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
Novolog Mix 70/30	021172	002	351(a)	insulin aspart protamine and insulin aspart	Injectable Suspension	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Autoinjector	2001/11/01	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Novolog Mix 70/30	021172	003	351(a)	insulin aspart protamine and insulin aspart	Injectable Suspension	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Pre-Filled Syringe	2001/11/01	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Nabi-HB	103945	001	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	312IU/ML	Single-Dose Vial	2001/10/23	ADMA Biologics, Inc.	Disc	Licensed		N/A
Nabi-HB	103945	002	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	1560IU/5ML	Single-Dose Vial	2001/10/23	ADMA Biologics, Inc.	Rx	Licensed		N/A
Aranesp	103951	001	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	25MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	002	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	40MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	003	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	60MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	004	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	100MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	005	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	200MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aranesp	103951	006	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	25MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	007	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	40MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	008	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	60MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	009	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	100MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Aranesp	103951	010	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	200MCG/1ML	Single-Dose Vial	2001/09/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Cathflo Activase	103172	003	351(a)	alteplase	For Injection	Intravenous	2MG	Single-Dose Vial	2001/09/04	Genentech, Inc.	Rx	Licensed	N/A	N/A
Digifab	103910	001	351(a)	Digoxin Immune Fab (Ovine)	For Injection	Intravenous	40MG	Single-Dose Vial	2001/08/31	BTG International Inc.	Rx	Licensed		N/A
Refacto	103779	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Vial	2001/07/06	Wyeth Pharmaceuticals LLC	Disc	Licensed		N/A
Refacto	103779	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Vial	2001/07/06	Wyeth Pharmaceuticals LLC	Disc	Licensed		N/A
Refacto	103779	004	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Vial	2001/07/06	Wyeth Pharmaceuticals LLC	Disc	Licensed		N/A
Refacto	103779	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2000IU	Vial	2001/06/27	Wyeth Pharmaceuticals LLC	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	-