药品注册申请号：021526
申请类型：NDA (新药申请)
申请人：MENARINI INTL
申请人全名：MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
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 RANEXA RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Yes No AB 2006/01/27 2007/02/12 Discontinued
002 RANEXA RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Yes No AB 2006/01/27 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
2019/10/29 SUPPL-35（补充） Approval Labeling STANDARD
2019/08/07 SUPPL-34（补充） Approval Labeling STANDARD
2016/04/22 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
2016/01/06 SUPPL-29（补充） Approval Labeling STANDARD
2015/12/15 SUPPL-28（补充） Approval Labeling STANDARD
2015/11/10 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2014/01/17 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2013/12/19 SUPPL-26（补充） Approval Labeling STANDARD
2013/11/12 SUPPL-25（补充） Approval Labeling STANDARD
2012/07/25 SUPPL-22（补充） Approval Labeling UNKNOWN
2011/12/21 SUPPL-18（补充） Approval Labeling UNKNOWN
2011/07/11 SUPPL-14（补充） Approval Labeling UNKNOWN
2010/09/23 SUPPL-12（补充） Approval Labeling UNKNOWN
2009/03/26 SUPPL-7（补充） Approval Manufacturing (CMC) N/A
2008/11/05 SUPPL-4（补充） Approval Efficacy UNKNOWN
2007/12/17 SUPPL-2（补充） Approval Labeling STANDARD
2006/01/27 ORIG-1（原始申请） 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 4567264 2007/05/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6303607 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6369062 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6369062 2019/05/27 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6479496 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6503911 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6525057 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6562826 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6617328 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6620814 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6852724 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6864258 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4567264 2007/05/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6303607 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6369062 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6479496 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6503911 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6525057 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6562826 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6617328 2019/05/27 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6620814 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6852724 2019/05/27 U-705 PDF格式**本条是由Drugfuture回溯的历史信息**
6864258 2019/05/27 U-705 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 2011/01/27**本条是由Drugfuture回溯的历史信息**
002 NCE 2011/01/27**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:RANOLAZINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1GM 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
021526 001 NDA RANEXA RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Discontinued Yes No AB 2007/02/12 MENARINI INTL
201046 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2013/07/29 CHARTWELL RX
208862 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2019/05/28 ACTAVIS ELIZABETH
210054 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2019/05/28 AJANTA PHARMA LTD
211707 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No Yes AB 2019/05/28 SUN PHARM
211829 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2019/06/04 SCIEGEN PHARMS INC
211082 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2019/07/05 GLENMARK PHARMS LTD
210188 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2019/08/19 CADILA
212284 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/02/12 MANKIND PHARMA
211745 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/02/27 MICRO LABS
211865 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/03/23 SUNSHINE
212781 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/03/23 PRAXGEN
209953 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/11/30 ALKEM LABS LTD
212889 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2021/01/28 RISING
214035 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2022/01/19 VKT PHARMA
213517 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2022/04/27 I3 PHARMS
212788 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2022/05/05 HETERO LABS LTD III
209081 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2022/12/23 AUROBINDO PHARMA
213083 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2023/03/16 UNICHEM
213085 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Discontinued No No AB 2023/07/25 PIRAMAL HLTHCARE UK
210668 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2023/09/27 NOVAST LABS
活性成分:RANOLAZINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:500MG 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
021526 002 NDA RANEXA RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued Yes No AB 2006/01/27 MENARINI INTL
201046 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2013/07/29 CHARTWELL RX
208862 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/05/28 ACTAVIS ELIZABETH
210054 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/05/28 AJANTA PHARMA LTD
211707 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/05/28 SUN PHARM
211829 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/06/04 SCIEGEN PHARMS INC
211082 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/07/05 GLENMARK PHARMS LTD
210188 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2019/08/19 CADILA
212284 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/02/12 MANKIND PHARMA
211745 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/02/27 MICRO LABS
211865 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/03/23 SUNSHINE
212781 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/03/23 PRAXGEN
209953 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/11/30 ALKEM LABS LTD
212889 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2021/01/28 RISING
214035 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2022/01/19 VKT PHARMA
213517 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2022/04/27 I3 PHARMS
212788 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2022/05/05 HETERO LABS LTD III
209081 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2022/12/23 AUROBINDO PHARMA
213083 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2023/03/16 UNICHEM
213085 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Discontinued No No AB 2023/07/25 PIRAMAL HLTHCARE UK
210668 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2023/09/27 NOVAST LABS
更多信息
药品NDC数据与药品包装、标签说明书
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