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
Chymodiactin	018663	001	351(a)	chymopapain	For Injection	Intrathecal	10,000UNITS	Single-Dose Vial	1982/11/10	DisCure Medical, LLC	Disc	Licensed	N/A	N/A
Humulin R U-100	018780	001	351(a)	insulin human	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	1982/10/28	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Humulin N	018781	001	351(a)	insulin isophane human	Injectable Suspension	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	1982/10/28	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Humulin N	018781	002	351(a)	insulin isophane human	Injectable Suspension	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Vial	1982/10/28	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Gamimune	101147	001	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5PCT	Vial	1981/09/11	Grifols Therapeutics LLC	Disc	Voluntarily Revoked
Gamimune	101147	002	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10PCT	Vial	1981/09/11	Grifols Therapeutics LLC	Disc	Voluntarily Revoked
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd	102476	001	351(a)	Factor IX Complex	For Injection	Intravenous	1000IU	Single-Dose Vial	1981/07/20	Grifols Biologicals LLC	Rx	Licensed		N/A
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd	102476	002	351(a)	Factor IX Complex	For Injection	Intravenous	1500IU	Single-Dose Vial	1981/07/20	Grifols Biologicals LLC	Rx	Licensed		N/A
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd	102476	003	351(a)	Factor IX Complex	For Injection	Intravenous	500IU	Single-Dose Vial	1981/07/20	Grifols Biologicals LLC	Rx	Licensed		N/A
Autoplex, Feiba Nf, Feiba Vh	101447	001	351(a)	Anti-Inhibitor Coagulant Complex	For Injection	Intravenous	1000IU	Bottle	1979/12/21	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
Autoplex, Feiba Nf, Feiba Vh	101447	002	351(a)	Anti-Inhibitor Coagulant Complex	For Injection	Intravenous	500IU	Bottle	1979/12/21	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
	101993	001	351(a)	Albumin (Human)	Injection	Intravenous	0.25	Multi-Dose Vial	1979/09/07	Central Laboratory of the Netherlands Red Cross Blood Transfusion Service	Rx	Licensed		N/A
Albutein	102478	004	351(a)	Albumin (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Albutein	102478	005	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanate	102475	001	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	250IU	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanate	102475	002	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanate	102475	003	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	1500IU	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Alphanate	102475	004	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Albutein	102478	001	351(a)	Albumin (Human)	Injection	Intravenous	10G/50ML	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	Rx	Licensed		N/A
Albutein	102478	002	351(a)	Albumin (Human)	Injection	Intravenous	20G/100ML	Single-Dose Vial	1978/08/15	Grifols Biologicals LLC	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	-