药品注册申请号：090058
申请类型：ANDA (仿制药申请)
申请人：SUN PHARM
申请人全名：SUN PHARMACEUTICAL INDUSTRIES LTD
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 TABLET;ORAL 5MG No No AB 2010/05/05 2010/05/05 Prescription
002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2010/05/05 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
2019/12/04 SUPPL-11（补充） Approval Labeling STANDARD
2019/12/04 SUPPL-5（补充） Approval Labeling STANDARD
2010/05/05 ORIG-1（原始申请） Approval
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:TABLET;ORAL 规格:5MG 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
021487 001 NDA NAMENDA MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB 2003/10/16 ABBVIE
090048 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2010/04/14 DR REDDYS LABS LTD
090058 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2010/05/05 SUN PHARM
090051 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/04/10 LUPIN LTD
090041 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/04/10 AMNEAL PHARMS
090043 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/07/31 UPSHER SMITH LABS
090073 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2015/09/04 ALLIED
200022 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/10/13 UNICHEM
200891 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/10/13 ALEMBIC
202840 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/10/13 MACLEODS PHARMS LTD
203175 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/10/13 AUROBINDO PHARMA LTD
206855 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/11/17 PURACAP PHARM LLC
206528 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/11/30 AJANTA PHARMA LTD
207236 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2016/11/10 LANNETT CO INC
202350 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/05/23 STRIDES PHARMA
090961 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/07/10 ZYDUS LIFESCIENCES
209527 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2018/05/07 ACME LABS
210587 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/12/11 POLYGEN PHARMS
204389 001 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2022/09/26 HETERO LABS LTD V
活性成分:MEMANTINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
021487 002 NDA NAMENDA MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes Yes AB 2003/10/16 ABBVIE
090048 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2010/04/14 DR REDDYS LABS LTD
090058 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2010/05/05 SUN PHARM
090051 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/04/10 LUPIN LTD
090041 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/04/10 AMNEAL PHARMS
090043 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/07/31 UPSHER SMITH LABS
090073 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2015/09/04 ALLIED
200022 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/10/13 UNICHEM
200891 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/10/13 ALEMBIC
202840 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/10/13 MACLEODS PHARMS LTD
203175 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/10/13 AUROBINDO PHARMA LTD
206855 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/11/17 PURACAP PHARM LLC
206528 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/11/30 AJANTA PHARMA LTD
207236 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2016/11/10 LANNETT CO INC
202350 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/05/23 STRIDES PHARMA
090961 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/07/10 ZYDUS LIFESCIENCES
209527 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2018/05/07 ACME LABS
210587 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/12/11 POLYGEN PHARMS
204389 002 ANDA MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/09/26 HETERO LABS LTD V
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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