药品注册申请号：201046
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL RX
申请人全名：CHARTWELL RX SCIENCES 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 RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG No No AB 2013/07/29 2013/07/29 Prescription
002 RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM No No AB 2013/07/29 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
2020/08/18 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
2020/02/25 SUPPL-7（补充） Approval Labeling STANDARD
2020/02/25 SUPPL-4（补充） Approval Labeling STANDARD
2020/02/25 SUPPL-2（补充） Approval Labeling STANDARD
2020/02/25 SUPPL-1（补充） Approval Labeling STANDARD
2013/07/29 ORIG-1（原始申请） Approval Not Applicable
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
无
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 PC 2019/05/27**本条是由Drugfuture回溯的历史信息**
002 PC 2019/05/27**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: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
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
212781 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/03/23 PRAXGEN
211865 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2020/03/23 SUNSHINE
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
210668 001 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 500MG 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: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
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
212781 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/03/23 PRAXGEN
211865 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB 2020/03/23 SUNSHINE
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
210668 002 ANDA RANOLAZINE RANOLAZINE TABLET, EXTENDED RELEASE;ORAL 1GM 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
参考引用1
参考引用2
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