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
IXCHIQ	125777	001	351(a)	Chikungunya Vaccine, Live	For Injection	Intramuscular	3.0 log10 TCID	Single-Dose Vial	2023/11/09	Valneva Austria GmbH	Rx	Licensed	N/A	N/A
ADZYNMA	125795	001	351(a)	ADAMTS13, recombinant-krhn	For Injection	Intravenous	500IU	Single-Dose Vial	2023/11/09	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
ADZYNMA	125795	002	351(a)	ADAMTS13, recombinant-krhn	For Injection	Intravenous	1500IU	Single-Dose Vial	2023/11/09	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Wezlana	761285	001	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761285	002	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761285	003	351(k) Interchangeable	ustekinumab-auub	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Wezlana	761331	001	351(k) Interchangeable	ustekinumab-auub	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2023/10/31	Amgen Inc.	Rx	Licensed	ustekinumab	Stelara
Zenpep	022210	008	351(a)	pancrelipase	Capsule, Delayed Release	Oral	60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS		2023/10/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Loqtorzi	761240	001	351(a)	toripalimab-tpzi	Injection	Intravenous	240MG/6ML (40MG/ML)	Single-Dose Vial	2023/10/27	Coherus BioSciences, Inc.	Rx	Licensed	N/A	N/A
Omvoh	761279	001	351(a)	mirikizumab-mrkz	Injection	Intravenous	300MG/15ML (20MG/ML)	Single-Dose Vial	2023/10/26	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Omvoh	761279	002	351(a)	mirikizumab-mrkz	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2023/10/26	Eli Lilly and Company	Rx	Licensed	N/A	N/A
PENBRAYA	125770	001	351(a)	Meningococcal Groups A, B, C, W, and Y Vaccine	Injection	Intramuscular	5UG	Pre-Filled Syringe	2023/10/20	Pfizer Ireland Pharmaceuticals	Rx	Licensed	N/A	N/A
Zymfentra	761358	001	351(a)	infliximab-dyyb	Injection	Subcutaneous	120MG/ML	Pre-Filled Syringe	2023/10/20	CELLTRION, Inc.	Rx	Licensed	N/A	N/A
Zymfentra	761358	002	351(a)	infliximab-dyyb	Injection	Subcutaneous	120MG/ML	Autoinjector	2023/10/20	CELLTRION, Inc.	Rx	Licensed	N/A	N/A
Bimzelx	761151	001	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	160MG/ML	Pre-Filled Syringe	2023/10/17	UCB, Inc.	Rx	Licensed	N/A	N/A
Bimzelx	761151	002	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	160MG/ML	Autoinjector	2023/10/17	UCB, Inc.	Rx	Licensed	N/A	N/A
Cosentyx	761349	001	351(a)	secukinumab	Injection	Intravenous	125MG/5ML	Single-Dose Vial	2023/10/06	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Yuflyma	761219	003	351(k) Interchangeable	adalimumab-aaty	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/09/29	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Yuflyma	761219	004	351(k) Interchangeable	adalimumab-aaty	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/09/29	CELLTRION, Inc.	Rx	Licensed	adalimumab	Humira
Yuflyma	761219	005	351(k) Interchangeable	adalimumab-aaty	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/09/29	CELLTRION, 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	-