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
Havrix	103475	004	351(a)	Hepatitis A Vaccine	Injection	Intramuscular	1440ELISA U/ML	Single-Dose Vial	1995/02/22	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Human Albumin Grifols	103352	001	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	1995/02/17	Instituto Grifols, S.A.	Disc	Licensed		N/A
Human Albumin Grifols	103352	003	351(a)	Albumin (Human)	Injection	Intravenous	10G/50ML	Single-Dose Vial	1995/02/17	Instituto Grifols, S.A.	Disc	Licensed		N/A
Reopro	103575	001	351(a)	abciximab	Injection	Intravenous	2MG/ML	Single-Dose Vial	1994/12/22	Janssen Biotech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
	103569	001	351(a)	Plague Vaccine	Injection	Intramuscular	2BIL. CELL/ML	Single-Dose Vial	1994/10/05	Greer Laboratories, Inc.	Disc	Licensed		N/A
Humegon	020328	001	351(a)	menotropins	For Injection	Intramuscular	75IU	Single-Dose Vial	1994/09/01	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Humegon	020328	002	351(a)	menotropins	For Injection	Intramuscular	150IU	Single-Dose Vial	1994/09/01	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Cerezyme	020367	001	351(a)	imiglucerase	For Injection	Intravenous	200UNITS/VIAL	Single-Dose Vial	1994/05/23	Genzyme Corporation	Disc	Licensed	N/A	N/A
Humulin R U-500	018780	004	351(a)	insulin human	Injection	Subcutaneous	10,000UNITS/20ML (500UNITS/ML)	Multi-Dose Vial	1994/03/31	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Oncaspar	103411	001	351(a)	pegaspargase	Injection	Intravenous, Intramuscular	3,750IU/5ML(750IU/ML)	Single-Dose Vial	1994/02/01	Servier Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Pulmozyme	103532	001	351(a)	dornase alfa	Solution	Inhalation	2.5MG/2.5ML (1MG/ML)	Ampule	1993/12/30	Genentech, Inc.	Rx	Licensed	N/A	N/A
Trasylol	020304	001	351(a)	aprotinin	Injection	Intravenous	1,000,000KIU/100ML (10,000KIU/ML)	Single-Dose Vial	1993/12/29	Bayer HealthCare Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Trasylol	020304	002	351(a)	aprotinin	Injection	Intravenous	2,000,000KIU/200ML (10,000KIU/ML)	Single-Dose Vial	1993/12/29	Bayer HealthCare Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Nutropin	020168	001	351(a)	somatropin	For Injection	Subcutaneous	5MG	Multi-Dose Vial	1993/11/17	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Nutropin	020168	002	351(a)	somatropin	For Injection	Subcutaneous	10MG	Multi-Dose Vial	1993/11/17	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Betaseron	103471	001	351(a)	interferon beta-1b	For Injection	Subcutaneous	0.3MG	Single-Dose Vial	1993/07/23	Bayer HealthCare Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Bioclate (Armour), Recombinate	103375	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Orthoclone OKT3	103463	001	351(a)	muromonab-CD3	Injection	Intravenous	1MG/ML	Ampule	1992/09/14	Centocor Ortho Biotech Products, L.P.	Disc	Voluntarily Revoked	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	-