药品注册申请号：209660
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL RX
申请人全名：CHARTWELL RX SCIENCES LLC
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 FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG No No AB 2019/02/11 2019/02/11 Prescription
002 FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG No No AB 2019/02/11 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
2021/06/03 SUPPL-3（补充） Approval Labeling STANDARD
2019/02/11 ORIG-1（原始申请） Approval 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
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:FENOFIBRATE 剂型/给药途径:TABLET;ORAL 规格:54MG 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
076433 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2005/05/13 RHODES PHARMS
076635 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Discontinued No No AB 2005/10/31 SUN PHARM INDS LTD
076520 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2007/10/25 MYLAN
076509 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2008/03/26 IMPAX LABS
204019 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2015/08/17 LUPIN LTD
207803 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2017/12/19 AUSTARPHARMA
209950 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2018/03/19 AMNEAL
210138 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2018/07/23 AJANTA PHARMA LTD
210606 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2018/08/17 RISING
209660 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2019/02/11 CHARTWELL RX
210670 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2019/09/06 DR REDDYS
213864 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2020/06/12 MANKIND PHARMA
216798 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2022/09/27 AUROBINDO PHARMA
218548 001 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 54MG Prescription No No AB 2024/04/24 YICHANG HUMANWELL
活性成分:FENOFIBRATE 剂型/给药途径:TABLET;ORAL 规格:160MG 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
076433 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2005/05/13 RHODES PHARMS
076635 003 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Discontinued No No AB 2005/10/31 SUN PHARM INDS LTD
076520 003 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2007/10/25 MYLAN
076509 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No Yes AB 2008/03/26 IMPAX LABS
204019 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2015/08/17 LUPIN LTD
207803 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2017/12/19 AUSTARPHARMA
209950 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2018/03/19 AMNEAL
210138 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2018/07/23 AJANTA PHARMA LTD
210606 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2018/08/17 RISING
209660 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2019/02/11 CHARTWELL RX
210670 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2019/09/06 DR REDDYS
213864 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2020/06/12 MANKIND PHARMA
216798 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2022/09/27 AUROBINDO PHARMA
218548 002 ANDA FENOFIBRATE FENOFIBRATE TABLET;ORAL 160MG Prescription No No AB 2024/04/24 YICHANG HUMANWELL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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