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"
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 211563 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 ALKEM LABS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211563 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 (TA) 2026/04/06 ALKEM LABS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 (TA) 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 (TA) 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 (TA) 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211579 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 (TA) 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211583 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.5MG;1GM No No 2026/04/06 2026/04/06 TEVA PHARMS USA INC Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211583 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 TEVA PHARMS USA INC Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211583 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 TEVA PHARMS USA INC Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211583 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 TEVA PHARMS USA INC Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211583 005 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 TEVA PHARMS USA INC Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211595 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 CIPLA Prescription
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