药品注册申请号：021742
申请类型：NDA (新药申请)
申请人：ALLERGAN
申请人全名：ALLERGAN SALES 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
002 BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Yes No AB 2007/12/17 2007/12/17 Prescription
003 BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Yes No AB 2007/12/17 Prescription
004 BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Yes No AB 2007/12/17 Prescription
005 BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Yes Yes AB 2008/10/08 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2007/12/17 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/06/16 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2017/11/30 SUPPL-22（补充） Approval Labeling-Package Insert STANDARD
2015/04/20 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2014/10/30 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2014/10/27 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2013/09/20 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2012/12/19 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2011/12/14 SUPPL-13（补充） Approval Labeling-Package Insert UNKNOWN
2010/02/19 SUPPL-7（补充） Approval Efficacy-New Indication STANDARD
2008/10/08 SUPPL-3（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels N/A
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
002 5759580 2015/06/02 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2020/04/08 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2021/12/17 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5759580 2015/06/02 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2020/04/08 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2021/12/17 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5759580 2015/06/02 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2020/04/08 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2021/12/17 Y U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5759580 2015/06/02 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6545040 2021/12/17 Y U-3 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
002 NCE 2012/12/17**本条是由Drugfuture回溯的历史信息**
003 NCE 2012/12/17**本条是由Drugfuture回溯的历史信息**
004 NCE 2012/12/17**本条是由Drugfuture回溯的历史信息**
005 NCE 2012/12/17**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:NEBIVOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 2.5MG 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
021742 002 NDA BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription Yes No AB 2007/12/17 ALLERGAN
203659 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2015/04/16 ANI PHARMS
203828 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2015/07/29 INDCHEMIE HEALTH
203821 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
203966 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2018/03/02 TORRENT
203825 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2020/11/03 HETERO LABS LTD III
208717 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2021/12/17 CADILA PHARMS LTD
211053 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2021/12/17 AUROBINDO PHARMA LTD
212917 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2021/12/17 REYOUNG
213830 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2022/03/15 UNICHEM
213349 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Discontinued No No AB 2022/03/31 CHARTWELL RX
212682 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2022/04/07 PRINSTON INC
216172 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2022/11/14 MANKIND PHARMA
216568 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2023/03/30 REGCON HOLDINGS
217397 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2024/10/01 MSN
212661 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2025/01/28 MACLEODS PHARMS LTD
>>>活性成分:NEBIVOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 5MG 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
021742 003 NDA BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2007/12/17 ALLERGAN
203659 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2015/04/16 ANI PHARMS
203828 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2015/07/29 INDCHEMIE HEALTH
203821 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
203966 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2018/03/02 TORRENT
203825 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2020/11/03 HETERO LABS LTD III
208717 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2021/12/17 CADILA PHARMS LTD
211053 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2021/12/17 AUROBINDO PHARMA LTD
212917 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2021/12/17 REYOUNG
213830 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2022/03/15 UNICHEM
213349 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Discontinued No No AB 2022/03/31 CHARTWELL RX
212682 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2022/04/07 PRINSTON INC
216172 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2022/11/14 MANKIND PHARMA
216568 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/30 REGCON HOLDINGS
217397 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2024/10/01 MSN
212661 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2025/01/28 MACLEODS PHARMS LTD
>>>活性成分:NEBIVOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG 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
021742 004 NDA BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 2007/12/17 ALLERGAN
203659 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/04/16 ANI PHARMS
203828 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2015/07/29 INDCHEMIE HEALTH
203821 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
203966 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2018/03/02 TORRENT
203825 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2020/11/03 HETERO LABS LTD III
208717 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/12/17 CADILA PHARMS LTD
211053 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/12/17 AUROBINDO PHARMA LTD
212917 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/12/17 REYOUNG
213830 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/03/15 UNICHEM
213349 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2022/03/31 CHARTWELL RX
212682 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/04/07 PRINSTON INC
216172 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2022/11/14 MANKIND PHARMA
216568 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2023/03/30 REGCON HOLDINGS
209741 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2024/02/27 APOTEX
217397 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2024/10/01 MSN
212661 003 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2025/01/28 MACLEODS PHARMS LTD
>>>活性成分:NEBIVOLOL HYDROCHLORIDE; 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
021742 005 NDA BYSTOLIC NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription Yes Yes AB 2008/10/08 ALLERGAN
203659 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2015/04/16 ANI PHARMS
203828 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2015/07/29 INDCHEMIE HEALTH
203821 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2017/05/25 GLENMARK PHARMS LTD
203966 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2018/03/02 TORRENT
203825 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2020/11/03 HETERO LABS LTD III
208717 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/12/17 CADILA PHARMS LTD
211053 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/12/17 AUROBINDO PHARMA LTD
212917 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2021/12/17 REYOUNG
213830 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2022/03/15 UNICHEM
213349 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2022/03/31 CHARTWELL RX
212682 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2022/04/07 PRINSTON INC
216172 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2022/11/14 MANKIND PHARMA
216568 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2023/03/30 REGCON HOLDINGS
209741 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2024/02/27 APOTEX
217397 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2024/10/01 MSN
212661 004 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2025/01/28 MACLEODS PHARMS LTD
更多信息
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