美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SITAGLIPTIN"
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
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 204144 002 ANDA METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE TABLET, EXTENDED RELEASE;ORAL 1GM; EQ 50MG BASE No No 2015/04/21 (TA) -- ANCHEN PHARMS None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 204144 003 ANDA METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE TABLET, EXTENDED RELEASE;ORAL 1GM; EQ 100MG BASE No No 2015/04/21 (TA) -- ANCHEN PHARMS None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 204591 001 ANDA SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 50MG;500MG No No 2015/09/29 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 204591 002 ANDA SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 50MG;1000MG No No 2015/09/29 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 204591 003 ANDA SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 100MG;1000MG No No 2015/09/29 (TA) -- TEVA PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 202365 001 ANDA SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE TABLET;ORAL 50MG;500MG No No 2015/10/30 (TA) -- WATSON LABS INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 202365 002 ANDA SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE TABLET;ORAL 50MG;1000MG No No 2015/10/30 (TA) -- WATSON LABS INC None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 208535 001 ANDA METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE TABLET;ORAL 50MG/500MG;50MG/1000MG No No 2017/07/03 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 208186 001 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 25MG BASE No No 2018/09/07 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 208186 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 50MG BASE No No 2018/09/07 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 208186 003 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 100MG BASE No No 2018/09/07 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214784 001 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 25MG BASE No No 2021/01/05 (TA) -- AJANTA PHARMA LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214784 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 50MG BASE No No 2021/01/05 (TA) -- AJANTA PHARMA LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214784 003 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 100MG BASE No No 2021/01/05 (TA) -- AJANTA PHARMA LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214693 001 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 25MG BASE No No 2021/07/09 (TA) -- UNICHEM LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214693 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 50MG BASE No No 2021/07/09 (TA) -- UNICHEM LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214693 003 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 100MG BASE No No 2021/07/09 (TA) -- UNICHEM LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 202387 001 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL EQ 25MG BASE No No 2021/12/27 (TA) -- SANDOZ INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 202387 002 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL EQ 50MG BASE No No 2021/12/27 (TA) -- SANDOZ INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 202387 003 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL EQ 100MG BASE No No 2021/12/27 (TA) -- SANDOZ INC None (Tentative Approval)
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