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 |
2024/09/17 |
SUPPL-45(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2024/02/08 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2023/06/06 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/04/29 |
SUPPL-43(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2019/05/16 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/04/26 |
SUPPL-32(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2018/10/25 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/10/20 |
SUPPL-35(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2017/09/05 |
SUPPL-34(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2016/12/16 |
SUPPL-30(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2016/10/20 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/12/04 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/12/04 |
SUPPL-27(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2013/07/01 |
SUPPL-25(补充) |
Approval |
REMS |
N/A
|
|
|
2013/06/03 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/10/04 |
SUPPL-22(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2012/10/02 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/02/08 |
SUPPL-19(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/02/19 |
SUPPL-18(补充) |
Approval |
REMS |
N/A
|
|
|
2009/08/07 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/08/07 |
SUPPL-12(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2009/03/17 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/02/13 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/06/01 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/02/15 |
SUPPL-10(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2005/11/29 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/11/29 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2004/11/24 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/10/06 |
SUPPL-1(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2001/11/20 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
;Orphan
|
|
|
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 |
5292740 |
2015/11/20 |
|
|
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |
002 |
5292740 |
2015/11/20 |
|
|
|
|
|
PDF格式 | **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:BOSENTAN 剂型/给药途径:TABLET;ORAL 规格:62.5MG 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 |
021290 |
001 |
NDA |
TRACLEER |
BOSENTAN |
TABLET;ORAL |
62.5MG |
Prescription |
Yes |
No |
AB |
2001/11/20
|
ACTELION |
205699 |
001 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
62.5MG |
Discontinued |
No |
No |
AB |
2019/04/26
|
ENDO OPERATIONS |
207110 |
001 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
62.5MG |
Prescription |
No |
No |
AB |
2019/04/26
|
WATSON LABS INC |
207760 |
001 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
62.5MG |
Prescription |
No |
No |
AB |
2019/04/26
|
ZYDUS PHARMS |
209324 |
001 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
62.5MG |
Prescription |
No |
No |
AB |
2019/04/26
|
SUN PHARM |
活性成分:BOSENTAN 剂型/给药途径:TABLET;ORAL 规格:125MG 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 |
021290 |
002 |
NDA |
TRACLEER |
BOSENTAN |
TABLET;ORAL |
125MG |
Prescription |
Yes |
Yes |
AB |
2001/11/20
|
ACTELION |
205699 |
002 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2019/04/26
|
ENDO OPERATIONS |
207110 |
002 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/04/26
|
WATSON LABS INC |
207760 |
002 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/04/26
|
ZYDUS PHARMS |
209324 |
002 |
ANDA |
BOSENTAN |
BOSENTAN |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/04/26
|
SUN PHARM |