美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=LINAGLIPTIN"
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
LINAGLIPTIN 208335 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No 2021/08/31 2021/08/31 SUNSHINE Prescription
EMPAGLIFLOZIN AND LINAGLIPTIN 212264 002 ANDA EMPAGLIFLOZIN; LINAGLIPTIN TABLET;ORAL 25MG;5MG No No 2022/01/20 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208473 002 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;850MG No No 2022/04/05 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208473 003 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;1GM No No 2022/04/05 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
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)
LINAGLIPTIN 208448 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No 2023/03/30 2023/03/30 ZYDUS PHARMS Discontinued
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208449 001 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG No No 2023/03/30 2023/03/30 ZYDUS PHARMS Discontinued
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208449 002 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;850MG No No 2023/03/30 2023/03/30 ZYDUS PHARMS Discontinued
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208449 003 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;1GM No No 2023/03/30 2023/03/30 ZYDUS PHARMS Discontinued
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)
LINAGLIPTIN 208423 001 ANDA LINAGLIPTIN TABLET;ORAL 5MG No No 2024/09/03 2024/09/03 INVAGEN PHARMS Prescription
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