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 |
|---|
| 2024/09/16 |
ORIG-1（原始申请） |
Approval |
|
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 |
与本品治疗等效的药品
活性成分:SACUBITRIL; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:24MG;26MG 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 |
|---|
| 207620 |
001 |
NDA |
ENTRESTO |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
Yes |
No |
AB |
2015/07/07
|
NOVARTIS PHARMS CORP |
| 213605 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/05/28
|
CRYSTAL |
| 213676 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/05/28
|
LAURUS |
| 213682 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/05/28
|
ALEMBIC |
| 213719 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/07/09
|
ZYDUS PHARMS |
| 213748 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/07/24
|
MSN |
| 213604 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/08/22
|
TORRENT |
| 213680 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/08/30
|
BIOCON PHARMA |
| 213764 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/09/16
|
ALKEM LABS LTD |
| 213728 |
001 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
24MG;26MG |
Prescription |
No |
No |
AB |
2024/10/16
|
MACLEODS PHARMS LTD |
活性成分:SACUBITRIL; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:49MG;51MG 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 |
|---|
| 207620 |
002 |
NDA |
ENTRESTO |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
Yes |
No |
AB |
2015/07/07
|
NOVARTIS PHARMS CORP |
| 213605 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/05/28
|
CRYSTAL |
| 213676 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/05/28
|
LAURUS |
| 213682 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/05/28
|
ALEMBIC |
| 213719 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/07/09
|
ZYDUS PHARMS |
| 213748 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/07/24
|
MSN |
| 213604 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/08/22
|
TORRENT |
| 213680 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/08/30
|
BIOCON PHARMA |
| 213764 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/09/16
|
ALKEM LABS LTD |
| 213728 |
002 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
49MG;51MG |
Prescription |
No |
No |
AB |
2024/10/16
|
MACLEODS PHARMS LTD |
活性成分:SACUBITRIL; VALSARTAN 剂型/给药途径:TABLET;ORAL 规格:97MG;103MG 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 |
|---|
| 207620 |
003 |
NDA |
ENTRESTO |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
Yes |
Yes |
AB |
2015/07/07
|
NOVARTIS PHARMS CORP |
| 213605 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/05/28
|
CRYSTAL |
| 213676 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/05/28
|
LAURUS |
| 213682 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/05/28
|
ALEMBIC |
| 213719 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/07/09
|
ZYDUS PHARMS |
| 213748 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/07/24
|
MSN |
| 213604 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/08/22
|
TORRENT |
| 213680 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/08/30
|
BIOCON PHARMA |
| 213764 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/09/16
|
ALKEM LABS LTD |
| 213728 |
003 |
ANDA |
SACUBITRIL AND VALSARTAN |
SACUBITRIL; VALSARTAN |
TABLET;ORAL |
97MG;103MG |
Prescription |
No |
No |
AB |
2024/10/16
|
MACLEODS PHARMS LTD |