Adacel	125111	001	351(a)	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed	Injection	Intramuscular	0.5ML	Single-Dose Vial	2005/06/10	Sanofi Pasteur Limited	Rx	Licensed		N/A
Naglazyme	125117	001	351(a)	galsulfase	Injection	Intravenous	5MG/5ML (1MG/ML)	Single-Dose Vial	2005/05/31	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Boostrix	125106	001	351(a)	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed	Injection	Intramuscular	2.5LF, 5LF, 2.5UG, 8UG UG/.5ML	Single-Dose Vial	2005/05/03	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Boostrix	125106	002	351(a)	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed	Injection	Intramuscular	2.5LF, 5LF, 2.5UG, 8UG UG/.5ML	Pre-Filled Syringe	2005/05/03	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Cnj-016	125109	001	351(a)	Vaccinia Immune Globulin Intravenous (Human)	Injection	Intravenous	>=50,000U	Single-Dose Vial	2005/05/02	Emergent BioSolutions Canada Inc.	Rx	Licensed		N/A
Gammagard Liquid	125105	001	351(a)	Immune Globulin Infusion (Human)	Injection	Intravenous, Subcutaneous	10% MG/ML	Single-Use Bottle	2005/04/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	007	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	15000IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	008	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	15000IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	009	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	5000IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	010	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	5000IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	011	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	2500IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	012	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	2500IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	013	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	1500IU	Vial	2005/03/31	Kamada Ltd.	Rx	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	014	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	1500IU	Vial	2005/03/31	Kamada Ltd.	Rx	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	015	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	600IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	016	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intravenous	600IU	Vial	2005/03/31	Kamada Ltd.	Disc	Licensed		N/A
Serostim	020604	005	351(a)	somatropin	Injection	Subcutaneous	6MG/0.5ML	Single-Dose Cartridge	2005/02/11	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Follistim AQ Cartridge	021211	003	351(a)	follitropin beta	Injection	Subcutaneous	175IU/0.21ML	Multi-Dose Cartridge	2005/02/11	Organon USA LLC, a subsidiary of Organon & Co.	Disc	Licensed	N/A	N/A
Follistim AQ Cartridge	021211	004	351(a)	follitropin beta	Injection	Subcutaneous	900IU/1.08ML	Multi-Dose Cartridge	2005/02/11	Organon USA LLC, a subsidiary of Organon & Co.	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	-