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	006	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	10G	Single-Use Bottle	2000/07/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Gammagard, Gammagard S/D, Iveegam	103133	007	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	2.5G	Single-Use Bottle	2000/07/27	Takeda Pharmaceuticals U.S.A., Inc.	Disc	Licensed		N/A
Gammagard, Gammagard S/D, Iveegam	103133	008	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	5.0G	Single-Use Bottle	2000/07/27	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	003	351(a)	Albumin (Human)	Injection	Intravenous	25G/100ML	Single-Dose Vial	2000/07/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	006	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	2000/07/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	007	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/250ML	Single-Dose Vial	2000/07/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	008	351(a)	Albumin (Human)	Injection	Intravenous	25G/500ML	Single-Dose Vial	2000/07/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Neupogen	103353	003	351(a)	filgrastim	Injection	Subcutaneous	300MCG/0.5ML	Pre-Filled Syringe	2000/06/28	Amgen Inc.	Rx	Licensed	N/A	N/A
Neupogen	103353	004	351(a)	filgrastim	Injection	Subcutaneous	480MCG/0.8ML	Pre-Filled Syringe	2000/06/28	Amgen Inc.	Rx	Licensed	N/A	N/A
Norditropin	021148	001	351(a)	somatropin	Injection	Subcutaneous	5MG/1.5ML	Multi-Dose Cartridge	2000/06/20	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Norditropin	021148	002	351(a)	somatropin	Injection	Subcutaneous	10MG/1.5ML	Multi-Dose Cartridge	2000/06/20	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Norditropin	021148	003	351(a)	somatropin	Injection	Subcutaneous	15MG/1.5ML	Multi-Dose Cartridge	2000/06/20	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Novolog	020986	001	351(a)	insulin aspart	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2000/06/07	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Novolog	020986	002	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2000/06/07	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
TNKase	103909	001	351(a)	tenecteplase	For Injection	Intravenous	50MG	Single-Dose Vial	2000/06/02	Genentech, Inc.	Rx	Licensed	N/A	N/A
Lantus	021081	001	351(a)	insulin glargine	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2000/04/20	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Lantus	021081	003	351(a)	insulin glargine	Injection	Subcutaneous	500UNITS/5ML (100UNITS/ML)	Multi-Dose Vial	2000/04/20	Sanofi-Aventis U.S. LLC	Disc	Licensed	N/A	N/A
Lantus	021081	004	351(a)	insulin glargine	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2000/04/20	Sanofi-Aventis U.S. LLC	Disc	Licensed	N/A	N/A
Humate-P	103960	001	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	2000/04/11	CSL Behring GmbH	Rx	Licensed		N/A
Humate-P	103960	002	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	250IU	Single-Dose Vial	2000/04/11	CSL Behring GmbH	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	-