| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZITUVIMET XR | 216778 | 001 | NDA | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 500MG;50MG | Yes | No | 2024/07/18 | 2024/07/18 | ZYDUS LIFESCIENCES | Prescription |
| ZITUVIMET XR | 216778 | 002 | NDA | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;50MG | Yes | No | 2024/07/18 | 2024/07/18 | ZYDUS LIFESCIENCES | Prescription |
| ZITUVIMET XR | 216778 | 003 | NDA | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;100MG | Yes | Yes | 2024/07/18 | 2024/07/18 | ZYDUS LIFESCIENCES | Prescription |