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
Trumenba	125549	001	351(a)	Meningococcal Group B Vaccine	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2014/10/29	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Obizur	125512	001	351(a)	Antihemophilic Factor (Recombinant), Porcine Sequence	For Injection	Intravenous	500U	Single-Dose Vial	2014/10/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Varizig	125430	002	351(a)	Varicella Zoster Immune Globulin (Human)	Injection	Intramuscular	125IU	Single-Dose Vial	2014/09/29	Kamada Ltd.	Rx	Licensed		N/A
Humira	125057	005	351(a)	adalimumab	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2014/09/23	AbbVie Inc.	Disc*	Licensed	N/A	N/A
Trulicity	125469	001	351(a)	dulaglutide	Injection	Subcutaneous	0.75MG/0.5ML	Autoinjector	2014/09/18	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Trulicity	125469	002	351(a)	dulaglutide	Injection	Subcutaneous	1.5MG/0.5ML	Autoinjector	2014/09/18	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Trulicity	125469	003	351(a)	dulaglutide	Injection	Subcutaneous	0.75MG/0.5ML	Pre-Filled Syringe	2014/09/18	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Trulicity	125469	004	351(a)	dulaglutide	Injection	Subcutaneous	1.5MG/0.5ML	Pre-Filled Syringe	2014/09/18	Eli Lilly and Company	Disc	Licensed	N/A	N/A
Hyqvia	125402	001	351(a)	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	Injection	Subcutaneous	0.1	Bottle	2014/09/12	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Keytruda	125514	001	351(a)	pembrolizumab	For Injection	Intravenous	50MG	Single-Dose Vial	2014/09/04	Merck Sharp & Dohme LLC	Disc	Licensed	N/A	N/A
Plegridy	125499	001	351(a)	peginterferon beta-1a	Injection	Subcutaneous	125MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	002	351(a)	peginterferon beta-1a	Injection	Subcutaneous	63MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	003	351(a)	peginterferon beta-1a	Injection	Subcutaneous	94MCG/0.5ML	Autoinjector	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	004	351(a)	peginterferon beta-1a	Injection	Subcutaneous, Intramuscular	125MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	005	351(a)	peginterferon beta-1a	Injection	Subcutaneous	63MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Plegridy	125499	006	351(a)	peginterferon beta-1a	Injection	Subcutaneous	94MCG/0.5ML	Pre-Filled Syringe	2014/08/15	Biogen Inc.	Rx	Licensed	N/A	N/A
Somavert	021106	004	351(a)	pegvisomant	For Injection	Subcutaneous	25MG	Single-Dose Vial	2014/07/31	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Somavert	021106	005	351(a)	pegvisomant	For Injection	Subcutaneous	30MG	Single-Dose Vial	2014/07/31	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Ruconest	125495	001	351(a)	C1 Esterase Inhibitor (Recombinant)	For Injection	Intravenous	2100IU	Single-Dose Vial	2014/07/16	Pharming Americas BV	Rx	Licensed		N/A
Octagam	125062	006	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10% 20G	Single-Use Bottle	2014/07/11	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	-