美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=NINTEDANIB"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
NINTEDANIB 212732 001 ANDA NINTEDANIB CAPSULE;ORAL EQ 100MG BASE No No 2020/08/04 (TA) -- ACCORD HLTHCARE INC None (Tentative Approval)
NINTEDANIB 212732 002 ANDA NINTEDANIB CAPSULE;ORAL EQ 150MG BASE No No 2020/08/04 (TA) -- ACCORD HLTHCARE INC None (Tentative Approval)
NINTEDANIB 212555 002 ANDA NINTEDANIB ESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2021/06/22 (TA) -- GLENMARK PHARMS LTD None (Tentative Approval)
NINTEDANIB 215123 002 ANDA NINTEDANIB CAPSULE;ORAL EQ 150MG BASE No No 2022/05/12 (TA) -- EUGIA PHARMA SPECLTS None (Tentative Approval)
NINTEDANIB 216915 001 ANDA NINTEDANIB CAPSULE;ORAL 100MG No No 2023/01/12 (TA) -- LOTUS PHARM CO LTD None (Tentative Approval)
NINTEDANIB 216915 002 ANDA NINTEDANIB CAPSULE;ORAL 150MG No No 2023/01/12 (TA) -- LOTUS PHARM CO LTD None (Tentative Approval)
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