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
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	N/A	N/A
Columvi	761309	002	351(a)	glofitamab-gxbm	Injection	Intravenous	10MG/10ML (1MG/ML)	Single-Dose Vial	2023/06/15	Genentech, Inc.	Rx	Licensed	N/A	N/A
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	N/A	N/A
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	N/A	N/A
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	N/A	N/A
Abrysvo	125769	001	351(a)	Respiratory Syncytial Virus Vaccine	Injection	Intramuscular	120UG	Single-Dose Vial	2023/05/31	Pfizer Inc.	Rx	Licensed	N/A	N/A
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	N/A	N/A
Epkinly	761324	001	351(a)	epcoritamab-bysp	Injection	Subcutaneous	4MG/0.8ML	Single-Dose Vial	2023/05/19	Genmab US, Inc.	Rx	Licensed	N/A	N/A
Epkinly	761324	002	351(a)	epcoritamab-bysp	Injection	Subcutaneous	48MG/0.8ML	Single-Dose Vial	2023/05/19	Genmab US, Inc.	Rx	Licensed	N/A	N/A
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
Cosentyx	125504	005	351(a)	secukinumab	Injection	Subcutaneous	300MG/2ML	Autoinjector	2023/05/11	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Cosentyx	125504	006	351(a)	secukinumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2023/05/11	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Elfabrio	761161	001	351(a)	pegunigalsidase alfa-iwxj	Injection	Intravenous	20MG/10ML (2MG/ML)	Single-Dose Vial	2023/05/09	Chiesi Farmaceutici S.p.A.	Rx	Licensed	N/A	N/A
Arexvy	125775	001	351(a)	Respiratory Syncytial Virus Vaccine, Adjuvanted	For Injection	Intramuscular	120UG/.5ML	Single-Dose Vial	2023/05/03	GlaxoSmithKline Biologicals	Rx	Licensed	N/A	N/A
Sogroya	761156	003	351(a)	somapacitan-beco	Injection	Subcutaneous	15MG/1.5ML (10MG/ML)	Autoinjector	2023/04/28	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Vowst	125757	001	351(a)	fecal microbiota spores, live-brpk	Capsule	Oral	1X10 LOG 6 AND 3X10 LOG 7CFU/TAB	Bottle	2023/04/26	Aimmune Therapeutics, Inc.	Rx	Licensed	N/A	N/A
OMISIRGE	125738	001	351(a)	omidubicel-onlv	For Injection	Intravenous	>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so	Bag	2023/04/17	Gamida Cell Ltd.	Rx	Licensed	N/A	N/A
Hizentra	125350	005	351(a)	Immune Globulin Subcutaneous (Human), 20% Liquid	Injection	Subcutaneous	10G/50ML	Pre-Filled Syringe	2023/04/13	CSL Behring AG	Rx	Licensed		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	-