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 |
|---|
| 2012/09/18 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
>>>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 |
|---|
| 2024/04/30 |
SUPPL-20（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2022/07/14 |
SUPPL-15（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2020/03/13 |
SUPPL-12（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2020/03/13 |
SUPPL-10（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2017/09/29 |
SUPPL-6（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2015/04/28 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/04/28 |
SUPPL-3（补充） |
Approval |
Labeling-Patient Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2015/04/28 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/06/10 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
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; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;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 |
|---|
| 020387 |
001 |
NDA |
HYZAAR |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
Yes |
No |
AB |
1995/04/28
|
ORGANON |
| 077157 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2010/04/06
|
TEVA PHARMS |
| 077948 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2010/10/06
|
CHARTWELL RX |
| 078245 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2010/10/06
|
LUPIN LTD |
| 078385 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2010/10/06
|
ZYDUS PHARMS USA INC |
| 091629 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2010/10/06
|
AUROBINDO PHARMA |
| 091617 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2012/02/17
|
ALEMBIC PHARMS LTD |
| 202289 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2012/08/09
|
MACLEODS PHARMS LTD |
| 201845 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2012/09/18
|
JUBILANT CADISTA |
| 201682 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Discontinued |
No |
No |
AB |
2013/03/01
|
IPCA LABS LTD |
| 204832 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2017/07/21
|
UNICHEM |
| 204901 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 218015 |
001 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;50MG |
Discontinued |
No |
No |
AB |
2023/09/29
|
GRANULES |
>>>活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:12.5MG;100MG; 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 |
|---|
| 020387 |
003 |
NDA |
HYZAAR |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
Yes |
No |
AB |
2005/10/20
|
ORGANON |
| 077157 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2010/04/06
|
TEVA PHARMS |
| 078245 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2010/05/21
|
LUPIN LTD |
| 077948 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2010/08/19
|
CHARTWELL RX |
| 091629 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2010/10/06
|
AUROBINDO PHARMA |
| 091617 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2012/02/17
|
ALEMBIC PHARMS LTD |
| 202289 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2012/08/09
|
MACLEODS PHARMS LTD |
| 201845 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2012/09/18
|
JUBILANT CADISTA |
| 201682 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Discontinued |
No |
No |
AB |
2013/03/01
|
IPCA LABS LTD |
| 204832 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2017/07/21
|
UNICHEM |
| 204901 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 218015 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
12.5MG;100MG |
Discontinued |
No |
No |
AB |
2023/09/29
|
GRANULES |
>>>活性成分:HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:25MG;100MG; 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 |
|---|
| 020387 |
002 |
NDA |
HYZAAR |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
Yes |
No |
AB |
1998/11/10
|
ORGANON |
| 091629 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
Yes |
AB |
2010/01/06
|
AUROBINDO PHARMA |
| 077157 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2010/04/06
|
TEVA PHARMS |
| 077948 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2010/10/06
|
CHARTWELL RX |
| 078245 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2010/10/06
|
LUPIN LTD |
| 078385 |
002 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2010/10/06
|
ZYDUS PHARMS USA INC |
| 091617 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2012/02/17
|
ALEMBIC PHARMS LTD |
| 202289 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2012/08/09
|
MACLEODS PHARMS LTD |
| 201845 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2012/09/18
|
JUBILANT CADISTA |
| 201682 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Discontinued |
No |
No |
AB |
2013/03/01
|
IPCA LABS LTD |
| 204832 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2017/07/21
|
UNICHEM |
| 204901 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Prescription |
No |
No |
AB |
2017/11/06
|
PRINSTON INC |
| 218015 |
003 |
ANDA |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TABLET;ORAL |
25MG;100MG |
Discontinued |
No |
No |
AB |
2023/09/29
|
GRANULES |