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
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	Rx	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
Bioclate (Armour), Recombinate	103375	004	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1500IU	Single-Dose Vial	2010/03/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	005	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2010/03/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Hizentra	125350	001	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	2G/10ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	002	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	1G/5ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	003	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	10G/50ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Hizentra	125350	004	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	4G/20ML	Single-Dose Vial	2010/03/04	CSL Behring AG	Rx	Licensed		N/A
Norditropin	021148	008	351(a)	somatropin	Injection	Subcutaneous	5MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Norditropin	021148	009	351(a)	somatropin	Injection	Subcutaneous	10MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Norditropin	021148	010	351(a)	somatropin	Injection	Subcutaneous	15MG/1.5ML	Autoinjector	2010/03/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
VPRIV	022575	001	351(a)	velaglucerase alfa	For Injection	Intravenous	400UNITS	Single-Dose Vial	2010/02/26	Takeda Pharmaceuticals U.S.A., 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	-