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
Pentacel	125145	001	351(a)	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2008/06/20	Sanofi Pasteur Limited	Rx	Licensed		N/A
PegIntron/ Rebetol Combo Pack	125196	001	351(a)	peginterferon alfa-2b and ribavirin			50MCG/0.5ML & 200MG		2008/06/13	Schering Corporation a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
PegIntron/ Rebetol Combo Pack	125196	002	351(a)	peginterferon alfa-2b and ribavirin			80MCG/0.5ML & 200MG		2008/06/13	Schering Corporation a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
PegIntron/ Rebetol Combo Pack	125196	003	351(a)	peginterferon alfa-2b and ribavirin			120MCG/0.5ML & 200MG		2008/06/13	Schering Corporation a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
PegIntron/ Rebetol Combo Pack	125196	004	351(a)	peginterferon alfa-2b and ribavirin			150MCG/0.5ML & 200MG		2008/06/13	Schering Corporation a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Recothrom	125248	002	351(a)	Thrombin topical (Recombinant)	For Solution	Topical	20000IU	Single-Dose Vial	2008/05/23	Baxter Healthcare Corporation	Rx	Licensed		N/A
Novoseven, Novoseven Rt	103665	004	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	5.0MG	Single-Dose Vial	2008/05/09	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoseven, Novoseven Rt	103665	005	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	1.0MG	Single-Dose Vial	2008/05/09	Novo Nordisk Inc.	Rx	Licensed		N/A
Novoseven, Novoseven Rt	103665	006	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	2.0MG	Single-Dose Vial	2008/05/09	Novo Nordisk Inc.	Rx	Licensed		N/A
Cimzia	125160	001	351(a)	certolizumab pegol	For Injection	Subcutaneous	200MG	Single-Dose Vial	2008/04/22	UCB, Inc.	Rx	Licensed	N/A	N/A
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

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	-