| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ROWASA | 019618 | 001 | NDA | MESALAMINE | ENEMA;RECTAL | 4GM/60ML | Yes | Yes | 1987/12/24 | 1987/12/24 | MYLAN SPECIALITY LP | Prescription |
| SFROWASA | 019618 | 002 | NDA | MESALAMINE | ENEMA;RECTAL | 4GM/60ML | Yes | No | 1987/12/24 | 2008/06/20 | MYLAN SPECIALITY LP | Prescription |
| ROWASA | 019919 | 001 | NDA | MESALAMINE | SUPPOSITORY;RECTAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1990/12/18 | 1990/12/18 | MEDA PHARMS | Discontinued |