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
Krystexxa	125293	002	351(a)	pegloticase	Injection	Intravenous	8MG/50ML (0.16MG/ML)	Single-Dose Vial	2025/08/29	Horizon Therapeutics Ireland DAC	Rx	Licensed	N/A	N/A
Leqembi IQLIK	761375	001	351(a)	lecanemab-irmb	Injection	Subcutaneous	360MG/1.8ML (200MG/ML)	Autoinjector	2025/08/29	Eisai, Incorporated	Rx	Licensed	N/A	N/A
Bildyos	761444	001	351(k) Interchangeable	denosumab-nxxp	Injection	Subcutaneous	60MG/ML	Single-Dose Vial	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Prolia
Bildyos	761444	002	351(k) Interchangeable	denosumab-nxxp	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Prolia
Bilprevda	761444	003	351(k) Interchangeable	denosumab-nxxp	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2025/08/29	Shanghai Henlius Biotech, Inc.	Rx	Licensed	denosumab	Xgeva
Comirnaty	125742	004	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	10UG	Single-Dose Vial	2025/08/27	BioNTech Manufacturing GmbH	Rx	Licensed	N/A	N/A
PAPZIMEOS	125832	001	351(a)	zopapogene imadenovec-drba	For Injection	Subcutaneous	5x10^11PARTICLE UNITS	Single-Dose Vial	2025/08/14	Precigen, Inc.	Rx	Licensed	N/A	N/A
Skytrofa	761177	010	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	0.7MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	011	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	1.4MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	012	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	1.8MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	013	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	2.1MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	014	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	2.5MG	Single-Dose Cartridge	2025/07/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Shingrix	125614	003	351(a)	Zoster Vaccine Recombinant, Adjuvanted	Injection	Intramuscular	50UG	Pre-Filled Syringe	2025/07/16	GlaxoSmithKline Biologicals	Rx	Licensed	N/A
Kirsty	761188	001	351(k) Interchangeable	insulin aspart-xjhz	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2025/07/15	Biocon Biologics Inc.	Rx	Licensed	insulin aspart	Novolog
Kirsty	761188	002	351(k) Interchangeable	insulin aspart-xjhz	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2025/07/15	Biocon Biologics Inc.	Rx	Licensed	insulin aspart	Novolog
Spikevax	125752	005	351(a)	COVID-19 Vaccine, mRNA	Injection	Intramuscular	25UG/0.25mL	Pre-Filled Syringe	2025/07/09	ModernaTX, Inc.	Rx	Licensed	N/A	N/A
Lynozyfic	761400	001	351(a)	linvoseltamab-gcpt	Injection	Intravenous	5MG/2.5ML (2MG/ML)	Single-Dose Vial	2025/07/02	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Lynozyfic	761400	002	351(a)	linvoseltamab-gcpt	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2025/07/02	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Pyzchiva	761373	004	351(k) Interchangeable	ustekinumab-ttwe	Injection	Subcutaneous	45MG/0.5ML	Autoinjector	2025/06/27	Samsung Bioepis Co., Ltd.	Rx	Licensed	ustekinumab	Stelara
Pyzchiva	761373	005	351(k) Interchangeable	ustekinumab-ttwe	Injection	Subcutaneous	90MG/ML	Autoinjector	2025/06/27	Samsung Bioepis Co., Ltd.	Rx	Licensed	ustekinumab	Stelara

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	-