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 |
|---|
| 2008/03/31 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2014/06/03 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2014/04/30 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/01/17 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2011/12/08 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
|
|
|
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:HYDROXYZINE HYDROCHLORIDE; 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 |
|---|
| 040842 |
001 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
--
|
NORTHSTAR HLTHCARE |
| 087871 |
003 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1982/12/20
|
AUROBINDO PHARMA LTD |
| 088618 |
001 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
Yes |
AB |
1986/01/10
|
PLIVA |
| 040604 |
003 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2004/12/28
|
EPIC PHARMA LLC |
| 040580 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2005/05/27
|
PRINSTON INC |
| 040786 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/03/20
|
KVK TECH |
| 040812 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2008/03/12
|
SOMERSET THERAPS LLC |
| 040840 |
003 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/03/31
|
NORTHSTAR HLTHCARE |
| 040805 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/05/29
|
HETERO LABS LTD III |
| 040804 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/06/30
|
CHARTWELL RX |
| 040808 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/09/24
|
AMNEAL PHARM |
| 204279 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/08/20
|
HERITAGE |
| 207121 |
001 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2017/03/29
|
NUVO PHARMS INC |
| 217652 |
002 |
ANDA |
HYDROXYZINE HYDROCHLORIDE |
HYDROXYZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2023/08/17
|
GRAVITI PHARMS |