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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ASACOL | 019651 | 001 | NDA | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 400MG | No | No | 1992/01/31 | 1992/01/31 | APIL | Discontinued |
ASACOL HD | 021830 | 001 | NDA | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/05/29 | 2008/05/29 | ABBVIE | Discontinued |