药品注册申请号：022100
申请类型：NDA (新药申请)
申请人：COSETTE
申请人全名：COSETTE PHARMACEUTICALS 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 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Yes No AB 2007/09/26 2007/09/26 Prescription
002 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Yes No AB 2007/09/26 Prescription
003 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Yes No AB 2007/09/26 Prescription
004 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Yes Yes AB 2007/09/26 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
2020/10/02 SUPPL-39（补充） Approval Labeling STANDARD
2017/01/05 SUPPL-33（补充） Approval Labeling STANDARD
2016/12/09 SUPPL-30（补充） Approval Labeling STANDARD
2016/11/01 SUPPL-32（补充） Approval Labeling STANDARD
2016/07/08 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2015/07/09 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2015/06/04 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2014/09/23 SUPPL-26（补充） Approval Labeling STANDARD
2014/07/02 SUPPL-25（补充） Approval Labeling STANDARD
2014/06/13 SUPPL-24（补充） Approval Labeling STANDARD
2014/05/14 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2013/07/03 SUPPL-22（补充） Approval Labeling STANDARD
2013/02/01 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2012/12/11 SUPPL-20（补充） Approval Labeling STANDARD
2012/09/28 SUPPL-19（补充） Approval Labeling UNKNOWN
2012/01/18 SUPPL-16（补充） Approval Labeling UNKNOWN
2011/11/14 SUPPL-13（补充） Approval Labeling UNKNOWN
2011/11/02 SUPPL-14（补充） Approval Labeling UNKNOWN
2011/05/19 SUPPL-12（补充） Approval Labeling UNKNOWN
2011/05/19 SUPPL-10（补充） Approval Labeling UNKNOWN
2009/05/11 SUPPL-2（补充） Approval Efficacy UNKNOWN
2008/08/07 SUPPL-3（补充） Approval Labeling STANDARD
2007/09/26 ORIG-1（原始申请） Approval Type 4 - New Combination STANDARD ;Orphan
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 5616599 2016/04/25 Y Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5616599 2016/04/25 Y Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5616599 2016/04/25 Y Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5616599 2016/04/25 Y Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5616599*PED 2016/10/25 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 NC 2010/09/26**本条是由Drugfuture回溯的历史信息**
002 NC 2010/09/26**本条是由Drugfuture回溯的历史信息**
003 NC 2010/09/26**本条是由Drugfuture回溯的历史信息**
004 NC 2010/09/26**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; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;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
022100 001 NDA AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription Yes No AB 2007/09/26 COSETTE
206884 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2016/10/26 MACLEODS PHARMS LTD
207216 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2016/10/28 AJANTA PHARMA LTD
202933 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Discontinued No No AB 2016/11/25 TORRENT
206906 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2017/05/15 AUROBINDO PHARMA
207807 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Discontinued No No AB 2017/07/05 GLENMARK PHARMS LTD
207073 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2017/07/17 ALEMBIC
209042 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2017/08/14 ALKEM LABS LTD
207771 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2017/09/22 ZYDUS PHARMS
207435 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2017/11/02 MICRO LABS
209010 001 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;20MG Prescription No No AB 2018/12/03 SCIEGEN PHARMS INC
活性成分:AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;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
022100 002 NDA AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription Yes No AB 2007/09/26 COSETTE
206884 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2016/10/26 MACLEODS PHARMS LTD
207216 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2016/10/28 AJANTA PHARMA LTD
202933 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Discontinued No No AB 2016/11/25 TORRENT
206906 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2017/05/15 AUROBINDO PHARMA
207807 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Discontinued No No AB 2017/07/05 GLENMARK PHARMS LTD
207073 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2017/07/17 ALEMBIC
209042 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2017/08/14 ALKEM LABS LTD
207771 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2017/09/22 ZYDUS PHARMS
207435 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2017/11/02 MICRO LABS
209010 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 5MG BASE;40MG Prescription No No AB 2018/12/03 SCIEGEN PHARMS INC
活性成分:AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;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
022100 003 NDA AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription Yes No AB 2007/09/26 COSETTE
206884 002 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2016/10/26 MACLEODS PHARMS LTD
207216 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2016/10/28 AJANTA PHARMA LTD
202933 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Discontinued No No AB 2016/11/25 TORRENT
206906 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2017/05/15 AUROBINDO PHARMA
207807 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Discontinued No No AB 2017/07/05 GLENMARK PHARMS LTD
207073 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2017/07/17 ALEMBIC
209042 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2017/08/14 ALKEM LABS LTD
207771 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2017/09/22 ZYDUS PHARMS
207435 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2017/11/02 MICRO LABS
209010 003 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;20MG Prescription No No AB 2018/12/03 SCIEGEN PHARMS INC
活性成分:AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;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
022100 004 NDA AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription Yes Yes AB 2007/09/26 COSETTE
206884 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2016/10/26 MACLEODS PHARMS LTD
207216 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2016/10/28 AJANTA PHARMA LTD
202933 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Discontinued No No AB 2016/11/25 TORRENT
206906 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2017/05/15 AUROBINDO PHARMA
207807 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Discontinued No No AB 2017/07/05 GLENMARK PHARMS LTD
207073 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2017/07/17 ALEMBIC
209042 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2017/08/14 ALKEM LABS LTD
207771 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2017/09/22 ZYDUS PHARMS
207435 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2017/11/02 MICRO LABS
209010 004 ANDA AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL TABLET;ORAL EQ 10MG BASE;40MG Prescription No No AB 2018/12/03 SCIEGEN PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
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