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
ALTUVIIIO	125771	1	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	250IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	2	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	500IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	3	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	750IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	4	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	1000IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	5	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	2000IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	6	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	3000IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
ALTUVIIIO	125771	7	351(a)	antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	For Injection	Intravenous	4000IU	Single-Dose Vial	2023/02/22	Bioverativ Therapeutics, Inc.	Rx	Licensed
Lamzede	761278	1	351(a)	velmanase alfa-tycv	For Injection	Intravenous	10MG	Single-Dose Vial	2023/02/16	Chiesi Farmaceutici S.p.A.	Rx	Licensed
Takhzyro	761090	3	351(a)	lanadelumab-flyo	Injection	Subcutaneous	150MG/1ML (150MG/ML)	Pre-Filled Syringe	2023/02/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Tezspire	761224	3	351(a)	tezepelumab-ekko	Injection	Subcutaneous	210MG/1.91ML (110MG/ML)	Autoinjector	2023/02/01	AstraZeneca AB	Rx	Licensed
Leqembi	761269	1	351(a)	lecanemab-irmb	Injection	Intravenous	200MG/2ML (100MG/ML)	Single-Dose Vial	2023/01/06	Eisai, Incorporated	Rx	Licensed
Leqembi	761269	2	351(a)	lecanemab-irmb	Injection	Intravenous	500MG/5ML (100MG/ML)	Single-Dose Vial	2023/01/06	Eisai, Incorporated	Rx	Licensed
Briumvi	761238	1	351(a)	ublituximab-xiiy	Injection	Intravenous	150MG/6ML (25MG/ML)	Single-Dose Vial	2022/12/28	TG Therapeutics, Inc.	Rx	Licensed
Nexobrid	761192	1	351(a)	anacaulase-bcdb	For Topical Gel	Topical	8.8% (1.94GM)	Single-Use Jar	2022/12/28	MediWound, Ltd.	Rx	Licensed
Nexobrid	761192	2	351(a)	anacaulase-bcdb	For Topical Gel	Topical	8.8% (4.85GM)	Single-Use Jar	2022/12/28	MediWound, Ltd.	Rx	Licensed
Lunsumio	761263	1	351(a)	mosunetuzumab-axgb	Injection	Intravenous	1MG/ML	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed
Lunsumio	761263	2	351(a)	mosunetuzumab-axgb	Injection	Intravenous	30MG/30ML (1MG/ML)	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed
Adstiladrin	125700	1	351(a)	nadofaragene firadenovec-vncg	For Suspension	Intravesical	3x10^11 viral particles (vp)/mL	Single-Dose Vial	2022/12/16	Ferring Pharmaceuticals A/S	Rx	Licensed
Idacio	761255	1	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Idacio	761255	2	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira

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	-