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
Rotarix	125265	001	351(a)	Rotavirus Vaccine, Live, Oral	For Suspension	Oral	1ML	Single-Dose Vial	2008/04/03	GlaxoSmithKline Biologicals	Disc	Licensed		N/A
Artiss	125266	001	351(a)	Fibrin Sealant (Human)	Solution	Topical	4ML	Pre-Filled Syringe	2008/03/19	Baxter Healthcare Corporation	Rx	Licensed		N/A
Artiss	125266	002	351(a)	Fibrin Sealant (Human)	Solution	Topical	10ML	Pre-Filled Syringe	2008/03/19	Baxter Healthcare Corporation	Rx	Licensed		N/A
Artiss	125266	003	351(a)	Fibrin Sealant (Human)	Solution	Topical	2ML	Pre-Filled Syringe	2008/03/19	Baxter Healthcare Corporation	Rx	Licensed		N/A
Artiss	125266	004	351(a)	Fibrin Sealant (Human)	For Solution	Topical	4ML	Single-Dose Vial	2008/03/19	Baxter Healthcare Corporation	Disc	Licensed		N/A
Artiss	125266	005	351(a)	Fibrin Sealant (Human)	For Solution	Topical	10ML	Single-Dose Vial	2008/03/19	Baxter Healthcare Corporation	Disc	Licensed		N/A
Artiss	125266	006	351(a)	Fibrin Sealant (Human)	For Solution	Topical	2ML	Single-Dose Vial	2008/03/19	Baxter Healthcare Corporation	Disc	Licensed		N/A
Arcalyst	125249	001	351(a)	rilonacept	For Injection	Subcutaneous	220MG	Single-Dose Vial	2008/02/27	Kiniksa Pharmaceuticals (UK), Ltd.	Rx	Licensed	N/A	N/A
Humira	125057	003	351(a)	adalimumab	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2008/02/21	AbbVie Inc.	Disc*	Licensed	N/A	N/A
Xyntha, Xyntha Solofuse	125264	001	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	2000IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	002	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	2000IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	003	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	1000IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	004	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	1000IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	005	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	250IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	006	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	250IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	007	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	500IU	Pre-Filled Syringe	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	008	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	500IU	Single-Dose Vial	2008/02/21	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Accretropin	021538	001	351(a)	somatropin	Injection	Subcutaneous	5MG/ML	Multi-Dose Vial	2008/01/23	Emergent Biosolutions Canada Inc.	Disc	Voluntarily Revoked	N/A	N/A
Recothrom	125248	001	351(a)	Thrombin topical (Recombinant)	For Solution	Topical	5000IU	Single-Dose Vial	2008/01/17	Baxter Healthcare Corporation	Rx	Licensed		N/A
Omnitrope	021426	003	351(a)	somatropin	Injection	Subcutaneous	5MG/1.5ML	Multi-Dose Cartridge	2008/01/16	Sandoz Inc.	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	-