药品注册申请号：020895
申请类型：NDA (新药申请)
申请人：VIATRIS
申请人全名：VIATRIS SPECIALTY 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 VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Yes No AB 1998/03/27 1998/03/27 Prescription
002 VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Yes No AB 1998/03/27 Prescription
003 VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Yes Yes AB 1998/03/27 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
2017/12/14 SUPPL-48（补充） Approval Labeling STANDARD
2017/08/17 SUPPL-49（补充） Approval Labeling STANDARD
2015/09/16 SUPPL-45（补充） Approval Labeling STANDARD
2015/03/26 SUPPL-44（补充） Approval Labeling STANDARD
2015/02/03 SUPPL-40（补充） Approval Manufacturing (CMC) PRIORITY
2015/01/26 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
2014/03/25 SUPPL-41（补充） Approval Manufacturing (CMC) PRIORITY
2014/03/11 SUPPL-42（补充） Approval Efficacy STANDARD
2014/03/11 SUPPL-39（补充） Approval Labeling STANDARD
2011/01/31 SUPPL-36（补充） Approval Labeling STANDARD
2010/01/11 SUPPL-33（补充） Approval Labeling STANDARD
2008/08/06 SUPPL-29（补充） Approval Labeling STANDARD
2008/08/06 SUPPL-28（补充） Approval Labeling STANDARD
2008/02/25 SUPPL-26（补充） Approval Labeling STANDARD
2007/10/18 SUPPL-27（补充） Approval Labeling STANDARD
2006/10/06 SUPPL-23（补充） Approval Labeling STANDARD
2006/06/26 SUPPL-20（补充） Approval Labeling STANDARD
2005/07/08 SUPPL-21（补充） Approval Labeling STANDARD
2002/09/19 SUPPL-18（补充） Approval Efficacy STANDARD
2002/09/19 SUPPL-15（补充） Approval Labeling STANDARD
2002/09/19 SUPPL-11（补充） Approval Labeling STANDARD
2002/02/14 SUPPL-7（补充） Approval Manufacturing (CMC) PRIORITY
2002/01/02 SUPPL-12（补充） Approval Labeling STANDARD
2001/08/24 SUPPL-16（补充） Approval Manufacturing (CMC) PRIORITY
2001/08/24 SUPPL-14（补充） Approval Manufacturing (CMC) PRIORITY
2000/03/16 SUPPL-10（补充） Approval Manufacturing (CMC) PRIORITY
2000/01/21 SUPPL-5（补充） Approval Labeling STANDARD
2000/01/20 SUPPL-9（补充） Approval Manufacturing (CMC) PRIORITY
1999/11/16 SUPPL-8（补充） Approval Manufacturing (CMC) PRIORITY
1999/06/18 SUPPL-6（补充） Approval Labeling STANDARD
1998/12/22 SUPPL-4（补充） Approval Labeling STANDARD
1998/11/24 SUPPL-3（补充） Approval Labeling STANDARD
1998/08/13 SUPPL-2（补充） Approval Labeling STANDARD
1998/05/04 SUPPL-1（补充） Approval Manufacturing (CMC) PRIORITY
1998/03/27 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
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 5250534 2012/03/27 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012 2019/10/22 U-155 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012*PED 2020/04/22 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5250534 2012/03/27 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012 2019/10/22 U-155 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012*PED 2020/04/22 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5250534 2012/03/27 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012 2019/10/22 U-155 PDF格式**本条是由Drugfuture回溯的历史信息**
6469012*PED 2020/04/22 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
无
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 25MG 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
020895 001 NDA VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription Yes No AB 1998/03/27 VIATRIS
077342 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2016/03/09 TEVA
091448 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/06/11 TORRENT
202659 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/06/11 HETERO LABS LTD V
203962 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/06/11 AUROBINDO PHARMA LTD
204882 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/06/11 RUBICON
202023 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/06/27 AMNEAL PHARMS NY
206401 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2018/10/12 AJANTA PHARMA LTD
212051 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2019/03/22 CHARTWELL RX
201171 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2019/03/25 MYLAN
207178 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2020/03/02 APPCO
213032 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2020/06/11 SUNSHINE
208494 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2020/06/12 REYOUNG
209302 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2021/06/15 UMEDICA
202255 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2023/04/19 MACLEODS PHARMS LTD
216383 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2023/08/29 NOVITIUM PHARMA
218045 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 25MG BASE Prescription No No AB 2023/11/28 CADILA PHARMS LTD
活性成分:SILDENAFIL CITRATE 剂型/给药途径:TABLET;ORAL 规格:EQ 50MG 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
020895 002 NDA VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription Yes No AB 1998/03/27 VIATRIS
077342 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2016/03/09 TEVA
091448 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/06/11 TORRENT
202659 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/06/11 HETERO LABS LTD V
203962 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/06/11 AUROBINDO PHARMA LTD
204882 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/06/11 RUBICON
202023 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/06/27 AMNEAL PHARMS NY
206401 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2018/10/12 AJANTA PHARMA LTD
212051 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2019/03/22 CHARTWELL RX
201171 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2019/03/25 MYLAN
207178 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2020/03/02 APPCO
213032 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2020/06/11 SUNSHINE
208494 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2020/06/12 REYOUNG
209302 001 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2020/08/25 UMEDICA
202255 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2023/04/19 MACLEODS PHARMS LTD
216383 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2023/08/29 NOVITIUM PHARMA
218045 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 50MG BASE Prescription No No AB 2023/11/28 CADILA PHARMS LTD
活性成分:SILDENAFIL CITRATE 剂型/给药途径:TABLET;ORAL 规格:EQ 100MG 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
020895 003 NDA VIAGRA SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription Yes Yes AB 1998/03/27 VIATRIS
077342 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2016/03/09 TEVA
091448 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/06/11 TORRENT
202659 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/06/11 HETERO LABS LTD V
203962 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/06/11 AUROBINDO PHARMA LTD
204882 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/06/11 RUBICON
202023 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/06/27 AMNEAL PHARMS NY
206401 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2018/10/12 AJANTA PHARMA LTD
212051 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2019/03/22 CHARTWELL RX
201171 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2019/03/25 MYLAN
207178 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2020/03/02 APPCO
213032 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2020/06/11 SUNSHINE
208494 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2020/06/12 REYOUNG
209302 002 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2020/08/25 UMEDICA
202255 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2023/04/19 MACLEODS PHARMS LTD
216383 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2023/08/29 NOVITIUM PHARMA
218045 003 ANDA SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET;ORAL EQ 100MG BASE Prescription No No AB 2023/11/28 CADILA PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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