药品注册申请号：076862
申请类型：ANDA (仿制药申请)
申请人：ACTAVIS LABS FL INC
申请人全名：ACTAVIS LABORATORIES FL 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 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE No No AB 2009/08/03 2009/08/03 Prescription
002 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE No No None 2009/08/03 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
>>>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
2009/08/03 ORIG-1（原始申请） Approval
>>>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
2015/06/29 SUPPL-17（补充） Approval Labeling-Package Insert STANDARD
2015/06/29 SUPPL-6（补充） Approval Labeling-Package Insert
2014/05/15 SUPPL-13（补充） Approval Labeling-Container/Carton Labels UNKNOWN
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:METOPROLOL SUCCINATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:EQ 50MG TARTRATE; 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
019962 001 NDA TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription Yes Yes AB 1992/01/10 TOPROL
076862 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2009/08/03 ACTAVIS LABS FL INC
090615 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2010/07/22 WOCKHARDT BIO AG
202033 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2011/12/15 MYLAN PHARMS INC
090617 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2012/08/01 DR REDDYS LABS LTD
204161 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2016/11/25 ACTAVIS ELIZABETH
204106 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2018/02/06 NOVAST LABS
203894 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2018/03/23 ZYDUS PHARMS
207465 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2018/10/26 CIPLA
207206 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2018/12/19 VISUM PHARM
203028 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2020/03/31 PHARMADAX INC
205541 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2020/11/06 HETERO LABS LTD III
211143 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2020/11/25 ALKEM LABS LTD
213854 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2021/11/08 YICHANG HUMANWELL
214004 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2022/09/26 SUNSHINE
215637 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Discontinued No No AB 2022/10/18 ACCORD HLTHCARE
216916 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2023/06/12 GRANULES
216509 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Discontinued No No AB 2023/08/07 GRANULES
209272 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Discontinued No No AB 2023/08/15 LUPIN
214110 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2024/07/26 ZHEJIANG JUTAI PHARM
206980 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Prescription No No AB 2025/06/25 IPCA LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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