药品注册申请号：203699
申请类型：ANDA (仿制药申请)
申请人：PHARMADAX INC
申请人全名：PHARMADAX 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 100MG TARTRATE No No AB 2020/03/30 2020/03/30 Prescription
002 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE No No AB 2020/03/30 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
2023/12/27 SUPPL-8（补充） Approval Labeling STANDARD
2023/12/27 SUPPL-6（补充） Approval Labeling STANDARD
2020/03/30 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:METOPROLOL SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 100MG 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 002 NDA TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription Yes No AB 1992/01/10 TOPROL
090615 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2010/07/22 WOCKHARDT
202033 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2011/12/15 MYLAN PHARMS INC
078889 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2012/08/15 REDDYS
204161 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2016/11/25 ACTAVIS ELIZABETH
204106 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2018/02/06 NOVAST LABS
203894 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2018/03/23 ZYDUS PHARMS
207465 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2018/10/26 CIPLA
207206 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2018/12/19 VISUM PHARM
203699 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2020/03/30 PHARMADAX INC
205541 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2020/11/06 HETERO LABS LTD III
211143 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2020/11/25 ALKEM LABS LTD
213854 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2021/02/12 YICHANG HUMANWELL
210597 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Discontinued No No AB 2022/01/04 PRINSTON INC
214004 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2022/09/26 SUNSHINE
215637 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Discontinued No No AB 2022/10/18 ACCORD HLTHCARE
216916 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2023/06/12 GRANULES
216509 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Discontinued No No AB 2023/08/07 GRANULES
209272 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Discontinued No No AB 2023/08/15 LUPIN
214110 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2024/07/26 ZHEJIANG JUTAI PHARM
活性成分:METOPROLOL SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 200MG 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 003 NDA TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription Yes Yes AB 1992/01/10 TOPROL
090615 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2010/07/22 WOCKHARDT
202033 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2011/12/15 MYLAN PHARMS INC
078889 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2012/08/15 REDDYS
204161 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2016/11/25 ACTAVIS ELIZABETH
204106 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2018/02/06 NOVAST LABS
203894 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2018/03/23 ZYDUS PHARMS
207465 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2018/10/26 CIPLA
207206 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2018/12/19 VISUM PHARM
203699 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2020/03/30 PHARMADAX INC
205541 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2020/11/06 HETERO LABS LTD III
211143 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2020/11/25 ALKEM LABS LTD
213854 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2021/02/12 YICHANG HUMANWELL
210597 002 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Discontinued No No AB 2022/01/04 PRINSTON INC
214004 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2022/09/26 SUNSHINE
215637 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Discontinued No No AB 2022/10/18 ACCORD HLTHCARE
216916 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2023/06/12 GRANULES
216509 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Discontinued No No AB 2023/08/07 GRANULES
209272 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Discontinued No No AB 2023/08/15 LUPIN
214110 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2024/07/26 ZHEJIANG JUTAI PHARM
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database