美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=APREMILAST"
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
APREMILAST 211819 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2021/02/17 2021/02/17 UNICHEM Discontinued
APREMILAST 211819 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2021/02/17 2021/02/17 UNICHEM Discontinued
APREMILAST 211819 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2021/02/17 2021/02/17 UNICHEM Discontinued
APREMILAST 211782 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2021/06/30 2021/06/30 AMNEAL Discontinued
APREMILAST 211782 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2021/06/30 2021/06/30 AMNEAL Discontinued
APREMILAST 211782 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2021/06/30 2021/06/30 AMNEAL Discontinued
APREMILAST 211761 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2021/09/21 2021/09/21 ALKEM LABS LTD Prescription
APREMILAST 211761 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2021/09/21 2021/09/21 ALKEM LABS LTD Prescription
APREMILAST 211761 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2021/09/21 2021/09/21 ALKEM LABS LTD Prescription
APREMILAST 211859 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2022/02/03 (TA) -- ZYDUS PHARMS None (Tentative Approval)
APREMILAST 211859 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2022/02/03 (TA) -- ZYDUS PHARMS None (Tentative Approval)
APREMILAST 211859 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2022/02/03 (TA) -- ZYDUS PHARMS None (Tentative Approval)
APREMILAST 211897 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2022/08/18 2022/08/18 TEVA PHARMS USA INC Discontinued
APREMILAST 211897 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2022/08/18 2022/08/18 TEVA PHARMS USA INC Discontinued
APREMILAST 211897 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2022/08/18 2022/08/18 TEVA PHARMS USA INC Discontinued
APREMILAST 211774 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2023/04/07 2023/04/07 SHILPA Prescription
APREMILAST 211774 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2023/04/07 2023/04/07 SHILPA Prescription
APREMILAST 211774 003 ANDA APREMILAST TABLET;ORAL 30MG No No 2023/04/07 2023/04/07 SHILPA Prescription
APREMILAST 211756 001 ANDA APREMILAST TABLET;ORAL 10MG No No 2023/07/14 2023/07/14 DR REDDYS Discontinued
APREMILAST 211756 002 ANDA APREMILAST TABLET;ORAL 20MG No No 2023/07/14 2023/07/14 DR REDDYS Discontinued
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