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
Mononine	103957	002	351(a)	Coagulation Factor IX (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
	103937	001	351(a)	Botulism Antitoxin Bivalent (Equine) Types A and B.	Injection	Intravenous	5000IU	Vial	2000/02/24	Sanofi Pasteur Limited	Rx	Voluntarily Revoked
Poliovax	103940	001	351(a)	Poliovirus Vaccine Inactivated (Human Diploid Cell)	Injection	Subcutaneous	0.5ML	Vial	2000/02/24	Sanofi Pasteur Limited	Disc	Licensed		N/A
Poliovax	103940	002	351(a)	Poliovirus Vaccine Inactivated (Human Diploid Cell)	Injection	Intramuscular	0.5ML	Vial	2000/02/24	Sanofi Pasteur Limited	Disc	Licensed		N/A
Tubersol	103941	001	351(a)	Tuberculin, Purified Protein Derivative	Injection	Intradermal	5TU/.1ML	Multi-Dose Vial	2000/02/24	Sanofi Pasteur Limited	Rx	Licensed		N/A
Mycobax	103942	001	351(a)	BCG Vaccine	For Injection	Intradermal	1.5MG	Multi-Dose Vial	2000/02/24	Sanofi Pasteur Limited	Rx	Voluntarily Revoked
TheraCys	103943	001	351(a)	BCG Live	For Injection	Intravesical	81MG	Vial	2000/02/24	Sanofi Pasteur Limited	Rx	Voluntarily Revoked
	103944	001	351(a)	Diphtheria & Tetanus Toxoids Adsorbed	Injection	Intramuscular	25/LF/5LF/0.5ML	Single-Dose Vial	2000/02/24	Sanofi Pasteur Limited	Disc	Voluntarily Revoked		N/A
prevnar	103905	001	351(a)	Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)	Injection	Intramuscular	0.5ML/VIAL	Pre-Filled Syringe	2000/02/17	Wyeth Pharmaceuticals LLC	Rx	Voluntarily Revoked
Ipol	103930	001	351(a)	Poliovirus Vaccine Inactivated	Injection	Intramuscular	32/40/8 DAU/.5ML	Multi-Dose Vial	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Ipol	103930	002	351(a)	Poliovirus Vaccine Inactivated	Injection	Subcutaneous	32/40/8 DAU/.5ML	Multi-Dose Vial	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Imovax Rabies	103931	001	351(a)	Rabies Vaccine	For Injection	Intramuscular	2.5IU/ML	Single-Dose Vial	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Acthib,Omnihib	103935	001	351(a)	Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)	For Injection	Intramuscular	24UG	Single-Dose Vial	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Typhim Vi	103936	001	351(a)	Typhoid Vi Polysaccharide Vaccine	Injection	Intramuscular	50UG/ML	Pre-Filled Syringe	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Typhim Vi	103936	002	351(a)	Typhoid Vi Polysaccharide Vaccine	Injection	Intramuscular	25UG/.5ML	Multi-Dose Vial	2000/02/04	Sanofi Pasteur SA	Rx	Licensed		N/A
Humalog Mix 75/25	021017	001	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	750UNITS/10ML (75UNITS/ML); 250UNITS/10ML (25UNITS/ML)	Multi-Dose Vial	1999/12/22	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Humalog Mix 75/25	021017	003	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	225UNITS/3ML (75UNITS/ML); 75UNITS/3ML (25UNITS/ML)	Autoinjector	1999/12/22	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Humalog Mix 50/50	021018	001	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	500UNITS/10ML (50UNITS/ML); 500UNITS/10ML (50UNITS/ML)	Multi-Dose Vial	1999/12/22	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Humalog Mix 50/50	021018	003	351(a)	insulin lispro protamine and insulin lispro	Injectable Suspension	Subcutaneous	150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML)	Autoinjector	1999/12/22	Eli Lilly and Company	Disc	Licensed	N/A	N/A
	103913	001	351(a)	Tetanus Toxoid Adsorbed	Injection	Intramuscular	5LF/.5ML	Vial	1999/12/09	Sanofi Pasteur Inc.	Rx	Voluntarily Revoked

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	-