美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE"
符合检索条件的记录共 56 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 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 AND METFORMIN HYDROCHLORIDE 211466 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 (TA) 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 (TA) 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 (TA) 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211466 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 (TA) 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211479 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211479 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211479 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211479 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211489 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211489 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211489 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211489 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
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