美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DAPAGLIFLOZIN"
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 211156 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 INVENTIA Prescription
DAPAGLIFLOZIN 211156 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 INVENTIA Prescription
DAPAGLIFLOZIN 211312 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 SANDOZ Prescription
DAPAGLIFLOZIN 211312 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 SANDOZ Prescription
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 211467 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN 211467 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 MICRO LABS Prescription
DAPAGLIFLOZIN 211468 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
DAPAGLIFLOZIN 211468 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 AUROBINDO PHARMA Prescription
DAPAGLIFLOZIN 211470 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 BIOCON PHARMA Prescription
DAPAGLIFLOZIN 211470 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 BIOCON PHARMA Prescription
DAPAGLIFLOZIN 211478 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN 211478 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 MSN Prescription
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