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1.回到旧版美国FDA药品数据库(2016历史数据


2.查询FDA历年批准新分子实体和生物制品请访问FDA历年批准NMEs和Biologics


3. 更多药品说明书和标签信息访问美国国家药品代码目录(NDC)


4.数据库新增中文名称,依据INN命名原则和CFDA翻译而来,错误之处,还望指出!

申请号 申请类型 商品名 活性成分 中文活性成分 剂型/给药途径 批准日期 申请机构
761078 BLA BAVENCIO AVELUMAB 阿维鲁单抗* INJECTABLE;INTRAVENOUS 2017-05-09 EMD SERONO INC
761069 BLA IMFINZI DURVALUMAB 度伐鲁单抗* INJECTABLE;INJECTION 2017-05-01 ASTRAZENECA UK LTD
761055 BLA DUPIXENT DUPILUMAB 度匹鲁单抗* INJECTABLE; INJECTION 2017-03-28 REGENERON PHARMACEUTICALS
761054 BLA RENFLEXIS INFLIXIMAB-ABDA 英利昔单抗-ABDA INJECTABLE;INJECTION 2017-04-21 SAMSUNG BIOEPSIS CO LTD
761053 BLA OCREVUS OCRELIZUMAB 奥瑞珠单抗* INJECTABLE;INJECTION 2017-03-28 GENENTECH INC
761052 BLA BRINEURA CERLIPONASE ALFA 塞利蛋白酶α* INJECTABLE;INJECTION 2017-04-27 BIOMARIN PHARM
761049 BLA BAVENCIO AVELUMAB 阿维鲁单抗* INJECTABLE;INJECTION 2017-03-23 EMD SERONO INC
761046 BLA ZINPLAVA BEZLOTOXUMAB 贝洛托人单抗 INJECTABLE;INJECTION 2016-10-21 MERCK SHARP DOHME
761044 BLA STELARA USTEKINUMAB 乌司奴单抗 INJECTABLE;INJECTION 2016-09-23 JANSSEN BIOTECH
761042 BLA ERELZI ETANERCEPT-SZZS 依那西普-SZZS INJECTABLE; INJECTION 2016-08-30 SANDOZ
761041 BLA TECENTRIQ ATEZOLIZUMAB 阿替利组单抗 INJECTABLE; INJECTION 2016-10-18 GENENTECH INC
761038 BLA LARTRUVO OLARATUMAB 奥拉妥单抗 INJECTABLE; INJECTION 2016-10-19 ELI LILLY AND CO
761037 BLA KEVZARA SARILUMAB 沙立芦人单抗* INJECTABLE;INJECTION 2017-05-22 SANOFI SYNTHELABO
761036 BLA DARZALEX DARATUMUMAB 达雷木单抗 INJECTABLE;INJECTION 2015-11-16 JANSSEN BIOTECH
761035 BLA EMPLICITI ELOTUZUMAB 依洛珠单抗 INJECTABLE;INJECTION 2015-11-30 BRISTOL MYERS SQUIBB
761034 BLA TECENTRIQ ATEZOLIZUMAB 阿替利组单抗 INJECTABLE;INJECTION 2016-05-18 GENENTECH INC
761033 BLA CINQAIR RESLIZUMAB 瑞利珠单抗 INJECTABLE;INJECTION 2016-03-23 TEVA RESPIRATORY LLC
761032 BLA SILIQ BRODALUMAB 布罗芦单抗 INJECTABLE;INJECTION 2017-02-15 VALEANT LUXEMBOURG
761029 BLA ZINBRYTA DACLIZUMAB 达克珠单抗 INJECTABLE;INJECTION 2016-05-27 BIOGEN
761025 BLA PRAXBIND IDARUCIZUMAB 依达组单抗 INJECTABLE;INJECTION 2015-10-16 BOEHRINGER INGELHEIM