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	004	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	N/A	N/A
ALTUVIIIO	125771	005	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	N/A	N/A
ALTUVIIIO	125771	006	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	N/A	N/A
ALTUVIIIO	125771	007	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	N/A	N/A
Lamzede	761278	001	351(a)	velmanase alfa-tycv	For Injection	Intravenous	10MG	Single-Dose Vial	2023/02/16	Chiesi Farmaceutici S.p.A.	Rx	Licensed	N/A	N/A
Takhzyro	761090	003	351(a)	lanadelumab-flyo	Injection	Subcutaneous	150MG/1ML (150MG/ML)	Pre-Filled Syringe	2023/02/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Tezspire	761224	003	351(a)	tezepelumab-ekko	Injection	Subcutaneous	210MG/1.91ML (110MG/ML)	Autoinjector	2023/02/01	AstraZeneca AB	Rx	Licensed	N/A	N/A
Leqembi	761269	001	351(a)	lecanemab-irmb	Injection	Intravenous	200MG/2ML (100MG/ML)	Single-Dose Vial	2023/01/06	Eisai, Incorporated	Rx	Licensed	N/A	N/A
Leqembi	761269	002	351(a)	lecanemab-irmb	Injection	Intravenous	500MG/5ML (100MG/ML)	Single-Dose Vial	2023/01/06	Eisai, Incorporated	Rx	Licensed	N/A	N/A
Nexobrid	761192	001	351(a)	anacaulase-bcdb	For Topical Gel	Topical	8.8% (1.94GM)	Single-Use Jar	2022/12/28	Vericel Corporation	Disc	Licensed	N/A	N/A
Nexobrid	761192	002	351(a)	anacaulase-bcdb	For Topical Gel	Topical	8.8% (4.85GM)	Single-Use Jar	2022/12/28	Vericel Corporation	Rx	Licensed	N/A	N/A
Briumvi	761238	001	351(a)	ublituximab-xiiy	Injection	Intravenous	150MG/6ML (25MG/ML)	Single-Dose Vial	2022/12/28	TG Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Lunsumio	761263	001	351(a)	mosunetuzumab-axgb	Injection	Intravenous	1MG/ML	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Lunsumio	761263	002	351(a)	mosunetuzumab-axgb	Injection	Intravenous	30MG/30ML (1MG/ML)	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Adstiladrin	125700	001	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	N/A	N/A
Idacio	761255	001	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Idacio	761255	002	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Rebyota	125739	001	351(a)	fecal microbiota, live-jslm	Suspension	Rectal	BETWEEN 1X10^8 AND 5X10^10CFU	Single-Use Bottle	2022/11/30	Ferring Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Albutein	102478	009	351(a)	Albumin (Human)	Injection	Intravenous	5G/100ML	Bag	2022/11/29	Grifols Biologicals LLC	Disc	Licensed	N/A	N/A
Hemgenix	125772	001	351(a)	etranacogene dezaparvovec-drlb	Injection	Intravenous	1X10E13GENOME COPIES/ML	Single-Dose Vial	2022/11/22	CSL Behring LLC	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	-