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
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
Alphanine, Alphanine Hp, Alphanine Sd	103249	001	351(a)	Coagulation Factor IX (Human)	Injection	Intravenous	500IU	Single-Dose Vial	1990/12/31	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanine, Alphanine Hp, Alphanine Sd	103249	002	351(a)	Coagulation Factor IX (Human)	Injection	Intravenous	1000IU	Single-Dose Vial	1990/12/31	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanine, Alphanine Hp, Alphanine Sd	103249	003	351(a)	Coagulation Factor IX (Human)	Injection	Intravenous	250IU	Single-Dose Vial	1990/12/31	Grifols Biologicals LLC	Disc	Licensed		N/A
Alphanine, Alphanine Hp, Alphanine Sd	103249	004	351(a)	Coagulation Factor IX (Human)	Injection	Intravenous	1500IU	Single-Dose Vial	1990/12/31	Grifols Biologicals LLC	Rx	Licensed		N/A
Cytogam	103189	001	351(a)	Cytomegalovirus Immune Globulin Intravenous (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	1990/04/17	Kamada Ltd.	Rx	Licensed		N/A
Adagen	019818	001	351(a)	pegademase bovine	Injection	Intramuscular	375UNITS/1.5ML (250UNITS/ML)	Single-Dose Vial	1990/03/21	Leadiant Biosciences, Inc	Disc	Licensed	N/A	N/A
Novarel	017016	011	351(a)	chorionic gonadotropin	For Injection	Intramuscular	2,000UNITS	Multi-Dose Vial	1990/02/16	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Pedvaxhib	103237	001	351(a)	Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)	Injection	Intramuscular	7.5UG/.5ML	Single-Dose Vial	1989/12/20	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Vivotif	103123	001	351(a)	Typhoid Vaccine Live Oral Ty21a	Capsule	Oral	2-6.8 BIL. CFU	Blister Pack	1989/12/15	Bavarian Nordic A/S	Rx	Licensed		N/A
Alferon N Injection	103158	001	351(a)	interferon alfa-n3 (human leukocyte derived)	Injection	Intravenous	5MILLION IU/1ML	Vial	1989/10/10	AIM ImmunoTech 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	-