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
Humira	125057	008	351(a)	adalimumab	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2016/10/17	AbbVie Inc.	Rx	Licensed	N/A	N/A
Lucentis	125156	003	351(a)	ranibizumab	Injection	Intravitreal	10MG/ML (0.5MG/0.05ML)	Pre-Filled Syringe	2016/10/13	Genentech, Inc.	Rx	Licensed	N/A	N/A
Flublok	125285	002	351(a)	Influenza Vaccine	Injection	Intramuscular	180UG/.5ML	Pre-Filled Syringe	2016/10/07	Protein Sciences Corporation	Rx	Licensed		N/A
Pertzye	022175	003	351(a)	pancrelipase	Capsule, Delayed Release	Oral	4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS		2016/10/06	Digestive Care, Inc.	Rx	Licensed	N/A	N/A
Amjevita	761024	001	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2016/09/23	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	002	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2016/09/23	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	003	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2016/09/23	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Stelara	761044	001	351(a)	ustekinumab	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2016/09/23	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Cuvitru	125596	001	351(a)	Immune Globulin Subcutaneous (Human), 20% Solution	Injection	Subcutaneous	1G/5ML	Single-Dose Vial	2016/09/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Cuvitru	125596	002	351(a)	Immune Globulin Subcutaneous (Human), 20% Solution	Injection	Subcutaneous	2G/10ML	Single-Dose Vial	2016/09/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
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

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	-