美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=SAXAGLIPTIN"
符合检索条件的记录共 28 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
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 205942 001 ANDA SAXAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG No No 2016/01/21 (TA) -- AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 205942 002 ANDA SAXAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.5MG;1000MG No No 2016/01/21 (TA) -- AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 205942 003 ANDA SAXAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;1000MG No No 2016/01/21 (TA) -- AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN 205959 002 ANDA SAXAGLIPTIN TABLET;ORAL 5MG No No 2016/08/17 (TA) -- PAR PHARM None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN 211533 001 ANDA DAPAGLIFLOZIN; SAXAGLIPTIN TABLET; ORAL 10MG/5MG No No 2020/05/28 (TA) -- MSN LABS PVT LTD None (Tentative Approval)
SAXAGLIPTIN 205994 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/02/15 (TA) 2023/07/31 GLENMARK PHARMS LTD Prescription
SAXAGLIPTIN 205994 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/02/15 (TA) 2023/07/31 GLENMARK PHARMS LTD Prescription
SAXAGLIPTIN 205941 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/07/31 2023/07/31 AMNEAL Discontinued
SAXAGLIPTIN 205941 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/07/31 2023/07/31 AMNEAL Discontinued
SAXAGLIPTIN 205972 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/07/31 2023/07/31 AUROBINDO PHARMA Prescription
SAXAGLIPTIN 205972 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/07/31 2023/07/31 AUROBINDO PHARMA Prescription
SAXAGLIPTIN 205980 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/07/31 2023/07/31 MYLAN Prescription
SAXAGLIPTIN 205980 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No Yes 2023/07/31 2023/07/31 MYLAN Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 205981 001 ANDA METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG;EQ 5MG BASE No No 2023/07/31 2023/07/31 MYLAN Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 205981 002 ANDA METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 2.5MG BASE No No 2023/07/31 2023/07/31 MYLAN Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 205981 003 ANDA METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM;EQ 5MG BASE No No 2023/07/31 2023/07/31 MYLAN Prescription
SAXAGLIPTIN 205994 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/07/31 2023/07/31 GLENMARK PHARMS LTD Prescription
SAXAGLIPTIN 205994 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/07/31 2023/07/31 GLENMARK PHARMS LTD Prescription
SAXAGLIPTIN 206078 001 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 2023/07/31 2023/07/31 SUN PHARM Prescription
SAXAGLIPTIN 206078 002 ANDA SAXAGLIPTIN HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 2023/07/31 2023/07/31 SUN PHARM Prescription
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