药品注册申请号：203828
申请类型：ANDA (仿制药申请)
申请人：INDCHEMIE HEALTH
申请人全名：INDCHEMIE HEALTH SPECIALTIES PVT 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 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No AB 2015/07/29 2015/07/29 Prescription
002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No AB 2015/07/29 Prescription
003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 2015/07/29 Prescription
004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No AB 2015/07/29 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
2024/08/27 SUPPL-10（补充） Approval Labeling STANDARD
2023/08/25 SUPPL-9（补充） Approval Labeling STANDARD
2021/11/19 SUPPL-3（补充） Approval Labeling STANDARD
2015/07/29 ORIG-1（原始申请） Approval
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
无
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 BEXIMCO PHARMS USA
217397 001 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE Prescription No No AB 2024/10/01 MSN
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 BEXIMCO PHARMS USA
217397 002 ANDA NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2024/10/01 MSN
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 BEXIMCO PHARMS USA
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
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 BEXIMCO PHARMS USA
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
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药品NDC数据与药品包装、标签说明书
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