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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DYAZIDE | 016042 | 002 | NDA | HYDROCHLOROTHIAZIDE; TRIAMTERENE | CAPSULE;ORAL | 25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1965/12/02 | Approved Prior to Jan 1, 1982 | GLAXOSMITHKLINE LLC | Discontinued |
DYAZIDE | 016042 | 003 | NDA | HYDROCHLOROTHIAZIDE; TRIAMTERENE | CAPSULE;ORAL | 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1965/12/02 | 1994/03/03 | GLAXOSMITHKLINE LLC | Discontinued |