| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TREST | 013420 | 001 | NDA | METHIXENE HYDROCHLORIDE | TABLET;ORAL | 1MG | No | No | -- | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |
| NUTRESTORE | 021667 | 001 | NDA | L-GLUTAMINE | FOR SOLUTION;ORAL | 5GM/PACKET | Yes | No | 2004/06/10 | 2004/06/10 | EMMAUS MEDCL | Discontinued |
| ENTRESTO | 207620 | 001 | NDA | SACUBITRIL; VALSARTAN | TABLET;ORAL | 24MG;26MG | Yes | No | 2015/07/07 | 2015/07/07 | NOVARTIS PHARMS CORP | Prescription |
| ENTRESTO | 207620 | 002 | NDA | SACUBITRIL; VALSARTAN | TABLET;ORAL | 49MG;51MG | Yes | No | 2015/07/07 | 2015/07/07 | NOVARTIS PHARMS CORP | Prescription |
| ENTRESTO | 207620 | 003 | NDA | SACUBITRIL; VALSARTAN | TABLET;ORAL | 97MG;103MG | Yes | Yes | 2015/07/07 | 2015/07/07 | NOVARTIS PHARMS CORP | Prescription |
| ENTRESTO SPRINKLE | 218591 | 001 | NDA | SACUBITRIL; VALSARTAN | CAPSULE, PELLETS;ORAL | 6MG;6MG | Yes | No | 2024/04/12 | 2024/04/12 | NOVARTIS | Prescription |
| ENTRESTO SPRINKLE | 218591 | 002 | NDA | SACUBITRIL; VALSARTAN | CAPSULE, PELLETS;ORAL | 15MG;16MG | Yes | Yes | 2024/04/12 | 2024/04/12 | NOVARTIS | Prescription |