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
Cosentyx	125504	003	351(a)	secukinumab	For Injection	Subcutaneous	150MG	Single-Dose Vial	2015/01/21	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Keytruda	125514	002	351(a)	pembrolizumab	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2015/01/15	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Neulasta Onpro	125031	002	351(a)	pegfilgrastim	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2014/12/23	Amgen Inc.	Rx	Licensed	N/A	N/A
Opdivo	125554	001	351(a)	nivolumab	Injection	Intravenous	40MG/4ML (10MG/ML)	Single-Dose Vial	2014/12/22	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Opdivo	125554	002	351(a)	nivolumab	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2014/12/22	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	008	351(a)	Influenza Virus Vaccine	Injection	Intradermal	36UG/.5ML	Pre-Filled Syringe	2014/12/11	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Gardasil 9	125508	001	351(a)	Human Papillomavirus 9-valent Vaccine, Recombinant	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2014/12/10	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Gardasil 9	125508	002	351(a)	Human Papillomavirus 9-valent Vaccine, Recombinant	Injection	Intramuscular	0.5ML	Single-dose vial	2014/12/10	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Blincyto	125557	001	351(a)	blinatumomab	For Injection	Intravenous	35MCG	Single-Dose Vial	2014/12/03	Amgen Inc.	Rx	Licensed	N/A	N/A
Lemtrada	103948	002	351(a)	alemtuzumab	Injection	Intravenous	12MG/1.2ML (10MG/ML)	Single-Dose Vial	2014/11/14	Genzyme Corporation	Rx	Licensed	N/A	N/A
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

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	-