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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
LOTENSIN HCT | 020033 | 001 | NDA | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1992/05/19 | 1992/05/19 | VALIDUS PHARMS | Discontinued |
LOTENSIN HCT | 020033 | 002 | NDA | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG | Yes | No | 1992/05/19 | 1992/05/19 | VALIDUS PHARMS | Prescription |
LOTENSIN HCT | 020033 | 003 | NDA | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;25MG | Yes | Yes | 1992/05/19 | 1992/05/19 | VALIDUS PHARMS | Prescription |
LOTENSIN HCT | 020033 | 004 | NDA | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG | Yes | No | 1992/05/19 | 1992/05/19 | VALIDUS PHARMS | Prescription |