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 |
2021/12/06 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/12/06 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/12/06 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/08/16 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/08/16 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/08/16 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/09 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/01/05 |
ORIG-1(原始申请) |
Approval |
Not Applicable |
|
|
|
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 | RLD | RS | TE 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
|
SQUARE PHARMS |
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 |
Prescription |
No |
No |
AB |
2024/08/05
|
ZENARA |
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 | RLD | RS | TE 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
|
SQUARE PHARMS |
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 |
Prescription |
No |
No |
AB |
2024/08/05
|
ZENARA |
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 | RLD | RS | TE 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
|
SQUARE PHARMS |
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 |
Prescription |
No |
No |
AB |
2024/08/05
|
ZENARA |
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 | RLD | RS | TE 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
|
SQUARE PHARMS |
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 |
Prescription |
No |
No |
AB |
2024/08/05
|
ZENARA |