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 R	019938	002	351(a)	insulin human	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2018/06/01	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Novolin 70/30	019991	002	351(a)	insulin isophane human and insulin human	Injection	Subcutaneous	90UNITS/3ML (30UNITS/ML); 210UNITS/3ML (70UNITS/ML)	Autoinjector	2018/06/01	Novo Nordisk Inc.	OTC	Licensed	N/A	N/A
Idelvion	125582	005	351(a)	Coagulation Factor IX (Recombinant), Albumin Fusion Protein	For Injection	Intravenous	3500IU	Single-Dose Vial	2018/05/30	CSL Behring Lengnau AG	Rx	Licensed		N/A
Humulin R U-100	018780	005	351(a)	insulin human	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Vial	2018/05/25	Eli Lilly and Company	OTC	Licensed	N/A	N/A
Palynziq	761079	001	351(a)	pegvaliase-pqpz	Injection	Subcutaneous	2.5MG/0.5ML	Pre-Filled Syringe	2018/05/24	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Palynziq	761079	002	351(a)	pegvaliase-pqpz	Injection	Subcutaneous	10MG/0.5ML	Pre-Filled Syringe	2018/05/24	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Palynziq	761079	003	351(a)	pegvaliase-pqpz	Injection	Subcutaneous	20MG/ML	Pre-Filled Syringe	2018/05/24	BioMarin Pharmaceutical Inc.	Rx	Licensed	N/A	N/A
Aimovig	761077	001	351(a)	erenumab-aooe	Injection	Subcutaneous	70MG/ML	Autoinjector	2018/05/17	Amgen Inc.	Rx	Licensed	N/A	N/A
Aimovig	761077	002	351(a)	erenumab-aooe	Injection	Subcutaneous	70MG/ML	Pre-Filled Syringe	2018/05/17	Amgen Inc.	Disc	Licensed	N/A	N/A
Retacrit	125545	001	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	2,000UNITS/ML	Single-Dose Vial	2018/05/15	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	002	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	3,000UNITS/ML	Single-Dose Vial	2018/05/15	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	003	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	4,000UNITS/ML	Single-Dose Vial	2018/05/15	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	004	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	10,000UNITS/ML	Single-Dose Vial	2018/05/15	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	005	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	40,000UNITS/ML	Single-Dose Vial	2018/05/15	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Andexxa	125586	001	351(a)	Coagulation Factor Xa (Recombinant), Inactivated-zhzo	Injection	Intravenous	100MG	Single-Dose Vial	2018/05/03	AstraZeneca AB	Disc	Licensed		N/A
Crysvita	761068	001	351(a)	burosumab-twza	Injection	Subcutaneous	10MG/ML	Single-Dose Vial	2018/04/17	Kyowa Kirin, Inc.	Rx	Licensed	N/A	N/A
Crysvita	761068	002	351(a)	burosumab-twza	Injection	Subcutaneous	20MG/ML	Single-Dose Vial	2018/04/17	Kyowa Kirin, Inc.	Rx	Licensed	N/A	N/A
Crysvita	761068	003	351(a)	burosumab-twza	Injection	Subcutaneous	30MG/ML	Single-Dose Vial	2018/04/17	Kyowa Kirin, Inc.	Rx	Licensed	N/A	N/A
Kevzara	761037	003	351(a)	sarilumab	Injection	Subcutaneous	150MG/1.14ML	Autoinjector	2018/04/13	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Kevzara	761037	004	351(a)	sarilumab	Injection	Subcutaneous	200MG/1.14ML	Autoinjector	2018/04/13	Sanofi-Aventis U.S. LLC	Rx	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	-