药品注册申请号：218939
申请类型：ANDA (仿制药申请)
申请人：ASCENT PHARMS INC
申请人全名：ASCENT 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 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG No No AB 2025/01/14 2025/01/14 Prescription
002 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG No No AB 2025/01/14 Prescription
003 CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG No No AB 2025/01/14 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/01/14 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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:CARBIDOPA; LEVODOPA; 剂型/给药途径:TABLET;ORAL; 规格:10MG;100MG; 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
017555 001 NDA SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ORGANON
073618 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 1992/08/28 DR REDDYS LABS SA
074260 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 1993/09/03 ACTAVIS ELIZABETH
077120 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Discontinued No No AB 2008/06/02 APOTEX INC
078536 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 2008/10/28 SUN PHARM INDS
090324 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Discontinued No No AB 2009/09/28 PHARMOBEDIENT
214092 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 2021/05/07 SCIEGEN PHARMS INC
216505 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 2022/09/21 RUBICON RESEARCH
216537 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 2022/11/28 AUROBINDO PHARMA LTD
215999 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Discontinued No No AB 2023/04/04 ZYDUS PHARMS
218939 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 10MG;100MG Prescription No No AB 2025/01/14 ASCENT PHARMS INC
>>>活性成分:CARBIDOPA; LEVODOPA; 剂型/给药途径:TABLET;ORAL; 规格:25MG;100MG; 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
017555 003 NDA SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ORGANON
073589 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 1992/08/28 DR REDDYS LABS SA
074260 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 1993/09/03 ACTAVIS ELIZABETH
077120 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Discontinued No No AB 2008/06/02 APOTEX INC
078536 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2008/10/28 SUN PHARM INDS
090324 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2009/09/28 PHARMOBEDIENT
214092 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2021/05/07 SCIEGEN PHARMS INC
216505 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2022/09/21 RUBICON RESEARCH
216537 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2022/11/28 AUROBINDO PHARMA LTD
215999 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Discontinued No No AB 2023/04/04 ZYDUS PHARMS
218939 002 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;100MG Prescription No No AB 2025/01/14 ASCENT PHARMS INC
>>>活性成分:CARBIDOPA; LEVODOPA; 剂型/给药途径:TABLET;ORAL; 规格:25MG;250MG; 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
017555 002 NDA SINEMET CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ORGANON
073607 001 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 1992/08/28 DR REDDYS LABS SA
074260 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No Yes AB 1993/09/03 ACTAVIS ELIZABETH
077120 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Discontinued No No AB 2008/06/02 APOTEX INC
078536 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 2008/10/28 SUN PHARM INDS
090324 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Discontinued No No AB 2009/09/28 PHARMOBEDIENT
214092 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 2021/05/07 SCIEGEN PHARMS INC
216505 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 2022/09/21 RUBICON RESEARCH
216537 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 2022/11/28 AUROBINDO PHARMA LTD
215999 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Discontinued No No AB 2023/04/04 ZYDUS PHARMS
218939 003 ANDA CARBIDOPA AND LEVODOPA CARBIDOPA; LEVODOPA TABLET;ORAL 25MG;250MG Prescription No No AB 2025/01/14 ASCENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
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