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
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
Amjevita	761024	004	351(k) Interchangeable	adalimumab-atto	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2023/04/06	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Xenpozyme	761261	002	351(a)	olipudase alfa-rpcp	For Injection	Intravenous	4MG	Single-Dose Vial	2023/03/31	Genzyme Corporation	Rx	Licensed	N/A	N/A
Skyrizi	761105	006	351(a)	risankizumab-rzaa	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2023/03/22	AbbVie Inc.	Rx	Licensed	N/A	N/A
Zynyz	761334	001	351(a)	retifanlimab-dlwr	Injection	Intravenous	500MG/20ML (25MG/ML)	Single-Dose Vial	2023/03/22	Incyte Corporation	Rx	Licensed	N/A	N/A
Hyrimoz	761071	004	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	005	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	006	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	007	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	008	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	009	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	10MG/0.1ML	Pre-Filled Syringe	2023/03/20	Sandoz Inc.	Rx	Licensed	adalimumab	Humira
Hyrimoz	761071	010	351(k) Interchangeable	adalimumab-adaz	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/03/20	Sandoz 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	-