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
Roctavian	125720	001	351(a)	valoctocogene roxaparvovec-rvox	Injection	Intravenous	16X 10E13GENOMES PER ML	Single-Dose Vial	2023/06/29	Biomarin Pharmaceutical Inc.	Rx	Licensed
Lantidra	125734	001	351(a)	donislecel-jujn	Suspension	Intravenous	1X10E6EQUIVALENT ISLET NUMBER (EIN)	Bag	2023/06/28	CellTrans Inc.	Rx	Licensed
Ngenla	761184	001	351(a)	somatrogon-ghla	Injection	Subcutaneous	24MG/1.2ML (20MG/ML)	Autoinjector	2023/06/27	Pfizer Ireland Pharmaceuticals Unlimited Company	Rx	Licensed
Ngenla	761184	002	351(a)	somatrogon-ghla	Injection	Subcutaneous	60MG/1.2ML (50MG/ML)	Autoinjector	2023/06/27	Pfizer Ireland Pharmaceuticals Unlimited Company	Rx	Licensed
Rystiggo	761286	001	351(a)	rozanolixizumab-noli	Injection	Subcutaneous	280MG/2ML (140MG/ML)	Single-Dose Vial	2023/06/26	UCB, Inc.	Rx	Licensed
ELEVIDYS	125781	001	351(a)	delandistrogene moxeparvovec-rokl	Suspension	Intravenous	1.33 10E14 vector genomes (vg)/kg/bodyweight(bw)	Single-Dose Vial	2023/06/22	Sarepta Therapeutics, Inc.	Rx	Licensed
Fiasp	208751	004	351(a)	insulin aspart	Injection	Subcutaneous	160UNITS/1.6ML (100UNITS/ML)	Multi-Dose Cartridge	2023/06/21	Novo Nordisk Inc.	Rx	Licensed
Vyvgart Hytrulo	761304	001	351(a)	efgartigimod alfa and hyaluronidase-qvfc	Injection	Subcutaneous	1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML)	Single-Dose Vial	2023/06/20	Argenx BV	Rx	Licensed
Columvi	761309	001	351(a)	glofitamab-gxbm	Injection	Intravenous	2.5MG/2.5ML (1MG/ML)	Single-Dose Vial	2023/06/15	Genentech, Inc.	Rx	Licensed
Columvi	761309	002	351(a)	glofitamab-gxbm	Injection	Intravenous	10MG/10ML (1MG/ML)	Single-Dose Vial	2023/06/15	Genentech, Inc.	Rx	Licensed
Gamifant	761107	004	351(a)	emapalumab-lzsg	Injection	Intravenous	50MG/2ML (25MG/ML)	Single-Dose Vial	2023/06/07	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed
Gamifant	761107	005	351(a)	emapalumab-lzsg	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2023/06/07	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed
Gamifant	761107	006	351(a)	emapalumab-lzsg	Injection	Intravenous	250MG/10ML (25MG/ML)	Single-Dose Vial	2023/06/07	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed
Abrysvo	125769	001	351(a)	Respiratory Syncytial Virus Vaccine	Injection	Intramuscular	120UG	Single-Dose Vial	2023/05/31	Pfizer Inc.	Rx	Licensed
Yuflyma	761219	001	351(k) Interchangeable	adalimumab-aaty	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2023/05/23	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Yuflyma	761219	002	351(k) Interchangeable	adalimumab-aaty	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/05/23	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
VYJUVEK	125774	001	351(a)	beremagene geperpavec-svdt	Gel	Topical	5.0x10^9 PFU/mL	Single-Dose Vial	2023/05/19	Krystal Biotech, Inc.	Rx	Licensed
Epkinly	761324	001	351(a)	epcoritamab-bysp	Injection	Subcutaneous	4MG/0.8ML	Single-Dose Vial	2023/05/19	Genmab US, Inc.	Rx	Licensed
Epkinly	761324	002	351(a)	epcoritamab-bysp	Injection	Subcutaneous	48MG/0.8ML	Single-Dose Vial	2023/05/19	Genmab US, Inc.	Rx	Licensed
Cyltezo	761058	004	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2023/05/18	Boehringer Ingelheim Pharmaceuticals, Inc.	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License 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	-