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
Krystexxa	125293	001	351(a)	pegloticase	Injection	Intravenous	8MG/ML	Single-Dose Vial	2010/09/14	Horizon Therapeutics Ireland DAC	Rx	Licensed	N/A	N/A
Novoseven, Novoseven Rt	103665	007	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	8.0MG	Single-Dose Vial	2010/08/06	Novo Nordisk Inc.	Rx	Licensed		N/A
Xyntha, Xyntha Solofuse	125264	009	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free	For Injection	Intravenous	3000IU	Pre-Filled Syringe	2010/08/06	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Xeomin	125360	001	351(a)	incobotulinumtoxinA	For Injection	Intramuscular, Intraglandular	50UNITS	Single-Dose Vial	2010/07/30	Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Xeomin	125360	002	351(a)	incobotulinumtoxinA	For Injection	Intramuscular, Intraglandular	100UNITS	Single-Dose Vial	2010/07/30	Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	006	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5G/50ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	007	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10G/100ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Flebogamma 5%, Flebogamma 5% Dif	125077	008	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	20G/200ML	Single-Dose Vial	2010/07/27	Instituto Grifols, S.A.	Disc	Licensed		N/A
Glassia	125325	001	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	1G	Single-Dose Vial	2010/07/01	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Prolia	125320	001	351(a)	denosumab	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2010/06/01	Amgen Inc.	Rx	Licensed	N/A	N/A
Prolia	125320	002	351(a)	denosumab	Injection	Subcutaneous	60MG/ML	Single-Dose Vial	2010/06/01	Amgen Inc.	Disc	Licensed	N/A	N/A
Lumizyme	125291	001	351(a)	alglucosidase alfa	For Injection	Intravenous	50MG	Single-Dose Vial	2010/05/24	Genzyme Corporation	Rx	Licensed	N/A	N/A
Provenge	125197	001	351(a)	sipuleucel-T	Injection	Intravenous	50 M CD54 + ACTIVATED CELLS/250 ML	Bag	2010/04/29	Dendreon Pharmaceuticals LLC	Disc	Licensed		N/A
Pancreaze	022523	001	351(a)	pancrelipase	Capsule, Delayed Release	Oral	4,200USP UNITS; 14,200USP UNITS; 24,600USP UNITS		2010/04/12	VIVUS LLC	Rx	Licensed	N/A	N/A
Pancreaze	022523	002	351(a)	pancrelipase	Capsule, Delayed Release	Oral	10,500USP UNITS; 35,500USP UNITS; 61,500USP UNITS		2010/04/12	VIVUS LLC	Rx	Licensed	N/A	N/A
Pancreaze	022523	003	351(a)	pancrelipase	Capsule, Delayed Release	Oral	16,800USP UNITS; 56,800USP UNITS; 98,400USP UNITS		2010/04/12	VIVUS LLC	Rx	Licensed	N/A	N/A
Pancreaze	022523	004	351(a)	pancrelipase	Capsule, Delayed Release	Oral	21,000USP UNITS; 54,700USP UNITS; 83,900USP UNITS		2010/04/12	VIVUS LLC	Rx	Licensed	N/A	N/A
Tachosil	125351	001	351(a)	Fibrin Sealant Patch	Patch	Topical	4.8 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN	Tray & Lid	2010/04/05	Corza Medical GmbH	Rx	Licensed		N/A
Tachosil	125351	002	351(a)	Fibrin Sealant Patch	Patch	Topical	9.5 CM X 4.8 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN	Tray & Lid	2010/04/05	Corza Medical GmbH	Rx	Licensed		N/A
Tachosil	125351	003	351(a)	Fibrin Sealant Patch	Patch	Topical	3.0 CM X 2.5 CM MG PER CM2 FOR FIBRINOGEN; IU PER CM2 FOR THROMBIN	Tray & Lid	2010/04/05	Corza Medical GmbH	Disc	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	-