| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | 204413 | 001 | ANDA | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | No | No | 2022/05/11 | 2022/05/11 | PRINSTON INC | Prescription |
| ROPINIROLE HYDROCHLORIDE | 204413 | 002 | ANDA | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | No | No | 2022/05/11 | 2022/05/11 | PRINSTON INC | Prescription |
| ROPINIROLE HYDROCHLORIDE | 204413 | 003 | ANDA | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 6MG BASE | No | No | 2022/05/11 | 2022/05/11 | PRINSTON INC | Prescription |
| ROPINIROLE HYDROCHLORIDE | 204413 | 004 | ANDA | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | No | No | 2022/05/11 | 2022/05/11 | PRINSTON INC | Prescription |
| ROPINIROLE HYDROCHLORIDE | 204413 | 005 | ANDA | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12MG BASE | No | No | 2022/05/11 | 2022/05/11 | PRINSTON INC | Prescription |