药品注册申请号:075180
申请类型:ANDA (仿制药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS LTD
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 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE No No AB 1999/01/28 1999/01/28 Discontinued
002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE No No AB 1999/01/28 Discontinued
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
2007/09/06 SUPPL-14(补充) Approval Labeling
2006/10/31 SUPPL-11(补充) Approval Labeling
2003/04/04 SUPPL-5(补充) Approval Labeling
2002/07/15 SUPPL-6(补充) Approval Manufacturing (CMC)
2001/01/18 SUPPL-1(补充) Approval Labeling
1999/01/28 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
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:RANITIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 150MG BASE 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
074467 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 1997/08/29 SANDOZ
074680 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 1997/09/12 APOTEX
075180 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Discontinued No No AB 1999/01/28 ENDO OPERATIONS
076705 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2005/07/27 DR REDDYS LABS INC
078542 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2008/11/19 GLENMARK PHARMS INC
211289 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2019/01/31 VKT PHARMA
活性成分:RANITIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 300MG BASE 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
074467 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 1997/08/29 SANDOZ
074680 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 1997/09/12 APOTEX
075180 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Discontinued No No AB 1999/01/28 ENDO OPERATIONS
076705 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2005/07/27 DR REDDYS LABS INC
078542 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2008/11/19 GLENMARK PHARMS INC
211289 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2019/01/31 VKT PHARMA
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