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 |
|---|
| 2024/04/30 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/20 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/09/24 |
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 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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 |
|---|
| 040707 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2007/02/27
|
ACTAVIS ELIZABETH |
| 040807 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2007/07/20
|
IPCA LABS LTD |
| 202556 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
Yes |
AB |
2012/09/24
|
ACCORD HLTHCARE |
| 040702 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2017/05/10
|
LEADING |
| 085182 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2023/05/02
|
HERITAGE |
| 083177 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2024/09/19
|
IVAX SUB TEVA PHARMS |
活性成分:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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 |
|---|
| 083177 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
IVAX SUB TEVA PHARMS |
| 085182 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
HERITAGE |
| 087059 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
OXFORD PHARMS |
| 040412 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2002/03/29
|
PRINSTON INC |
| 040702 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/03/16
|
LEADING |
| 040780 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/07/20
|
AUROBINDO PHARMA |
| 040807 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/07/20
|
IPCA LABS LTD |
| 040907 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/08/15
|
UNICHEM |
| 202556 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2012/09/24
|
ACCORD HLTHCARE |
| 203018 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/07/23
|
SCIEGEN PHARMS INC |
活性成分:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
|---|
| 083177 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
IVAX SUB TEVA PHARMS |
| 085182 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
HERITAGE |
| 087068 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
OXFORD PHARMS |
| 040412 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2002/03/29
|
PRINSTON INC |
| 040702 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/03/16
|
LEADING |
| 040780 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/07/20
|
AUROBINDO PHARMA |
| 040807 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/07/20
|
IPCA LABS LTD |
| 040907 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2008/08/15
|
UNICHEM |
| 202556 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2012/09/24
|
ACCORD HLTHCARE |
| 203018 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/07/23
|
SCIEGEN PHARMS INC |