| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PRUCALOPRIDE SUCCINATE | 218492 | 001 | ANDA | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/12/26 | 2024/12/26 | NOVITIUM PHARMA | Prescription |
| PRUCALOPRIDE SUCCINATE | 218492 | 002 | ANDA | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 2MG BASE | No | No | 2024/12/26 | 2024/12/26 | NOVITIUM PHARMA | Prescription |
| PRUCALOPRIDE | 218812 | 001 | ANDA | PRUCALOPRIDE | TABLET;ORAL | 1MG | No | No | 2025/01/24 (TA) | -- | SKG PHARMA | None (Tentative Approval) |
| PRUCALOPRIDE | 218812 | 002 | ANDA | PRUCALOPRIDE | TABLET;ORAL | 2MG | No | No | 2025/01/24 (TA) | -- | SKG PHARMA | None (Tentative Approval) |
| PRUCALOPRIDE SUCCINATE | 219193 | 002 | ANDA | PRUCALOPRIDE SUCCINATE | TABLET; FILM COATED | 1MG | No | No | 2025/03/03 (TA) | -- | AGGREGA PHARMA, LLC | None (Tentative Approval) |
| PRUCALOPRIDE | 219071 | 001 | ANDA | PRUCALOPRIDE | TABLET;ORAL | 1MG | No | No | 2025/03/17 (TA) | -- | TEVA PHARMS INC | None (Tentative Approval) |
| PRUCALOPRIDE | 219071 | 002 | ANDA | PRUCALOPRIDE | TABLET;ORAL | 2MG | No | No | 2025/03/17 (TA) | -- | TEVA PHARMS INC | None (Tentative Approval) |
| PRUCALOPRIDE | 218963 | 002 | ANDA | PRUCALOPRIDE | TABLET | 1MG | No | No | 2025/03/18 (TA) | -- | APPCO PHARMA LLC | None (Tentative Approval) |