药品注册申请号：021416
申请类型：NDA (新药申请)
申请人：GLAXOSMITHKLINE LLC
申请人全名：GLAXOSMITHKLINE 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 RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Yes No AB 2003/09/04 2003/09/04 Discontinued
002 RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Yes No AB 2003/09/04 Discontinued
003 RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Yes No AB 2003/09/04 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
2018/11/02 SUPPL-15（补充） Approval Labeling STANDARD
2014/07/11 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2013/09/09 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2013/02/14 SUPPL-11（补充） Approval Labeling UNKNOWN
2011/04/13 SUPPL-10（补充） Approval Labeling UNKNOWN
2010/10/29 SUPPL-7（补充） Approval Labeling STANDARD
2004/09/13 SUPPL-1（补充） Approval Labeling STANDARD
2003/09/04 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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 5681588 2014/10/28 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5681588 2014/10/28 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5681588 2014/10/28 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 NDF 2006/09/04**本条是由Drugfuture回溯的历史信息**
002 NDF 2006/09/04**本条是由Drugfuture回溯的历史信息**
003 NDF 2006/09/04**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:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:225MG 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
021416 001 NDA RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Discontinued Yes No AB 2003/09/04 GLAXOSMITHKLINE LLC
078540 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2010/10/18 STRIDES PHARMA
202688 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2015/08/24 WATSON LABS INC
205268 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2017/09/08 GLENMARK PHARMS LTD
205956 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2018/07/02 RISING
210339 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2019/01/04 SINOTHERAPEUTICS INC
212928 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Discontinued No No AB 2020/06/18 TWI PHARMS
212744 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2020/06/25 UPSHER SMITH LABS
214184 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2021/04/21 ZYDUS LIFESCIENCES
213096 001 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG Prescription No No AB 2023/02/21 AUROBINDO PHARMA LTD
活性成分:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:325MG 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
021416 002 NDA RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Discontinued Yes No AB 2003/09/04 GLAXOSMITHKLINE LLC
078540 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2010/10/18 STRIDES PHARMA
202688 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2015/08/24 WATSON LABS INC
205268 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2017/09/08 GLENMARK PHARMS LTD
205956 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2018/07/02 RISING
210339 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2019/01/04 SINOTHERAPEUTICS INC
212928 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Discontinued No No AB 2020/06/18 TWI PHARMS
212744 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2020/06/25 UPSHER SMITH LABS
214184 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2021/04/21 ZYDUS LIFESCIENCES
213096 002 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG Prescription No No AB 2023/02/21 AUROBINDO PHARMA LTD
活性成分:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:425MG 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
021416 003 NDA RYTHMOL SR PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Discontinued Yes No AB 2003/09/04 GLAXOSMITHKLINE LLC
078540 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No Yes AB 2010/10/18 STRIDES PHARMA
202688 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2015/08/24 WATSON LABS INC
205268 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2017/09/08 GLENMARK PHARMS LTD
205956 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2018/07/02 RISING
210339 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2019/01/04 SINOTHERAPEUTICS INC
212928 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Discontinued No No AB 2020/06/18 TWI PHARMS
212744 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2020/06/25 UPSHER SMITH LABS
214184 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2021/04/21 ZYDUS LIFESCIENCES
213096 003 ANDA PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG Prescription No No AB 2023/02/21 AUROBINDO PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
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