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
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
Humate-P	103960	003	351(a)	Antihemophilic Factor/von Willebrand Factor Complex (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2000/04/11	CSL Behring GmbH	Rx	Licensed		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	001	351(a)	Albumin (Human)	Injection	Intravenous	10G/50ML	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	002	351(a)	Albumin (Human)	Injection	Intravenous	20G/100ML	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	004	351(a)	Albumin (Human)	Injection	Intravenous	5G/20ML	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5	103955	005	351(a)	Albumin (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
gammar i.v.,gammar-p i.v.	103956	001	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	10G	Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked
gammar i.v.,gammar-p i.v.	103956	002	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	5G	Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked
gammar i.v.,gammar-p i.v.	103956	003	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	2.5G	Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked
gammar i.v.,gammar-p i.v.	103956	004	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	1G	Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked
Mononine	103957	001	351(a)	Coagulation Factor IX (Human)	For Injection	Intravenous	1000IU	Single-Dose Vial	2000/03/17	CSL Behring LLC	Disc	Voluntarily Revoked		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	-