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
Pharmalgen	103970	001	351(a)	Venoms, Mixed Vespid Venom Protein	For Injection	Subcutaneous	300UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103970	002	351(a)	Venoms, Mixed Vespid Venom Protein	For Injection	Intradermal	300UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103971	001	351(a)	Venoms, Wasp Venom Protein	For Injection	Subcutaneous	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103971	002	351(a)	Venoms, Wasp Venom Protein	For Injection	Intradermal	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103972	001	351(a)	Venoms, White Faced Hornet Venom Protein	For Injection	Subcutaneous	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103972	002	351(a)	Venoms, White Faced Hornet Venom Protein	For Injection	Intradermal	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103973	001	351(a)	Venoms, Yellow Hornet Venom Protein	For Injection	Subcutaneous	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103973	002	351(a)	Venoms, Yellow Hornet Venom Protein	For Injection	Intradermal	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103974	001	351(a)	Venoms, Yellow Jacket Venom Protein	For Injection	Subcutaneous	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103974	002	351(a)	Venoms, Yellow Jacket Venom Protein	For Injection	Intradermal	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Novolin N	019959	001	351(a)	insulin isophane human	Injectable Suspension	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	1991/07/01	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Novolin N	019959	002	351(a)	insulin isophane human	Injectable Suspension	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	1991/07/01	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Survanta	020032	001	351(a)	beractant	Suspension	Intratracheal	100MG/4ML (25MG/ML)	Single-Dose Vial	1991/07/01	AbbVie Inc.	Rx	Licensed	N/A	N/A
Survanta	020032	002	351(a)	beractant	Suspension	Intratracheal	200MG/8ML (25MG/ML)	Single-Dose Vial	1991/07/01	AbbVie Inc.	Rx	Licensed	N/A	N/A
Novolin R	019938	001	351(a)	insulin human	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	1991/06/25	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Novolin 70/30	019991	001	351(a)	insulin isophane human and insulin human	Injection	Subcutaneous	300UNITS/10ML (30UNITS/ML); 700UNITS/10ML (70UNITS/ML)	Multi-Dose Vial	1991/06/25	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Leukine	103362	001	351(a)	sargramostim	For Injection	Intravenous, Subcutaneous	250MCG	Single-Dose Vial	1991/03/05	Partner Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Leukine	103362	002	351(a)	sargramostim	Injection	Intravenous, Subcutaneous	500MCG/ML	Multi-Dose Vial	1991/03/05	Partner Therapeutics, Inc.	Disc	Licensed	N/A	N/A
Neupogen	103353	001	351(a)	filgrastim	Injection	Intravenous, Subcutaneous	300MCG/ML	Single-Dose Vial	1991/02/20	Amgen Inc.	Rx	Licensed	N/A	N/A
Neupogen	103353	002	351(a)	filgrastim	Injection	Intravenous, Subcutaneous	480MCG/1.6ML	Single-Dose Vial	1991/02/20	Amgen Inc.	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	-