| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GYNOREST | 017388 | 001 | NDA | DYDROGESTERONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | -- | Approved Prior to Jan 1, 1982 | SOLVAY | Discontinued |
| GYNOREST | 017388 | 002 | NDA | DYDROGESTERONE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | -- | Approved Prior to Jan 1, 1982 | SOLVAY | Discontinued |