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
Zenpep	022210	005	351(a)	pancrelipase	Capsule, Delayed Release	Oral	3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS		2011/06/15	Zenpep, LLC	Rx	Licensed	N/A	N/A
Nulojix	125288	001	351(a)	belatacept	For Injection	Intravenous	250MG	Single-Dose Vial	2011/06/15	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Creon	020725	004	351(a)	pancrelipase	Capsule, Delayed Release	Oral	3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS		2011/06/10	AbbVie Inc.	Rx	Licensed	N/A	N/A
Kedbumin	125384	001	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	2011/06/03	Kedrion Biopharma Inc.	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	004	351(a)	Influenza Virus Vaccine	Injection	Intradermal	27UG/0.1	Syringe	2011/05/09	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Arzerra	125326	002	351(a)	ofatumumab	Injection	Intravenous	1,000MG/50ML	Single-Dose Vial	2011/04/01	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Sylatron	103949	002	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	200MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Sylatron	103949	003	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	300MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Sylatron	103949	004	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	600MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Yervoy	125377	001	351(a)	ipilimumab	Injection	Intravenous	50MG/10ML (5MG/ML)	Single-Dose Vial	2011/03/25	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Yervoy	125377	002	351(a)	ipilimumab	Injection	Intravenous	200MG/40ML (5MG/ML)	Single-Dose Vial	2011/03/25	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
	125296	001	351(a)	Adenovirus Type 4 and Type 7 Vaccine, Live, Oral	Tablet	Oral	4.5LOG 10TCID	Bottle	2011/03/16	Teva Women's Health, Inc.	Rx	Licensed		N/A
Benlysta	125370	001	351(a)	belimumab	For Injection	Intravenous	120MG	Single-Dose Vial	2011/03/09	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Benlysta	125370	002	351(a)	belimumab	For Injection	Intravenous	400MG	Single-Dose Vial	2011/03/09	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Corifact	125385	001	351(a)	Factor XIII Concentrate (Human)	For Injection	Intravenous	1000-1600IU	Single-Dose Vial	2011/02/17	CSL Behring GmbH	Rx	Licensed		N/A
Thrombin-Jmi, Thrombocoll	102865	002	351(a)	Thrombin, Topical (Bovine)	Powder	Topical	5,000IU	Vial	2011/02/10	GenTrac, Inc.	Rx	Licensed		N/A
Wilate	125251	001	351(a)	von Willebrand Factor/Coagulation Factor VIII Complex (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2010/12/20	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Wilate	125251	002	351(a)	von Willebrand Factor/Coagulation Factor VIII Complex (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	2010/12/20	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Xgeva	125320	003	351(a)	denosumab	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2010/11/18	Amgen Inc.	Rx	Licensed	N/A	N/A
Egrifta	022505	001	351(a)	tesamorelin	For Injection	Subcutaneous	1MG	Single-Dose Vial	2010/11/10	Theratechnologies Inc.	Disc	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	-