药品注册申请号:209597
申请类型:ANDA (仿制药申请)
申请人:TAGI
申请人全名:TAGI PHARMA 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 CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET No No AB 2021/03/09 2021/03/09 Prescription
002 CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL No No AB 2021/03/09 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
2021/03/09 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
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
与本品治疗等效的药品
活性成分:CHOLESTYRAMINE 剂型/给药途径:POWDER;ORAL 规格:EQ 4GM RESIN/PACKET 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
073263 001 ANDA PREVALITE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 1996/02/22 UPSHER SMITH LABS
074557 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No Yes AB 1996/08/15 EPIC PHARMA LLC
074558 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No Yes AB 1996/08/15 EPIC PHARMA LLC
074561 001 ANDA LOCHOLEST CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 1996/08/15 CHARTWELL RX
074562 001 ANDA LOCHOLEST LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 1996/08/15 CHARTWELL RX
074554 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Discontinued No No AB 1996/10/02 ANI PHARMS
077203 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2005/08/26 PAR PHARM
077204 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2005/08/26 PAR PHARM
211119 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2020/04/06 AJANTA PHARMA LTD
209599 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2020/11/12 TAGI
209597 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2021/03/09 TAGI
211799 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2021/10/19 ALKEM LABS LTD
211856 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 2021/10/19 ALKEM LABS LTD
活性成分:CHOLESTYRAMINE 剂型/给药途径:POWDER;ORAL 规格:EQ 4GM RESIN/SCOOPFUL 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
074557 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/08/15 EPIC PHARMA LLC
074558 002 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/08/15 EPIC PHARMA LLC
074561 002 ANDA LOCHOLEST CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/08/15 CHARTWELL RX
074562 002 ANDA LOCHOLEST LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/08/15 CHARTWELL RX
074554 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Discontinued No No AB 1996/10/02 ANI PHARMS
073263 002 ANDA PREVALITE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1997/10/30 UPSHER SMITH LABS
077203 002 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2005/08/26 PAR PHARM
077204 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2005/08/26 PAR PHARM
202902 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2017/04/25 ZYDUS PHARMS
202901 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2018/07/02 ZYDUS PHARMS
211119 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2020/04/06 AJANTA PHARMA LTD
209599 002 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2020/11/12 TAGI
209597 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2021/03/09 TAGI
211799 002 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2021/10/19 ALKEM LABS LTD
211856 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 2021/10/19 ALKEM LABS LTD
更多信息
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