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
Andembry	761367	001	351(a)	garadacimab-gxii	Injection	Subcutaneous	200MG/1.2ML (167MG/ML)	Autoinjector	2025/06/16	CSL Behring LLC	Rx	Licensed	N/A	N/A
Andembry	761367	002	351(a)	garadacimab-gxii	Injection	Subcutaneous	200MG/1.2ML (167MG/ML)	Pre-Filled Syringe	2025/06/16	CSL Behring LLC	Rx	Licensed	N/A	N/A
Steqeyma	761338	004	351(k) Interchangeable	ustekinumab-stba	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2025/06/12	CELLTRION, Inc.	Rx	Licensed	ustekinumab	Stelara
Enflonsia	761432	001	351(a)	clesrovimab-cfor	Injection	Intramuscular	105MG/0.7ML	Pre-Filled Syringe	2025/06/09	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
mnexspike	125835	001	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	10UG	Pre-Filled Syringe	2025/05/30	ModernaTX, Inc.	Rx	Licensed	N/A	N/A
Spevigo	761244	003	351(a)	spesolimab-sbzo	Injection	Subcutaneous	300MG/2ML (150MG/ML)	Pre-Filled Syringe	2025/05/28	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Starjemza	761419	001	351(k) Interchangeable	ustekinumab-hmny	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2025/05/22	Bio-Thera Solutions, Ltd.	Rx	Licensed	ustekinumab	Stelara
Starjemza	761419	002	351(k) Interchangeable	ustekinumab-hmny	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2025/05/22	Bio-Thera Solutions, Ltd.	Rx	Licensed	ustekinumab	Stelara
Starjemza	761419	003	351(k) Interchangeable	ustekinumab-hmny	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2025/05/22	Bio-Thera Solutions, Ltd.	Rx	Licensed	ustekinumab	Stelara
Starjemza	761419	004	351(k) Interchangeable	ustekinumab-hmny	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2025/05/22	Bio-Thera Solutions, Ltd.	Rx	Licensed	ustekinumab	Stelara
NUVAXOVID	125817	001	351(a)	COVID-19 Vaccine, Adjuvanted	Injection	Intramuscular	5UG	Pre-Filled Syringe	2025/05/16	Novavax, Inc.	Rx	Licensed	N/A	N/A
Emrelis	761384	001	351(a)	telisotuzumab vedotin-tllv	Injection	Intravenous	20MG	Single-Dose Vial	2025/05/14	AbbVie Inc.	Rx	Licensed	N/A	N/A
Emrelis	761384	002	351(a)	telisotuzumab vedotin-tllv	Injection	Intravenous	100MG	Single-Dose Vial	2025/05/14	AbbVie Inc.	Rx	Licensed	N/A	N/A
Humalog	205747	002	351(a)	insulin lispro	Injection	Subcutaneous	600UNITS/3ML (200UNITS/ML)	Autoinjector	2025/05/07	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Imaavy	761430	001	351(a)	nipocalimab-aahu	Injection	Intravenous	300MG/1.62ML (185MG/ML)	Single-Dose Vial	2025/04/29	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Imaavy	761430	002	351(a)	nipocalimab-aahu	Injection	Intravenous	1,200MG/6.5ML (185MG/ML)	Single-Dose Vial	2025/04/29	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
zevaskyn	125807	001	351(a)	Prademagene zamikeracel	Cellular Sheet	Topical	41.25CM^2	Tray & Lid	2025/04/28	Abeona Therapeutics Inc.	Rx	Licensed	N/A	N/A
	761258	001	351(a)	penpulimab-kcqx	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2025/04/23	Akeso Biopharma Co., Ltd.	Rx	Licensed	N/A	N/A
Ahzantive	761378	002	351(k) Biosimilar	aflibercept-mrbb	Injection	Intravitreal	2MG/0.05ML	Pre-Filled Syringe	2025/04/17	Formycon AG	Rx	Licensed	aflibercept	Eylea
Vyvgart Hytrulo	761304	002	351(a)	efgartigimod alfa and hyaluronidase-qvfc	Injection	Subcutaneous	1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML)	Pre-Filled Syringe	2025/04/10	Argenx BV	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	-