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 28 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 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 211541 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2019/02/04 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
DAPAGLIFLOZIN 211541 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2019/02/04 (TA) -- TEVA PHARMS USA INC 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 211479 001 ANDA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 5MG; 500MG No No 2020/05/01 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN 211479 002 ANDA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 5MG; 1GM No No 2020/05/01 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN 211479 003 ANDA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 10MG; 500MG No No 2020/05/01 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN 211479 004 ANDA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 10MG; 1GM No No 2020/05/01 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN 211533 001 ANDA DAPAGLIFLOZIN; SAXAGLIPTIN TABLET; ORAL 10MG/5MG No No 2020/05/28 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN 211478 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2021/02/26 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
DAPAGLIFLOZIN 211478 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2021/02/26 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
DAPAGLIFLOZIN 216119 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2022/08/01 (TA) -- JIANGSU HANSOH PHARM None (Tentative Approval)
DAPAGLIFLOZIN 216119 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2022/08/01 (TA) -- JIANGSU HANSOH PHARM None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 211583 001 ANDA DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.5MG/1000MG No No 2022/08/03 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 211583 002 ANDA DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG/500MG No No 2022/08/03 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 211583 003 ANDA DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG/1000MG No No 2022/08/03 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
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