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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
LEVATOL | 018976 | 001 | NDA | PENBUTOLOL SULFATE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1987/12/30 | 1987/12/30 | ENDO OPERATIONS | Discontinued |
LEVATOL | 018976 | 004 | NDA | PENBUTOLOL SULFATE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1987/12/30 | 1989/01/05 | ENDO OPERATIONS | Discontinued |