药品注册申请号：216509
申请类型：ANDA (仿制药申请)
申请人：GRANULES
申请人全名：GRANULES INDIA 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 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE No No AB 2023/08/07 2023/08/07 Discontinued
002 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE No No AB 2023/08/07 Discontinued
003 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE No No AB 2023/08/07 Discontinued
004 METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE No No AB 2023/08/07 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
2023/08/07 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:METOPROLOL SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 25MG 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 004 NDA TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription Yes No AB 2001/02/05 TOPROL
090615 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2010/07/22 WOCKHARDT
202033 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2011/12/15 MYLAN PHARMS INC
090617 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2012/08/01 DR REDDYS LABS LTD
204161 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2016/11/25 ACTAVIS ELIZABETH
204106 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2018/02/06 NOVAST LABS
203894 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2018/03/23 ZYDUS PHARMS
207206 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2018/12/19 VISUM PHARM
203028 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2020/03/31 PHARMADAX INC
205541 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2020/11/06 HETERO LABS LTD III
211143 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2020/11/25 ALKEM LABS LTD
213854 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2022/08/01 YICHANG HUMANWELL
215637 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Discontinued No No AB 2022/10/18 ACCORD HLTHCARE
216916 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2023/06/12 GRANULES
216509 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Discontinued No No AB 2023/08/07 GRANULES
209272 001 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Discontinued No No AB 2023/08/15 LUPIN
214004 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Prescription No No AB 2024/05/23 SUNSHINE
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
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
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
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