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
Tzield	761183	001	351(a)	teplizumab-mzwv	Injection	Intravenous	2MG/2ML (1MG/ML)	Single-Dose Vial	2022/11/17	Provention Bio, Inc.	Rx	Licensed	N/A	N/A
Elahere	761310	001	351(a)	mirvetuximab soravtansine-gynx	Injection	Intravenous	100MG/20ML (5MG/ML)	Single-Dose Vial	2022/11/14	ImmunoGen, Inc.	Rx	Licensed	N/A	N/A
Erelzi	761042	004	351(k) Biosimilar	etanercept-szzs	For Injection	Subcutaneous	25MG	Multi-Dose Vial	2022/11/10	Sandoz Inc.	Disc	Licensed	etanercept	Enbrel
Rotarix	125265	002	351(a)	Rotavirus Vaccine, Live, Oral	Suspension	Oral	106.0CCID50	Tube	2022/11/04	GlaxoSmithKline Biologicals	Disc	Licensed
Rotarix	125265	003	351(a)	Rotavirus Vaccine, Live, Oral	Suspension	Oral	106.0CCID50	Oral Applicator	2022/11/04	GlaxoSmithKline Biologicals	Rx	Licensed
Tecvayli	761291	001	351(a)	teclistamab-cqyv	Injection	Subcutaneous	30MG/3ML (10MG/ML)	Single-Dose Vial	2022/10/25	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Tecvayli	761291	002	351(a)	teclistamab-cqyv	Injection	Subcutaneous	153MG/1.7ML (90MG/ML)	Single-Dose Vial	2022/10/25	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Imjudo	761289	001	351(a)	tremelimumab-actl	Injection	Intravenous	25MG/1.25ML (20MG/ML)	Single-Dose Vial	2022/10/21	AstraZeneca AB	Rx	Licensed	N/A	N/A
Imjudo	761289	002	351(a)	tremelimumab-actl	Injection	Intravenous	300MG/15ML (20MG/ML)	Single-Dose Vial	2022/10/21	AstraZeneca AB	Rx	Licensed	N/A	N/A
Menveo	125300	002	351(a)	Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2022/10/14	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Vegzelma	761268	001	351(k) Biosimilar	bevacizumab-adcd	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2022/09/27	CELLTRION, Inc.	Rx	Licensed	bevacizumab	Avastin
Vegzelma	761268	002	351(k) Biosimilar	bevacizumab-adcd	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2022/09/27	CELLTRION, Inc.	Rx	Licensed	bevacizumab	Avastin
Skyrizi	761105	004	351(a)	risankizumab-rzaa	Injection	Subcutaneous	180MG/1.2ML (150MG/ML)	Single-Dose Cartridge	2022/09/23	AbbVie Inc.	Rx	Licensed	N/A	N/A
Skysona	125755	001	351(a)	elivaldogene autotemcel	Injection	Intravenous	2-30 × 10^6 CELL/ML	Bag	2022/09/16	Bluebird Bio Inc.	Rx	Licensed
Rolvedon	761148	001	351(a)	eflapegrastim-xnst	Injection	Subcutaneous	13.2MG/0.6ML	Pre-Filled Syringe	2022/09/09	Spectrum Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Daxxify	761127	001	351(a)	daxibotulinumtoxinA-lanm	For Injection	Intramuscular	50UNITS	Single-Dose Vial	2022/09/07	Revance Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Daxxify	761127	002	351(a)	daxibotulinumtoxinA-lanm	For Injection	Intramuscular	100UNITS	Single-Dose Vial	2022/09/07	Revance Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Stimufend	761173	001	351(k) Biosimilar	pegfilgrastim-fpgk	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2022/09/01	Fresenius Kabi USA, LLC	Rx	Licensed	pegfilgrastim	Neulasta
Spevigo	761244	001	351(a)	spesolimab-sbzo	Injection	Intravenous	450MG/7.5ML (60MG/ML)	Single-Dose Vial	2022/09/01	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Xenpozyme	761261	001	351(a)	olipudase alfa-rpcp	For Injection	Intravenous	20MG	Single-Dose Vial	2022/08/31	Genzyme Corporation	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	-