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
Gammagard, Gammagard S/D, Iveegam	103133	003	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	2500MG	Single-Use Bottle	1986/02/18	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
Gammagard, Gammagard S/D, Iveegam	103133	004	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	500MG	Single-Use Bottle	1986/02/18	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
Gammagard, Gammagard S/D, Iveegam	103133	005	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	5000MG	Single-Use Bottle	1986/02/18	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
Thrombin-Jmi, Thrombocoll	102865	001	351(a)	Thrombin, Topical (Bovine)	Powder	Topical	20,000IU	Vial	1986/02/03	GenTrac, Inc.	Rx	Licensed		N/A
Pergonal	017646	002	351(a)	menotropins	For Injection	Subcutaneous, Intramuscular	150IU	Single-Dose Vial	1985/05/20	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Novarel	017016	010	351(a)	chorionic gonadotropin	For Injection	Intramuscular	15,000UNITS	Multi-Dose Vial	1985/02/15	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Novarel	017016	009	351(a)	chorionic gonadotropin	For Injection	Intramuscular	2,000UNITS	Multi-Dose Vial	1984/12/27	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Chymodiactin	018663	002	351(a)	chymopapain	For Injection	Intrathecal	4,000UNITS	Single-Dose Vial	1984/08/21	DisCure Medical, LLC	Disc	Licensed	N/A	N/A
Panhematin	101246	001	351(a)	Hemin for Injection	For Injection	Intravenous	350MG	Single-Dose Vial	1983/07/20	Recordati Rare Diseases, Inc.	Rx	Licensed		N/A
Microlite	018263	001	351(a)	radiolabeled albumin technetium Tc-99m albumin colloid kit				Single-Dose Vial	1983/03/25	Pharmalucence Inc	Disc	Voluntarily Revoked	N/A	N/A
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

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	-