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药智数据企业版注册数据库:增设了"联合申报"、"临床试验默认许可日期"等搜索条件,让搜索页面纬度更加全面,还有热点搜索和高级条件组合检索等检索功能 等你来体验!
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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NDC及药品标签


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!

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
761145 DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ INJECTABLE;INJECTION
761143 BLA TEPEZZA TEPROTUMUMAB-TRBW INJECTABLE;INJECTION 2020-01-21 HORIZON THERAPEUTICS IRELAND
761139 BLA ENHERTU FAM-TRASTUZUMAB DERUXTECAN-NXKI INJECTABLE;INJECTION 2019-12-20 DAIICHI SANKYO
761137 BLA PADCEV ENFORTUMAB VEDOTIN-EJFV INJECTABLE;INJECTION 2019-12-18 ASTELLAS
761136 BLA REBLOZYL LUSPATERCEPT-AAMT POWDER;SUBCUTANEOUS 2019-11-08 CELGENE CORP
761128 BLA ADAKVEO CRIZANLIZUMAB-TMCA INJECTABLE; INJECTION 2019-11-15 NOVARTIS PHARMS CORP
761125 BLA BEOVU brolucizumab-dbll INJECTABLE; INTRAVITREAL 2019-10-07 NOVARTIS PHARMS CORP
761122 BLA NUCALA MEPOLIZUMAB 美泊珠单抗 INJECTABLE;SUBCUTANEOUS 2019-06-06 GLAXOSMITHKLINE
761121 BLA POLIVY POLATUZUMAB VEDOTIN-PIIQ INJECTABLE;INJECTION 2019-06-10 GENENTECH
761119 BLA VYEPTI EPTINEZUMAB-JJMR INJECTABLE;INJECTION 2020-02-21 Lundbeck Seattle BioPharmaceuticals, Inc.
761118 BLA ABRILADA ADALIMUMAB-AFZB INJECTABLE;INJECTION 2019-11-15 PFIZER INC
761116 BLA ELZONRIS TAGRAXOFUSP-ERZS * SOLUTION;INJECTION 2018-12-21 STEMLINE THERAPEUTICS INC
761115 TRODELVY SACITUZUMAB GOVITECAN-HZIY INJECTABLE;INJECTION
761113 BLA SARCLISA ISATUXIMAB-IRFC INJECTABLE;INJECTION 2020-03-02 SANOFI AVENTIS US
761112 BLA CABLIVI CAPLACIZUMAB-YHDP 卡拉西组单抗-YHDP INJECTABLE;INJECTION 2019-02-06 ABLYNX NV
761108 BLA ULTOMIRIS RAVULIZUMAB-CWVZ 长春夫利*-CWVZ INJECTABLE;INJECTION 2018-12-21 ALEXION PHARM
761107 BLA GAMIFANT EMAPALUMAB-LZSG 依马利人单抗-LZSG INJECTABLE;INJECTION 2018-11-20 NOVIMMUNE S.A.
761106 BLA HERCEPTIN HYLECTA TRASTUZUMAB; HYALURONIDASE-OYSK INJECTABLE;SUBCUTANEOUS 2019-02-28 GENENTECH INC
761105 BLA SKYRIZI RISANKIZUMAB-RZAA 利生奇组单抗 INJECTABLE;INJECTION 2019-04-23 ABBVIE INC
761104 BLA LUMOXITI MOXETUMOMAB PASUDOTOX-TDFK 帕西妥莫单抗-TDFK INJECTABLE;INJECTION 2018-09-13 ASTRAZENECA AB