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
Advate	125063	005	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method	For Injection	Intravenous	2000IU	Single-Dose Vial	2006/04/12	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Rotateq	125122	001	351(a)	Rotavirus Vaccine, Live, Oral, Pentavalent	Suspension	Oral	2.2X10E6 IU	Tube	2006/02/03	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Hepagam B	125035	001	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	>1560IU/5ML	Single-Dose Vial	2006/01/27	Kamada Ltd.	Rx	Licensed		N/A
Hepagam B	125035	002	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	>312IU/ML	Single-Dose Vial	2006/01/27	Kamada Ltd.	Rx	Licensed		N/A
Vivaglobin	125115	001	351(a)	Immune Globulin Subcutaneous (Human)	For Injection	Subcutaneous	160MG/ML	Vial	2006/01/09	CSL Behring GmbH	Disc	Voluntarily Revoked
Elitek	103946	002	351(a)	rasburicase	For Injection	Intravenous	7.5MG	Single-Dose Vial	2006/01/06	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Orencia	125118	001	351(a)	abatacept	For Injection	Intravenous	250MG	Single-Dose Vial	2005/12/23	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Apidra	021629	002	351(a)	insulin glulisine	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2005/12/20	Sanofi-Aventis U.S. LLC	Disc	Licensed	N/A	N/A
Iplex	021884	001	351(a)	mecasermin rinfabate	Injection	Subcutaneous	36MG/0.6ML (60MG/ML)	Single-Dose Vial	2005/12/12	Insmed Incorporated	Disc	Voluntarily Revoked	N/A	N/A
Hylenex recombinant	021859	001	351(a)	hyaluronidase human	Injection	Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous	150UNITS/ML	Single-Dose Vial	2005/12/02	Halozyme Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Hydase	021716	001	351(a)	hyaluronidase	Injection	Subcutaneous	150UNITS/ML	Single-Dose Vial	2005/10/25	Akorn, Inc.	Disc	Licensed	N/A	N/A
Proquad	125108	001	351(a)	Measles, Mumps, Rubella and Varicella Virus Vaccine Live	For Injection	Subcutaneous	0.5ML	Single-Dose Vial	2005/09/06	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Fluarix, Fluarix Quadrivalent	125127	001	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2005/08/31	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Increlex	021839	001	351(a)	mecasermin	Injection	Subcutaneous	40MG/4ML (10MG/ML)	Multi-Dose Vial	2005/08/30	Eton Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Follistim AQ	021273	001	351(a)	follitropin beta	Injection	Subcutaneous, Intramuscular	75IU/0.5ML	Single-Dose Vial	2005/08/26	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Follistim AQ	021273	002	351(a)	follitropin beta	Injection	Subcutaneous, Intramuscular	150IU/0.5ML	Single-Dose Vial	2005/08/26	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Autoplex, Feiba Nf, Feiba Vh	101447	005	351(a)	Anti-Inhibitor Coagulant Complex	For Injection	Intravenous	2500U	Single-Dose Vial	2005/08/11	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Levemir	021536	001	351(a)	insulin detemir	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2005/06/16	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Levemir	021536	002	351(a)	insulin detemir	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2005/06/16	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Levemir	021536	003	351(a)	insulin detemir	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2005/06/16	Novo Nordisk Inc.	Disc	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	-