药品注册申请号:019908
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 ZOLPIDEM TARTRATE TABLET;ORAL 5MG Yes No AB 1992/12/16 1992/12/16 Prescription
002 AMBIEN ZOLPIDEM TARTRATE TABLET;ORAL 10MG Yes Yes AB 1992/12/16 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-47(补充) Approval Labeling STANDARD
2022/02/23 SUPPL-44(补充) Approval Labeling STANDARD
2022/02/23 SUPPL-40(补充) Approval Labeling STANDARD
2019/08/18 SUPPL-46(补充) Approval Labeling STANDARD
2019/02/06 SUPPL-45(补充) Approval Labeling 901 REQUIRED
2018/09/14 SUPPL-42(补充) Approval Labeling STANDARD
2017/03/03 SUPPL-38(补充) Approval Labeling STANDARD
2016/12/02 SUPPL-37(补充) Approval Labeling STANDARD
2016/08/11 SUPPL-36(补充) Approval Labeling STANDARD
2014/10/07 SUPPL-35(补充) Approval Labeling STANDARD
2013/06/05 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL-34(补充) Approval Labeling 901 REQUIRED
2013/04/19 SUPPL-32(补充) Approval Labeling STANDARD
2010/04/14 SUPPL-29(补充) Approval Labeling UNKNOWN
2008/05/07 SUPPL-27(补充) Approval Labeling STANDARD
2007/10/04 SUPPL-25(补充) Approval Labeling STANDARD
2007/10/04 SUPPL-24(补充) Approval Labeling STANDARD
2007/10/04 SUPPL-20(补充) Approval Labeling STANDARD
2007/03/28 SUPPL-22(补充) Approval Efficacy PRIORITY
2002/09/25 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2002/05/21 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2002/01/15 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2001/11/15 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2001/05/04 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2001/04/13 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1999/12/01 SUPPL-9(补充) Approval Labeling STANDARD
1996/04/18 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1995/10/04 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1995/07/14 SUPPL-2(补充) Approval Labeling STANDARD
1995/07/14 SUPPL-1(补充) Approval Labeling STANDARD
1995/01/09 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1992/12/16 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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 U-74 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**
002 4382938 2006/10/21 U-74 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**
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 M-54 2010/03/29**本条是由Drugfuture回溯的历史信息**
PED 2010/09/29**本条是由Drugfuture回溯的历史信息**
002 M-54 2010/03/29**本条是由Drugfuture回溯的历史信息**
PED 2010/09/29**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;ORAL 规格: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
019908 001 NDA AMBIEN ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription Yes No AB 1992/12/16 SANOFI AVENTIS US
076410 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/04/23 TEVA
077214 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/04/23 ACME LABS
077322 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/04/23 SANDOZ
077884 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/04/23 APOTEX INC
078413 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/05/04 AUROBINDO PHARMA
077903 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2007/08/17 TORRENT PHARMS
078184 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Discontinued No No AB 2007/09/07 INVAGEN PHARMS
077388 001 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG Prescription No No AB 2012/07/30 CHARTWELL MOLECULAR
活性成分:ZOLPIDEM TARTRATE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
019908 002 NDA AMBIEN ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription Yes Yes AB 1992/12/16 SANOFI AVENTIS US
076410 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/04/23 TEVA
077214 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/04/23 ACME LABS
077322 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/04/23 SANDOZ
077884 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/04/23 APOTEX INC
078413 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/05/04 AUROBINDO PHARMA
077903 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2007/08/17 TORRENT PHARMS
078184 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Discontinued No No AB 2007/09/07 INVAGEN PHARMS
077388 002 ANDA ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG Prescription No No AB 2012/07/30 CHARTWELL MOLECULAR
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