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
Fluvirin	103837	001	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	15UG/.5ML	Pre-Filled Syringe	1998/11/03	Seqirus Vaccines Limited	Disc	Licensed		N/A
Enbrel	103795	001	351(a)	etanercept	For Injection	Subcutaneous	25MG	Single-Dose Vial	1998/11/02	Immunex Corporation	Disc	Licensed	N/A	N/A
Verluma	103769	001	351(a)	nofetumomab	Injection	Intravenous	10MG/ML		1998/10/13	Boehringer Ingelheim Pharma GmbH & Co. KG	Disc	Voluntarily Revoked	N/A	N/A
Herceptin	103792	001	351(a)	trastuzumab	For Injection	Intravenous	420MG	Multi-Dose Vial	1998/09/25	Genentech, Inc.	Disc*	Licensed	N/A	N/A
Remicade	103772	001	351(a)	infliximab	For Injection	Intravenous	100MG	Single-Dose Vial	1998/08/24	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Humulin R U-100	018780	003	351(a)	insulin human	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	1998/08/06	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Humalog	020563	002	351(a)	insulin lispro	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	1998/08/06	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Infasurf	020521	001	351(a)	calfactant	Suspension	Intratracheal	210MG/6ML (35MG/ML)	Single-Dose Vial	1998/07/01	ONY Biotech Inc.	Rx	Licensed	N/A	N/A
Synagis	103770	001	351(a)	palivizumab	For Injection	Intramuscular	50MG	Single-Dose Vial	1998/06/19	Swedish Orphan Biovitrum AB (publ)	Disc	Licensed	N/A	N/A
Synagis	103770	002	351(a)	palivizumab	For Injection	Intramuscular	100MG	Single-Dose Vial	1998/06/19	Swedish Orphan Biovitrum AB (publ)	Disc	Licensed	N/A	N/A
Simulect	103764	001	351(a)	basiliximab	For Injection	Intravenous	20MG	Single-Dose Vial	1998/05/12	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Tisseel	103980	001	351(a)	Fibrin Sealant (Tisseel)	For Solution	Topical	86.5 MG/ML Fibrinogen; 3000 KIU/ML Fibrinolysis Inh; 500 U/ML Thrombin	Single-Dose Vial	1998/05/01	Baxter Healthcare Corporation	Rx	Licensed		N/A
Micrhogam, Rhogam	103777	001	351(a)	Rho(D) Immune Globulin (Human)	Injection	Intramuscular	50UG	Pre-Filled Syringe	1998/04/23	Kedrion Biopharma Inc.	Disc	Licensed		N/A
Micrhogam, Rhogam	103777	002	351(a)	Rho(D) Immune Globulin (Human)	Injection	Intramuscular	300UG	Pre-Filled Syringe	1998/04/23	Kedrion Biopharma Inc.	Rx	Licensed		N/A
Aplisol	103782	001	351(a)	Tuberculin, Purified Protein Derivative	Injection	Intradermal	5TU/.1ML	Multi-Dose Vial	1998/04/20	Endo Operations Limited	Rx	Licensed		N/A
Sucraid	020772	001	351(a)	sacrosidase	Solution For Oral	Oral	1,003,000IU/118ML (8,500IU/ML)	Bottle	1998/04/09	QOL Medical, LLC	Rx	Licensed	N/A	N/A
Genotropin	020280	003	351(a)	somatropin	For Injection	Subcutaneous	0.6MG	Pre-Filled Syringe	1998/01/27	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Genotropin	020280	004	351(a)	somatropin	For Injection	Subcutaneous	0.2MG	Pre-Filled Syringe	1998/01/27	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Genotropin	020280	005	351(a)	somatropin	For Injection	Subcutaneous	0.8MG	Pre-Filled Syringe	1998/01/27	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Genotropin	020280	006	351(a)	somatropin	For Injection	Subcutaneous	0.4MG	Pre-Filled Syringe	1998/01/27	Pharmacia & Upjohn Company LLC	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	-