药品注册申请号：203615
申请类型：ANDA (仿制药申请)
申请人：ACTAVIS ELIZABETH
申请人全名：ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
产品信息
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 2.25MG No No AB;AB 2016/10/14 2016/10/14 Prescription
002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3.75MG No No AB;AB 2017/01/03 Prescription
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE Code产品号批准日期申请人
022421 006 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.25MG Discontinued 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RLDRSTE Code产品号批准日期申请人
022421 006 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.25MG Discontinued 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RLDRSTE Code产品号批准日期申请人
022421 007 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3.75MG Discontinued 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RLDRSTE Code产品号批准日期申请人
022421 007 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3.75MG Discontinued 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
更多信息
药品NDC数据与药品包装、标签说明书
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