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
Zarxio	125553	002	351(k) Biosimilar	filgrastim-sndz	Injection	Intravenous, Subcutaneous	480MCG/0.8ML	Pre-Filled Syringe	2015/03/06	Sandoz Inc.	Rx	Licensed	filgrastim	Neupogen
Toujeo	206538	001	351(a)	insulin glargine	Injection	Subcutaneous	450UNITS/1.5ML (300UNITS/ML)	Autoinjector	2015/02/25	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Norditropin	021148	011	351(a)	somatropin	Injection	Subcutaneous	30MG/3ML	Autoinjector	2015/01/23	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Natpara	125511	001	351(a)	parathyroid hormone	For Injection	Subcutaneous	25MCG	Multi-Dose Vial	2015/01/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Natpara	125511	002	351(a)	parathyroid hormone	For Injection	Subcutaneous	50MCG	Multi-Dose Vial	2015/01/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Natpara	125511	003	351(a)	parathyroid hormone	For Injection	Subcutaneous	75MCG	Multi-Dose Vial	2015/01/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Natpara	125511	004	351(a)	parathyroid hormone	For Injection	Subcutaneous	100MCG	Multi-Dose Vial	2015/01/23	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Bexsero	125546	001	351(a)	Meningococcal Group B Vaccine	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2015/01/23	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Cosentyx	125504	001	351(a)	secukinumab	Injection	Subcutaneous	150MG/ML	Autoinjector	2015/01/21	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Cosentyx	125504	002	351(a)	secukinumab	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2015/01/21	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
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

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	-