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
Shingrix	125614	001	351(a)	Zoster Vaccine Recombinant, Adjuvanted	Injection	Intramuscular	0.5ML	Single-Dose Vial	2017/10/20	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Yescarta	125643	001	351(a)	axicabtagene ciloleucel	Injection	Intravenous	2 × 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT	Bag	2017/10/18	Kite Pharma, Inc.	Rx	Licensed		N/A
Opdivo	125554	003	351(a)	nivolumab	Injection	Intravenous	240MG/24ML (10MG/ML)	Single-Dose Vial	2017/10/04	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Fiasp	208751	001	351(a)	insulin aspart	Injection	Intravenous, Subcutaneous	1000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2017/09/29	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Fiasp	208751	002	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2017/09/29	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Enbrel Mini	103795	005	351(a)	etanercept	Injection	Subcutaneous	50MG/ML	Single-Dose Cartridge	2017/09/14	Immunex Corporation	Rx	Licensed	N/A	N/A
Mvasi	761028	001	351(k) Biosimilar	bevacizumab-awwb	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2017/09/14	Amgen Inc.	Rx	Licensed	bevacizumab	Avastin
Mvasi	761028	002	351(k) Biosimilar	bevacizumab-awwb	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2017/09/14	Amgen Inc.	Rx	Licensed	bevacizumab	Avastin
prolastin,prolastin-c,prolastin-c liquid	103174	003	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	1000MG/20ML	Single-Dose Vial	2017/09/08	Grifols Therapeutics LLC	Rx	Licensed		N/A
Mylotarg	761060	001	351(a)	gemtuzumab ozogamicin	For Injection	Intravenous	4.5MG	Single-Dose Vial	2017/09/01	Wyeth Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Kymriah	125646	001	351(a)	tisagenlecleucel	Injection	Intravenous	0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS	Bag	2017/08/30	Novartis Pharmaceuticals Corporation	Rx	Licensed		N/A
Cyltezo	761058	001	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2017/08/25	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
Kedrab	125613	001	351(a)	Rabies Immune Globulin (Human)	Solution	Subcutaneous	150IU/ML	Single-Dose Vial	2017/08/23	Kamada Ltd.	Rx	Licensed		N/A
Besponsa	761040	001	351(a)	inotuzumab ozogamicin	For Injection	Intravenous	0.9MG	Single-Dose Vial	2017/08/17	Wyeth Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Benlysta	761043	001	351(a)	belimumab	Injection	Subcutaneous	200MG/ML	Autoinjector	2017/07/20	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Benlysta	761043	002	351(a)	belimumab	Injection	Subcutaneous	200MG/ML	Pre-Filled Syringe	2017/07/20	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Pertzye	022175	004	351(a)	pancrelipase	Capsule, Delayed Release	Oral	24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS		2017/07/13	Digestive Care, Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	001	351(a)	guselkumab	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2017/07/13	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Lartruvo	761038	002	351(a)	olaratumab	Injection	Intravenous	190MG/19ML (10MG/ML)	Single-Dose Vial	2017/07/10	Eli Lilly and Company	Disc	Voluntarily Revoked	N/A	N/A
Nuwiq	125555	005	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	2500IU	Single-Dose Vial	2017/07/07	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		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	-