药品注册申请号：022525
申请类型：NDA (新药申请)
申请人：ABBVIE
申请人全名：ABBVIE INC
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 NAMENDA XR MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 2010/06/21 2010/06/21 Discontinued
002 NAMENDA XR MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 14MG Yes No AB 2010/06/21 Discontinued
003 NAMENDA XR MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 21MG Yes No AB 2010/06/21 Discontinued
004 NAMENDA XR MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 28MG Yes No AB 2010/06/21 Discontinued
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）
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
001 8039009 2029/03/24 U-539 2011/11/16 PDF格式
8039009*PED 2029/09/24 PDF格式
002 8039009 2029/03/24 U-539 PDF格式
8039009*PED 2029/09/24 PDF格式
003 8039009 2029/03/24 U-539 PDF格式
8039009*PED 2029/09/24 PDF格式
004 8039009 2029/03/24 U-539 PDF格式
8039009*PED 2029/09/24 PDF格式
001 5061703 2015/04/11 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8168209 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8168209*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8329752 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8329752*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5061703 2015/04/11 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8168209 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8168209*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8329752 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8329752*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5061703 2015/04/11 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8168209 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8168209*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8329752 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8329752*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5061703 2015/04/11 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8168209 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8168209*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8173708*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8283379*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8329752 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8329752*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085 2025/11/22 U-539 PDF格式**本条是由Drugfuture回溯的历史信息**
8362085*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
8598233 2025/11/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8598233*PED 2026/05/22 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-138 2017/07/03**本条是由Drugfuture回溯的历史信息**
PED 2018/01/03**本条是由Drugfuture回溯的历史信息**
002 M-138 2017/07/03**本条是由Drugfuture回溯的历史信息**
PED 2018/01/03**本条是由Drugfuture回溯的历史信息**
003 M-138 2017/07/03**本条是由Drugfuture回溯的历史信息**
PED 2018/01/03**本条是由Drugfuture回溯的历史信息**
004 M-138 2017/07/03**本条是由Drugfuture回溯的历史信息**
PED 2018/01/03**本条是由Drugfuture回溯的历史信息**
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RLDRSTE 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RLDRSTE 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RLDRSTE 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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
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