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
Eloctate	125487	009	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	6000IU	Single-Dose Vial	2017/01/27	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	010	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	4000IU	Single-Dose Vial	2017/01/27	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Ilaris	125319	002	351(a)	canakinumab	Injection	Subcutaneous	150MG/ML	Single-Dose Vial	2016/12/22	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Maci	125603	001	351(a)	autologous cultured chondrocytes on porcine collagen membrane	Cell Sheets	Implantation	500,000 CM2 CM2	Pouch	2016/12/13	Vericel Corporation	Rx	Licensed		N/A
Xultophy 100/3.6	208583	001	351(a)	insulin degludec and liraglutide	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML); 10.8MG/3ML (3.6MG/ML)	Autoinjector	2016/11/21	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Soliqua 100/33	208673	001	351(a)	insulin glargine and lixisenatide	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML)	Autoinjector	2016/11/21	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Adynovate	125566	005	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	1500IU	Single-Dose Vial	2016/10/25	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Adynovate	125566	006	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	750IU	Single-Dose Vial	2016/10/25	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Zinplava	761046	001	351(a)	bezlotoxumab	Injection	Intravenous	1,000MG/40ML (25MG/ML)	Single-Dose Vial	2016/10/21	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Lartruvo	761038	001	351(a)	olaratumab	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2016/10/19	Eli Lilly and Company	Disc	Voluntarily Revoked	N/A	N/A
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

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	-