药品注册申请号:021286
申请类型:NDA (新药申请)
申请人:DAIICHI SANKYO
申请人全名:DAIICHI SANKYO 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 BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Yes No AB 2002/04/25 2002/04/25 Prescription
003 BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Yes No AB 2002/04/25 Prescription
004 BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Yes Yes AB 2002/04/25 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/17 SUPPL 40 Approval Labeling STANDARD
2016/11/01 SUPPL 36 Approval Labeling STANDARD
2016/07/08 SUPPL 35 Approval Manufacturing (CMC) STANDARD
2016/06/10 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2014/10/07 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2014/09/23 SUPPL 32 Approval Labeling STANDARD
2014/07/03 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2014/06/27 SUPPL 31 Approval Labeling STANDARD
2014/06/13 SUPPL 30 Approval Labeling STANDARD
2013/07/03 SUPPL 27 Approval Labeling STANDARD
2013/02/01 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2012/12/11 SUPPL 26 Approval Labeling STANDARD
2012/09/28 SUPPL 25 Approval Labeling UNKNOWN
2012/03/29 SUPPL 23 Approval Labeling UNKNOWN
2012/02/15 SUPPL 21 Approval Labeling UNKNOWN
2011/06/06 SUPPL 20 Approval Labeling UNKNOWN
2011/05/19 SUPPL 19 Approval Labeling UNKNOWN
2010/02/04 SUPPL 18 Approval Efficacy PRIORITY
2007/09/26 SUPPL 12 Approval Labeling STANDARD
2005/07/13 SUPPL 10 Approval Labeling STANDARD
2004/11/12 SUPPL 6 Approval Labeling STANDARD
2003/02/12 SUPPL 2 Approval Labeling STANDARD
2002/10/25 SUPPL 1 Approval Labeling STANDARD
2002/04/25 ORIG 1 Approval Type 1 - New Molecular Entity 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
001 5616599 2016/04/25 Y Y U-500 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**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5616599 2016/04/25 Y Y U-500 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**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5616599 2016/04/25 Y Y U-500 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**
6878703 2021/11/19 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6878703*PED 2022/05/19 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 NCE 2007/04/25**本条是由Drugfuture回溯的历史信息**
PED 2013/08/04**本条是由Drugfuture回溯的历史信息**
003 NCE 2007/04/25**本条是由Drugfuture回溯的历史信息**
PED 2013/08/04**本条是由Drugfuture回溯的历史信息**
004 NCE 2007/04/25**本条是由Drugfuture回溯的历史信息**
PED 2013/08/04**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:OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:5MG 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
021286 001 NDA BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription Yes No AB 2002/04/25 DAIICHI SANKYO
078276 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2016/10/26 MYLAN
202375 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 TORRENT
203012 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
204798 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
204814 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 MACLEODS PHARMS LTD
205192 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 ZYDUS PHARMS
206763 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 ALKEM LABS LTD
207662 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/24 ACCORD HLTHCARE
206631 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/04/27 LUPIN LTD
203281 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
208130 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2018/06/29 SCIEGEN PHARMS INC
210552 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2019/01/10 QILU
211049 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2019/02/22 SUNSHINE LAKE
207135 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2019/07/18 UMEDICA LABS PVT LTD
206372 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2019/09/17 MICRO LABS
090237 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2020/04/13 SANDOZ INC
208659 001 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 5MG Prescription No No AB 2020/05/18 INVENTIA
活性成分:OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格: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
021286 003 NDA BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription Yes No AB 2002/04/25 DAIICHI SANKYO
078276 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2016/10/26 MYLAN
204814 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 MACLEODS PHARMS LTD
207662 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 ACCORD HLTHCARE
203012 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
206763 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 ALKEM LABS LTD
204798 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
205192 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 ZYDUS PHARMS
202375 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/24 TORRENT
206631 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/04/27 LUPIN LTD
203281 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
208130 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2018/06/29 SCIEGEN PHARMS INC
210552 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2019/01/10 QILU
211049 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2019/02/22 SUNSHINE LAKE
207135 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2019/07/18 UMEDICA LABS PVT LTD
206372 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2019/09/17 MICRO LABS
090237 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2020/04/13 SANDOZ INC
208659 002 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 20MG Prescription No No AB 2020/05/18 INVENTIA
活性成分:OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格: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
021286 004 NDA BENICAR OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription Yes Yes AB 2002/04/25 DAIICHI SANKYO
078276 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2016/10/26 MYLAN
204814 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 MACLEODS PHARMS LTD
207662 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 ACCORD HLTHCARE
203012 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 ALEMBIC PHARMS LTD
206763 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 ALKEM LABS LTD
204798 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 AUROBINDO PHARMA LTD
205192 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 ZYDUS PHARMS
202375 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/24 TORRENT
206631 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/04/27 LUPIN LTD
203281 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
208130 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2018/06/29 SCIEGEN PHARMS INC
210552 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2019/01/10 QILU
211049 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2019/02/22 SUNSHINE LAKE
207135 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2019/07/18 UMEDICA LABS PVT LTD
206372 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2019/09/17 MICRO LABS
090237 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2020/04/13 SANDOZ INC
208659 003 ANDA OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET;ORAL 40MG Prescription No No AB 2020/05/18 INVENTIA
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