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 38 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 LINAGLIPTIN 212359 001 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 10MG; 5MG No No 2020/07/07 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN AND LINAGLIPTIN 212359 002 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 25MG; 5MG No No 2020/07/07 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN 212354 001 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET; ORAL 10MG/5MG No No 2020/08/26 (TA) -- KINAPSE LIMITED None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN 212354 002 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 25MG/5MG No No 2020/08/26 (TA) -- KINAPSE LIMITED None (Tentative Approval)
EMPAGLIFLOZIN 212322 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 2.5MG No No 2020/12/29 (TA) -- AIZANT None (Tentative Approval)
EMPAGLIFLOZIN 212322 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2020/12/29 (TA) -- AIZANT None (Tentative Approval)
EMPAGLIFLOZIN 212322 003 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2020/12/29 (TA) -- AIZANT None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 213654 001 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG; 1GM No No 2021/01/06 (TA) -- LUPIN LTD None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 213654 002 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG; 1GM No No 2021/01/06 (TA) -- LUPIN LTD None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 213654 003 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 12.5MG; 1GM No No 2021/01/06 (TA) -- LUPIN LTD None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 213654 004 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 25MG; 1GM No No 2021/01/06 (TA) -- LUPIN LTD None (Tentative Approval)
EMPAGLIFLOZIN 212365 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2021/01/28 (TA) -- ANNORA PHARMA None (Tentative Approval)
EMPAGLIFLOZIN 212365 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2021/01/28 (TA) -- ANNORA PHARMA None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN 212364 001 ANDA EMPAGLIFLOZIN;LINAGLIPTIN TABLET;ORAL 10MG; 5MG No No 2021/03/30 (TA) -- ANNORA PHARMA None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN 212364 002 ANDA EMPAGLIFLOZIN;LINAGLIPTIN TABLET;ORAL 25MG; 5MG No No 2021/03/30 (TA) -- ANNORA PHARMA None (Tentative Approval)
EMPAGLIFLOZIN AND LINAGLIPTIN 212264 002 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 25MG;5MG No No 2022/01/20 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
EMPAGLIFLOZIN 212421 001 ANDA EMPAGLIFLOZIN TABLET;ORAL 10MG No No 2022/06/30 (TA) -- LAURUS GENERICS INC None (Tentative Approval)
EMPAGLIFLOZIN 212421 002 ANDA EMPAGLIFLOZIN TABLET;ORAL 25MG No No 2022/06/30 (TA) -- LAURUS GENERICS INC None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 212198 001 ANDA EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG No No 2022/07/07 2022/07/07 ZYDUS PHARMS Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 212198 002 ANDA EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;1GM No No 2022/07/07 2022/07/07 ZYDUS PHARMS Discontinued
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