药品注册申请号:204883
申请类型:ANDA (仿制药申请)
申请人:RUBICON
申请人全名:RUBICON RESEARCH PRIVATE LTD
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 SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE No No AB 2016/06/20 2016/06/20 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
2020/02/19 SUPPL-5(补充) Approval Labeling STANDARD
2020/02/19 SUPPL-4(补充) Approval Labeling STANDARD
2020/02/19 SUPPL-3(补充) Approval Labeling STANDARD
2020/02/19 SUPPL-1(补充) Approval Labeling STANDARD
2016/06/20 ORIG-1(原始申请) Approval 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
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
与本品治疗等效的药品
活性成分:SILDENAFIL CITRATE 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG BASE 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
021845 001 NDA REVATIO SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription Yes Yes AB 2005/06/03 VIATRIS
091479 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/11/06 TORRENT PHARMS LTD
202503 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/11/06 WATSON LABS INC
202598 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2012/11/06 CHARTWELL RX
201150 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2012/11/09 MYLAN PHARMS INC
078380 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2013/01/07 TEVA PHARMS
202025 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2013/02/28 AMNEAL PHARMS
203814 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2013/12/17 MACLEODS PHARMS LTD
203623 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2014/11/26 HETERO LABS LTD V
203963 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2015/11/18 AUROBINDO PHARMA LTD
204883 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2016/06/20 RUBICON
210394 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/05/04 AJANTA PHARMA LTD
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