美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SAXAGLIPTIN"
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 205941 001 ANDA SAXAGLIPTIN TABLET;ORAL 2.5MG No 2016/01/21 (TA) AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN 205941 002 ANDA SAXAGLIPTIN TABLET;ORAL 5MG No 2016/01/21 (TA) AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 205942 001 ANDA SAXAGLIPTIN;METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;500MG 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 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 2016/01/21 (TA) AMNEAL PHARMS None (Tentative Approval)
SAXAGLIPTIN 205972 001 ANDA SAXAGLIPTIN TABLET;ORAL 2.5MG No 2016/01/27 (TA) AUROBINDO PHARMA LTD None (Tentative Approval)
SAXAGLIPTIN 205972 002 ANDA SAXAGLIPTIN TABLET;ORAL 5MG No 2016/01/27 (TA) AUROBINDO PHARMA LTD None (Tentative Approval)
SAXAGLIPTIN 205959 002 ANDA SAXAGLIPTIN TABLET;ORAL 5MG No 2016/08/17 (TA) PAR PHARM None (Tentative Approval)
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