药品注册申请号:077884
申请类型:ANDA (仿制药申请)
申请人:APOTEX INC
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 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 5MG No No AB 2007/04/23 2007/04/23 Prescription
002 ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET;ORAL 10MG No No AB 2007/04/23 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
2022/09/28 SUPPL-22(补充) Approval Labeling STANDARD
2019/10/25 SUPPL-19(补充) Approval Labeling STANDARD
2019/10/25 SUPPL-18(补充) Approval Labeling STANDARD
2019/10/25 SUPPL-17(补充) Approval Labeling STANDARD
2019/10/25 SUPPL-16(补充) Approval Labeling STANDARD
2019/10/25 SUPPL-15(补充) Approval Labeling STANDARD
2014/12/13 SUPPL-14(补充) Approval Labeling STANDARD
2014/12/13 SUPPL-13(补充) Approval Labeling STANDARD
2011/02/04 SUPPL-11(补充) Approval Labeling
2009/01/21 SUPPL-9(补充) Approval Labeling
2008/05/29 SUPPL-5(补充) Approval Labeling
2007/04/23 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: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
更多信息
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