药品注册申请号:078826
申请类型:ANDA (仿制药申请)
申请人:AMNEAL PHARMS
申请人全名:AMNEAL PHARMACEUTICALS
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 LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG No No AB 2010/06/23 2010/06/23 Discontinued
002 LORAZEPAM LORAZEPAM TABLET;ORAL 1MG No No AB 2010/06/23 Discontinued
003 LORAZEPAM LORAZEPAM TABLET;ORAL 2MG No No AB 2010/06/23 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
2012/08/10 SUPPL-1(补充) Approval Manufacturing (CMC)
2010/06/23 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:LORAZEPAM 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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
071403 001 LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB --
017794 001 NDA ATIVAN LORAZEPAM TABLET;ORAL 0.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 BAUSCH
071141 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1987/04/21 SANDOZ
072926 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 1991/10/31 WATSON LABS
076045 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2001/08/29 SUN PHARM INDS LTD
077754 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2006/05/10 OXFORD PHARMS
078203 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2007/07/30 LEADING
078826 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Discontinued No No AB 2010/06/23 AMNEAL PHARMS
203572 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 0.5MG Prescription No No AB 2017/12/22 AUROLIFE PHARMA LLC
活性成分:LORAZEPAM 剂型/给药途径:TABLET;ORAL 规格:1MG 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
071404 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB -- SANDOZ
017794 002 NDA ATIVAN LORAZEPAM TABLET;ORAL 1MG Prescription Yes No AB Approved Prior to Jan 1, 1982 BAUSCH
071141 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 1987/04/21 SANDOZ
072927 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 1991/10/31 WATSON LABS
076045 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 2001/08/29 SUN PHARM INDS LTD
077754 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 2006/05/10 OXFORD PHARMS
078203 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 2007/07/30 LEADING
078826 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Discontinued No No AB 2010/06/23 AMNEAL PHARMS
203572 002 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 1MG Prescription No No AB 2017/12/22 AUROLIFE PHARMA LLC
活性成分:LORAZEPAM 剂型/给药途径:TABLET;ORAL 规格:2MG 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
017794 003 NDA ATIVAN LORAZEPAM TABLET;ORAL 2MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 BAUSCH
071141 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 1987/04/21 SANDOZ
072928 001 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 1991/10/31 WATSON LABS
076045 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 2001/08/29 SUN PHARM INDS LTD
077754 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 2006/05/10 OXFORD PHARMS
078203 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 2007/07/30 LEADING
078826 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Discontinued No No AB 2010/06/23 AMNEAL PHARMS
203572 003 ANDA LORAZEPAM LORAZEPAM TABLET;ORAL 2MG Prescription No No AB 2017/12/22 AUROLIFE PHARMA LLC
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