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 |
2022/05/26 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/05/26 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/05/26 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/05/26 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/02/16 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/04/26 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/26 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/26 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/26 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/26 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/11/26 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
2011/11/28 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
2011/08/02 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
2010/07/30 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
2007/08/24 |
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 |
与本品治疗等效的药品
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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 |
076374 |
001 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2004/03/31
|
CHARTWELL RX |
078450 |
001 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 10MG BASE |
Prescription |
No |
No |
AB |
2007/08/24
|
AUROBINDO PHARMA |
201356 |
001 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2011/04/20
|
INVAGEN PHARMS |
091524 |
001 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 10MG BASE |
Prescription |
No |
No |
AB |
2013/03/12
|
APOTEX |
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG;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 |
076374 |
002 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2004/03/31
|
CHARTWELL RX |
078450 |
002 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 20MG BASE |
Prescription |
No |
No |
AB |
2007/08/24
|
AUROBINDO PHARMA |
201356 |
002 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2011/04/20
|
INVAGEN PHARMS |
091524 |
002 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
12.5MG;EQ 20MG BASE |
Prescription |
No |
No |
AB |
2013/03/12
|
APOTEX |
活性成分:HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG;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 |
076374 |
003 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
25MG;EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2004/03/31
|
CHARTWELL RX |
078450 |
003 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
25MG;EQ 20MG BASE |
Prescription |
No |
Yes |
AB |
2007/08/24
|
AUROBINDO PHARMA |
201356 |
003 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
25MG;EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2011/04/20
|
INVAGEN PHARMS |
091524 |
003 |
ANDA |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
TABLET;ORAL |
25MG;EQ 20MG BASE |
Prescription |
No |
No |
AB |
2013/03/12
|
APOTEX |