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; HYDROCHLOROTHIAZIDE 090815 001 ANDA IRBESARTAN; HYDROCHLOROTHIAZIDE TABLET; ORAL 150MG; 12.5MG No No 2011/02/16 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE 090815 002 ANDA IRBESARTAN; HYDROCHLOROTHIAZIDE TABLET; ORAL 300MG; 12.5MG No No 2011/02/16 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE 090815 003 ANDA IRBESARTAN; HYDROCHLOROTHIAZIDE TABLET; ORAL 300MG; 25MG No No 2011/02/16 (TA) -- ZYDUS PHARMS USA INC None (Tentative Approval)
IRBESARTAN 077159 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/03/30 2012/03/30 TEVA PHARMS Prescription
IRBESARTAN 077159 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/03/30 2012/03/30 TEVA PHARMS Prescription
IRBESARTAN 077159 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/03/30 2012/03/30 TEVA PHARMS Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077369 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/03/30 2012/03/30 TEVA Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077369 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/03/30 2012/03/30 TEVA Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077369 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG No No 2012/03/30 2012/03/30 TEVA Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077446 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/09/27 2012/09/27 SANDOZ Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077446 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/09/27 2012/09/27 SANDOZ Prescription
IRBESARTAN 077466 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/09/27 2012/09/27 SANDOZ Prescription
IRBESARTAN 077466 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/09/27 2012/09/27 SANDOZ Prescription
IRBESARTAN 077466 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/09/27 2012/09/27 SANDOZ Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077969 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/09/27 2012/09/27 MYLAN PHARMS INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077969 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/09/27 2012/09/27 MYLAN PHARMS INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 077969 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG No No 2012/09/27 2016/07/20 MYLAN PHARMS INC Discontinued
IRBESARTAN 079213 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/09/27 2012/09/27 ZYDUS PHARMS USA INC Prescription
IRBESARTAN 079213 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/09/27 2012/09/27 ZYDUS PHARMS USA INC Prescription
IRBESARTAN 079213 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/09/27 2012/09/27 ZYDUS PHARMS USA INC Prescription
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