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 211523 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 AIZANT Prescription
DAPAGLIFLOZIN 211531 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN 211531 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 LUPIN LTD Prescription
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE 211533 001 ANDA DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL 10MG;EQ 5MG BASE No Yes 2026/04/06 2026/04/06 MSN Prescription
DAPAGLIFLOZIN 211535 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 CIPLA Prescription
DAPAGLIFLOZIN 211535 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 CIPLA Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211536 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 CIPLA LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211536 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 CIPLA LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211536 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 CIPLA LTD Prescription
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE 211537 001 ANDA DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL 10MG;EQ 5MG BASE No No 2026/04/06 2026/04/06 TORRENT Prescription
DAPAGLIFLOZIN 211541 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 TEVA PHARMS USA Prescription
DAPAGLIFLOZIN 211541 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 TEVA PHARMS USA Prescription
DAPAGLIFLOZIN 211545 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 ALKEM LABS LTD Prescription
DAPAGLIFLOZIN 211545 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 ALKEM LABS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 001 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2026/04/06 2026/04/06 MACLEODS PHARMS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 002 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1GM No No 2026/04/06 2026/04/06 MACLEODS PHARMS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 003 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;500MG No No 2026/04/06 2026/04/06 MACLEODS PHARMS LTD Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 004 ANDA DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;1GM No No 2026/04/06 2026/04/06 MACLEODS PHARMS LTD Prescription
DAPAGLIFLOZIN 211560 001 ANDA DAPAGLIFLOZIN TABLET;ORAL 5MG No No 2026/04/06 2026/04/06 ALEMBIC Prescription
DAPAGLIFLOZIN 211560 002 ANDA DAPAGLIFLOZIN TABLET;ORAL 10MG No No 2026/04/06 2026/04/06 ALEMBIC Prescription
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