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 |
|---|
| 2016/11/08 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/03/30 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/03/29 |
SUPPL-44（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/06/05 |
SUPPL-43（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/08/05 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 2004/02/04 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2002/01/30 |
SUPPL-12（补充） |
Approval |
Labeling |
|
|
|
| 2000/07/07 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/02/06 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/02/06 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/05/24 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1994/05/11 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/01/14 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1986/08/01 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/04/11 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/05 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/10 |
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: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
|
INVAGEN PHARMS |
| 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 PHARMA |
| 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 |
