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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
APRESAZIDE | 084735 | 001 | ANDA | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 25MG;25MG | Yes | No | 1976/05/26 | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |
APRESAZIDE | 084810 | 001 | ANDA | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 50MG;50MG | Yes | No | 1976/05/26 | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |
APRESAZIDE | 084811 | 001 | ANDA | HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | CAPSULE;ORAL | 100MG;50MG | No | No | 1976/05/26 | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |