药品注册申请号：020364
申请类型：NDA (新药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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
002 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Yes No AB 1995/03/03 1995/03/03 Prescription
003 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Yes No AB 1995/03/03 Prescription
004 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Yes No AB 1995/03/03 Prescription
005 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Yes No AB 2002/06/20 Prescription
006 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Yes Yes AB 2006/04/11 Prescription
007 LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Yes No AB 2006/04/11 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
1995/03/03 ORIG-1（原始申请） Approval Type 4 - New Combination 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
2021/04/21 SUPPL-68（补充） Approval Labeling-Container/Carton Labels STANDARD
2020/02/10 SUPPL-66（补充） Approval Labeling-Package Insert STANDARD
2017/07/21 SUPPL-65（补充） Approval Labeling-Package Insert STANDARD
2017/01/27 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
2016/02/08 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
2015/06/16 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2015/05/18 SUPPL-61（补充） Approval Labeling-Package Insert STANDARD
2015/04/22 SUPPL-60（补充） Approval Labeling-Package Insert STANDARD
2014/12/31 SUPPL-58（补充） Approval Labeling-Package Insert STANDARD
2012/10/05 SUPPL-57（补充） Approval Labeling-Package Insert UNKNOWN
2012/10/05 SUPPL-56（补充） Approval Labeling-Package Insert UNKNOWN
2012/01/19 SUPPL-55（补充） Approval Labeling-Package Insert UNKNOWN
2011/10/28 SUPPL-54（补充） Approval Labeling-Package Insert UNKNOWN
2011/06/20 SUPPL-52（补充） Approval Labeling-Package Insert UNKNOWN
2011/01/04 SUPPL-50（补充） Approval Labeling-Package Insert STANDARD
2010/03/29 SUPPL-47（补充） Approval Labeling STANDARD
2009/12/22 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
2009/10/28 SUPPL-46（补充） Approval Labeling STANDARD
2007/08/31 SUPPL-39（补充） Approval Labeling-Package Insert N/A
2007/02/23 SUPPL-36（补充） Approval Labeling STANDARD
2006/04/11 SUPPL-23（补充） Approval Efficacy-New Dosing Regimen STANDARD
2004/08/11 SUPPL-28（补充） Approval Labeling STANDARD
2004/07/02 SUPPL-24（补充） Approval Labeling STANDARD
2003/08/29 SUPPL-14（补充） Approval Labeling STANDARD
2002/10/25 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/09/20 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2002/06/20 SUPPL-16（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2002/04/29 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2001/12/12 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/11/30 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/11/02 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2000/05/10 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1999/06/16 SUPPL-8（补充） Approval Labeling STANDARD
1999/04/28 SUPPL-11（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/02/18 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1998/07/21 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1997/03/14 SUPPL-7（补充） Approval Labeling STANDARD
1996/04/29 SUPPL-2（补充） Approval Labeling STANDARD
1995/11/17 SUPPL-5（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1995/11/06 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/11/02 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1995/08/15 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/07/06 SUPPL-1（补充） Approval Manufacturing (CMC)-Packaging 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
002 4572909 2006/07/31 PDF格式**本条是由Drugfuture回溯的历史信息**
4879303 2007/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 U-367 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4572909 2006/07/31 PDF格式**本条是由Drugfuture回溯的历史信息**
4879303 2007/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 U-367 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4572909 2006/07/31 PDF格式**本条是由Drugfuture回溯的历史信息**
4879303 2007/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 U-367 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4572909 2006/07/31 PDF格式**本条是由Drugfuture回溯的历史信息**
4879303 2007/03/25 PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 U-367 PDF格式**本条是由Drugfuture回溯的历史信息**
006 4879303 2007/03/25 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 Y Y U-185 PDF格式**本条是由Drugfuture回溯的历史信息**
007 4879303 2007/03/25 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6162802 2017/12/19 Y Y U-185 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
006 NS 2009/04/11**本条是由Drugfuture回溯的历史信息**
007 NS 2009/04/11**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:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 2.5MG BASE;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
020364 002 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription Yes No AB 1995/03/03 SANDOZ
078466 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription No No AB 2010/02/05 LUPIN PHARMS
077183 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription No No AB 2010/04/15 DR REDDYS LABS INC
077890 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription No No AB 2010/10/14 WATSON LABS
202239 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 2.5MG BASE;10MG Prescription No No AB 2013/12/30 HERITAGE
>>>活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 5MG BASE;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
020364 003 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription Yes No AB 1995/03/03 SANDOZ
078466 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription No No AB 2010/02/05 LUPIN PHARMS
077183 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription No No AB 2010/04/15 DR REDDYS LABS INC
077890 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription No No AB 2010/10/14 WATSON LABS
202239 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;10MG Prescription No No AB 2013/12/30 HERITAGE
>>>活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 5MG BASE;20MG; 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
020364 004 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription Yes No AB 1995/03/03 SANDOZ
078466 003 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription No No AB 2010/02/05 LUPIN PHARMS
077183 003 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription No No AB 2010/04/15 DR REDDYS LABS INC
077890 003 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription No No AB 2010/10/14 WATSON LABS
202239 003 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 003 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;20MG Prescription No No AB 2013/12/30 HERITAGE
>>>活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 10MG BASE;20MG; 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
020364 005 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription Yes No AB 2002/06/20 SANDOZ
078466 004 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription No No AB 2010/02/05 LUPIN PHARMS
077183 004 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription No No AB 2010/04/15 DR REDDYS LABS INC
077890 004 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription No No AB 2010/10/14 WATSON LABS
202239 005 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 005 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;20MG Prescription No No AB 2013/12/30 HERITAGE
>>>活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 10MG BASE;40MG; 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
020364 006 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription Yes Yes AB 2006/04/11 SANDOZ
078466 006 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription No No AB 2011/07/05 LUPIN PHARMS
090149 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription No No AB 2011/07/05 DR REDDYS LABS INC
090364 002 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription No No AB 2011/07/05 WATSON LABS INC
202239 006 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 006 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE;40MG Prescription No No AB 2013/12/30 HERITAGE
>>>活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 5MG BASE;40MG; 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
020364 007 NDA LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription Yes No AB 2006/04/11 SANDOZ
078466 005 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription No No AB 2011/07/05 LUPIN PHARMS
090149 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription No No AB 2011/07/05 DR REDDYS LABS INC
090364 001 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription No No AB 2011/07/05 WATSON LABS INC
202239 004 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription No No AB 2012/09/05 AUROBINDO PHARMA LTD
091431 004 ANDA AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE;40MG Prescription No No AB 2013/12/30 HERITAGE
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