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
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	001	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	1999/12/09	Sanofi Pasteur Inc.	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	002	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	45UG/.5ML	Single-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Yf-Vax	103915	001	351(a)	Yellow Fever Vaccine	For Injection	Subcutaneous	23.7PFU/.5ML	Multi-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Yf-Vax	103915	002	351(a)	Yellow Fever Vaccine	For Injection	Subcutaneous	4.74PFU/.5ML	Single-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Rx	Licensed		N/A
	103919	001	351(a)	Diphtheria & Tetanus Toxoids Adsorbed	Injection	Intramuscular	6.6; 5 UNITS	Vial	1999/12/09	Sanofi Pasteur Inc.	Rx	Voluntarily Revoked
	103921	001	351(a)	Tetanus and Diphtheria Toxoids Adsorbed	Injection	Intramuscular	2.5LF, 5LF, 2.5UG, 8UG/.5ML	Pre-Filled Syringe	1999/12/09	Sanofi Pasteur Inc.	Rx	Voluntarily Revoked
	103921	002	351(a)	Tetanus and Diphtheria Toxoids Adsorbed	Injection	Intramuscular	2.5LF, 5LF, 2.5UG, 8UG/.5ML	Single-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Rx	Voluntarily Revoked
Tripedia	103922	001	351(a)	Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	Injection	Intramuscular	6.7LF, 5LF, 46.8UG/.5ML	Vial	1999/12/09	Sanofi Pasteur Inc.	Rx	Voluntarily Revoked
Menomune-C	103923	001	351(a)	Meningococcal Polysaccharide Vaccine, Group C	For Injection	Subcutaneous	0.5ML	Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Voluntarily Revoked		N/A
Menomune-A	103924	001	351(a)	Meningococcal Polysaccharide Vaccine, Group A	For Injection	Subcutaneous	0.5ML	Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Voluntarily Revoked		N/A
Menomune-A/C	103925	001	351(a)	Meningococcal Polysaccharide Vaccine, Groups A and C Combined	For Injection	Subcutaneous	50UG/.5ML	Single-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Voluntarily Revoked		N/A
Menomune-A/C	103925	002	351(a)	Meningococcal Polysaccharide Vaccine, Groups A and C Combined	For Injection	Subcutaneous	50UG/.5ML	Multi-Dose Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Voluntarily Revoked		N/A
Menomune	103926	001	351(a)	Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined	For Injection	Subcutaneous	50UG/.5ML	Vial	1999/12/09	Sanofi Pasteur Inc.	Disc	Voluntarily Revoked		N/A
Curosurf	020744	001	351(a)	poractant alfa	Suspension	Intratracheal	120MG/1.5ML (80MG/ML)	Single-Dose Vial	1999/11/18	Chiesi USA, Inc.	Rx	Licensed	N/A	N/A
Curosurf	020744	002	351(a)	poractant alfa	Suspension	Intratracheal	240MG/3ML (80MG/ML)	Single-Dose Vial	1999/11/18	Chiesi USA, Inc.	Rx	Licensed	N/A	N/A
Cerezyme	020367	002	351(a)	imiglucerase	For Injection	Intravenous	400UNITS/VIAL	Single-Dose Vial	1999/09/22	Genzyme Corporation	Rx	Licensed	N/A	N/A
Repronex	021047	001	351(a)	menotropins	For Injection	Subcutaneous, Intramuscular	75IU	Single-Dose Vial	1999/08/27	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Repronex	021047	002	351(a)	menotropins	For Injection	Subcutaneous, Intramuscular	150IU	Single-Dose Vial	1999/08/27	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Enbrel	103795	002	351(a)	etanercept	For Injection	Subcutaneous	25MG	Multi-Dose Vial	1999/05/27	Immunex Corporation	Rx	Licensed	N/A	N/A
Thymoglobulin	103869	001	351(a)	Anti-thymocyte Globulin (Rabbit)	For Injection	Intravenous	25MG	Single-Dose Vial	1999/05/19	Genzyme Corporation	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	-