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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
KERLONE | 019507 | 001 | NDA | BETAXOLOL HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1989/10/27 | 1989/10/27 | SANOFI AVENTIS US | Discontinued |
KERLONE | 019507 | 002 | NDA | BETAXOLOL HYDROCHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1989/10/27 | 1989/10/27 | SANOFI AVENTIS US | Discontinued |