药品注册申请号:076341
申请类型:ANDA (仿制药申请)
申请人:APOTEX
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 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG No No AB 2006/10/23 2006/10/23 Prescription
002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG No No AB 2006/10/23 Prescription
003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG No No AB 2006/10/23 Prescription
004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG No No AB 2007/12/28 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
2023/04/26 SUPPL-26(补充) Approval Labeling STANDARD
2021/03/05 SUPPL-25(补充) Approval Labeling STANDARD
2017/07/07 SUPPL-19(补充) Approval Labeling STANDARD
2013/07/26 SUPPL-15(补充) Approval Labeling STANDARD
2012/07/12 SUPPL-13(补充) Approval Labeling
2007/12/28 SUPPL-2(补充) Approval Labeling
2007/12/28 SUPPL-1(补充) Approval Manufacturing (CMC)
2006/10/23 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:PRAVASTATIN SODIUM 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
076056 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/04/24 AUROBINDO PHARMA USA
076341 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/10/23 APOTEX
076714 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/10/23 DR REDDYS LABS INC
076939 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/10/23 WATSON LABS
077491 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/10/23 APNAR PHARMA LP
077904 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/10/23 CIPLA
077987 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2007/05/11 GLENMARK PHARMS LTD
077917 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2008/01/08 CHARTWELL RX
207068 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2016/11/17 ACCORD HLTHCARE
203367 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2017/02/02 AUROBINDO PHARMA
209869 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2018/04/13 BIOCON PHARMA
活性成分:PRAVASTATIN SODIUM 剂型/给药途径:TABLET;ORAL 规格:20MG 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
076056 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/04/24 AUROBINDO PHARMA USA
076341 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/10/23 APOTEX
076714 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/10/23 DR REDDYS LABS INC
076939 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/10/23 WATSON LABS
077491 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/10/23 APNAR PHARMA LP
077904 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2006/10/23 CIPLA
077987 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2007/05/11 GLENMARK PHARMS LTD
077917 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2008/01/08 CHARTWELL RX
077751 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2008/04/30 ZYDUS PHARMS USA
207068 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2016/11/17 ACCORD HLTHCARE
203367 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2017/02/02 AUROBINDO PHARMA
209869 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG Prescription No No AB 2018/04/13 BIOCON PHARMA
活性成分:PRAVASTATIN SODIUM 剂型/给药途径:TABLET;ORAL 规格:40MG 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
076056 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/04/24 AUROBINDO PHARMA USA
076341 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/10/23 APOTEX
076714 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/10/23 DR REDDYS LABS INC
076939 002 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/10/23 WATSON LABS
077491 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/10/23 APNAR PHARMA LP
077904 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2006/10/23 CIPLA
077987 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2007/05/11 GLENMARK PHARMS LTD
077917 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2008/01/08 CHARTWELL RX
077751 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2008/04/30 ZYDUS PHARMS USA
207068 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2016/11/17 ACCORD HLTHCARE
203367 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2017/02/02 AUROBINDO PHARMA
209869 003 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG Prescription No No AB 2018/04/13 BIOCON PHARMA
活性成分:PRAVASTATIN SODIUM 剂型/给药途径:TABLET;ORAL 规格:80MG 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
076341 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2007/12/28 APOTEX
076714 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2007/12/28 DR REDDYS LABS INC
076939 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2007/12/28 WATSON LABS
077987 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2007/12/28 GLENMARK PHARMS LTD
077917 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2008/01/08 CHARTWELL RX
077793 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No Yes AB 2008/01/15 AUROBINDO PHARMA USA
077491 001 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2008/02/11 APNAR PHARMA LP
077751 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2008/04/30 ZYDUS PHARMS USA
077904 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2016/03/22 CIPLA
207068 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2016/11/17 ACCORD HLTHCARE
203367 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2017/02/02 AUROBINDO PHARMA
209869 004 ANDA PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG Prescription No No AB 2018/04/13 BIOCON PHARMA
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