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 AND HYDROCHLOROTHIAZIDE 091370 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/10/15 2012/10/15 ALEMBIC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091370 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/10/15 2012/10/15 ALEMBIC Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091370 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 25MG;300MG No No 2012/10/15 2016/10/12 ALEMBIC Prescription
IRBESARTAN 200832 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/10/15 2012/10/15 APOTEX INC Discontinued
IRBESARTAN 200832 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/10/15 2012/10/15 APOTEX INC Discontinued
IRBESARTAN 200832 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/10/15 2012/10/15 APOTEX INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201505 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/10/15 (TA) 2012/10/15 APOTEX INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201505 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/10/15 2012/10/15 APOTEX INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201505 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/10/15 (TA) 2012/10/15 APOTEX INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 201505 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/10/15 2012/10/15 APOTEX INC Discontinued
IRBESARTAN HYDROCHLOROTHIAZIDE 201505 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET; ORAL 25MG;300MG No No 2012/10/15 (TA) -- APOTEX INC None (Tentative Approval)
IRBESARTAN HYDROCHLOROTHIAZIDE 201505 003 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET; ORAL 25MG;300MG No No 2012/10/15 -- APOTEX INC None (Tentative Approval)
IRBESARTAN 201531 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/10/15 2012/10/15 LUPIN LTD Prescription
IRBESARTAN 201531 002 ANDA IRBESARTAN TABLET;ORAL 150MG No No 2012/10/15 2012/10/15 LUPIN LTD Prescription
IRBESARTAN 201531 003 ANDA IRBESARTAN TABLET;ORAL 300MG No No 2012/10/15 2012/10/15 LUPIN LTD Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091539 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/10/22 2012/10/22 WATSON LABS INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091539 001 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;150MG No No 2012/10/22 (TA) 2012/10/22 WATSON LABS INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091539 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/10/22 2012/10/22 WATSON LABS INC Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE 091539 002 ANDA HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET;ORAL 12.5MG;300MG No No 2012/10/22 (TA) 2012/10/22 WATSON LABS INC Discontinued
IRBESARTAN 077205 001 ANDA IRBESARTAN TABLET;ORAL 75MG No No 2012/11/14 2012/11/14 CHARTWELL MOLECULAR Prescription
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