| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LINACLOTIDE | 209564 | 001 | ANDA | LINACLOTIDE | CAPSULE;ORAL | 145MCG | No | No | 2021/02/09 | 2021/02/09 | MYLAN | Discontinued |
| LINACLOTIDE | 209564 | 002 | ANDA | LINACLOTIDE | CAPSULE;ORAL | 290MCG | No | No | 2021/02/09 | 2021/02/09 | MYLAN | Discontinued |
| LINACLOTIDE | 211255 | 001 | ANDA | LINACLOTIDE | CAPSULE;ORAL | 72MCG | No | No | 2022/06/16 (TA) | -- | ACTAVIS LABS FL INC | None (Tentative Approval) |
| LINACLOTIDE | 209611 | 001 | ANDA | LINACLOTIDE | CAPSULE;ORAL | 145MCG | No | No | 2023/02/07 | 2023/02/07 | AUROBINDO PHARMA | Discontinued |
| LINACLOTIDE | 209611 | 002 | ANDA | LINACLOTIDE | CAPSULE;ORAL | 290MCG | No | No | 2023/02/07 | 2023/02/07 | AUROBINDO PHARMA | Discontinued |