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
Hulio	761154	003	351(k) Interchangeable	adalimumab-fkjp	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2020/07/06	Biocon Biologics Inc.	Rx	Licensed	adalimumab	Humira
Retacrit	125545	006	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	20,000UNITS/2ML (10,000UNITS/ML)	Multi-Dose Vial	2020/06/30	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	007	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	20,000UNITS/ML	Multi-Dose Vial	2020/06/30	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Phesgo	761170	001	351(a)	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Injection	Subcutaneous	1,200MG, 600MG, 30,000UNITS/15ML (80MG, 40MG, 2,000UNITS/ML)	Single-Dose Vial	2020/06/29	Genentech, Inc.	Rx	Licensed	N/A	N/A
Phesgo	761170	002	351(a)	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Injection	Subcutaneous	600MG, 600MG, 20,000UNITS/10ML (60MG, 60MG, 2,000UNITS/ML)	Single-Dose Vial	2020/06/29	Genentech, Inc.	Rx	Licensed	N/A	N/A
Gamifant	761107	003	351(a)	emapalumab-lzsg	Injection	Intravenous	100MG/20ML (5MG/ML)	Single-Dose Vial	2020/06/26	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
Dupixent	761055	004	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Autoinjector	2020/06/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Lyumjev	761109	001	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2020/06/15	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Lyumjev	761109	002	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Lyumjev	761109	003	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Lyumjev	761109	004	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Lyumjev	761109	005	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2020/06/15	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Lyumjev	761109	006	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	600UNITS/3ML (200UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Semglee	210605	001	351(a)	insulin glargine	Injection	Subcutaneous	1,000UNITS/10ML (100 UNITS/ML)	Multi-Dose Vial	2020/06/11	Mylan Pharmaceuticals Inc.	Disc	Voluntarily Revoked	N/A	N/A
Semglee	210605	002	351(a)	insulin glargine	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/11	Mylan Pharmaceuticals Inc.	Disc	Voluntarily Revoked	N/A	N/A
Uplizna	761142	001	351(a)	inebilizumab-cdon	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2020/06/11	Horizon Therapeutics Ireland DAC	Rx	Licensed	N/A	N/A
Nyvepria	761111	001	351(k) Biosimilar	pegfilgrastim-apgf	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2020/06/10	Hospira Inc., a Pfizer Company	Rx	Licensed	pegfilgrastim	Neulasta
Darzalex Faspro	761145	001	351(a)	daratumumab and hyaluronidase-fihj	Injection	Subcutaneous	1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2020/05/01	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Menquadfi	125701	001	351(a)	Meningococcal (Groups A, C, Y, W) Conjugate Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2020/04/23	Sanofi Pasteur Inc.	Rx	Licensed
Trodelvy	761115	001	351(a)	sacituzumab govitecan-hziy	For Injection	Intravenous	180MG	Single-Dose Vial	2020/04/22	Gilead Sciences, Inc.	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	-