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
Trazimera	761081	002	351(k) Biosimilar	trastuzumab-qyyp	For Injection	Intravenous	150MG	Multi-Dose Vial	2020/11/30	Pfizer Ireland Pharmaceuticals	Rx	Licensed	trastuzumab	Herceptin
Danyelza	761171	001	351(a)	naxitamab-gqgk	Injection	Intravenous	40MG/10ML (4MG/ML)	Single-Dose Vial	2020/11/25	Y-mABs Therapeutics, Inc	Rx	Licensed	N/A	N/A
Inmazeb	761169	001	351(a)	atoltivimab, maftivimab, and odesivimab-ebgn	Injection	Intravenous	241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)	Single-Dose Vial	2020/10/14	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Ultomiris	761108	002	351(a)	ravulizumab-cwvz	Injection	Intravenous	300MG/3ML (100MG/ML)	Single-Dose Vial	2020/10/09	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Ultomiris	761108	003	351(a)	ravulizumab-cwvz	Injection	Intravenous	1,100MG/11ML (100MG/ML)	Single-Dose Vial	2020/10/09	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Vaxelis	125563	002	351(a)	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2020/09/25	MSP Vaccine Company	Rx	Licensed		N/A
Polivy	761121	002	351(a)	polatuzumab vedotin-piiq	For Injection	Intravenous	30MG	Single-Dose Vial	2020/09/18	Genentech, Inc.	Rx	Licensed	N/A	N/A
Trulicity	125469	005	351(a)	dulaglutide	Injection	Subcutaneous	3MG/0.5ML	Autoinjector	2020/09/04	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Trulicity	125469	006	351(a)	dulaglutide	Injection	Subcutaneous	4.5MG/0.5ML	Autoinjector	2020/09/04	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Sogroya	761156	001	351(a)	somapacitan-beco	Injection	Subcutaneous	10MG/1.5ML (6.7MG/ML)	Autoinjector	2020/08/28	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
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

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	-