• 简体中文
  • English
登录 注册
当前位置: 首页 > 美国FDA药品数据库 反馈纠错 帮助中心
-
-

1.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


2. 更多药品说明书和标签信息访问美国NDC及药品标签


3.数据库新增中文名称,依据INN命名原则翻译而来,“*”号部分翻译还有待商榷!

导出数据
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
761104 BLA LUMOXITI MOXETUMOMAB PASUDOTOX-TDFK 帕西妥莫单抗-TDFK INJECTABLE;INJECTION 2018-09-13 ASTRAZENECA AB
761097 BLA LIBTAYO CEMIPLIMAB-RWLC -RWLC* INJECTABLE;INTRAVENOUS 2018-09-28 REGENERON PHARMACEUTICALS
761094 BLA OXERVATE CENEGERMIN-BKBJ 塞奈吉明-BKBJ SOLUTION;OPHTHALMIC 2018-08-22 DOMPE FARMACEUTICI
761092 BLA REVCOVI ELAPEGADEMASE-LVLR 依拉培加酶-LVLR INJECTABLE;INJECTION 2018-10-05 LEADIANT BIOSCI INC
761090 BLA TAKHZYRO LANADELUMAB (SHP643) 拉那芦人单抗* INJECTABLE;INJECTION 2018-08-23 DYAX CORP.
761089 BLA AJOVY FREMANEZUMAB-VFRM 夫瑞奈组单抗-VFRM INJECTABLE;INJECTION 2018-09-14 TEVA PHARMS USA
761083 BLA HEMLIBRA EMICIZUMAB 依米赛珠单抗* INJECTABLE;INJECTION 2017-11-16 GENENTECH INC
761080 BLA NIVESTYM FILGRASTIM-AAFI 非格司亭 VIAL;SINGLE-DOSE 2018-07-20 HOSPIRA INC
761079 BLA PALYNZIQ PEGVALIASE-PQPZ 培伐利酶-PQPZ INJECTABLE;INJECTION 2018-05-24 BIOMARIN PHARM
761078 BLA BAVENCIO AVELUMAB 阿维鲁单抗* INJECTABLE;INTRAVENOUS 2017-05-09 EMD SERONO INC
761077 BLA AIMOVIG ERENUMAB-AOOE 依瑞奈人单抗-AOOE INJECTABLE;INJECTION 2018-05-17 AMGEN INC
761075 BLA FULPHILA PEGFILGRASTIM-JMDB 培非司亭 INJECTABLE;INJECTION 2018-06-04 MYLAN GMBH
761074 BLA OGIVRI TRASTUZUMAB-DKST 曲司珠单抗-DKST INJECTABLE;INJECTION 2017-12-01 MYLAN GMBH
761072 BLA IXIFI INFLIXIMAB-QBTX 英利昔单抗 INJECTABLE;INJECTION 2017-12-13 PFIZER INC
761071 BLA HYRIMOZ ADALIMUMAB-ADAZ INJECTABLE;INJECTION 2018-10-30 SANDOZ INC
761070 BLA FASENRA BENRALIZUMAB 本雷利珠单抗* INJECTABLE;INJECTION 2017-11-14 ASTRAZENECA AB
761069 BLA IMFINZI DURVALUMAB 度伐鲁单抗* INJECTABLE;INJECTION 2017-05-01 ASTRAZENECA UK LTD
761068 BLA CRYSVITA BUROSUMAB-TWZA 布罗索人单抗-TWZA* INJECTABLE;INJECTION 2018-04-17 ULTRAGENYX PHARM INC
761067 BLA ILUMYA TILDRAKIZUMAB-ASMN 替卓组单抗-ASMN INJECTABLE;INJECTION 2018-03-20 SUN PHARMA GLOBAL
761065 BLA TROGARZO IBALIZUMAB-UIYK 伊巴珠单抗-UIYK INJECTABLE;INJECTION 2018-03-06 TAIMED BIOLOGICS USA