药品注册申请号:076768
申请类型:ANDA (仿制药申请)
申请人:CIPLA
申请人全名:CIPLA LTD
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 ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 5MG BASE No No AB 2008/08/04 2008/08/04 Prescription
002 ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE No No AB 2008/08/04 Prescription
003 ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE No No AB 2008/08/04 Prescription
004 ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 40MG BASE No No AB 2008/08/04 Prescription
005 ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE No No AB 2008/08/04 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
2019/01/15 SUPPL-7(补充) Approval Labeling STANDARD
2016/02/12 SUPPL-6(补充) Approval Labeling STANDARD
2016/02/12 SUPPL-4(补充) Approval Labeling STANDARD
2011/07/07 SUPPL-2(补充) Approval Labeling
2008/08/04 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:ALENDRONATE SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 5MG 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
076768 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2008/08/04 CIPLA
077982 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2008/08/04 APOTEX
090022 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2008/09/10 SUN PHARM
090258 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 5MG BASE Prescription No No AB 2009/09/24 HANGZHOU BINJIANG
活性成分:ALENDRONATE SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG 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
076768 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/08/04 CIPLA
077982 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/08/04 APOTEX
090124 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/08/04 AUROBINDO PHARMA
090022 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/09/10 SUN PHARM
090258 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2009/09/24 HANGZHOU BINJIANG
206387 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/06/04 IPCA LABS LTD
活性成分:ALENDRONATE SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 35MG 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
076768 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2008/08/04 CIPLA
076984 001 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2008/08/04 WATSON LABS
077982 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2008/08/04 APOTEX
090124 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2008/08/04 AUROBINDO PHARMA
090022 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2008/09/10 SUN PHARM
090258 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2009/09/24 HANGZHOU BINJIANG
206387 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 35MG BASE Prescription No No AB 2024/06/04 IPCA LABS LTD
活性成分:ALENDRONATE SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 40MG 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
076768 004 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2008/08/04 CIPLA
076984 002 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2008/08/04 WATSON LABS
206387 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 40MG BASE Prescription No No AB 2024/06/04 IPCA LABS LTD
活性成分:ALENDRONATE SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 70MG 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
020560 005 NDA FOSAMAX ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription Yes Yes AB 2000/10/20 ORGANON
076768 005 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2008/08/04 CIPLA
076984 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2008/08/04 WATSON LABS
077982 004 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2008/08/04 APOTEX
090124 003 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2008/08/04 AUROBINDO PHARMA
090022 004 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2008/09/10 SUN PHARM
090258 004 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2009/09/24 HANGZHOU BINJIANG
206387 004 ANDA ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET;ORAL EQ 70MG BASE Prescription No No AB 2024/06/04 IPCA LABS LTD
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