| 产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|
| 001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | No | No | AB | 2021/06/11 | 2021/06/11 | Prescription |
| 002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | No | No | AB | 2021/06/11 | Prescription |
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2023/05/26 | SUPPL-1（补充） | Approval | Labeling | STANDARD | ||
| 2021/06/11 | ORIG-1（原始申请） | Approval | STANDARD |
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|---|---|---|---|---|---|---|---|---|
| 无 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 022421 | 001 | NDA | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Discontinued | Yes | No | AB | 2010/02/19 | BOEHRINGER INGELHEIM |
| 202206 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Discontinued | No | No | AB | 2014/02/06 | ENDO OPERATIONS |
| 202353 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2014/12/04 | SANDOZ |
| 203354 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | Yes | AB | 2015/08/07 | DR REDDYS |
| 201963 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2016/04/21 | ACTAVIS ELIZABETH |
| 206156 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2016/06/24 | MACLEODS PHARMS LTD |
| 202891 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2017/12/12 | ZYDUS PHARMS |
| 204518 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2019/01/02 | ALEMBIC |
| 212797 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2021/06/11 | XIAMEN LP PHARM CO |
| 213444 | 001 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.375MG | Prescription | No | No | AB | 2022/02/03 | NOVAST LABS |
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 022421 | 002 | NDA | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Discontinued | Yes | No | AB | 2010/02/19 | BOEHRINGER INGELHEIM |
| 202206 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Discontinued | No | No | AB | 2014/02/06 | ENDO OPERATIONS |
| 202353 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2014/12/04 | SANDOZ |
| 203354 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2015/08/07 | DR REDDYS |
| 201963 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2016/04/21 | ACTAVIS ELIZABETH |
| 206156 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2016/06/24 | MACLEODS PHARMS LTD |
| 202891 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2017/12/12 | ZYDUS PHARMS |
| 204518 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2019/01/02 | ALEMBIC |
| 212797 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2021/06/11 | XIAMEN LP PHARM CO |
| 213444 | 002 | ANDA | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.75MG | Prescription | No | No | AB | 2022/02/03 | NOVAST LABS |