美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=METFORMIN HYDROCHLORIDE"
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; METFORMIN HYDROCHLORIDE 212373 003 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;500MG No No 2025/07/16 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 212373 004 ANDA EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE TABLET;ORAL 12.5MG;1000MG No No 2025/07/16 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 216516 002 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET 50MG No No 2025/07/24 (TA) -- AJANTA PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 216516 003 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET 1000MG No No 2025/07/24 (TA) -- AJANTA PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 219296 002 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET, EXTENDED RELEASE EQ 100MG BASE TABLET No No 2025/08/12 (TA) -- FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 219296 003 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET, EXTENDED RELEASE 500MG No No 2025/08/12 (TA) -- FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 219296 004 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET, EXTENDED RELEASE 50MG No No 2025/08/12 (TA) -- FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 219296 005 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN TABLET, EXTENDED RELEASE 1000MG No No 2025/08/12 (TA) -- FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 002 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 10MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 003 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 5MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 004 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 211559 005 ANDA DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 2.5MG No No 2025/08/19 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 215255 001 ANDA METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN TABLET, EXTENDED RELEASE 1000MG No No 2025/10/01 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 215255 002 ANDA METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN TABLET, EXTENDED RELEASE 50MG No No 2025/10/01 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 215255 003 ANDA METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN TABLET, EXTENDED RELEASE 150MG No No 2025/10/01 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 215255 004 ANDA METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN TABLET, EXTENDED RELEASE 500MG No No 2025/10/01 (TA) -- MACLEODS PHARMACEUTICALS LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 212869 002 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 100MG No No 2025/10/15 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 212869 003 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG No No 2025/10/15 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE 212869 004 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 50MG No No 2025/10/15 (TA) -- SINOTHERAPEUTICS INC None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 208427 001 ANDA LINAGLIPTIN; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG No No 2025/11/03 2025/11/03 DR REDDYS Prescription
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