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 |
|---|
| 2023/10/20 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/10/20 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/07/18 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/07/18 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/07/18 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/08/21 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 2003/06/13 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/01 |
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; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;10MG 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 |
|---|
| 019888 |
003 |
NDA |
ZESTORETIC |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
Yes |
No |
AB |
1993/11/18
|
ALMATICA |
| 076007 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SUN PHARM INDS LTD |
| 076194 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2002/07/01
|
WATSON LABS |
| 076230 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2002/07/01
|
PRINSTON INC |
| 076262 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SANDOZ |
| 077606 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2006/03/14
|
AUROBINDO |
| 077912 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2006/09/27
|
LUPIN |
| 204058 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;10MG |
Prescription |
No |
No |
AB |
2017/05/23
|
INVAGEN PHARMS |
活性成分:HYDROCHLOROTHIAZIDE; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:12.5MG;20MG 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 |
|---|
| 019888 |
001 |
NDA |
ZESTORETIC |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
Yes |
No |
AB |
1990/09/20
|
ALMATICA |
| 076007 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SUN PHARM INDS LTD |
| 076194 |
001 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
WATSON LABS |
| 076230 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
PRINSTON INC |
| 076262 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SANDOZ |
| 077606 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2006/03/14
|
AUROBINDO |
| 077912 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2006/09/27
|
LUPIN |
| 204058 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
Yes |
AB |
2017/05/23
|
INVAGEN PHARMS |
活性成分:HYDROCHLOROTHIAZIDE; LISINOPRIL 剂型/给药途径:TABLET;ORAL 规格:25MG;20MG 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 |
|---|
| 019888 |
002 |
NDA |
ZESTORETIC |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
Yes |
No |
AB |
1989/07/20
|
ALMATICA |
| 076007 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SUN PHARM INDS LTD |
| 076194 |
002 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
WATSON LABS |
| 076230 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
PRINSTON INC |
| 076262 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2002/07/01
|
SANDOZ |
| 077606 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2006/03/14
|
AUROBINDO |
| 077912 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
No |
AB |
2006/09/27
|
LUPIN |
| 204058 |
003 |
ANDA |
LISINOPRIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TABLET;ORAL |
25MG;20MG |
Prescription |
No |
Yes |
AB |
2017/05/23
|
INVAGEN PHARMS |