药品注册申请号：078920
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS USA INC
申请人全名：ZYDUS 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;ORAL 0.125MG No No AB 2010/07/06 2010/07/06 Prescription
002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG No No AB 2010/07/06 Prescription
003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG No No AB 2010/07/06 Prescription
004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG No No AB 2010/07/06 Prescription
005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG No No AB 2010/07/06 Prescription
006 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG No No AB 2022/11/23 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
2020/12/22 SUPPL-18（补充） Approval Labeling STANDARD
2019/11/15 SUPPL-15（补充） Approval Labeling STANDARD
2019/11/15 SUPPL-14（补充） Approval Labeling STANDARD
2019/11/15 SUPPL-12（补充） Approval Labeling STANDARD
2019/11/15 SUPPL-10（补充） Approval Labeling STANDARD
2019/11/15 SUPPL-9（补充） Approval Labeling STANDARD
2013/11/27 SUPPL-6（补充） Approval Labeling STANDARD
2013/11/27 SUPPL-5（补充） Approval Labeling STANDARD
2012/05/15 SUPPL-4（补充） Approval Labeling
2012/05/09 SUPPL-1（补充） Approval Manufacturing (CMC)
2010/07/06 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;ORAL 规格:0.125MG 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
078920 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2010/07/06 ZYDUS PHARMS USA INC
090781 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2010/10/08 GLENMARK PHARMS LTD
090865 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2012/04/30 ZENNOVA
202633 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.125MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:0.25MG 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
078920 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2010/07/06 ZYDUS PHARMS USA INC
090781 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No Yes AB 2010/10/08 GLENMARK PHARMS LTD
090865 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2012/04/30 ZENNOVA
202633 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
211088 001 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.25MG Prescription No No AB 2018/10/03 RISING
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
078920 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2010/07/06 ZYDUS PHARMS USA INC
090781 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2010/10/08 GLENMARK PHARMS LTD
090865 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2012/04/30 ZENNOVA
202633 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
211088 002 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.5MG Prescription No No AB 2018/10/03 RISING
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:1MG 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
078920 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2010/07/06 ZYDUS PHARMS USA INC
090781 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2010/10/08 GLENMARK PHARMS LTD
090865 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2012/04/30 ZENNOVA
202633 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
211088 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1MG Prescription No No AB 2018/10/03 RISING
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET;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
078920 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2010/07/06 ZYDUS PHARMS USA INC
090781 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2010/10/08 GLENMARK PHARMS LTD
090865 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2012/04/30 ZENNOVA
202633 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
211088 005 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 1.5MG Prescription No No AB 2018/10/03 RISING
活性成分:PRAMIPEXOLE DIHYDROCHLORIDE 剂型/给药途径:TABLET;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
090865 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2010/10/08 TORRENT PHARMS
090151 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2012/04/30 ZENNOVA
202633 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2012/10/26 AUROBINDO PHARMA LTD
202702 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2014/06/03 STRIDES PHARMA
203855 004 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2014/10/28 SCIEGEN PHARMS INC
090781 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2015/09/11 GLENMARK PHARMS LTD
211088 003 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2018/10/03 RISING
078920 006 ANDA PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL 0.75MG Prescription No No AB 2022/11/23 ZYDUS PHARMS USA INC
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药品NDC数据与药品包装、标签说明书
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