美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=IRBESARTAN"
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
IRBESARTAN 077205 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/11/14 2012/11/14 CHARTWELL MOLECULAR Prescription
IRBESARTAN 077205 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/11/14 2012/11/14 CHARTWELL MOLECULAR Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203630 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2013/02/22 2013/02/22 AUROBINDO PHARMA LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203630 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2013/02/22 2013/02/22 AUROBINDO PHARMA LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203630 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG No No 2013/02/22 2016/03/31 AUROBINDO PHARMA LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201524 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2013/02/27 2013/02/27 LUPIN LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201524 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2013/02/27 (TA) 2013/02/27 LUPIN LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201524 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2013/02/27 2013/02/27 LUPIN LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201524 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2013/02/27 (TA) 2013/02/27 LUPIN LTD Prescription
IRBESARTAN; HYDROCHLOROTHIAZIDE 201524 003 ANDA IRBESARTAN; HYDROCHLOROTHIAZIDE TABLET; ORAL 300MG; 25MG No No 2013/02/27 -- LUPIN LTD None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE 201524 003 ANDA IRBESARTAN; HYDROCHLOROTHIAZIDE TABLET; ORAL 300MG; 25MG No No 2013/02/27 (TA) -- LUPIN LTD None (Tentative Approval)
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2014/05/09 2014/05/09 PRINSTON INC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2014/05/09 (TA) 2014/05/09 PRINSTON INC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2014/05/09 2014/05/09 PRINSTON INC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2014/05/09 (TA) 2014/05/09 PRINSTON INC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG/300MG No No 2014/05/09 -- PRINSTON INC None (Tentative Approval)
IRBESARTAN AND HYDROCHLOROTHIAZIDE 203072 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG/300MG No No 2014/05/09 (TA) -- PRINSTON INC None (Tentative Approval)
IRBESARTAN 203534 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2015/02/23 2015/02/23 JUBILANT GENERICS Prescription
IRBESARTAN 203534 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2015/02/23 2015/02/23 JUBILANT GENERICS Prescription
IRBESARTAN 203534 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2015/02/23 2015/02/23 JUBILANT GENERICS Prescription
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