美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TRANDATE"
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
TRANDATE HCT 019174 001 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;100MG No No -- 1987/04/10 GLAXOSMITHKLINE Discontinued
TRANDATE HCT 019174 002 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;200MG No No -- 1987/04/10 GLAXOSMITHKLINE Discontinued
TRANDATE HCT 019174 003 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;300MG No No -- 1987/04/10 GLAXOSMITHKLINE Discontinued
TRANDATE HCT 019174 004 NDA HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE TABLET;ORAL 25MG;400MG No No -- 1987/04/10 GLAXOSMITHKLINE Discontinued
TRANDATE 018716 001 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Yes No 1984/08/01 1985/05/24 CNTY LINE PHARMS Prescription
TRANDATE 018716 002 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Yes No 1984/08/01 1984/08/01 CNTY LINE PHARMS Prescription
TRANDATE 018716 003 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Yes No 1984/08/01 1984/08/01 CNTY LINE PHARMS Prescription
TRANDATE 018716 004 NDA LABETALOL HYDROCHLORIDE TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1984/08/01 1984/08/01 CNTY LINE PHARMS Discontinued
TRANDATE 019425 001 NDA LABETALOL HYDROCHLORIDE INJECTABLE;INJECTION 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1985/12/31 1985/12/31 SEBELA IRELAND LTD Discontinued
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