药品注册申请号:021774
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
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 AMBIEN CR ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Yes Yes AB 2005/09/02 2005/09/02 Prescription
002 AMBIEN CR ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Yes No AB 2005/09/02 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
2022/02/23 SUPPL-28(补充) Approval Labeling STANDARD
2022/02/23 SUPPL-25(补充) Approval Labeling STANDARD
2022/02/23 SUPPL-21(补充) Approval Labeling STANDARD
2019/08/18 SUPPL-27(补充) Approval Labeling STANDARD
2019/02/06 SUPPL-26(补充) Approval Labeling 901 REQUIRED
2018/09/14 SUPPL-23(补充) Approval Labeling STANDARD
2017/03/03 SUPPL-19(补充) Approval Labeling STANDARD
2016/12/02 SUPPL-18(补充) Approval Labeling STANDARD
2016/08/11 SUPPL-17(补充) Approval Labeling STANDARD
2014/10/07 SUPPL-16(补充) Approval Labeling STANDARD
2013/04/19 SUPPL-15(补充) Approval Labeling STANDARD
2013/04/19 SUPPL-13(补充) Approval Labeling STANDARD
2010/04/14 SUPPL-10(补充) Approval Labeling UNKNOWN
2007/12/20 SUPPL-8(补充) Approval Efficacy STANDARD
2007/12/20 SUPPL-7(补充) Approval Labeling STANDARD
2007/12/20 SUPPL-5(补充) Approval Efficacy STANDARD
2007/12/20 SUPPL-4(补充) Approval Efficacy STANDARD
2007/12/20 SUPPL-3(补充) Approval Efficacy UNKNOWN
2005/09/02 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
001 4382938 2006/10/21 Y U-682 PDF格式**本条是由Drugfuture回溯的历史信息**
4382938*PED 2007/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
6514531 2019/12/01 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6514531*PED 2020/06/01 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4382938 2006/10/21 Y U-682 PDF格式**本条是由Drugfuture回溯的历史信息**
4382938*PED 2007/04/21 PDF格式**本条是由Drugfuture回溯的历史信息**
6514531 2019/12/01 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6514531*PED 2020/06/01 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 NDF 2008/09/02**本条是由Drugfuture回溯的历史信息**
PED 2009/03/02**本条是由Drugfuture回溯的历史信息**
002 NDF 2008/09/02**本条是由Drugfuture回溯的历史信息**
PED 2009/03/02**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:ZOLPIDEM TARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:12.5MG 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
021774 001 NDA AMBIEN CR ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Prescription Yes Yes AB 2005/09/02 SANOFI AVENTIS US
078148 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Discontinued No No AB 2010/12/03 ENDO OPERATIONS
090107 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Prescription No No AB 2011/07/01 SANDOZ
200266 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Prescription No No AB 2013/09/10 APOTEX
078970 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Prescription No No AB 2013/09/11 LUPIN LTD
204170 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Prescription No No AB 2017/01/24 SUN PHARM
213592 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 12.5MG Discontinued No No AB 2020/06/04 BRECKENRIDGE
活性成分:ZOLPIDEM TARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:6.25MG 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
021774 002 NDA AMBIEN CR ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Prescription Yes No AB 2005/09/02 SANOFI AVENTIS US
078148 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Discontinued No No AB 2011/04/14 ENDO OPERATIONS
090107 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Prescription No No AB 2011/07/01 SANDOZ
200266 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Prescription No No AB 2013/09/10 APOTEX
078970 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Prescription No No AB 2013/09/11 LUPIN LTD
204170 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Prescription No No AB 2017/01/24 SUN PHARM
213592 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE;ORAL 6.25MG Discontinued No No AB 2020/06/04 BRECKENRIDGE
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