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
Nucala	761122	004	351(a)	mepolizumab	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2022/01/22	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Adbry	761180	001	351(a)	tralokinumab-ldrm	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2021/12/27	LEO Pharma A/S	Rx	Licensed	N/A	N/A
Vyvgart	761195	001	351(a)	efgartigimod alfa-fcab	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2021/12/17	Argenx BV	Rx	Licensed	N/A	N/A
Rezvoglar	761215	001	351(k) Interchangeable	insulin glargine-aglr	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2021/12/17	Eli Lilly and Company	Rx	Licensed	insulin glargine	Lantus
Yusimry	761216	001	351(k) Biosimilar	adalimumab-aqvh	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2021/12/17	Hong Kong King-Friend Industrial Company Limited	Rx	Licensed	adalimumab	Humira
Tezspire	761224	001	351(a)	tezepelumab-ekko	Injection	Subcutaneous	210MG/1.91ML (110MG/ML)	Single-Dose Vial	2021/12/17	AstraZeneca AB	Rx	Licensed	N/A	N/A
Tezspire	761224	002	351(a)	tezepelumab-ekko	Injection	Subcutaneous	210MG/1.91ML (110MG/ML)	Pre-Filled Syringe	2021/12/17	AstraZeneca AB	Rx	Licensed	N/A	N/A
Nuwiq	125555	008	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1500IU	Single-Dose Vial	2021/12/07	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Prehevbrio	125737	001	351(a)	Hepatitis B Vaccine (Recombinant)	For Injection	Intramuscular	10UG/ML	Single-Dose Vial	2021/11/30	VBI Vaccines (Delaware), Inc.	Disc	Licensed	N/A	N/A
Besremi	761166	001	351(a)	ropeginterferon alfa-2b-njft	Injection	Subcutaneous	500MCG/ML	Pre-Filled Syringe	2021/11/12	PharmaEssentia Corporation	Rx	Licensed	N/A	N/A
Susvimo	761197	001	351(a)	ranibizumab	Injection	Intravitreal	100MG/ML	Single-Dose Vial	2021/10/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Dupixent	761055	006	351(a)	dupilumab	Injection	Subcutaneous	100MG/0.67ML	Pre-Filled Syringe	2021/10/20	Regeneron Pharmaceuticals, Inc.	Disc	Licensed	N/A	N/A
Rethymic	125685	001	351(a)	allogeneic processed thymus tissue-agdc	For Suspension	Implantation	SEMI-QUANTITATIVE	Dish	2021/10/08	Sumitomo Pharma Switzerland GmbH	Rx	Licensed	N/A	N/A
Sogroya	761156	002	351(a)	somapacitan-beco	Injection	Subcutaneous	5MG/1.5ML (3.3MG/ML)	Autoinjector	2021/10/01	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Inmazeb	761169	002	351(a)	atoltivimab, maftivimab, and odesivimab-ebgn	Injection	Intravenous	483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML)	Single-Dose Vial	2021/09/29	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Tivdak	761208	001	351(a)	tisotumab vedotin-tftv	For Injection	Intravenous	40MG	Single-Dose Vial	2021/09/20	Seagen Inc.	Rx	Licensed	N/A	N/A
Byooviz	761202	001	351(k) Interchangeable	ranibizumab-nuna	Injection	Intravitreal	10MG/ML	Single-Dose Vial	2021/09/17	Samsung Bioepis Co., Ltd.	Rx	Licensed	ranibizumab	Lucentis
Opdivo	125554	004	351(a)	nivolumab	Injection	Intravenous	120MG/12ML (10MG/ML)	Single-Dose Vial	2021/08/27	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Skytrofa	761177	001	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	3MG	Single-Dose Cartridge	2021/08/25	Ascendis Pharma Endocrinology Division A/S	Rx	Licensed	N/A	N/A
Skytrofa	761177	002	351(a)	lonapegsomatropin-tcgd	For Injection	Subcutaneous	3.6MG	Single-Dose Cartridge	2021/08/25	Ascendis Pharma Endocrinology Division A/S	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	-