药品注册申请号:074680
申请类型:ANDA (仿制药申请)
申请人:APOTEX
申请人全名:APOTEX 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 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE No No AB 1997/09/12 1997/09/12 Prescription
002 RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE No No AB 1997/09/12 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
2012/06/18 SUPPL 16 Approval Labeling
2005/12/23 SUPPL 13 Approval Labeling
2000/05/01 SUPPL 3 Approval Manufacturing (CMC)
2000/05/01 SUPPL 2 Approval Manufacturing (CMC)
1999/03/24 SUPPL 1 Approval Manufacturing (CMC)
1997/09/12 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: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
075208 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 1998/12/17 WOCKHARDT LTD
075180 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 1999/01/28 PAR PHARM
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
203694 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2017/11/30 ACIC PHARMS
211289 001 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE Prescription No No AB 2019/01/31 VKT PHARMA PVT LTD
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
075208 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 1998/12/17 WOCKHARDT LTD
075180 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 1999/01/28 PAR PHARM
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
203694 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2017/11/30 ACIC PHARMS
211289 002 ANDA RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET;ORAL EQ 300MG BASE Prescription No No AB 2019/01/31 VKT PHARMA PVT LTD
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database