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 38 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 211523 002 ANDA DAPAGLIFLOZIN TABLET; ORAL 10MG No No 2023/03/03 (TA) -- AIZANT 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 211582 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2024/02/28 (TA) -- ZYDUS PHARMS None (Tentative Approval)
DAPAGLIFLOZIN 211582 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2024/02/28 (TA) -- ZYDUS PHARMS 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 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)
DAPAGLIFLOZIN AND SAXAGLIPTIN 211533 001 ANDA DAPAGLIFLOZIN; SAXAGLIPTIN TABLET; ORAL 10MG/5MG No No 2025/09/05 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
DAPAGLIFLOZIN 211468 002 ANDA DAPAGLIFLOZIN TABLET 10MG No No 2025/09/15 (TA) -- AUROBINDO PHARMA LIMITED None (Tentative Approval)
DAPAGLIFLOZIN 211506 002 ANDA DAPAGLIFLOZIN TABLET 10MG No No 2025/10/15 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN 211478 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2025/10/31 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
DAPAGLIFLOZIN 211478 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2025/10/31 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
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