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
Hemlibra	761083	005	351(a)	emicizumab-kxwh	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Single-Dose Vial	2023/03/16	Genentech, Inc.	Rx	Licensed	N/A	N/A
Udenyca	761039	002	351(k) Biosimilar	pegfilgrastim-cbqv	Injection	Subcutaneous	6MG/0.6ML	Autoinjector	2023/03/03	Accord BioPharma Inc.	Rx	Licensed	pegfilgrastim	Neulasta
M-M-R Ii	101069	002	351(a)	Measles, Mumps and Rubella Virus Vaccine Live	For Injection	Intramuscular	0.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Varivax	103552	002	351(a)	Varicella Virus Vaccine Live	For Injection	Intramuscular	NLT 1350PFU/.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Proquad	125108	002	351(a)	Measles, Mumps, Rubella and Varicella Virus Vaccine Live	For Injection	Intramuscular	0.5ML	Single-Dose Vial	2023/02/27	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Yusimry	761216	002	351(k) Biosimilar	adalimumab-aqvh	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2023/02/27	Hong Kong King-Friend Industrial Company Limited	Rx	Licensed	adalimumab	Humira
ALTUVIIIO	125771	001	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	N/A	N/A
ALTUVIIIO	125771	002	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	N/A	N/A
ALTUVIIIO	125771	003	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	N/A	N/A
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

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	-