美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DAPAGLIFLOZIN"
符合检索条件的记录共 104 条
共 6 页，当前第 1 页
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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 211442 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2019/01/04 (TA) -- APOTEX INC None (Tentative Approval)
DAPAGLIFLOZIN 211442 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2019/01/04 (TA) -- APOTEX INC None (Tentative Approval)
DAPAGLIFLOZIN 211439 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2019/01/18 (TA) -- HETERO LABS UNIT III None (Tentative Approval)
DAPAGLIFLOZIN 211439 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2019/01/18 (TA) -- HETERO LABS UNIT III None (Tentative Approval)
DAPAGLIFLOZIN 211564 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2020/03/20 (TA) -- GLENMARK GENERICS None (Tentative Approval)
DAPAGLIFLOZIN 211564 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2020/03/20 (TA) -- GLENMARK GENERICS None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE 211532 001 ANDA DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE TABLET; ORAL 5MG No No 2024/01/03 (TA) -- LUPIN LTD None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE 211532 002 ANDA DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE TABLET; ORAL 10MG No No 2024/01/03 (TA) -- LUPIN LTD None (Tentative Approval)
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 219408 001 ANDA DAPAGLIFLOZIN TABLET 5MG No No 2026/01/08 (TA) -- SCIEGEN PHARMACEUTICALS INC None (Tentative Approval)
DAPAGLIFLOZIN 219408 002 ANDA DAPAGLIFLOZIN TABLET 10MG No No 2026/01/08 (TA) -- SCIEGEN PHARMACEUTICALS INC None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 219755 002 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 10MG No No 2026/01/29 (TA) -- INVENTIA HEALTHCARE LIMITED None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 219755 003 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 5MG No No 2026/01/29 (TA) -- INVENTIA HEALTHCARE LIMITED None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 219755 004 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG No No 2026/01/29 (TA) -- INVENTIA HEALTHCARE LIMITED None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 219755 005 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 2.5MG No No 2026/01/29 (TA) -- INVENTIA HEALTHCARE LIMITED None (Tentative Approval)
DAPAGLIFLOZIN 216119 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/02 (TA) -- JIANGSU HANSOH PHARM None (Tentative Approval)
DAPAGLIFLOZIN 216119 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/02 (TA) -- JIANGSU HANSOH PHARM None (Tentative Approval)
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