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 |
2019/11/22 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/06 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2016/05/17 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/18 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/09/26 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/09 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/07/03 |
SUPPL-5(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2013/11/14 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/20 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/06/21 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 治疗等效代码:AB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 |
001 |
NDA |
NAMENDA XR |
MEMANTINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2010/06/21
|
ABBVIE |
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 |
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 |
Prescription |
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
|
ENDO OPERATIONS |
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
|
XIAMEN LP PHARM CO |
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 |
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 |
Prescription |
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
|
ENDO OPERATIONS |
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
|
XIAMEN LP PHARM CO |
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 |
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 |
Prescription |
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
|
ENDO OPERATIONS |
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
|
XIAMEN LP PHARM CO |