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
Engerix-B	103239	001	351(a)	Hepatitis B Vaccine (Recombinant)	Injection	Intramuscular	20UG/ML	Pre-Filled Syringe	1989/08/28	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Engerix-B	103239	002	351(a)	Hepatitis B Vaccine (Recombinant)	Injection	Intramuscular	20UG/ML	Single-Dose Vial	1989/08/28	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Engerix-B	103239	003	351(a)	Hepatitis B Vaccine (Recombinant)	Injection	Intramuscular	10UG/.5ML	Pre-Filled Syringe	1989/08/28	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Engerix-B	103239	004	351(a)	Hepatitis B Vaccine (Recombinant)	Injection	Intramuscular	10UG/.5ML	Single-Dose Vial	1989/08/28	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Tice Bcg	102821	001	351(a)	BCG Live	For Injection	Intravesical	100-800 MIL CFU	Single-Dose Vial	1989/06/21	Merck Teknika LLC	Rx	Licensed		N/A
	103050	001	351(a)	BCG Vaccine	For Injection	Percutaneous	100-800 MIL CFU	Single-Dose Vial	1989/06/21	Merck Teknika LLC	Rx	Licensed		N/A
Epogen/Procrit	103234	001	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	10,000UNITS/ML	Single-Dose Vial	1989/06/01	Amgen Inc.	Rx	Licensed	N/A	N/A
Epogen/Procrit	103234	004	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	2,000UNITS/ML	Single-Dose Vial	1989/06/01	Amgen Inc.	Rx	Licensed	N/A	N/A
Epogen/Procrit	103234	005	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	3,000UNITS/ML	Single-Dose Vial	1989/06/01	Amgen Inc.	Rx	Licensed	N/A	N/A
Epogen/Procrit	103234	007	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	4,000UNITS/ML	Single-Dose Vial	1989/06/01	Amgen Inc.	Rx	Licensed	N/A	N/A
Humulin 70/30	019717	001	351(a)	insulin isophane human and insulin human	Injectable Suspension	Subcutaneous	700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML)	Multi-Dose Vial	1989/04/25	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Humulin 70/30	019717	002	351(a)	insulin isophane human and insulin human	Injectable Suspension	Subcutaneous	210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML)	Multi-Dose Vial	1989/04/25	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Draximage MAA	017881	001	351(a)	kit for the preparation of technetium Tc-99m albumin aggregated	For Injectable Suspension	Intravenous	2.5MG/5MG/0.6MG/ 1.2MG	Multi-Dose Vial	1987/12/30	Jubilant DraxImage Inc.	Rx	Licensed	N/A	N/A
prolastin,prolastin-c,prolastin-c liquid	103174	001	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	1000MG	Single-Dose Vial	1987/12/02	Grifols Therapeutics LLC	Rx	Licensed		N/A
prolastin,prolastin-c,prolastin-c liquid	103174	002	351(a)	Alpha-1-Proteinase Inhibitor (Human)	For Injection	Intravenous	500MG	Single-Dose Vial	1987/12/02	Grifols Therapeutics LLC	Disc	Licensed		N/A
Activase	103172	001	351(a)	alteplase	For Injection	Intravenous	50MG	Single-Dose Vial	1987/11/13	Genentech, Inc.	Rx	Licensed	N/A	N/A
Activase	103172	002	351(a)	alteplase	For Injection	Intravenous	100MG	Single-Dose Vial	1987/11/13	Genentech, Inc.	Rx	Licensed	N/A	N/A
Humatrope	019640	001	351(a)	somatropin	For Injection	Subcutaneous	2MG	Single-Dose Vial	1987/06/23	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Humatrope	019640	004	351(a)	somatropin	For Injection	Subcutaneous	5MG	Single-Dose Vial	1986/10/16	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Recombivax, Recombivax Hb	101066	001	351(a)	Hepatitis B Vaccine (Recombinant)	Injection	Intramuscular	5UG/ML	Single-Dose Vial	1986/07/23	Merck Sharp & Dohme 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	-