美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=IBRUTINIB"
符合检索条件的记录共 18 条
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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
IBRUTINIB 211350 001 ANDA IBRUTINIB CAPSULE;ORAL 140MG No No 2021/03/01 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
IBRUTINIB 211344 001 ANDA IBRUTINIB CAPSULE;ORAL 70MG No No 2021/03/31 2021/03/31 ZYDUS Discontinued
IBRUTINIB 211344 002 ANDA IBRUTINIB CAPSULE;ORAL 140MG No No 2021/03/31 2021/03/31 ZYDUS Discontinued
IBRUTINIB 212763 001 ANDA IBRUTINIB TABLET;ORAL 140MG No No 2021/04/09 (TA) -- ALVOGEN PINE BROOK None (Tentative Approval)
IBRUTINIB 212763 002 ANDA IBRUTINIB TABLET;ORAL 280MG No No 2021/04/09 (TA) -- ALVOGEN PINE BROOK None (Tentative Approval)
IBRUTINIB 212763 003 ANDA IBRUTINIB TABLET;ORAL 420MG No No 2021/04/09 (TA) -- ALVOGEN PINE BROOK None (Tentative Approval)
IBRUTINIB 212763 004 ANDA IBRUTINIB TABLET;ORAL 560MG No No 2021/04/09 (TA) -- ALVOGEN PINE BROOK None (Tentative Approval)
IBRUTINIB 214498 001 ANDA IBRUTINIB CAPSULE;ORAL 70MG No No 2021/06/03 (TA) -- ALVOGEN INC None (Tentative Approval)
IBRUTINIB 214498 002 ANDA IBRUTINIB CAPSULE;ORAL 140MG No No 2021/06/03 (TA) -- ALVOGEN INC None (Tentative Approval)
IBRUTINIB 214296 001 ANDA IBRUTINIB TABLET;ORAL 140MG No No 2021/07/19 (TA) -- ZYDUS WORLDWIDE DMCC None (Tentative Approval)
IBRUTINIB 214296 002 ANDA IBRUTINIB TABLET;ORAL 280MG No No 2021/07/19 (TA) -- ZYDUS WORLDWIDE DMCC None (Tentative Approval)
IBRUTINIB 214296 003 ANDA IBRUTINIB TABLET;ORAL 420MG No No 2021/07/19 (TA) -- ZYDUS WORLDWIDE DMCC None (Tentative Approval)
IBRUTINIB 214296 004 ANDA IBRUTINIB TABLET;ORAL 560MG No No 2021/07/19 (TA) -- ZYDUS WORLDWIDE DMCC None (Tentative Approval)
IBRUTINIB 211267 001 ANDA IBRUTINIB CAPSULE;ORAL 140MG No No 2022/03/15 (TA) -- SANDOZ INC None (Tentative Approval)
IBRUTINIB 215464 001 ANDA IBRUTINIB TABLET;ORAL 140MG No No 2023/02/10 (TA) -- SANDOZ INC None (Tentative Approval)
IBRUTINIB 215464 002 ANDA IBRUTINIB TABLET;ORAL 280MG No No 2023/02/10 (TA) -- SANDOZ INC None (Tentative Approval)
IBRUTINIB 215464 003 ANDA IBRUTINIB TABLET;ORAL 420MG No No 2023/02/10 (TA) -- SANDOZ INC None (Tentative Approval)
IBRUTINIB 215464 004 ANDA IBRUTINIB TABLET;ORAL 560MG No No 2023/02/10 (TA) -- SANDOZ INC None (Tentative Approval)
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