| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LUBIPROSTONE | 209450 | 001 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No | 2021/11/30 | 2021/11/30 | AMNEAL | Prescription |
| LUBIPROSTONE | 209450 | 002 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No | 2021/11/30 | 2021/11/30 | AMNEAL | Prescription |
| LUBIPROSTONE | 209920 | 001 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No | 2022/01/18 | 2022/01/18 | TEVA PHARMS USA INC | Prescription |
| LUBIPROSTONE | 209920 | 002 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No | 2022/01/18 | 2022/01/18 | TEVA PHARMS USA INC | Prescription |
| LUBIPROSTONE | 206994 | 001 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No | 2022/02/08 | 2022/02/08 | DR REDDYS | Prescription |
| LUBIPROSTONE | 206994 | 002 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No | 2022/02/08 | 2022/02/08 | DR REDDYS | Prescription |
| LUBIPROSTONE | 201442 | 001 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No | 2022/06/27 | 2022/06/27 | ENDO OPERATIONS | Discontinued |
| LUBIPROSTONE | 201442 | 002 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No | 2022/06/27 | 2022/06/27 | ENDO OPERATIONS | Discontinued |
| LUBIPROSTONE | 214131 | 001 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No | 2023/03/23 | 2023/03/23 | ZYDUS PHARMS | Prescription |
| LUBIPROSTONE | 214131 | 002 | ANDA | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No | 2023/03/23 | 2023/03/23 | ZYDUS PHARMS | Prescription |