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
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
Fiasp	208751	003	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Cartridge	2018/09/24	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Ajovy	761089	001	351(a)	fremanezumab-vfrm	Injection	Subcutaneous	225MG/1.5ML	Pre-Filled Syringe	2018/09/14	Teva Branded Pharmaceutical Products R&D, Inc.	Rx	Licensed	N/A	N/A
Lumoxiti	761104	001	351(a)	moxetumomab pasudotox-tdfk	For Injection	Intravenous	1MG	Single-Dose Vial	2018/09/13	AstraZeneca AB	Disc	Voluntarily Revoked	N/A	N/A
Jivi	125661	001	351(a)	Antihemophilic factor (recombinant), PEGylated-aucl	For Injection	Intravenous	1000IU	Single-Dose Vial	2018/08/29	Bayer HealthCare LLC	Rx	Licensed		N/A
Jivi	125661	002	351(a)	Antihemophilic factor (recombinant), PEGylated-aucl	For Injection	Intravenous	3000IU	Single-Dose Vial	2018/08/29	Bayer HealthCare LLC	Rx	Licensed		N/A
Jivi	125661	003	351(a)	Antihemophilic factor (recombinant), PEGylated-aucl	For Injection	Intravenous	2000IU	Single-Dose Vial	2018/08/29	Bayer HealthCare LLC	Rx	Licensed		N/A
Jivi	125661	004	351(a)	Antihemophilic factor (recombinant), PEGylated-aucl	For Injection	Intravenous	500IU	Single-Dose Vial	2018/08/29	Bayer HealthCare LLC	Rx	Licensed		N/A
Takhzyro	761090	001	351(a)	lanadelumab-flyo	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Single-Dose Vial	2018/08/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Oxervate	761094	001	351(a)	cenegermin-bkbj	Solution	Topical	0.002% (20MCG/ML)	Multi-Dose Vial	2018/08/22	Dompé farmaceutici S.p.A.	Rx	Licensed	N/A	N/A
Eylea	125387	002	351(a)	aflibercept	Injection	Intravitreal	2MG/0.05ML	Pre-Filled Syringe	2018/08/16	Regeneron Pharmaceuticals, 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	-