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
Kesimpta	125326	003	351(a)	ofatumumab	Injection	Subcutaneous	20MG/0.4ML	Autoinjector	2020/08/20	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Kesimpta	125326	004	351(a)	ofatumumab	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2020/08/20	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Enspryng	761149	001	351(a)	satralizumab-mwge	Injection	Subcutaneous	120MG/ML	Pre-Filled Syringe	2020/08/14	Genentech, Inc.	Rx	Licensed	N/A	N/A
Blenrep	761158	001	351(a)	belantamab mafodotin-blmf	For Injection	Intravenous	100MG	Single-Dose Vial	2020/08/05	GlaxoSmithKline Intellectual Property Development Ltd. England	Disc	Voluntarily Revoked	N/A	N/A
Monjuvi	761163	001	351(a)	tafasitamab-cxix	For Injection	Intravenous	200MG	Single-Dose Vial	2020/07/31	Incyte Corporation	Rx	Licensed	N/A	N/A
Tecartus	125703	001	351(a)	Brexucabtagene Autoleucel	For Injection	Intravenous	2×10^6 CAR-positive viable T cells per kg body weight	Bag	2020/07/24	Kite Pharma, Inc.	Rx	Licensed
Qwo	761146	001	351(a)	collagenase clostridium histolyticum-aaes	For Injection	Subcutaneous	.92MG	Single-Dose Vial	2020/07/06	Endo Global Aesthetics Limited	Rx	Licensed	N/A	N/A
Qwo	761146	002	351(a)	collagenase clostridium histolyticum-aaes	For Injection	Subcutaneous	1.84MG	Single-Dose Vial	2020/07/06	Endo Global Aesthetics Limited	Rx	Licensed	N/A	N/A
Hulio	761154	001	351(k) Interchangeable	adalimumab-fkjp	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2020/07/06	Biocon Biologics Inc.	Rx	Licensed	adalimumab	Humira
Hulio	761154	002	351(k) Interchangeable	adalimumab-fkjp	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2020/07/06	Biocon Biologics Inc.	Rx	Licensed	adalimumab	Humira
Hulio	761154	003	351(k) Interchangeable	adalimumab-fkjp	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2020/07/06	Biocon Biologics Inc.	Rx	Licensed	adalimumab	Humira
Retacrit	125545	006	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	20,000UNITS/2ML (10,000UNITS/ML)	Multi-Dose Vial	2020/06/30	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Retacrit	125545	007	351(k) Biosimilar	epoetin alfa-epbx	Injection	Intravenous, Subcutaneous	20,000UNITS/ML	Multi-Dose Vial	2020/06/30	Hospira Inc., a Pfizer Company	Rx	Licensed	epoetin alfa	Procrit
Phesgo	761170	001	351(a)	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Injection	Subcutaneous	1,200MG, 600MG, 30,000UNITS/15ML (80MG, 40MG, 2,000UNITS/ML)	Single-Dose Vial	2020/06/29	Genentech, Inc.	Rx	Licensed	N/A	N/A
Phesgo	761170	002	351(a)	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Injection	Subcutaneous	600MG, 600MG, 20,000UNITS/10ML (60MG, 60MG, 2,000UNITS/ML)	Single-Dose Vial	2020/06/29	Genentech, Inc.	Rx	Licensed	N/A	N/A
Gamifant	761107	003	351(a)	emapalumab-lzsg	Injection	Intravenous	100MG/20ML (5MG/ML)	Single-Dose Vial	2020/06/26	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
Dupixent	761055	004	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Autoinjector	2020/06/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Lyumjev	761109	001	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2020/06/15	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Lyumjev	761109	002	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Lyumjev	761109	003	351(a)	insulin lispro-aabc	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2020/06/15	Eli Lilly and Company	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	-