美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=APIXABAN"
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
APIXABAN 209845 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2021/07/26 2021/07/26 BRECKENRIDGE Discontinued
APIXABAN 209845 002 ANDA APIXABAN TABLET;ORAL 5MG No No 2021/07/26 2021/07/26 BRECKENRIDGE Discontinued
APIXABAN 210053 001 ANDA APIXABAN TABLET; ORAL 2.5MG No No 2022/02/01 (TA) -- SIGMAPHARM LABS LLC None (Tentative Approval)
APIXABAN 210053 002 ANDA APIXABAN TABLET; ORAL 5MG No No 2022/02/01 (TA) -- SIGMAPHARM LABS LLC None (Tentative Approval)
APIXABAN 210133 002 ANDA APIXABAN TABLET; ORAL 5mg No No 2022/04/12 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
APIXABAN 213903 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2022/06/21 (TA) -- ZHEJIANG YONGNING PHARMACEUTICAL CO LTD None (Tentative Approval)
APIXABAN 210185 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2023/02/27 2023/02/27 ZYDUS PHARMS Discontinued
APIXABAN 210185 002 ANDA APIXABAN TABLET;ORAL 5MG No No 2023/02/27 2023/02/27 ZYDUS PHARMS Discontinued
APIXABAN 210026 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2023/05/26 2023/05/26 AUROBINDO PHARMA LTD Discontinued
APIXABAN 210026 002 ANDA APIXABAN TABLET;ORAL 5MG No No 2023/05/26 2023/05/26 AUROBINDO PHARMA LTD Discontinued
APIXABAN 210066 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2023/11/21 2023/11/21 HETERO LABS LTD V Prescription
APIXABAN 210066 002 ANDA APIXABAN TABLET;ORAL 5MG No No 2023/11/21 2023/11/21 HETERO LABS LTD V Prescription
APIXABAN 210091 001 ANDA APIXABAN TABLET;ORAL 2.5MG No No 2024/02/16 2024/02/16 APOTEX Prescription
APIXABAN 210091 002 ANDA APIXABAN TABLET;ORAL 5MG No No 2024/02/16 2024/02/16 APOTEX Prescription
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