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
Cuvitru	125596	003	351(a)	Immune Globulin Subcutaneous (Human), 20% Solution	Injection	Subcutaneous	8G/40ML	Single-Dose Vial	2016/09/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Cuvitru	125596	004	351(a)	Immune Globulin Subcutaneous (Human), 20% Solution	Injection	Subcutaneous	4G/20ML	Single-Dose Vial	2016/09/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Clevecord	125594	001	351(a)	HPC, Cord Blood	Injection	Intravenous	5 x 10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 x 106 VIABLE CD34+ CELLS	Bag	2016/09/01	Cleveland Cord Blood Center	Rx	Licensed		N/A
Erelzi	761042	001	351(k) Biosimilar	etanercept-szzs	Injection	Subcutaneous	25MG/0.5ML	Pre-Filled Syringe	2016/08/30	Sandoz Inc.	Disc	Licensed	etanercept	Enbrel
Erelzi	761042	002	351(k) Biosimilar	etanercept-szzs	Injection	Subcutaneous	50MG/ML	Pre-Filled Syringe	2016/08/30	Sandoz Inc.	Disc	Licensed	etanercept	Enbrel
Erelzi Sensoready	761042	003	351(k) Biosimilar	etanercept-szzs	Injection	Subcutaneous	50MG/ML	Autoinjector	2016/08/30	Sandoz Inc.	Disc	Licensed	etanercept	Enbrel
Afluria, Afluria Quadrivalent	125254	003	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2016/08/26	Seqirus Pty Ltd.	Disc	Licensed		N/A
Afluria, Afluria Quadrivalent	125254	004	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Multi-Dose Vial	2016/08/26	Seqirus Pty Ltd.	Disc	Licensed		N/A
Adlyxin	208471	001	351(a)	lixisenatide	Injection	Subcutaneous	150MCG/3ML (50MCG/ML)	Autoinjector	2016/07/27	Sanofi-Aventis U.S. LLC	Disc	Licensed	N/A	N/A
Adlyxin	208471	002	351(a)	lixisenatide	Injection	Subcutaneous	300MCG/3ML (100MCG/ML)	Autoinjector	2016/07/27	Sanofi-Aventis U.S. LLC	Disc	Licensed	N/A	N/A
Alprolix	125444	006	351(a)	Coagulation Factor IX (Recombinant), Fc Fusion Protein	For Injection	Intravenous	4000IU	Single-Dose Vial	2016/07/14	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Repatha	125522	003	351(a)	evolocumab	Injection	Subcutaneous	420MG/3.5ML	Autoinjector	2016/07/08	Amgen Inc.	Disc	Licensed	N/A	N/A
Vaxchora	125597	001	351(a)	Cholera Vaccine, Live, Oral	Suspension	Oral	100ML	Packet	2016/06/10	Bavarian Nordic A/S	Rx	Licensed		N/A
Orencia	125118	003	351(a)	abatacept	Injection	Subcutaneous	125MG/ML	Autoinjector	2016/06/07	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Zinbryta	761029	001	351(a)	daclizumab	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2016/05/27	Biogen Inc.	Disc	Voluntarily Revoked	N/A	N/A
Afstyla	125591	001	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	3000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	002	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	1000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	003	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	250IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	004	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	2000IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	005	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	500IU	Single-Dose Vial	2016/05/25	CSL Behring Lengnau AG	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	-