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
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
Nuwiq	125555	006	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	4000IU	Single-Dose Vial	2017/07/07	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Nuwiq	125555	007	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	3000IU	Single-Dose Vial	2017/07/07	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Haegarda	125606	001	351(a)	C1 Esterase Inhibitor Subcutaneous (Human)	For Injection	Subcutaneous	2000IU	Single-Dose Vial	2017/06/22	CSL Behring GmbH	Rx	Licensed		N/A
Haegarda	125606	002	351(a)	C1 Esterase Inhibitor Subcutaneous (Human)	For Injection	Subcutaneous	3000IU	Single-Dose Vial	2017/06/22	CSL Behring GmbH	Rx	Licensed		N/A
Rituxan Hycela	761064	001	351(a)	rituximab and hyaluronidase human	Injection	Subcutaneous	1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2017/06/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Rituxan Hycela	761064	002	351(a)	rituximab and hyaluronidase human	Injection	Subcutaneous	1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML)	Single-Dose Vial	2017/06/22	Genentech, Inc.	Rx	Licensed	N/A	N/A
Fibryga	125612	001	351(a)	Fibrinogen (Human)	For Injection	Intravenous	1G	Single-Use Bottle	2017/06/07	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Humalog	020563	004	351(a)	insulin lispro	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2017/06/06	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Rebinyn	125611	001	351(a)	Coagulation Factor IX (Recombinant), GlycoPEGylated	For Injection	Intravenous	2000IU	Single-Dose Vial	2017/05/31	Novo Nordisk Inc.	Rx	Licensed		N/A
Rebinyn	125611	002	351(a)	Coagulation Factor IX (Recombinant), GlycoPEGylated	For Injection	Intravenous	500IU	Single-Dose Vial	2017/05/31	Novo Nordisk Inc.	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	-