美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SITAGLIPTIN PHOSPHATE"
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 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)
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 PHOSPHATE AND METFORMIN HYDROCHLORIDE 216885 001 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 1000MG No No 2025/03/13 (TA) -- PRINSTON PHARMACEUTICAL INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE 216885 002 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 50MG No No 2025/03/13 (TA) -- PRINSTON PHARMACEUTICAL INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE 216885 003 ANDA METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 500MG No No 2025/03/13 (TA) -- PRINSTON PHARMACEUTICAL INC None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 211073 001 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL 25MG TBD No 2025/04/02 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 211073 002 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL 50MG TBD No 2025/04/02 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 211073 003 ANDA SITAGLIPTIN PHOSPHATE TABLET; ORAL 100MG TBD No 2025/04/02 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214700 001 ANDA SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 25MG No No 2025/05/12 (TA) -- DR REDDYS LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214700 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 50MG No No 2025/05/12 (TA) -- DR REDDYS LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 214700 003 ANDA SITAGLIPTIN PHOSPHATE TABLET;FILM COATED 100MG No No 2025/05/12 (TA) -- DR REDDYS LABS LTD None (Tentative Approval)
SITAGLIPTIN PHOSPHATE 202327 001 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 25MG BASE No No 2025/12/29 2025/12/30 WATSON LABS INC Prescription
SITAGLIPTIN PHOSPHATE 202327 002 ANDA SITAGLIPTIN PHOSPHATE TABLET;ORAL EQ 50MG BASE No No 2025/12/29 2025/12/30 WATSON LABS INC Prescription
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