药品注册申请号:077203
申请类型:ANDA (仿制药申请)
申请人:PAR PHARM
申请人全名:PAR PHARMACEUTICAL 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 LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET No No AB 2005/08/26 2005/08/26 Prescription
002 CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL No No AB 2005/08/26 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2013/07/26 SUPPL 16 Approval Labeling STANDARD
2005/08/26 ORIG 1 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
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 SANDOZ
074558 001 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No Yes AB 1996/08/15 SANDOZ
074554 001 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/PACKET Prescription No No AB 1996/10/02 ANI PHARMS INC
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
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 SANDOZ
074558 002 ANDA CHOLESTYRAMINE LIGHT CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/08/15 SANDOZ
074554 002 ANDA CHOLESTYRAMINE CHOLESTYRAMINE POWDER;ORAL EQ 4GM RESIN/SCOOPFUL Prescription No No AB 1996/10/02 ANI PHARMS INC
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
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