美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=SITAGLIPTIN"
符合检索条件的记录共 96 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
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 215155 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 50MG BASE No No 2022/04/08 (TA) -- ALKEM LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 215155 003 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 100MG BASE No No 2022/04/08 (TA) -- ALKEM LABS LTD None (Tentative Approval)
SITAGLIPTIN 216919 001 ANDA SITAGLIPTIN PHOSPHATE TABLET; FILM COATED 25MG No No 2024/01/02 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN 216919 002 ANDA SITAGLIPTIN PHOSPHATE TABLET; FILM COATED 50MG No No 2024/01/02 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN 216919 003 ANDA SITAGLIPTIN PHOSPHATE TABLET; FILM COATED 100MG No No 2024/01/02 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HCL 218971 001 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET 1000MG ER TABLET No No 2024/12/11 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HCL 218971 002 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET EQ 100MG BASE TABLET No No 2024/12/11 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HCL 218971 003 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET 500MG No No 2024/12/11 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HCL 218971 004 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET 50MG No No 2024/12/11 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HCL 218971 005 ANDA SITAGLIPTIN, METFORMIN HYDROCHLORIDE TABLET 1000MG No No 2024/12/11 (TA) -- MANKIND PHARMA LTD None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 212338 001 ANDA METFORMIN HYDROCHLORIDE || SITAGLIPTIN TABLET:FILM COATED 50MG No No 2025/01/07 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 212338 002 ANDA METFORMIN HYDROCHLORIDE || SITAGLIPTIN TABLET;FILM COATED 500MG No No 2025/01/07 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE 212338 003 ANDA METFORMIN HYDROCHLORIDE || SITAGLIPTIN TABLET;FILM COATED 1000MG No No 2025/01/07 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
SITAGLIPTIN 216337 001 ANDA SITAGLIPTIN TABLET; FILM COATED 25MG No No 2025/03/06 (TA) -- SCIEGEN PHARMACEUTICALS INC None (Tentative Approval)
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