批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
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 |
2023/05/31 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/03 |
ORIG-2(原始申请) |
Approval |
|
|
|
|
2016/10/14 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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 |
与本品治疗等效的药品
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:2.25MG 治疗等效代码:AB
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 |
006 |
NDA |
MIRAPEX ER |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
Yes |
No |
AB |
2011/06/17
|
BOEHRINGER INGELHEIM |
202206 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Discontinued |
No |
No |
AB |
2014/02/06
|
ENDO OPERATIONS |
206156 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2016/06/24
|
MACLEODS PHARMS LTD |
203615 |
001 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2016/10/14
|
ACTAVIS ELIZABETH |
202891 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
204518 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2019/01/02
|
ALEMBIC |
213444 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2022/02/03
|
NOVAST LABS |
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:2.25MG 治疗等效代码:AB
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 |
006 |
NDA |
MIRAPEX ER |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
Yes |
No |
AB |
2011/06/17
|
BOEHRINGER INGELHEIM |
202206 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Discontinued |
No |
No |
AB |
2014/02/06
|
ENDO OPERATIONS |
206156 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2016/06/24
|
MACLEODS PHARMS LTD |
203615 |
001 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2016/10/14
|
ACTAVIS ELIZABETH |
202891 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
204518 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2019/01/02
|
ALEMBIC |
213444 |
004 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
2.25MG |
Prescription |
No |
No |
AB |
2022/02/03
|
NOVAST LABS |
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:3.75MG 治疗等效代码:AB
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 |
007 |
NDA |
MIRAPEX ER |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
Yes |
No |
AB |
2011/06/17
|
BOEHRINGER INGELHEIM |
202206 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Discontinued |
No |
No |
AB |
2014/02/06
|
ENDO OPERATIONS |
203615 |
002 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/01/03
|
ACTAVIS ELIZABETH |
206156 |
007 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/01/23
|
MACLEODS PHARMS LTD |
202891 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
204518 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2019/01/02
|
ALEMBIC |
213444 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2022/02/03
|
NOVAST LABS |
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:3.75MG 治疗等效代码:AB
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 |
007 |
NDA |
MIRAPEX ER |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
Yes |
No |
AB |
2011/06/17
|
BOEHRINGER INGELHEIM |
202206 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Discontinued |
No |
No |
AB |
2014/02/06
|
ENDO OPERATIONS |
203615 |
002 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/01/03
|
ACTAVIS ELIZABETH |
206156 |
007 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/01/23
|
MACLEODS PHARMS LTD |
202891 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2017/12/12
|
ZYDUS PHARMS |
204518 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2019/01/02
|
ALEMBIC |
213444 |
006 |
ANDA |
PRAMIPEXOLE DIHYDROCHLORIDE |
PRAMIPEXOLE DIHYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
3.75MG |
Prescription |
No |
No |
AB |
2022/02/03
|
NOVAST LABS |