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
Abecma	125736	001	351(a)	idecabtagene vicleucel	Suspension	Intravenous	300 to 460 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS	Bag	2021/03/03	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Evkeeza	761181	001	351(a)	evinacumab-dgnb	Injection	Intravenous	345MG/2.3ML (150MG/ML)	Single-Dose Vial	2021/02/11	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Evkeeza	761181	002	351(a)	evinacumab-dgnb	Injection	Intravenous	1,200MG/8ML (150MG/ML)	Single-Dose Vial	2021/02/11	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Breyanzi	125714	001	351(a)	lisocabtagene maraleucel	Injection	Intravenous	4.6ML/VIAL	Single-Dose Vial	2021/02/05	Juno Therapeutics, Inc. a Bristol Myer-Squibb Company	Rx	Licensed
Vaxchora	125597	002	351(a)	Cholera Vaccine, Live, Oral	Suspension	Oral	50ML	Packet	2020/12/23	Bavarian Nordic A/S	Rx	Licensed	N/A	N/A
Vaxchora	125597	003	351(a)	Cholera Vaccine, Live, Oral	Suspension	Oral	100ML	Packet	2020/12/23	Bavarian Nordic A/S	Rx	Licensed	N/A	N/A
Ebanga	761172	001	351(a)	ansuvimab-zykl	For Injection	Intravenous	400MG	Single-Dose Vial	2020/12/21	Emergent Manufacturing Operations Baltimore LLC	Rx	Licensed	N/A	N/A
Riabni	761140	001	351(k) Biosimilar	rituximab-arrx	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2020/12/17	Amgen Inc.	Rx	Licensed	rituximab	Rituxan
Riabni	761140	002	351(k) Biosimilar	rituximab-arrx	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2020/12/17	Amgen Inc.	Rx	Licensed	rituximab	Rituxan
Margenza	761150	001	351(a)	margetuximab-cmkb	Injection	Intravenous	250MG/10ML (25MG/ML)	Single-Dose Vial	2020/12/16	MacroGenics Inc.	Rx	Licensed	N/A	N/A
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

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	-