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
Cutaquig	125668	005	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	8G/48ML	Single-Dose Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Cutaquig	125668	006	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	4G/24ML	Single-Dose Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Truxima	761088	001	351(k) Biosimilar	rituximab-abbs	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2018/11/28	CELLTRION, Inc.	Rx	Licensed	rituximab	Rituxan
Truxima	761088	002	351(k) Biosimilar	rituximab-abbs	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2018/11/28	CELLTRION, Inc.	Rx	Licensed	rituximab	Rituxan
Tresiba	203314	003	351(a)	insulin degludec	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2018/11/21	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Gamifant	761107	001	351(a)	emapalumab-lzsg	Injection	Intravenous	10MG/2ML (5MG/ML)	Single-Dose Vial	2018/11/20	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
Gamifant	761107	002	351(a)	emapalumab-lzsg	Injection	Intravenous	50MG/10ML (5MG/ML)	Single-Dose Vial	2018/11/20	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
Actemra	125472	002	351(a)	tocilizumab	Injection	Subcutaneous	162MG/0.9ML	Autoinjector	2018/11/19	Genentech, Inc.	Rx	Licensed	N/A	N/A
Udenyca	761039	001	351(k) Biosimilar	pegfilgrastim-cbqv	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2018/11/02	Accord BioPharma Inc.	Rx	Licensed	pegfilgrastim	Neulasta
Hyrimoz	761071	001	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2018/10/30	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	002	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2018/10/30	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Admelog	209196	003	351(a)	insulin lispro	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Vial	2018/10/19	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Dupixent	761055	003	351(a)	dupilumab	Injection	Subcutaneous	200MG/1.14ML	Pre-Filled Syringe	2018/10/19	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Revcovi	761092	001	351(a)	elapegademase-lvlr	Injection	Intramuscular	2.4MG/1.5ML (1.6MG/ML)	Single-Dose Vial	2018/10/05	Chiesi USA, Inc.	Rx	Licensed	N/A	N/A
Afluria, Afluria Quadrivalent	125254	005	351(a)	Influenza Vaccine	Injection	Intramuscular	30UG/.25ML	Pre-Filled Syringe	2018/10/04	Seqirus Pty Ltd.	Disc	Licensed	N/A	N/A
Xolair	103976	002	351(a)	omalizumab	Injection	Subcutaneous	75MG/0.5ML	Pre-Filled Syringe	2018/09/28	Genentech, Inc.	Rx	Licensed	N/A	N/A
Xolair	103976	003	351(a)	omalizumab	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2018/09/28	Genentech, Inc.	Rx	Licensed	N/A	N/A
Libtayo	761097	001	351(a)	cemiplimab-rwlc	Injection	Intravenous	350MG/7ML (50MG/ML)	Single-Dose Vial	2018/09/28	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Emgality	761063	001	351(a)	galcanezumab-gnlm	Injection	Subcutaneous	120MG/ML	Autoinjector	2018/09/27	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Emgality	761063	002	351(a)	galcanezumab-gnlm	Injection	Subcutaneous	120MG/ML	Pre-Filled Syringe	2018/09/27	Eli Lilly and Company	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	-