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
Briumvi	761238	001	351(a)	ublituximab-xiiy	Injection	Intravenous	150MG/6ML (25MG/ML)	Single-Dose Vial	2022/12/28	TG Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Lunsumio	761263	001	351(a)	mosunetuzumab-axgb	Injection	Intravenous	1MG/ML	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Lunsumio	761263	002	351(a)	mosunetuzumab-axgb	Injection	Intravenous	30MG/30ML (1MG/ML)	Single-Dose Vial	2022/12/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Adstiladrin	125700	001	351(a)	nadofaragene firadenovec-vncg	For Suspension	Intravesical	3x10^11 viral particles (vp)/mL	Single-Dose Vial	2022/12/16	Ferring Pharmaceuticals A/S	Rx	Licensed	N/A	N/A
Idacio	761255	001	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Idacio	761255	002	351(k) Biosimilar	adalimumab-aacf	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2022/12/13	Fresenius Kabi USA, LLC	Rx	Licensed	adalimumab	Humira
Rebyota	125739	001	351(a)	fecal microbiota, live-jslm	Suspension	Rectal	BETWEEN 1X10^8 AND 5X10^10CFU	Single-Use Bottle	2022/11/30	Ferring Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Albutein	102478	009	351(a)	Albumin (Human)	Injection	Intravenous	5G/100ML	Bag	2022/11/29	Grifols Biologicals LLC	Disc	Licensed	N/A	N/A
Hemgenix	125772	001	351(a)	etranacogene dezaparvovec-drlb	Injection	Intravenous	1X10E13GENOME COPIES/ML	Single-Dose Vial	2022/11/22	CSL Behring LLC	Rx	Licensed	N/A	N/A
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

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	-