美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=EMPAGLIFLOZIN"
符合检索条件的记录共 39 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
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 212198 003 ANDA EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;500MG No No 2022/07/07 2022/07/07 ZYDUS PHARMS Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 212198 004 ANDA EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;1GM No No 2022/07/07 2022/07/07 ZYDUS PHARMS Discontinued
EMPAGLIFLOZIN 212138 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2022/08/03 2022/08/03 ZYDUS PHARMS Discontinued
EMPAGLIFLOZIN 212138 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2022/08/03 2022/08/03 ZYDUS PHARMS Discontinued
EMPAGLIFLOZIN; LINAGLIPTIN 212366 001 ANDA EMPAGLIFLOZIN;LINAGLIPTIN TABLET;ORAL 10MG/5MG No No 2022/08/09 (TA) -- ALKEM LABS LTD None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN 212366 002 ANDA EMPAGLIFLOZIN;LINAGLIPTIN TABLET;ORAL 25MG/5MG No No 2022/08/09 (TA) -- ALKEM LABS LTD None (Tentative Approval)
EMPAGLIFLOZIN 212382 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2022/09/28 (TA) -- ALKEM LABS LTD None (Tentative Approval)
EMPAGLIFLOZIN 212382 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2022/09/28 (TA) -- ALKEM LABS LTD None (Tentative Approval)
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE 212362 001 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 5MG/1000MG No No 2023/01/31 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE 212362 002 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 10MG/1000MG No No 2023/01/31 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE 212362 003 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 12.5MG/1000MG No No 2023/01/31 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE 212362 004 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL 25MG/1000MG No No 2023/01/31 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN 212343 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2023/03/10 (TA) -- SUN PHARM INDS LTD None (Tentative Approval)
EMPAGLIFLOZIN 212343 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2023/03/10 (TA) -- SUN PHARM INDS LTD None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 217049 001 ANDA EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;2.5MG;1000MG No No 2024/03/06 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 217049 002 ANDA EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG;5MG;1000MG No No 2024/03/06 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 217049 003 ANDA EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 12.5MG;2.5MG;1000MG No No 2024/03/06 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 217049 004 ANDA EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 25MG;5MG;1000MG No No 2024/03/06 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 218483 004 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;1000MG No No 2024/10/15 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
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