| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE | 215155 | 002 | ANDA | SITAGLIPTIN PHOSPHATE | TABLET;ORAL | EQ 50MG BASE | No | No | 2022/04/08 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
| SITAGLIPTIN PHOSPHATE | 215155 | 003 | ANDA | SITAGLIPTIN PHOSPHATE | TABLET;ORAL | EQ 100MG BASE | No | No | 2022/04/08 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | 215220 | 002 | ANDA | SITAGLIPTIN; METFORMIN HYDROCHLORIDE | TABLET; ORAL | 50MG/1000MG | No | No | 2022/05/31 (TA) | -- | AJANTA PHARMA LTD | None (Tentative Approval) |
| SITAGLIPTIN | 216919 | 001 | ANDA | SITAGLIPTIN PHOSPHATE | TABLET; FILM COATED | 25MG | No | No | 2024/01/02 (TA) | -- | MANKIND PHARMA LTD | Prescription |
| SITAGLIPTIN | 216919 | 002 | ANDA | SITAGLIPTIN PHOSPHATE | TABLET; FILM COATED | 50MG | No | No | 2024/01/02 (TA) | -- | MANKIND PHARMA LTD | Prescription |
| SITAGLIPTIN | 216919 | 003 | ANDA | SITAGLIPTIN PHOSPHATE | TABLET; FILM COATED | 100MG | No | No | 2024/01/02 (TA) | -- | MANKIND PHARMA LTD | Prescription |