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 |
|---|
| 2016/09/28 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 2025/04/18 |
SUPPL-6（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
UNKNOWN
|
|
|
| 2020/03/15 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2020/03/15 |
SUPPL-1（补充） |
Approval |
Labeling-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 |
与本品治疗等效的药品
>>>活性成分:MEMANTINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:7MG; 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 |
|---|
| 206028 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2016/09/28
|
LUPIN LTD |
| 206032 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2016/09/28
|
RISING |
| 205825 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2016/10/12
|
AMNEAL PHARMS |
| 206135 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2016/11/22
|
APOTEX |
| 205784 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2017/06/09
|
PH HEALTH |
| 203293 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2017/08/03
|
ZYDUS PHARMS |
| 205365 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Discontinued |
No |
No |
AB |
2020/02/28
|
ANI PHARMS |
| 211100 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2021/04/02
|
YICHANG HUMANWELL |
| 214651 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2021/08/09
|
AUROBINDO PHARMA LTD |
| 213985 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2022/10/11
|
VITRUVIAS |
| 206310 |
001 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG |
Prescription |
No |
No |
AB |
2025/08/28
|
MACLEODS PHARMS LTD |
>>>活性成分:MEMANTINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:14MG; 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 |
|---|
| 022525 |
002 |
NDA |
NAMENDA XR |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Discontinued |
Yes |
No |
AB |
2010/06/21
|
ABBVIE |
| 206028 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2016/09/28
|
LUPIN LTD |
| 206032 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2016/09/28
|
RISING |
| 205825 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2016/10/12
|
AMNEAL PHARMS |
| 206135 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Discontinued |
No |
No |
AB |
2016/11/22
|
APOTEX |
| 205784 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Discontinued |
No |
No |
AB |
2017/06/09
|
PH HEALTH |
| 203293 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2017/08/03
|
ZYDUS PHARMS |
| 211100 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2021/04/02
|
YICHANG HUMANWELL |
| 214651 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2021/08/09
|
AUROBINDO PHARMA LTD |
| 213985 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2022/10/11
|
VITRUVIAS |
| 206310 |
002 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
14MG |
Prescription |
No |
No |
AB |
2025/08/28
|
MACLEODS PHARMS LTD |
>>>活性成分:MEMANTINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:21MG; 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 |
|---|
| 022525 |
003 |
NDA |
NAMENDA XR |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Discontinued |
Yes |
No |
AB |
2010/06/21
|
ABBVIE |
| 206028 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2016/09/28
|
LUPIN LTD |
| 206032 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2016/09/28
|
RISING |
| 205825 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2016/10/12
|
AMNEAL PHARMS |
| 206135 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Discontinued |
No |
No |
AB |
2016/11/22
|
APOTEX |
| 205784 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Discontinued |
No |
No |
AB |
2017/06/09
|
PH HEALTH |
| 203293 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2017/08/03
|
ZYDUS PHARMS |
| 205365 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Discontinued |
No |
No |
AB |
2020/02/28
|
ANI PHARMS |
| 211100 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2021/04/02
|
YICHANG HUMANWELL |
| 214651 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2021/08/09
|
AUROBINDO PHARMA LTD |
| 213985 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2024/02/06
|
VITRUVIAS |
| 206310 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
21MG |
Prescription |
No |
No |
AB |
2025/08/28
|
MACLEODS PHARMS LTD |
>>>活性成分:MEMANTINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:28MG; 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 |
|---|
| 022525 |
004 |
NDA |
NAMENDA XR |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Discontinued |
Yes |
No |
AB |
2010/06/21
|
ABBVIE |
| 206028 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2016/09/28
|
LUPIN LTD |
| 206032 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2016/09/28
|
RISING |
| 205825 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2016/10/12
|
AMNEAL PHARMS |
| 206135 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Discontinued |
No |
No |
AB |
2016/11/22
|
APOTEX |
| 205784 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Discontinued |
No |
No |
AB |
2017/06/09
|
PH HEALTH |
| 203293 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
Yes |
AB |
2017/08/03
|
ZYDUS PHARMS |
| 205365 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Discontinued |
No |
No |
AB |
2020/02/28
|
ANI PHARMS |
| 211100 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2021/04/02
|
YICHANG HUMANWELL |
| 214651 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2021/08/09
|
AUROBINDO PHARMA LTD |
| 213985 |
003 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2022/10/11
|
VITRUVIAS |
| 206310 |
004 |
ANDA |
MEMANTINE HYDROCHLORIDE |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
28MG |
Prescription |
No |
No |
AB |
2025/08/28
|
MACLEODS PHARMS LTD |
