药品注册申请号：203293
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA 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 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 7MG No No AB 2017/08/03 2017/08/03 Prescription
002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 14MG No No AB 2017/08/03 Prescription
003 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 21MG No No AB 2017/08/03 Prescription
004 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 28MG No Yes AB 2017/08/03 Prescription
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
2020/03/15 SUPPL-1（补充） Approval Labeling STANDARD
2017/08/03 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
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RLDRSTE 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
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 Prescription 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 ENDO OPERATIONS
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 XIAMEN LP PHARM CO
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
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药品NDC数据与药品包装、标签说明书
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