药品注册申请号：202696
申请类型：ANDA (仿制药申请)
申请人：MACLEODS PHARMS LTD
申请人全名：MACLEODS PHARMACEUTICALS 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 VALSARTAN VALSARTAN TABLET;ORAL 40MG No No AB 2016/09/16 2016/09/16 Prescription
002 VALSARTAN VALSARTAN TABLET;ORAL 80MG No No AB 2016/09/16 Prescription
003 VALSARTAN VALSARTAN TABLET;ORAL 160MG No No AB 2016/09/16 Prescription
004 VALSARTAN VALSARTAN TABLET;ORAL 320MG No No AB 2016/09/16 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2016/09/16 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/06/07 SUPPL-25（补充） Approval Labeling-Medication Guide,Labeling-Patient Package Insert,Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2021/12/06 SUPPL-23（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert,Labeling-Container/Carton Labels STANDARD
2020/04/08 SUPPL-2（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2019/09/04 SUPPL-13（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert 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
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:VALSARTAN; 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
021283 004 NDA DIOVAN VALSARTAN TABLET;ORAL 40MG Prescription Yes No AB 2002/08/14 NOVARTIS
077492 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2014/06/26 OHM LABS INC
090866 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 MYLAN
091367 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 ALEMBIC
203311 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 HETERO LABS LTD V
203536 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 JUBILANT GENERICS
201677 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 LUPIN LTD
202223 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/01/05 AUROBINDO PHARMA LTD
204821 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2015/06/09 PRINSTON INC
204011 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2016/01/11 AMNEAL PHARMS
202696 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2016/09/16 MACLEODS PHARMS LTD
205347 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2018/04/09 ACME LABS
205536 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2019/03/12 ALKEM LABS LTD
201618 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2021/10/05 DR REDDYS
204038 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2021/10/27 SCIEGEN PHARMS INC
218991 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Prescription No No AB 2024/07/22 ZYDUS LIFESCIENCES
218169 001 ANDA VALSARTAN VALSARTAN TABLET;ORAL 40MG Discontinued No No AB 2024/08/05 SOMERSET THERAPS LLC
>>>活性成分:VALSARTAN; 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
021283 001 NDA DIOVAN VALSARTAN TABLET;ORAL 80MG Prescription Yes No AB 2001/07/18 NOVARTIS
077492 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2014/06/26 OHM LABS INC
090866 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 MYLAN
091367 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 ALEMBIC
203311 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 HETERO LABS LTD V
203536 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 JUBILANT GENERICS
201677 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 LUPIN LTD
202223 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/01/05 AUROBINDO PHARMA LTD
204821 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2015/06/09 PRINSTON INC
204011 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2016/01/11 AMNEAL PHARMS
202696 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2016/09/16 MACLEODS PHARMS LTD
205347 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2018/04/09 ACME LABS
205536 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2019/03/12 ALKEM LABS LTD
201618 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2021/10/05 DR REDDYS
204038 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2021/10/27 SCIEGEN PHARMS INC
218991 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Prescription No No AB 2024/07/22 ZYDUS LIFESCIENCES
218169 002 ANDA VALSARTAN VALSARTAN TABLET;ORAL 80MG Discontinued No No AB 2024/08/05 SOMERSET THERAPS LLC
>>>活性成分:VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格:160MG; 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
021283 002 NDA DIOVAN VALSARTAN TABLET;ORAL 160MG Prescription Yes No AB 2001/07/18 NOVARTIS
077492 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2014/06/26 OHM LABS INC
090866 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 MYLAN
091367 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 ALEMBIC
203311 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 HETERO LABS LTD V
203536 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 JUBILANT GENERICS
201677 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 LUPIN LTD
202223 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/01/05 AUROBINDO PHARMA LTD
204821 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2015/06/09 PRINSTON INC
204011 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2016/01/11 AMNEAL PHARMS
202696 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2016/09/16 MACLEODS PHARMS LTD
205347 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2018/04/09 ACME LABS
205536 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2019/03/12 ALKEM LABS LTD
201618 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2021/10/05 DR REDDYS
204038 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2021/10/27 SCIEGEN PHARMS INC
218991 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Prescription No No AB 2024/07/22 ZYDUS LIFESCIENCES
218169 003 ANDA VALSARTAN VALSARTAN TABLET;ORAL 160MG Discontinued No No AB 2024/08/05 SOMERSET THERAPS LLC
>>>活性成分:VALSARTAN; 剂型/给药途径:TABLET;ORAL; 规格:320MG; 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
021283 003 NDA DIOVAN VALSARTAN TABLET;ORAL 320MG Prescription Yes Yes AB 2001/07/18 NOVARTIS
077492 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2014/06/26 OHM LABS INC
090866 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 MYLAN
091367 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 ALEMBIC
203311 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 HETERO LABS LTD V
203536 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 JUBILANT GENERICS
201677 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 LUPIN LTD
202223 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/01/05 AUROBINDO PHARMA LTD
204821 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2015/06/09 PRINSTON INC
204011 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2016/01/11 AMNEAL PHARMS
202696 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2016/09/16 MACLEODS PHARMS LTD
205347 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2018/04/09 ACME LABS
205536 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2019/03/12 ALKEM LABS LTD
201618 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2021/10/05 DR REDDYS
204038 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2021/10/27 SCIEGEN PHARMS INC
218991 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Prescription No No AB 2024/07/22 ZYDUS LIFESCIENCES
218169 004 ANDA VALSARTAN VALSARTAN TABLET;ORAL 320MG Discontinued No No AB 2024/08/05 SOMERSET THERAPS LLC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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