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 |
2024/08/08 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2023/03/30 |
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 |
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 | RLD | RS | TE 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 |
Discontinued |
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
|
AJANTA PHARMA LTD |
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 |
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 | RLD | RS | TE 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 |
Discontinued |
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
|
AJANTA PHARMA LTD |
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 |
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 | RLD | RS | TE 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 |
Discontinued |
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
|
AJANTA PHARMA LTD |
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 |
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 | RLD | RS | TE 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 |
Discontinued |
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
|
AJANTA PHARMA LTD |
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 |