药品注册申请号：019962
申请类型：NDA (新药申请)
申请人：TOPROL
申请人全名：TOPROL ACQUISITION LLC
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 TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG TARTRATE Yes Yes AB 1992/01/10 1992/01/10 Prescription
002 TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Yes No AB 1992/01/10 Prescription
003 TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Yes Yes AB 1992/01/10 Prescription
004 TOPROL-XL METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG TARTRATE Yes No AB 2001/02/05 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
>>>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
1992/01/10 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient STANDARD
>>>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
2023/03/10 SUPPL-52（补充） Approval Labeling-Package Insert STANDARD
2023/03/10 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2022/06/01 SUPPL-49（补充） Approval Labeling-Package Insert STANDARD
2022/01/12 SUPPL-48（补充） Approval Labeling-Package Insert STANDARD
2014/05/12 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
2014/05/06 SUPPL-44（补充） Approval Labeling-Package Insert STANDARD
2012/10/31 SUPPL-43（补充） Approval Labeling-Package Insert UNKNOWN
2010/03/19 SUPPL-41（补充） Approval Labeling STANDARD
2010/01/19 SUPPL-42（补充） Approval Labeling STANDARD
2009/02/12 SUPPL-38（补充） Approval Labeling STANDARD
2008/02/15 SUPPL-36（补充） Approval Labeling-Package Insert N/A
2007/07/18 SUPPL-33（补充） Approval Efficacy-New Patient Population PRIORITY
2007/03/14 SUPPL-34（补充） Approval Labeling STANDARD
2006/07/27 SUPPL-32（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
2006/05/04 SUPPL-31（补充） Approval Labeling STANDARD
2005/04/05 SUPPL-28（补充） Approval Labeling STANDARD
2005/02/15 SUPPL-27（补充） Approval Efficacy-New Dosing Regimen STANDARD
2003/01/27 SUPPL-24（补充） Approval Labeling STANDARD
2002/03/05 SUPPL-22（补充） Approval Labeling STANDARD
2001/10/25 SUPPL-21（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/09/26 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2001/08/22 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2001/06/12 SUPPL-19（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/02/05 SUPPL-13（补充） Approval Efficacy-New Indication STANDARD
2001/02/02 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2000/11/22 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2000/10/13 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
2000/09/28 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1999/03/05 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/01/14 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1996/06/25 SUPPL-9（补充） Approval Labeling STANDARD
1996/03/12 SUPPL-7（补充） Approval Labeling STANDARD
1996/03/11 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/06/13 SUPPL-6（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1995/02/07 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/10/27 SUPPL-4（补充） Approval Labeling STANDARD
1994/03/04 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/06/24 SUPPL-2（补充） Approval Labeling
1992/02/27 SUPPL-1（补充） Approval Labeling
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
001 4927640 2007/05/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
4927640*PED 2007/11/22 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5001161 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5001161*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5081154 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5081154*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4927640 2007/05/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
4927640*PED 2007/11/22 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5001161 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5001161*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5081154 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5081154*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5246714 2010/09/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5246714*PED 2011/03/21 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4927640 2007/05/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
4927640*PED 2007/11/22 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5001161 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5001161*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5081154 2007/09/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5081154*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5246714 2010/09/21 PDF格式**本条是由Drugfuture回溯的历史信息**
5246714*PED 2011/03/21 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4927640 2007/05/22 Y PDF格式**本条是由Drugfuture回溯的历史信息**
4927640*PED 2007/11/22 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
4957745*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5001161 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5001161*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
5081154 2007/09/18 Y U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5081154*PED 2008/03/18 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 D-95 2008/02/15**本条是由Drugfuture回溯的历史信息**
M-61 2010/07/18**本条是由Drugfuture回溯的历史信息**
PED 2008/08/15**本条是由Drugfuture回溯的历史信息**
PED 2011/01/18**本条是由Drugfuture回溯的历史信息**
002 D-95 2008/02/15**本条是由Drugfuture回溯的历史信息**
M-61 2010/07/18**本条是由Drugfuture回溯的历史信息**
PED 2008/08/15**本条是由Drugfuture回溯的历史信息**
PED 2011/01/18**本条是由Drugfuture回溯的历史信息**
003 D-95 2008/02/15**本条是由Drugfuture回溯的历史信息**
M-61 2010/07/18**本条是由Drugfuture回溯的历史信息**
PED 2008/08/15**本条是由Drugfuture回溯的历史信息**
PED 2011/01/18**本条是由Drugfuture回溯的历史信息**
004 D-95 2008/02/15**本条是由Drugfuture回溯的历史信息**
M-61 2010/07/18**本条是由Drugfuture回溯的历史信息**
PED 2008/08/15**本条是由Drugfuture回溯的历史信息**
PED 2011/01/18**本条是由Drugfuture回溯的历史信息**
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
>>>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 BIO AG
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
206980 003 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG TARTRATE Prescription No No AB 2025/06/25 IPCA LABS LTD
>>>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 BIO AG
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
206980 004 ANDA METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 200MG TARTRATE Prescription No No AB 2025/06/25 IPCA LABS LTD
>>>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 BIO AG
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
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