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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2025/03/03 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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; TELMISARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;40MG; 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 |
|---|
| 021162 |
001 |
NDA |
MICARDIS HCT |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
Yes |
No |
AB |
2000/11/17
|
BOEHRINGER INGELHEIM |
| 203010 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2014/02/25
|
ALEMBIC |
| 091351 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2014/08/07
|
LUPIN LTD |
| 208727 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2016/12/15
|
AUROBINDO PHARMA |
| 204221 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2017/08/15
|
ZYDUS PHARMS |
| 209028 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 202544 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2019/03/04
|
GLENMARK PHARMS LTD |
| 218406 |
001 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;40MG |
Discontinued |
No |
No |
AB |
2025/03/03
|
MANKIND PHARMA |
>>>活性成分:HYDROCHLOROTHIAZIDE; TELMISARTAN; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;80MG; 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 |
|---|
| 021162 |
002 |
NDA |
MICARDIS HCT |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
Yes |
No |
AB |
2000/11/17
|
BOEHRINGER INGELHEIM |
| 203010 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2014/02/25
|
ALEMBIC |
| 091351 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2014/08/07
|
LUPIN LTD |
| 208727 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2016/12/15
|
AUROBINDO PHARMA |
| 204221 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2017/08/15
|
ZYDUS PHARMS |
| 209028 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 202544 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Prescription |
No |
No |
AB |
2019/03/04
|
GLENMARK PHARMS LTD |
| 218406 |
002 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
12.5MG;80MG |
Discontinued |
No |
No |
AB |
2025/03/03
|
MANKIND PHARMA |
>>>活性成分:HYDROCHLOROTHIAZIDE; TELMISARTAN; 剂型/给药途径:TABLET;ORAL; 规格:25MG;80MG; 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 |
|---|
| 021162 |
003 |
NDA |
MICARDIS HCT |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
Yes |
Yes |
AB |
2004/04/19
|
BOEHRINGER INGELHEIM |
| 203010 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2014/02/25
|
ALEMBIC |
| 091351 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2014/08/07
|
LUPIN LTD |
| 208727 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2016/12/15
|
AUROBINDO PHARMA |
| 204221 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2017/08/15
|
ZYDUS PHARMS |
| 209028 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 202544 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Prescription |
No |
No |
AB |
2019/03/04
|
GLENMARK PHARMS LTD |
| 218406 |
003 |
ANDA |
TELMISARTAN AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TABLET;ORAL |
25MG;80MG |
Discontinued |
No |
No |
AB |
2025/03/03
|
MANKIND PHARMA |