药品注册申请号：077691
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA
申请人全名：AUROBINDO PHARMA 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 SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG No No AB 2006/12/20 2006/12/20 Prescription
002 SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG No No AB 2006/12/20 Prescription
003 SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG No No AB 2006/12/20 Prescription
004 SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG No No AB 2006/12/20 Prescription
005 SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG No No AB 2006/12/20 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
2024/01/31 SUPPL-48（补充） Approval Labeling STANDARD
2023/07/31 SUPPL-47（补充） Approval Labeling STANDARD
2022/08/29 SUPPL-45（补充） Approval Labeling STANDARD
2022/08/29 SUPPL-44（补充） Approval Labeling STANDARD
2022/08/29 SUPPL-43（补充） Approval Labeling STANDARD
2020/05/05 SUPPL-40（补充） Approval Labeling STANDARD
2019/08/07 SUPPL-38（补充） Approval Labeling STANDARD
2018/12/31 SUPPL-36（补充） Approval Labeling STANDARD
2015/10/15 SUPPL-33（补充） Approval Labeling STANDARD
2014/11/05 SUPPL-28（补充） Approval Labeling STANDARD
2014/11/05 SUPPL-26（补充） Approval Labeling STANDARD
2012/11/28 SUPPL-19（补充） Approval Labeling STANDARD
2012/04/26 SUPPL-18（补充） Approval Labeling
2012/03/02 SUPPL-10（补充） Approval Manufacturing (CMC)
2012/01/11 SUPPL-16（补充） Approval Labeling
2011/07/26 SUPPL-15（补充） Approval Labeling
2011/05/08 SUPPL-14（补充） Approval Labeling
2010/09/18 SUPPL-12（补充） Approval Manufacturing (CMC)
2010/09/08 SUPPL-11（补充） Approval Labeling
2009/04/03 SUPPL-5（补充） Approval Labeling
2008/06/09 SUPPL-3（补充） Approval Labeling
2006/12/20 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
无
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
无
与本品治疗等效的药品
活性成分:SIMVASTATIN 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
019766 001 NDA ZOCOR SIMVASTATIN TABLET;ORAL 5MG Prescription Yes No AB 1991/12/23 ORGANON
076685 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077837 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2006/12/20 BIOCON PHARMA
077752 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2008/01/23 DR REDDYS LABS INC
078103 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2009/04/14 LUPIN
078735 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2011/09/16 MICRO LABS
078155 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2013/04/05 ACCORD HLTHCARE
200895 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 5MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
活性成分:SIMVASTATIN 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
019766 002 NDA ZOCOR SIMVASTATIN TABLET;ORAL 10MG Prescription Yes No AB 1991/12/23 ORGANON
076685 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2007/05/11 LUPIN
078155 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2011/09/16 MICRO LABS
200895 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
211394 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG Prescription No No AB 2024/11/27 YILING
活性成分:SIMVASTATIN 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
019766 003 NDA ZOCOR SIMVASTATIN TABLET;ORAL 20MG Prescription Yes No AB 1991/12/23 ORGANON
076685 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2007/05/11 LUPIN
078155 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2011/09/16 MICRO LABS
200895 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
211394 002 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG Prescription No No AB 2024/11/27 YILING
活性成分:SIMVASTATIN 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
019766 004 NDA ZOCOR SIMVASTATIN TABLET;ORAL 40MG Prescription Yes No AB 1991/12/23 ORGANON
076685 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2007/05/11 LUPIN
078155 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2011/09/16 MICRO LABS
200895 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
211394 003 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG Prescription No No AB 2024/11/27 YILING
活性成分:SIMVASTATIN 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
076685 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Discontinued No No AB 2006/12/20 WATSON LABS TEVA
077691 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2006/12/20 AUROBINDO PHARMA
077752 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2006/12/20 DR REDDYS LABS INC
077837 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2006/12/20 ZYDUS PHARMS USA
078034 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2006/12/20 BIOCON PHARMA
078103 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No Yes AB 2007/05/11 LUPIN
078155 001 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2008/02/26 ACCORD HLTHCARE
078735 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2010/08/30 OXFORD PHARMS
090383 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2011/09/16 MICRO LABS
200895 005 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2014/11/25 HETERO LABS LTD III
206557 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2017/11/13 INVAGEN PHARMS
211394 004 ANDA SIMVASTATIN SIMVASTATIN TABLET;ORAL 80MG Prescription No No AB 2024/11/27 YILING
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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