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 |
|---|
| 2012/09/27 |
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; IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:12.5MG;150MG 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 |
|---|
| 020758 |
002 |
NDA |
AVALIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
Yes |
Yes |
AB |
1997/09/30
|
SANOFI AVENTIS US |
| 077369 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/03/30
|
TEVA |
| 077446 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/09/27
|
SANDOZ |
| 202414 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/09/27
|
MACLEODS PHARMS LTD |
| 203500 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/09/27
|
DR REDDYS LABS LTD |
| 090351 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/10/15
|
HIKMA |
| 091370 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2012/10/15
|
ALEMBIC |
| 203630 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2013/02/22
|
AUROBINDO PHARMA LTD |
| 201524 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2013/02/27
|
LUPIN LTD |
| 203072 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2014/05/09
|
PRINSTON INC |
| 207896 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Prescription |
No |
No |
AB |
2016/10/14
|
HISUN PHARM HANGZHOU |
| 207018 |
001 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;150MG |
Discontinued |
No |
No |
AB |
2017/09/19
|
UNICHEM |
活性成分:HYDROCHLOROTHIAZIDE; IRBESARTAN 剂型/给药途径:TABLET;ORAL 规格:12.5MG;300MG 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 |
|---|
| 020758 |
003 |
NDA |
AVALIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
Yes |
Yes |
AB |
1998/08/31
|
SANOFI AVENTIS US |
| 077369 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/03/30
|
TEVA |
| 077446 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/09/27
|
SANDOZ |
| 202414 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/09/27
|
MACLEODS PHARMS LTD |
| 203500 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/09/27
|
DR REDDYS LABS LTD |
| 090351 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/10/15
|
HIKMA |
| 091370 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2012/10/15
|
ALEMBIC |
| 203630 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2013/02/22
|
AUROBINDO PHARMA LTD |
| 201524 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2013/02/27
|
LUPIN LTD |
| 203072 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2014/05/09
|
PRINSTON INC |
| 207896 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Prescription |
No |
No |
AB |
2016/10/14
|
HISUN PHARM HANGZHOU |
| 207018 |
002 |
ANDA |
IRBESARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
TABLET;ORAL |
12.5MG;300MG |
Discontinued |
No |
No |
AB |
2017/09/19
|
UNICHEM |