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
Steqeyma	761338	003	351(k) Interchangeable	ustekinumab-stba	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/12/17	CELLTRION, Inc.	Rx	Licensed	ustekinumab	Stelara
Unloxcyt	761297	001	351(a)	cosibelimab-ipdl	Injection	Intravenous	300MG/5ML (60MG/ML)	Single-Dose Vial	2024/12/13	Checkpoint Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Bizengri	761352	001	351(a)	zenocutuzumab-zbco	Injection	Intravenous	375MG/18.75ML (20MG/ML)	Single-Dose Vial	2024/12/04	Merus NV	Rx	Licensed	N/A	N/A
Jivi	125661	005	351(a)	Antihemophilic factor (recombinant), PEGylated-aucl	For Injection	Intravenous	4000IU	Single-Dose Vial	2024/12/02	Bayer HealthCare LLC	Rx	Licensed	N/A	N/A
Yesintek	761406	001	351(k) Interchangeable	ustekinumab-kfce	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2024/11/29	Biocon Biologics Inc.	Rx	Licensed	ustekinumab	Stelara
Yesintek	761406	002	351(k) Interchangeable	ustekinumab-kfce	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/11/29	Biocon Biologics Inc.	Rx	Licensed	ustekinumab	Stelara
Yesintek	761406	003	351(k) Interchangeable	ustekinumab-kfce	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/11/29	Biocon Biologics Inc.	Rx	Licensed	ustekinumab	Stelara
Yesintek	761406	004	351(k) Interchangeable	ustekinumab-kfce	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/11/29	Biocon Biologics Inc.	Rx	Licensed	ustekinumab	Stelara
regenecyte	125764	001	351(a)	HPC, Cord Blood	Injection	Intravenous	>/=1.25x10E6 VIABLE CD34+ CELLS/UNIT IN >/=9x10E8 TNCs/UNIT	Bag	2024/11/21	StemCyte, Inc.	Rx	Licensed	N/A	N/A
Ziihera	761416	001	351(a)	zanidatamab-hrii	For Injection	Intravenous	300MG	Single-Dose Vial	2024/11/20	Jazz Pharmaceuticals Ireland Limited	Rx	Licensed	N/A	N/A
KEBILIDI	125722	001	351(a)	eladocagene exuparvovec-tneq	Suspension	Intraputaminal	5.6x10^11VG/ML	Single-Dose Vial	2024/11/13	PTC Therapeutics	Rx	Licensed	N/A	N/A
Aucatzyl	125813	001	351(a)	Obecabtagene autoleucel	Suspension	Intravenous	410 × 10^6CAR+ T CELLS TOTAL; DELIVERED AS A SPLIT DOSE IN 3-5 BAGS ON DAY 1 & 10	Bag	2024/11/08	Autolus, Inc.	Rx	Licensed	N/A	N/A
Selarsdi	761343	003	351(k) Interchangeable	ustekinumab-aekn	Injection	Intravenous	130MG/26ML (5MG/ML)	Single-Dose Vial	2024/10/18	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Vyloy	761365	001	351(a)	zolbetuximab-clzb	Injection	Intravenous	100MG	Single-Dose Vial	2024/10/18	Astellas Pharma US, Inc.	Rx	Licensed	N/A	N/A
Bimzelx	761151	003	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	320MG/2ML (160MG/2ML)	Pre-Filled Syringe	2024/10/11	UCB, Inc.	Rx	Licensed	N/A	N/A
Bimzelx	761151	004	351(a)	bimekizumab-bkzx	Injection	Subcutaneous	320MG/2ML (160MG/2ML)	Autoinjector	2024/10/11	UCB, Inc.	Rx	Licensed	N/A	N/A
Hympavzi	761369	001	351(a)	marstacimab-hncq	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2024/10/11	Pfizer Inc.	Rx	Licensed	N/A	N/A
Hympavzi	761369	002	351(a)	marstacimab-hncq	Injection	Subcutaneous	150MG/ML	Autoinjector	2024/10/11	Pfizer Inc.	Rx	Licensed	N/A	N/A
Imuldosa	761364	001	351(k) Biosimilar	ustekinumab-srlf	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/10/10	Accord BioPharma Inc.	Rx	Licensed	ustekinumab	Stelara
Imuldosa	761364	002	351(k) Biosimilar	ustekinumab-srlf	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/10/10	Accord BioPharma Inc.	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	-