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 |
|---|
| 2021/01/25 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/17 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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; OLMESARTAN MEDOXOMIL 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 |
|---|
| 021532 |
002 |
NDA |
BENICAR HCT |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
Yes |
No |
AB |
2003/06/05
|
COSETTE |
| 204233 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2017/04/24
|
ALEMBIC |
| 205391 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2017/04/24
|
AUROBINDO PHARMA |
| 207804 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2017/04/24
|
PRINSTON INC |
| 206515 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Discontinued |
No |
No |
AB |
2017/05/03
|
TORRENT |
| 209281 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ACCORD HLTHCARE |
| 208847 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2019/09/17
|
UMEDICA |
| 206377 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Discontinued |
No |
No |
AB |
2023/02/24
|
ZYDUS PHARMS |
| 204801 |
001 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2023/06/01
|
MACLEODS PHARMS LTD |
| 207037 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;20MG |
Prescription |
No |
No |
AB |
2024/07/11
|
ALKEM LABS LTD |
活性成分:HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 剂型/给药途径:TABLET;ORAL 规格:25MG;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 |
|---|
| 021532 |
005 |
NDA |
BENICAR HCT |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
Yes |
Yes |
AB |
2003/06/05
|
COSETTE |
| 204233 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
ALEMBIC |
| 205391 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
AUROBINDO PHARMA |
| 207804 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
PRINSTON INC |
| 206515 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Discontinued |
No |
No |
AB |
2017/05/03
|
TORRENT |
| 209281 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ACCORD HLTHCARE |
| 208847 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2019/09/17
|
UMEDICA |
| 206377 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Discontinued |
No |
No |
AB |
2023/02/24
|
ZYDUS PHARMS |
| 204801 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2023/06/01
|
MACLEODS PHARMS LTD |
| 207037 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
25MG;40MG |
Prescription |
No |
No |
AB |
2024/07/11
|
ALKEM LABS LTD |
活性成分:HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 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 |
|---|
| 021532 |
003 |
NDA |
BENICAR HCT |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
Yes |
No |
AB |
2003/06/05
|
COSETTE |
| 200532 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Discontinued |
No |
No |
AB |
2017/04/24
|
TEVA PHARMS USA |
| 204233 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
ALEMBIC |
| 205391 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
AUROBINDO PHARMA |
| 207804 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2017/04/24
|
PRINSTON INC |
| 206515 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Discontinued |
No |
No |
AB |
2017/05/03
|
TORRENT |
| 209281 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2019/02/07
|
ACCORD HLTHCARE |
| 208847 |
003 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2019/09/17
|
UMEDICA |
| 206377 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Discontinued |
No |
No |
AB |
2023/02/24
|
ZYDUS PHARMS |
| 204801 |
002 |
ANDA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2023/06/01
|
MACLEODS PHARMS LTD |
| 207037 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
TABLET;ORAL |
12.5MG;40MG |
Prescription |
No |
No |
AB |
2024/07/11
|
ALKEM LABS LTD |