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
Skyrizi	761105	4	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	1	351(a)	elivaldogene autotemcel	Injection	Intravenous	2-30 × 10^6 CELL/ML	Bag	2022/09/16	Bluebird Bio Inc.	Rx	Licensed	N/A	N/A
Rolvedon	761148	1	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	1	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	2	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	1	351(k) Biosimilar	pegfilgrastim-fpgk	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2022/09/01	Fresenius Kabi USA, LLC	Rx	Licensed	pegfilgrastim-fpgk	Neulasta
Spevigo	761244	1	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	1	351(a)	olipudase alfa-rpcp	For Injection	Intravenous	20MG	Single-Dose Vial	2022/08/31	Genzyme Corporation	Rx	Licensed	N/A	N/A
Zynteglo	125717	1	351(a)	betibeglogene autotemcel	For Injection	Intravenous	1.7-20 X 10^6CELL/ML	Bag	2022/08/17	Bluebird Bio Inc.	Rx	Licensed	N/A	N/A
Hadlima	761059	4	351(k) Biosimilar	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2022/08/15	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Hadlima	761059	5	351(k) Biosimilar	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2022/08/15	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Cimerli	761165	1	351(k) Interchangeable	ranibizumab-eqrn	Injection	Intravitreal	10MG/ML (0.5MG/0.05ML)	Single-Dose Vial	2022/08/02	Coherus BioSciences, Inc.	Rx	Licensed	ranibizumab	Lucentis
Cimerli	761165	2	351(k) Interchangeable	ranibizumab-eqrn	Injection	Intravitreal	6MG/ML (0.3MG/0.05ML)	Single-Dose Vial	2022/08/02	Coherus BioSciences, Inc.	Rx	Licensed	ranibizumab	Lucentis
Ultomiris	761108	4	351(a)	ravulizumab-cwvz	Injection	Subcutaneous	245MG/3.5ML (70MG/ML)	Single-Dose Cartridge	2022/06/22	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Hadlima	761059	3	351(k) Biosimilar	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.8ML	Single-Dose Vial	2022/06/17	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Skyrizi	761105	5	351(a)	risankizumab-rzaa	Injection	Subcutaneous	360MG/2.4ML (150MG/ML)	Single-Dose Cartridge	2022/06/16	AbbVie Inc.	Rx	Licensed	N/A	N/A
Skyrizi	761105	6	351(a)	risankizumab-rzaa	Injection	Intravenous	600MG/10ML (60MG/ML)	Single-Dose Vial	2022/06/16	AbbVie Inc.	Rx	Licensed	N/A	N/A
PRIORIX	125748	1	351(a)	Measles, Mumps and Rubella Virus Vaccine Live	For Injection	Subcutaneous	3.4, 4.2 and 3.3LOG10	Single-Dose Vial	2022/06/03	GlaxoSmithKline Biologicals	Rx	Licensed	N/A	N/A
Beovu	761125	2	351(a)	brolucizumab-dbll	Injection	Intravitreal	6MG/0.05ML	Pre-Filled Syringe	2022/05/27	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Fylnetra	761084	1	351(k) Biosimilar	pegfilgrastim-pbbk	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2022/05/26	Kashiv BioSciences, LLC	Rx	Licensed	pegfilgrastim	Neulasta

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	-