药品注册申请号：022421
申请类型：NDA (新药申请)
申请人：BOEHRINGER INGELHEIM
申请人全名：BOEHRINGER INGELHEIM PHARMACEUTICALS 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 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.375MG Yes No AB 2010/02/19 2010/02/19 Discontinued
002 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 0.75MG Yes No AB 2010/02/19 Discontinued
003 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Yes No AB 2010/02/19 Discontinued
004 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Yes No AB 2010/02/19 Discontinued
005 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Yes No AB 2010/02/19 Discontinued
006 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2.25MG Yes No AB 2011/06/17 Discontinued
007 MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3.75MG Yes No AB 2011/06/17 Discontinued
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
2024/06/07 SUPPL-23（补充） Approval Labeling STANDARD
2021/07/12 SUPPL-22（补充） Approval Labeling STANDARD
2020/01/30 SUPPL-20（补充） Approval Labeling STANDARD
2018/05/10 SUPPL-17（补充） Approval Labeling STANDARD
2016/07/28 SUPPL-14（补充） Approval Labeling STANDARD
2016/01/14 SUPPL-13（补充） Approval Labeling STANDARD
2015/03/27 SUPPL-10（补充） Approval Labeling STANDARD
2014/05/08 SUPPL-3（补充） Approval Labeling STANDARD
2013/08/23 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
2013/07/15 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
2013/03/01 SUPPL-7（补充） Approval Labeling STANDARD
2012/08/31 SUPPL-6（补充） Approval Efficacy STANDARD
2010/07/13 SUPPL-1（补充） Approval Labeling UNKNOWN
2010/02/19 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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
001 7695734 2028/04/26 Y PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
002 7695734 2028/04/26 Y PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
003 7695734 2028/04/26 Y PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
004 7695734 2028/04/26 Y PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
005 7695734 2028/04/26 Y PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
006 7695734 2028/04/26 Y 2011/06/30 PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
007 7695734 2028/04/26 Y 2011/06/30 PDF格式
8679533 2029/09/08 Y U-219 2014/03/25 PDF格式
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:0.375MG 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 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
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:0.75MG 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 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
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1.5MG 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 003 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Discontinued Yes No AB 2010/02/19 BOEHRINGER INGELHEIM
202206 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Discontinued No No AB 2014/02/06 ENDO OPERATIONS
202353 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2014/12/04 SANDOZ
203354 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2015/08/07 DR REDDYS
201963 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2016/04/21 ACTAVIS ELIZABETH
206156 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2016/06/24 MACLEODS PHARMS LTD
202891 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2017/12/12 ZYDUS PHARMS
204518 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG Prescription No No AB 2019/01/02 ALEMBIC
213444 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1.5MG 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:3MG 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 004 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Discontinued Yes No AB 2010/02/19 BOEHRINGER INGELHEIM
202206 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Discontinued No No AB 2014/02/06 ENDO OPERATIONS
202353 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2014/12/04 SANDOZ
203354 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2015/08/07 DR REDDYS
201963 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2016/04/21 ACTAVIS ELIZABETH
206156 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2016/06/24 MACLEODS PHARMS LTD
202891 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2017/12/12 ZYDUS PHARMS
204518 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2019/01/02 ALEMBIC
213444 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 3MG 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:4.5MG 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 005 NDA MIRAPEX ER PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Discontinued Yes No AB 2010/02/19 BOEHRINGER INGELHEIM
202206 007 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Discontinued No No AB 2014/02/06 ENDO OPERATIONS
202353 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2014/12/04 SANDOZ
203354 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2015/08/07 DR REDDYS
201963 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2016/04/21 ACTAVIS ELIZABETH
206156 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2016/06/24 MACLEODS PHARMS LTD
202891 007 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2017/12/12 ZYDUS PHARMS
204518 007 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG Prescription No No AB 2019/01/02 ALEMBIC
213444 007 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4.5MG 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
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