美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DAPAGLIFLOZIN AND METFORMIN"
符合检索条件的记录共 8 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
DAPAGLIFLOZIN AND METFORMIN 218091 002 ANDA DAPAGLIFLOZIN || METFORMIN TABLET 5MG No No 2025/05/08 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN 218091 003 ANDA DAPAGLIFLOZIN || METFORMIN TABLET 10MG No No 2025/05/08 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN 218091 004 ANDA DAPAGLIFLOZIN || METFORMIN TABLET 500MG No No 2025/05/08 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN 218091 005 ANDA DAPAGLIFLOZIN || METFORMIN TABLET 1000MG No No 2025/05/08 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 002 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 10MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 003 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 5MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 004 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 005 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 2.5MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
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